CNS Generic Drugs: Prospects and Opportunities to 2012

Date: April 22, 2008
Pages: 290
Price:
US$ 1,740.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
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ID: CC12CFCF2FDEN
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CNS Generic Drugs: Prospects and Opportunities to 2012
One of the fastest growing drug sectors in terms of product and market value, CNS presents the generics industry with much needed on-going product opportunities

ANTIDEPRESSANTS

Antidepressant sales in 2005 were approximately US$16.2 billion, and accounted for around 25% of the total CNS market. Global sales of the depression drugs analysed in this report in 2006 were worth some US$11.5 billion, with the largest selling, Effexor (venlafaxine), seeing sales worth US$3.7 billion. However, Effexor is now open to generic competition in the United States, with Teva having had an ANDA approved in 2006, and so it is likely that sales of the branded version will decline.

SCHIZOPHRENIA

Sales of schizophrenia drugs in 2005 were worth some US$15.5 billion, accounting for 23% of global CNS sales, making the segment the second largest CNS category. Global sales in 2006 of the schizophrenia drugs listed in this report were worth US$9.7 billion, with Zyprexa (olanzapine) and Risperdal (risperidone) accounting for US$4.4 billion and US$4.2 billion of this, respectively. Currently there are no generic equivalents to any of the schizophrenia drugs listed in the report in the US. However, a number of ANDAs for generic versions of Zyprexa and Risperdal have been tentatively approved.

NEURODEGENERATION (ALZHEIMER’S DISEASE & PARKINSON’S DISEASE)

The neurodegenerative disorders segment is divided into two components, drugs for treating Alzheimer’s disease, and drugs for treating Parkinson’s disease. In 2005, some US$6.8 billion was spent on treatments for these two conditions, despite the fact that they only affect around 1% of the world’s population. In 2006, global sales of the five Alzheimer’s disease drugs listed in this report were worth some US$1.6 billion, whilst those for treating Parkinson’s disease were worth some US$1.5 billion.

MULTIPLE SCLEROSIS

The multiple sclerosis market was estimated to be worth some US$$4.8 billion in 2005. Global sales of the MS drugs listed in this report in 2006 were worth some US$5.8 billion. Of these, only one, Novantrone (mitoxantrone), is currently subject to generic competition in the US.

ADHD

The ADHD market had global sales of US$2.6 billion in 2005, and accounted for 3.8% of global CNS sales. Global sales for the drugs listed in this report were worth over US$2.8 billion, with the largest selling, Concerta (methylphenidate), having sales worth US$930 million.

INSOMNIA

The global market for insomnia products in 2005 was worth US$2.4 billion, and accounted for 3.5% of global CNS sales. In 2006, global sales for Ambien (zolpidem) were worth some US$2.7 billion. However, zolpidem has now been opened to generic competition in the US, with a number of companies gaining ANDA approvals for versions of the drug in 2007.

Among the 63 products evaluated in the report

· Abilify
· Aricept
· Azilect
· Carbatrol
· Copaxone
· Cymbalta
· Durotep
· Effexor
· Exelon
· Invega
· Keppra
· Lamictal
· Lyrica
· Namenda
· Prozac
· Rebif
· ReQuip
· Risperdal
· Seroxat
· Zoloft
· Zyprexa

Companies active in the CNS market are reviewed with respect to

· CNS Products
· Recent Product Approvals
· Financials
· Significant developments

Companies covered:

· Apotex
· Aurobindo Pharma
· Barr Pharmaceuticals
· Bedford Laboratories
· Caraco Pharmaceutical Labs
· Dr Reddy’s Laboratories
· Impax Laboratories
· Interpharm
· KV Pharmaceutical
· Mallinckrodt
· Mikart
· Mylan
· Perrigo
· Ranbaxy Laboratories
· Roxane Laboratories
· Sandoz
· Sun Pharmaceutical Industries
· Teva Pharmaceutical Industries
· United Research Laboratories/Mutual Pharmaceutical Company
· Watson Pharmaceuticals
FOREWORD

