Innovative Drug Delivery Systems: Novel Product and Formulation Technology Licensing Opportunities for Generic Pharmaceutical Companies

Date: June 15, 2013
Pages: 123
Price:
US$ 2,500.00
Publisher: MP Advisors
Report type: Company Report
Delivery: E-mail Delivery (PDF)
ID: IBAC6E4DC47EN
Leaflet:

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Innovative Drug Delivery Systems: Novel Product and Formulation Technology Licensing Opportunities for Generic Pharmaceutical Companies
There are more than 1400 sustained or controlled release drugs have been approved all over the world. Revenues within the global generics market reached an estimated value of $265 b in 2012, showing a growth of 9.3% throughout the year. The contribution of generics is approximately 20% of overall international pharmaceutical market. The utilization of generic in terms of volume is higher in the US and lower in Japan, 89% and 24% respectively.

The oral drug delivery market remains the largest slice of the overall drug delivery market, with more than 52% of the market share. It is presently valued at $49 billion and is expected to reach over $90 billion by 2016, at a CAGR of 11%. The growth in the oral drug delivery market shall be driven primarily by newer technologies enabling controlled release formulations of oral drugs and oral formulations of injectable only drugs. Global injectable drug delivery market is expected to be worth $29b by 2015.

Novel drug delivery systems (NDDS) offers many more advantages, which include improved therapy by increasing the efficacy and duration of drug activity, increased patient compliance through decreased dosing frequency and convenient routes of administration and improved targeting for a specific site to reduce unwanted side effects.

The challenge for both drug and drug delivery companies is to deliver both existing and emerging drug technologies in a manner that improves the benefits to the patients. The generic market with reference to innovative molecule (NCE) has become very competitive as several companies have already filed the ANDA for the potential generic drugs in the near term. The study of novel drug delivery companies and their formulation technologies will provide the potential value added opportunity in the generic field in terms of patient’s compliance or bioavailability enhancement. It will also provide enhanced life cycle for the drugs under patent coverage (life cycle extension).

This comprehensive report on novel drug delivery system focused mainly on oral and injectable formulations for the pharma and specialty companies. This report enumerates the various formulation technology involved in making value added formulations, pharmaceutical applications and advantages of the specific technology. Wherever available, the marketed drugs using the similar technology as the proof of validation and the status of additional pipeline have also been discussed. The discussed proprietary formulations technologies includes Colal, Glide SDI, Arestat, GeoClock, GeoMatrix, FlashTab, Lock Tab, Medusa, Eligen, Oradur, EnteriCare and Saber.

This report will be helpful for the pharma companies exploring novel opportunities for their growth by in-licensing the formulation technology or value added pipeline drugs available/being studied in the market.
1. GLOBAL GENERIC BUSINESS – PRESENT STATUS AND FUTURE OPPORTUNITIES

2. THERAPEUTIC FOCUS AND TRENDS IN ADVANCED DRUG DELIVERY SYSTEM BASED ON RECENT DEALS

3. PATENT EXPIRY IMPACT AND GENERIC COMPANIES STRATEGIES –SUPER GENERICS

4. THE RELATIONSHIP BETWEEN SOLUBILITY AND PERMEABILITY IN FORMULATIONS

5. FORMULATION APPROACH FOR WATER –INSOLUBLE DRUGS AND ORAL PEPTIDE DELIVERY

6. FDA GUIDELINES FOR 505 (B)(2) APPLICATIONS AND ADVANTAGE OF DEVELOPMENT

7. TYPES OF CHANGES ALLOWED IN 505 (B)(2) DEVELOPMENT AND ITS ADVANTAGE

8. REGULATORY CHALLENGES IN CLINICAL DATA REQUIREMENT IN 505(B)(2) DEVELOPMENT AND SAFETY STUDIES

9. ANALYSIS, APPLICATION AND ADVANTAGES OF FORMULATIONS TECHNOLOGIES FOR MORE THAN 75 PHARMA COMPANIES WITH OVER 100 FORMULATION TECHNOLOGIES IN ORAL AND INJECTABLE FORMULATIONS DISCUSSED

10. LATE STAGE PIPELINE DEVELOPMENT FOR DISCUSSED SPECIALTY AND MAJOR PHARMA COMPANIES

11. THE DISCUSSED FORMULATIONS PROPRIETARY TECHNOLOGIES INCLUDES COLAL, GLIDE SDI, ARESTAT, GEOCLOCK, GEOMATRIX, FLASHTAB, LOCK TAB, MEDUSA, ELIGEN, ORADUR, ENTERICARE AND SABER

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