Forest initiates lawsuits over generic Savella

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Forest initiates lawsuits over generic Savella

Generics/News | Posted 18/10/2013 0 Post your comment

Forest Laboratories and Forest Laboratories Holdings (Forest) announced that Forest and Royalty Pharma Collection Trust (Royalty Pharma) are suing several generics manufacturers regarding generics of Savella (milnacipran).

Forest and Royalty Pharma have jointly filed lawsuits in the US District Court for the District of Delaware against generics companies Apotex, Hetero USA, Lupin, Mylan Pharmaceuticals (Mylan), Par Pharmaceutical and Ranbaxy Laboratories for infringement of their ‘911, ‘342 and ‘220 patents. Forest licenses the ‘911, ‘342 and ‘220 patents from Royalty Pharma. The ‘911 patent expires in January 2023, the ‘342 patent expires in November 2021 and the ‘220 patent expires in September 2029.

Savella is used to treat a chronic pain disorder called fibromyalgia. The drug is a serotonin–norepinephrine reuptake inhibitor (SNRI), which treats fibromyalgia by reducing pain perception in the brain.

The generics companies have all filed abbreviated new drug applications (ANDAs) with Paragraph IV certifications seeking approval to market generic versions of Savella before the expiration of the three patents.

Mylan said in a press statement that it ‘believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon final FDA approval.’

For the 12 months ending 30 June 2013, Savella had US sales of approximately US$123 million, according to IMS Health.

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Source: Forest Laboratories, Mylan