EXECUTIVE SUMMARY

ATTENTION DEFICIT HYPERACTIVITY DISORDER
US Patent Expiry for Attention Deficit Hyperactivity Disorder Drugs
The Generic Market for Attention Deficit Hyperactivity Disorder Drugs
Generic ADHD Drugs Currently Approved in the United States by Company
FDA ANDA Approvals for Attention Deficit Hyperactivity Disorder Drugs, 2001-2007
Adderall (mixed amphetamine salts)
Key Markets/Indications/Formulations
Adderall XR for ADHD in children aged six to 12 years
Adderall XR for ADHD in adults aged 18 years and older
Adderall XR for ADHD in adolescents aged 13 to 17 years
Patents and Data Exclusivity
Adderall US Patents
Adderall XR US Patents
Adderall US Patents
Adderall XR US Data Exclusivity
Generic Competition
Barr Pharmaceuticals
FDA ANDA Approvals for Adderall
Market Outlook
Adderall XR Sales (2001A-2012E)
Strattera (atomoxetine hydrochloride)
Patents and Data Exclusivity
Strattera US Patents
Strattera US Data Exclusivity
Generic competition
Anexate / Romazicon (flumazenil)
Generic competition
FDA ANDA Approvals for flumazenil
Vyvanse (lisdexamphetamine dimesylate)
Patents and Data Exclusivity
Vyvanse US Patents
Vyvanse US Data Exclusivity
Market Outlook
Vyvanse Sales (2007E-2012E)
Concerta (methylphenidate)
Key Markets/Indications/Formulations
Treatment of ADHD in patients aged over six years (18 and 36mg tablets)
54mg extended-release tablet for ADHD
27mg extended-release tablet for ADHD
72mg extended-release for ADHD*
Further Development
Patents and Data Exclusivity
Concerta US Data Exclusivity
Generic Competition
Market Outlook
Concerta Sales (2004-2012E)
Daytrana (methylphenidate)
Key Markets/Indications/Formulations
ADHD
Patents and Data Exclusivity
Daytrana US Patents
Daytrana US Data Exclusivity
Market Outlook
Daytrana Sales (2006-2012E)
Metadate / Equasym (methylphenidate)
Key Markets/Indications
Attention deficit hyperactivity disorder (ADHD)
Patents
Metadate CD US Patents
Generic Competition
FDA ANDA Approvals for Metadate ER
Market Outlook
Metadate Sales (2004A-2012E)
Ritalin (methylphenidate)
Key Markets/Indications
ADHD - Ritalin LA (extended-release MPH)
Further Development
Patents
Ritalin LA US Patents
Generic Competition
FDA ANDA Approvals for Ritalin
FDA ANDA Approvals for Ritalin SR
Market Outlook

DEPRESSION

US Patent Expiry for Depression Drugs
The Generic Market for Depression Drugs
Generic Depression Drugs Currently Approved in the United States by Company
FDA ANDA Approvals for Depression Drugs, 2001-2007
Wellbutrin (bupropion)
Key Markets/Indications
Depression in patients aged 18 years and over
Wellbutrin Once-Daily/Wellbutrin XL
Depression in patients aged 18 years and over
Seasonal major depressive (SMD) episodes in patients with seasonal affective disorder (SAD)
Patents and Data Exclusivity
Wellbutrin SR US Patents
Wellbutrin XL US Patents
Wellbutrin XL US Data Exclusivity
Generic Competition
FDA ANDA Approvals for Wellbutrin
FDA ANDA Approvals for Wellbutrin SR
FDA ANDA Approvals for Wellbutrin XL
Market Outlook
Wellbutrin Sales (2001A-2012E)
Celexa (citalopram)
Licensees
Markets/Indications
Generic Competition
FDA ANDA Approvals for Celexa
Market Outlook
Cipramil Sales (2001A-2011E)
Cymbalta / Xeristar (duloxetine)
Key Markets/Indications
Depression
SUI*
DPNP
Further Development
Patents and Data Exclusivity
Cymbalta US Patents
Cymbalta US Data Exclusivity
Market Outlook
Lexapro (escitalopram)
Key Markets/Indications
Depression (long-term)/panic disorder
Generalised anxiety disorder
Social anxiety disorder (SAD)
Obsessive-compulsive disorder (OCD)
Further Development
Patents
Lexapro US Patents
Generic Competition
FDA ANDA Approvals for Lexapro
Market Outlook
Lexapro Sales (2002A-2012E)
Prozac (fluoxetine)
Patents
Sarafem US Patents
Prozac Weekly US Patents
Generic Competition
FDA ANDA Approvals for Prozac
Luvox (fluvoxamine)
Key Markets/Indications
Depression
OCD
Social anxiety disorder
Immediate-release tablets for the treatment of OCD
Further Development
Data Exclusivity
Luvox CR US Data Exclusivity
Generic Competition
FDA ANDA Approvals for Luvox
Market Outlook
Luvox Sales (2001A-2012E)
Remeron (mirtazapine)
Key Markets/Indications
Patents
Remeron Soltab US Patents
Generic Competition
FDA ANDA Approvals for Remeron
FDA ANDA Approvals for Remeron Soltab
Market Outlook
Remeron Sales (2003A-2012E)
Seroxat / Paxil (paroxetine)
Key Markets/Indications
Depression
Panic disorder
OCD
Social anxiety disorder (SAD)
Generalised anxiety disorder (GAD)
Post-traumatic stress disorder
Paxil CR
Depression
Panic disorder
Premenstrual dysphoric disorder (PMDD)
Social anxiety disorder (SAD)
Patents
Paxil US Patents
Paxil CR US Patents
Paxil oral suspension US Patents
Generic Competition
Sandoz/Apotex/Torpharm/Ivax
Pentech/Par Pharmaceutical
Endo Pharmaceuticals
Synthon
Laboratorios Davur/Bentley Pharmaceuticals
Others
Paxil CR
FDA ANDA Approvals for Paxil
FDA ANDA Approvals for Paxil CR
Market Outlook
Seroxat/Paxil Sales (2001A-2012E)
Zoloft (sertraline)
Key Markets/Indications/Formulations
Depression
Obsessive-compulsive disorder
Panic disorder
Oral liquid dosage form
Post-traumatic stress disorder (PTSD)
Pre-menstrual dysphoric disorder (PMDD)
Social phobia/social anxiety disorder
Patents
Zoloft US Patents
Generic Competition
FDA ANDA Approvals for Zoloft
Market Outlook
Effexor (venlafaxine hydrochloride)
Key Markets/Indications
Effexor for depression
Effexor XR (once-daily slow-release capsule formulation) for depression
Effexor XR for generalised anxiety disorder (GAD)*
Effexor XR for prevention of recurrence and relapse of depression
Effexor XR for social anxiety disorder (SAD)
Effexor XR for depression and GAD in paediatric patients
Effexor XR for panic disorder
Effexor XR for major depressive disorder (MDD)
Further Development
Patents and Data Exclusivity
Effexor US Patents
Effexor XR US Data Exclusivity
Generic Competition
Lawsuits
FDA ANDA Approvals for Effexor
Market Outlook
Effexor Sales (2001A-2012E)

