Product Profiles: Allergic Rhinitis - Heavily Genericized Market Sees Areas of Innovation

14 Jul 2011 • by Natalie Aster

“The allergic rhinitis market continues to see areas of innovation, as seen with the April 2011 FDA filing of Dymista (azelastine/fluticasone; Meda/Cipla). Within the immunotherapy class, novel therapies are making progress in the EU, and continuing to pursue development in the US. Amongst established symptomatic therapies, strategies are used to resist generic erosion.”

The report “Product Profiles: Allergic Rhinitis - Heavily Genericized Market Sees Areas of Innovation” by Datamonitor provides an overview of important clinical developments for key pipeline agents with analysis of the latest clinical trial data.

The oral antihistamine class has seen an additional over-the-counter (OTC) shift, as the FDA approved Allegra (fexofenadine, Sanofi-Aventis) for OTC use in January 2011, which led to an OTC launch of the product in March 2011. This, and other methods of combating generic erosion, can be seen throughout the allergic rhinitis market.

In April 2011, Meda filed its fixed dose nasal antihistamine/corticosteroid combination Dymista (azelastine/fluticasone) with the FDA for the treatment of seasonal allergic rhinitis in patients aged 12 years and older. If approved, Dymista would be the first of its class to reach the market, addressing unmet needs in treating allergic rhinitis.

Movements have been seen in the allergen immunotherapy class; in January 2011 the FDA announced that it would lift the clinical hold that had been placed on Allergy Therapeutics’ Pollinex Quattro range in 2007. The sublingual tablet based grass allergens Grazax and Oralair continue to roll-out in the EU, and hope remains for their US approval.

Report Details:

Product Profiles: Allergic Rhinitis - Heavily Genericized Market Sees Areas of Innovation

Published: June 2011

Pages: 146

Price: US$ 11,400.00

Report Sample Abstract

Product positioning

In the US, the product patent for desloratadine expired in October 2004 and the US Court of Appeals ruled that desloratadine was neither a new nor unique ingredient warranting patent protection, as it is the active metabolite of loratadine. Schering-Plough was granted a 1,074-day extension on the patent, as well as an additional 6 months for having conducted pediatric trials, extending its marketing exclusivity to June 2007 (Thomson Pharma, April 2010). The US Food and Drug Administration (FDA) Orange Book lists several other patents related to desloratadine that expire in December 2014, with pediatric extensions to June 2015, and, in addition, Merck, after acquiring Schering-Plough, holds various patents for the product that extent to 2022 (FDA Orange Book, 2011; MedTRACK, February 2011, Copyright Datamonitor). A number of companies have filed Abbreviated New Drug Applications (ANDAs) for generic versions of desloratadine.

Schering-Plough has settled patent litigations with several of these, reaching agreements for generic desloratadine to enter the market starting in 2012. In April 2009, Mylan announced that patent litigation against it was settled. Under the agreement, Mylan has the right to market desloratadine 5mg tablets starting in July 2012. The generic may be introduced as a prescription medicine or as an over-the-counter (OTC) version, depending on the status of Clarinex at the time of launch (Mylan announces Clarinex settlement agreement, 2009).

More information can be found in the report “Product Profiles: Allergic Rhinitis - Heavily Genericized Market Sees Areas of Innovation” by Datamonitor.

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