Bayer has launched a lawsuit against Glenmark Generics after the India-based firm filed for US approval of a generic version of skin disorder treatment Finacea.
Glenmark filed an Abbreviated New Drug Application (ANDA) to the US FDA for its own version of azeliac acid gel, which is approved for the treatment of inflammatory papules and pustules of mild to moderate rosacea – a chronic skin condition that mainly affects the face.
However, Bayer – alongside its subsidiaries Intendis and Intraserv – claims Glenmark’s product infringes on Finacea’s patent, and it wants a legal order preventing Glenmark from commercialising generic azeliac acid gel until this time.
In court papers filed at the US District Court for the District of Delaware, Bayer said it will suffer “irreparable harm for which they have no adequate remedy at law” if Glenmark was allowed to market generic Finacea ahead of patent expiry.
Bayer doesn’t give full details of Finacea’s revenues in its financial results, but according to IMS data for the 12 months ending September 30, the treatment achieved US sales of about $95m.
Despite the lawsuit and risk of related penalties, by becoming the first company to file an ANDA for generic Finacea, Glenmark may be entitled to 180 days of generic market exclusivity.
This would give Glenmark a significant edge over rival generics firms by allowing it to establish a foothold in the market as the only generic drug available.
The lawsuit comes three months after Glenmark was one of several generic companies to lose a challenge against AstraZeneca, which had its patent for cholesterol drug Crestor upheld by an appeals court until its expiration in 2016.
And in 2011, Glenmark settled with Astellas and Triax following a court battle about the launch of a generic version of Locoid Lipocream for inflammation of the skin.
As part of this settlement, Glenmark was permitted to market and distribute its version of the cream under a royalty-bearing licence from Astellas and Triax in the US by the end of 2013.