INSOMNIA

US Patent Expiry for Insomnia Drugs
The Generic Market for Insomnia Drugs
Generic Insomnia Drugs Currently Marketed in the United States by Company
FDA ANDA Approvals for Insomnia Drugs, 2001-2007
Rozerem (ramelteon)
Key Markets/Indications/Formulations
8mg tablets for the long-term treatment of insomnia characterised by difficulty with sleep onset (circadian rhythm sleep
disorder) in adults
Further Development
Patents and Data Exclusivity
Rozerem US Patents
Rozerem US Data Exclusivity
Market Outlook
Rozerem Sales (2002A-2012E)
Ambien (zolpidem)
Patents/Licensees
Key Markets/Indications/Formulations
Ambien CR C-IV (extended-release formulation)*
Further Development
Patents and Data Exclusivity
Ambien CR US Patents
Ambien US Data Exclusivity
Ambien CR US Data Exclusivity
Generic Competition
FDA ANDA Approvals for Ambien
Market Outlook
Stilnox Sales (2001A-2012E)
Myslee Sales (2002A-2012E)

MULTIPLE SCLEROSIS

US Patent Expiry for Multiple Sclerosis Drugs
The Generic Market for Multiple Sclerosis Drugs
Generic MS Drugs Currently Approved in the United States by Company
FDA ANDA Approvals for Multiple Sclerosis Drugs, 2001-2007
Copaxone (glatiramer)
Key Markets/Indications/Formulations
Relapsing-remitting multiple sclerosis (RRMS)
Prefilled syringe formulation, Copaxone PFS
Further Development
Patents
Copaxone US Patents
Generic Competition
Market Outlook
Avonex (interferon beta 1a)
Key Markets/Indications
The treatment of relapsing MS, after a patient experiences at least 2 clinical events
Avonex in a prefilled syringe for the treatment of relapsing MS
The treatment of MS patients with a first clinical episode and MRI features consistent with MS
Market Outlook
Avonex Sales (2003A-2012E)
Betaferon (interferon beta 1b)
Key Markets/Indications
Relapsing-remitting multiple sclerosis (1)
Secondary-progressive multiple sclerosis
Room temperature formulation (25°C) for 24-month storage
Prefilled syringe
Treatment of patients with first clinical event suggestive of MS
Further Development
Lawsuits
Market Outlook
Betaferon/Betaseron sales (2001A-2011E)
Rebif (interferon beta-1a)
Key Markets/Indications
Treatment of relapsing-remitting multiple sclerosis (RRMS)
RRMS - 44mcg dose
Further Development
Competitor Products/Lawsuits
Market Outlook
Rebif Sales (2001A-2012E)
Tysabri (natalizumab)
Key Markets/Indications
Relapsing-remitting multiple sclerosis
Crohn's disease (moderate-to-severely active)
Lawsuits
Sales Forecast
Novantrone (mitoxantrone)
Key Markets/Indications
Generic Competition
FDA ANDA Approvals for Novantrone
Market Outlook
Novantrone Sales (2003A-2012E)

