Dow Pharmaceutical Solutions (Dow) filed a lawsuit against Actavis (a subsidiary of Teva Pharmaceuticals) in the US District Court for New Jersey in March 2017. The lawsuit pertains to generic versions of the acne drug Onexton (benzoyl peroxide/clindamycin), which Dow (a Valeant Pharmaceuticals International Inc subsidiary) claims violate two patents protecting the drug’s chemical formulation and method of action. The patents are currently held by Valeant and not set to expire until 2029.

Actavis claims it will market a generic version of the drug that does not violate these patents, however, Dow argues that the drug will still infringe on several claims because it is ‘substantially the same’ as Onexton. Dow therefore requests the court conclude that Actavis has infringed on Valeant’s patents and that it be prohibited from marketing a generic version of Onexton before these patents expire.                                                                                                                            

In more recent news, US-based manufacturer of central nervous system agents Acorda Therapeutics (Acorda) has had four major patents on its multiple sclerosis (MS) treatment Ampyra invalidated. Ampyra (4-Aminopyridine) has been shown to improve walking ability in adults with MS and has been approved in the US since 2010.

A judge in the District Court for Delaware ruled that the patents covering Ampyra’s active ingredient for use in MS patients and its dosing structure are clear to trained professionals, and therefore invalid. This contradicts the previous move of the Patent and Trademark Office (PTO), which upheld Acorda’s patents and stated that there was insufficient support to challenge them.

Several generic drugs manufacturers have reached agreements with Acorda over patents on Ampyra, including Actavis [1], who submitted a generic drug application in 2014, as well as America’s fifth largest generics firm Par Pharmaceutical and Indian multinational Sun Pharmaceutical Industries. 

This decision will open the door to generics manufacturers. This will come as a major blow to Acorda, as sales of the drug accounted for almost 90% of its revenue in 2016 and the latest of their patents was not set to expire until 2027. Although one additional patent (for a sustained-release version of the drug) was validated by the court, this is set to expire much sooner, in July 2018.

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Generics manufacturers focus on MS drug Ampyra

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Actavis submits generic dalfampridine ANDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 April 28]. Available from: www.gabionline.net/Generics/News/Actavis-submits-generic-dalfampridine-ANDA

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