NEURODEGENERATIVE DISORDERS

US Patent Expiry for Alzheimer's Disease Drugs
US Patent Expiry for Parkinson's Disease Drugs
The Generic Market for Neurodegenerative Disorders Drugs
Generic Neurodegenerative Disorder Drugs Currently Approved in the United States by Company
FDA ANDA Approvals for Alzheimer's Disease Drugs, 2001-2007

ALZHEIMER’S DISEASE DRUGS

Aricept (donepezil hydrochloride)
Key Markets/Indications/Formulations
Alzheimer's disease (mild-to-moderate)
Severe AD
New Formulations
Further Development
Clinical Trial Results - Continuous Treatment Study
Patents and Data Exclusivity
Aricept ODT US Patents
Aricept US Patents
Aricept, Aricept ODT US Data Exclusivity
Generic Competition
Tentative approvals for donepezil ANDAs
Market Outlook
Aricept Sales (2001A-2012E)
Razadyne / Reminyl (galantamine)
Key Markets/Indications/Formulations
Tablet formulation for AD
Solution formulation for AD
Synthetic oral solution for AD*
Extended-release formulation for mild-to-moderate AD
Patents and Data Exclusivity
Razadyne tablets and oral solution
Razadyne ER
Razadyne ER US Data Exclusivity
Generic Competition
Tentative approvals for galantamine ANDAs
Market Outlook
Reminyl Sales (2004A-2012E)
Namenda (memantine)
Key Markets/Indications
Moderatlye-severe to severe Alzheimer's disease
Moderate Alzheimer's disease.
Further Development
Patents and Data Exclusivity
Namenda US Patents
Namenda US Data Exclusivity
Generic Competition
Market Outlook
Exelon (rivastigmine)
Key Markets/Indications
Mild-to-moderately severe AD
Mild-to-moderately severe dementia in patients with idiopathic Parkinson's disease (PD)
Exelon TDS (transdermal patch for patients with mild-to-moderately severe AD)
Exelon TDS (transdermal patch for patients with mild-to-moderate PD dementia)
Further Development
Patents and Data Exclusivity
Exelon capsules and solution US Patents
Exelon extended release transdermal film US Patents
Exelon extended release transdermal film US Data Exclusivity
Generic Competition
FDA ANDA Approvals for Exelon
Market Outlook
Exelon Sales (2001A-2012E)

PARKINSON’S DISEASE

DOPS (droxidopa)
Comtan (entacapone)
Key Markets/Indications
Parkinson's disease
Further Development
Patents
Comtan US Patents
Patents/Generic Competition
Market Outlook
Sifrol / Mirapex (pramipexole)
Key Markets/Indications
PD
Advanced idiopathic PD combined with levodopa when the effect of levodopa wears off or becomes inconsistent over the
course of the disease
Monotherapy for the treatment of the signs and symptoms of idiopathic early PD*
Moderate-to-severe restless legs syndrome (RLS)
Patents and Data Exclusivity
Mirapex US Patents
Mirapex US Data Exclusivity
Generic Competition/Lawsuits
FDA ANDA Approvals for Mirapex
Market Outlook
Sifrol/Mirapex/Mirapexin Sales (2001A-2012E)
Azilect (rasagiline)
Markets/Indications
Parkinson's disease (as monotherapy and as adjunct in moderate-to-advanced PD)
Patents and Data Exclusivity
Azilect US Patents
Azilect US Data Exclusivity
Market Outlook
ReQuip (ropinirole)
Key Markets/Indications
Parkinson's disease (immediate-release tablets, three-times daily)
Restless legs syndrome (RLS; immediate-release tablets, three-times daily)
Parkinson's disease (prolonged-release tablets, once-daily)
Further Development
Patents and Data Exclusivity
ReQuip US Patents
ReQuip US Data Exclusivity
Generic Competition
Market Outlook
ReQuip/Adartel Sales (2001A-2012E)
Neupro (rotigotine)
Key Markets/Indications/Formulations
Signs and symptoms of early-stage idiopathic PD*
Advanced-stage PD in combination with levodopa
Further Development
Patents and Data Exclusivity
Neupro US Patents
Neupro US Data Exclusivity
Market Outlook

SCHIZOPHRENIA

US Patent Expiry for Schizophrenia Drugs
The Generic Market for Schizophrenia Drugs
Abilify (aripiprazole)
Key Markets/Indications/Formulations
Schizophrenia - once-daily oral tablet for short-term use (dose range 10 to 30mg)
Schizophrenia - oral solution
Long-term treatment of maintaining stability in patients with schizophrenia
Acute bipolar mania including manic and mixed episodes associated with BPD - oral formulation
Abilify Injection for intramuscular use in the control of agitation in adults with schizophrenia or bipolar mania
Further Development
Patents and Data Exclusivity
Abilify US Patents
Abilify US Data Exclusivity
Zyprexa (olanzapine)
Key Markets/Indications
Long-term maintenance treatment of schizophrenia and the treatment of co-morbid depression, or depression that may occur with schizophrenia
Bipolar disorder (BPD)
Orally-disintegrating Tablets (ODT)*
Long-term therapy and maintenance of treatment response of schizophrenia
Zyprexa powder solution for injection for rapid control of agitation and disturbed behaviours in schizophrenics
Combination therapy with either lithium or Depakote (divalproex) for the treatment of acute manic episodes associated
with BPD
Long-term prevention of relapsing into manic, mixed manic or depressive episodes, in patients with BPD (maintenance of BPD)
Zyprexa IntraMuscular for controlling the effects of acute agitation in patients suffering with schizophrenia and bipolar mania
Granule formulation
Further Development
Patents and Data Exclusivity
Zyprexa US Patents
Zyprexa Zydis US Patents
Zyprexa, Zyprexa ODT US Data Exclusivity
Zyprexa Intramuscular Injection US Data Exclusivity
Generic Competition
Tentative approvals for olanzapine ANDAs
Market Outlook
Invega (paliperidone)
Key Markets/Indications/Formulations
Schizophrenia
Further Development
Patents and Data Exclusivity
Invega US Patents
Invega US Data Exclusivity
Market Outlook
Invega Sales (2007A-2012E)
Seroquel (quetiapine fumarate)
Key Markets/Indications/Formulations
Schizophrenia
Seroquel (quetiapine) 50% Fine Granules for schizophrenia
Further Development
Patents and Data Exclusivity
Seroquel US Patents
Seroquel XR US Patents
Seroquel US Data Exclusivity
Seroquel ER US Data Exclusivity
Market Outlook
Seroquel Sales (2002A-2012E)
Risperdal (risperidone)
Key Markets/Indications/Formulations
Treatment of schizophreniform disorders
Oral solution for behavioural disturbances
Once-daily dosing regimen (tablet and solution)
Behavioural and psychological symptoms of dementia (BPSD)
Delaying relapse in the long-term treatment of schizophrenia
Short-term treatment of acute manic or mixed episodes associated with bipolar I disorder*
Fast-dissolving oral formulation (1)
Irritability associated with autistic disorder in children and adolescents aged five to 16 years*
Risperdal Consta
Further Development
Patents and Data Exclusivity
Risperdal US Patents
Risperdal Consta US Patents
Risperdal US Data Exclusivity
Generic Competition
Market Outlook
Risperdal Sales (2001A-2012E)
Dogmatyl (sulpride)
Key Markets
Market Outlook
Dogmatyl Sales (2002A-2012E)
Ceredist (taltireline)
Key Markets/Indications/Formulations
Ceredist Tablets 5 for the treatment of spinocerebellar degeneration
Market Outlook
Ceredist Sales (2002A-2012E)
Champix (varenicline)
Key Markets/Indications/Formulations
Smoking cessation
Patents and Data Exclusivity
Chantix US patents
Chantix US Data Exclusivity
Market Outlook
Geodon (ziprasidone mesylate)
Key Markets/Indications/Formulations
Schizophrenia
Intramuscular formulation
Bipolar mania
Further Development
Patents
Geodon US Patents
Generic Competition
Tentative approvals for ziprasidone ANDAs
Market Outlook
Geodon/Zeldox Sales (2001A-2012E)

OTHER CNS DRUGS


EPILEPSY

US Patent Expiry for Epilepsy Drugs
The Generic Market for Epilepsy Drugs
Generic Epilepsy Drugs Currently Marketed in the United States by Company
FDA ANDA Approvals for Epilepsy Drugs, 2001-2007
Carbatrol (carbamazepine)
Patents
Carbatrol US Patents
FDA ANDA Approvals for carbamazepine
Generic Competition
Tentative approvals for carbamazepine ANDAs
Depakote (divalproex sodium)
Key Markets/Indications
Manic episodes of bipolar disorder (BPD)*
Prevention of migraine
Complex partial seizures*
Depacon (sodium valproate for injection) for temporary treatment of certain types of epilepsy
Depakote ER Tablets 500mg (controlled-release) for migraine prevention
Depakote ER Tablets 500mg for sole and adjunctive therapy to treat complex partial seizures and simple and complex
absence seizures in adults with epilepsy
Depakote ER tablets for sole and adjunctive therapy to treat complex partial seizures in isolation, or in association with other types of seizures, including simple and complex absence seizures in children, aged ten years and above, with epilepsy
Depakote ER tablets for the treatment of acute manic or mixed episodes associated with BPD, with or without psychotic features
Patents and Data Exclusivity
Depakote US Patents
Depakote ER US Patents
Depakote ER US Data Exclusivity
Generic Competition
Tentative approvals for divalproex ANDAs
Market Outlook
Depakote Sales (2003A-2012E)
Myonal (eperisone)
Key Markets/Indications
Market Outlook
Myonal Sales (2002A-2012E)
Neurontin (gabapentin)
Key Markets/Indications/Formulations
Adjunctive therapy in epilepsy for adults and children aged 12 and over
Adjunctive therapy in the treatment of partial seizures with and without secondary generalisation in adults
Adjunctive therapy in the treatment of partial seizures in paediatric patients
Neuropathic pain
Further Development
Patents
Neurontin US Patents
Generic Competition
FDA ANDA Approvals for Neurontin
Market Outlook
Neurontin Sales (2001A-2012E)
Lamictal (lamotrigine)
Key Markets/Indications
Epilepsy (as a monotherapy)
Generalised seizures associated with Lennox-Gastaut Syndrome
Long-term maintenance treatment of bipolar I disorder (BPID)
Add-on therapy in partial seizures in children aged two years and over
Monotherapy for treatment of partial seizures in patients aged 16 years and older
Primary generalised tonic-clonic (PGTC) seizures in children aged two years and older, as well as in adults
Further Development
Patents and Data Exclusivity
Lamictal US Patents
Lamictal CD US Patents
Lamictal, Lamictal CD US Data Exclusivity
Generic Competition
FDA ANDA Approvals for Lamictal
Market Outlook
Lamictal Sales (2001A-2012E)
Keppra (levitracetam)
Key Markets/Indications
Epilepsy (including children aged 16 years and older)
Epilepsy (intravenous formulation)
Epilepsy (adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalisation, in children aged four years and older)
Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy
Monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly-diagnosed epilepsy
Adjunctive therapy for the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy
1,000mg tablet for the treatment of epilepsy
Further Development
Patents and Data Exclusivity
Keppra US Patents
Keppra US Data Exclusivity
Keppra injectable IV infusion US Data Exclusivity
Generic Competition
Market Outlook
Keppra Sales (2001A-2012E)
Lyrica (pregabalin)
Key Markets/Indications/Formulations
Adjunctive treatment of partial epileptic seizues
Neuropathic pain
Generalised anxiety disorder (GAD)
Central neuropathic pain
Management of fibromyalgia
Further Development
Patents and Data Exclusivity
Lyrica US Patents
Lyrica US Data Exclusivity
Market Outlook
Lyrica Sales (2004A-2012E)
Topamax (topiramate)
Key Markets/Indications/Formulations
Add-on treatment for adults with POS
Topamax Sprinkles, for use as adjunctive therapy for the treatment of adults with POS
Topamax to treat POS as add-on therapy in paediatric patients aged two-16 years
Topamax Tablets and Topamax Sprinkle Capsules as add-on treatment for primary generalised TCS in adults and paediatric patients
Topamax Tablets and Sprinkle Capsules as an adjunctive treatment for seizures associated with Lennox-Gastaut
syndrome*
Epilepsy 200mg dose
Migraine and headache prophylaxis in adults
Topamax Tablets and Sprinkle Capsules as initial monotherapy in patients ten years of age and older with partial-onset or
primary generalised tonic-clonic seizures
Further Development
Patents and Data Exclusivity
Topamax, Topamax Sprinkle US Patents
Topamax, Topamax Sprinkle US Data Exclusivity
Generic Competition
Market Outlook
Topamax Sales (2001A-2012E)
Depakene (valproic acid)
Key Markets/Indications/Formulations
Epilepsy
Acute mania
Manic disorders and the manic phase of bipolar disorder
Patents
Generic Competition
FDA ANDA Approvals for Depakene
Market Outlook
Depakene Sales (2002A-2012E)
Zonegran (zonisamide)
Key Markets/Indications/Formulations
100mg dosage as an adjunctive therapy for partial (focal) seizures in adults with epilepsy*
Further Development
Generic Competition
FDA ANDA Approvals for Zonegran
Market Outlook
Excegran Sales (2002A-2012E)

PAIN

Neuropathic Pain (NP)
Diabetic peripheral neuropathy (DPN)
Cancer neuropathic pain (CNP)
HIV neuropathic pain (HIVNP)
Postherpetic neuralgia (PHN)
US Patent Expiry for Pain Drugs
The Generic Market for Pain Drugs
FDA ANDA Approvals for Pain Drugs, 2001-2007
Duragesic (fentanyl)
Key Markets/Indications/Formulations
Chronic severe pain
Management of chronic intractable pain due to cancer*
Treatment of chronic intractable pain (not just for cancer)
Duragesic 12 CII, for moderate to severe chronic pain (12.5mcg/hour)
Ionsys (patient-activated transdermal system 40mcg/dose) for the management of acute moderate-to-severe postoperative pain, for use by adults, in a hospital setting only*
Generic Competition
FDA ANDA Approvals for Duragesic
Market Outlook
Duragesic Sales (2001A-2012E)
Durotep (fentanyl)
Key Markets/Indications/Formulations
Durotep Patch for persistent cancer pain
Market Outlook
Durotep Sales (2002A-2012E)
Matrifen(fentanyl)
Key Markets/Indications/Formulations
Severe chronic pain
Market Outlook
Matrifen Sales (2006A-2012E)
Toradol (ketorolac trometamol)
Generic Competition
Market Outlook
Toradol Sales (2001A-2012E)
Xefo (lornoxicam)
Key Markets/Indications/Formulations
Market Outlook
OxyContin (oxycodone)
Key Markets/Indications/Formulations
Moderate-to-severe cancer pain - OxyContin
Moderate-to-severe cancer pain - OxyNorm (an oral immediate-release formulation)
Patents
Oxycontin US Patents
Generic competition
Branded products containing oxycodone
Market Outlook
OxyContin Sales (2002A-2012E)

MIGRAINE

US Patent Expiry for Migraine Drugs
The Generic Market for Migraine Drugs
Relpax (eletriptan)
Key Markets/Indications/Formulations
Patents
Relpax US Patents
Market Outlook
Relpax Sales (2001A-2012E)
Maxalt (rizatriptan)
Key Markets/Indications/Formulations
Migraine and associated symptoms
Adolescent migraine sufferers
Patents
Maxalt US Patents
Maxalt-MLT US Patents
Generic Competition
Tentative approvals for rizatriptan ANDAs
Market Outlook
Imigran / Imitrex (sumatriptan)
Key Markets/Indications
Further Development
Patents
Imitrex US Patents
Generic Competition
Market Outlook
Imigran/Imitrex Sales (2001A-2012E)
Zomig (zolmitriptan)
Patents
Zomig US Patents
Zomig-ZMT US Patents

BRANDED COMPANY CNS R&D PROJECTS

COMPANY PROFILES

Apotex
CNS Products
Apotex: FDA ANDA Approvals for CNS drugs, 2002-07
Novex Pharma ANDA Approvals, 2002-05
TorPharm ANDA Approvals, 2002-05
Sertraline hydrochloride
Financial results
Major developments
Apotex acquires Lareq Pharma
Topgen
Beijing Med-Pharm
Litigation
Abbott
Aurobindo Pharma
CNS Products
Aurobindo Pharma: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent Product Approvals
Sumatriptan (tentative)
Citalopram (South Africa)
Zolpidem
Sertraline
Sertraline (South Africa)
Citalopram (Canada)
Financials
Major Developments
Mergers, Acquisitions and Agreements
Pharmacin International
Barr Pharmaceuticals
CNS Products
Oxycodone/ibuprofen tablets
Pramipexole tablets (tentative)
Cabergoline
Galantamine hydrobromide (tentative)
Risperidone (tentative)
Sertraline (Pliva)
Barr Laboratories: FDA ANDA Approvals for CNS drugs, 2002-07
Financial results
Major developments
Litigation
Barr initiates dexmethylphenidate patent challenge
Novartis sues Barr over methylphenidate patent challenge
Barr and Par settle diazepam patent challenge with Valeant
Barr withdraws from Zyprexa Zydis patent challenge
Barr and Lilly voluntarily dismiss Prozac Weekly patent litigation
Bedford Laboratories
CNS Products
Bedford Laboratories: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent Product Approvals
Fosphenytoin
Caraco Pharmaceutical Laboratories
CNS Products
Caraco Pharmaceutical Laboratories: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent Product Approvals
Zolpidem
Paroxetine
Modafinil (Tentative)
Phentermine
Oxcarbazepine
Lamotrigine (tentative)
Escitalopram (tentative)
Financial results
Major Developments
Litigation
Caraco gains tramadol / acetaminophen appellate court ruling
Dr Reddy's Laboratories
CNS products
Dr Reddy's: FDA ANDA Approvals for CNS Drugs, 2002-07
Zolpidem
Financial results
Major developments
Mergers, acquisitions & agreements
Sygnis
Litigation
Sertraline action
Impax Laboratories
CNS Products
Impax Laboratories: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent Product Approvals
Oxymorphone ANDA acceptable for filing
Venlafaxine (tentative)
Alprazolam
Bupropion hydrochloride extended-release
Financials
Major Developments
Mergers, Acquisitions and Agreements
Intec and Impax to collaborate on CNS drug
Litigation
Oxymorphone
Oxycodone
Divalproex
Wellbutrin XL
Wyeth files venlafaxine lawsuit against Impax
Impax and Shire reach Adderall XR settlement & carbamazepine deal
Interpharm
CNS Products
Interpharm ANDA Approvals, 2002-07
Financials
Major Developments
Mergers, Acquisitions and Agreements
Watson Laboratories
Litigation
Forest and Merz file second suit against memantine challengers
KV Pharmaceutical
CNS Products
KV Pharmaceuticals / Ethex: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent Product Approvals
Morphine
Financial Results
Major Developments
Mergers, Acquisitions and Agreements
Gedeon Richter
Strides Arcolab
Glenmark Pharmaceuticals
Mallinckrodt
CNS Products
Mallinckrodt / Tyco Healthcare: FDA ANDA Approvals for CNS Drugs, 2002-07
Major Developments
Mergers, Acquisitions and Agreements
Zydus Cadila
Mikart
CNS Products
Mikart: FDA ANDA Approvals for CNS Drugs, 2002-07
Mylan
CNS Products
Mylan: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent product approvals
Lamotrigine
Topiramate capsules (tentative)
Paroxetine ER
Fluoxetine capsules
Zolpidem
Divalproex ER (tentative)
Companies gain sertraline hydrochloride approvals, as Teva takes legal action
Financial results
Major developments
Mergers, acquisitions and agreements
Mylan agrees to acquire Merck Generics for EUR 4.9 billion
Litigation
Mylan and GSK settle generic Paxil dispute
UCB settles levetiracetam patent litigation
Perrigo
CNS Products
Perrigo: FDA ANDA approvals for CNS Drugs, 2002 - 2007
Recent product approvals
Nicotine gum
Sertraline
Financial results
Ranbaxy Laboratories
CNS Products
Ranbaxy: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent product approvals
Galantamine (tentative)
Hydrocodone bitartrate+acetaminophen
Zolpidem
Sertraline
Financial results
Roxane Laboratories
CNS Products
Roxane Laboratories: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent Product Approvals
Oxcarbazepine
Sertraline
Sandoz
CNS Products
Sandoz: FDA ANDA Approvals for CNS Drugs, 2002-07
Eon Labs: FDA ANDA Approvals for CNS Drugs, 2002-05
Geneva Pharmaceuticals: FDA ANDA Approvals for CNS Drugs, 2002-03
Lek: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent product approvals – Lek
Zolpidem
Financial results
Major developments
Litigation
Abbot sues Zydus and Sandoz over divalproex
Atomoxetine patent litigations launched
Sun Pharmaceutical Industries
CNS Products
Sun Pharmaceutical Laboratories: FDA ANDA Approvals for CNS Drugs, 2002-07
Taro Pharmaceutical Industries: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent Product Approvals
Carbidopa/levodopa
Galantamine (tentative)
Rivastigmine
Oxcarbazepine
Divalproex (tentative)
Financials
Major Developments
Mergers, Acquisitions and Agreements
Able Laboratories
Taro Pharmaceutical Industries
Litigation
Venlafaxine
Carbidopa / levodopa / entacapone
Rivastigmine
Memantine
Teva Pharmaceutical Industries
CNS products
Teva: FDA ANDA Approvals for CNS Drugs, 2002-07
IVAX: FDA ANDA Approvals for CNS Drugs, 2002-07
Gensia Sicor Pharmaceuticals / Sicor: FDA ANDA Approvals for CNS Drugs, 2003-07
Goldline Laboratories / Zenith Goldline: FDA ANDA Approvals for CNS Drugs, 2002-05
Recent product approvals
Risperidone (UK)
Oxcarbazepine
Ropinirole (tentative)
Teva gains positive olanzapine opinion
Zolpidem
Cabergoline
Alprazolam ER tablets
Dexmethylphenidate
Financial results
Major developments
Litigation
Appeals court favours Pfizer over Teva in gabapentin case
Dr Reddy’s and Teva settle sertraline action
Appeals court upholds escitalopram decision
Biovail reaches comprehensive settlement related to Wellbutrin XL
United Research Laboratories / Mutual Pharmaceutical Company
CNS Products
URL / Mutual: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent Product Approvals
Zolpidem
Major Developments
Litigation
Eisai
Watson Pharmaceuticals
Andrx
CNS Products
Watson: FDA ANDA Approvals for CNS Drugs, 2002-07
Andrx: FDA ANDA Approvals for CNS Drugs, 2002-07
Recent product approvals
Oxycodone/ibuprofen
Fentanyl
Zolpidem
Sertraline
Financial results
Major developments
Litigation
Bupropion XL
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Booming Generics Drug Market in India US$ 1,000.00 Aug, 2011 · 60 pages
Generic Drugs: World Market 2013-2023 US$ 2,400.00 Nov, 2012 · 149 pages

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