Allergan closes the book on Fetzima generics suit

Allergan has struck a deal with two generic manufacturers to resolve a long-running patent infringement suit over its antidepressant drug Fetzima (Levomilnacipran).

In two orders filed on September 14, US District Court for the District of New Jersey judge Esther Salas signed off agreements between Allergan and MSN Laboratories and Aurobindo Pharma.

MSN and Aurobindo agreed that they should be blocked from making generic versions of the antidepressant until the patents have either expired or been invalidated.

Both companies also agreed that the products outlined in their Abbreviated New Drug Application’s (ANDA) would infringe on US patent numbers 8,481,598 (’598), 8,865,937 (’937) and reissue patent RE43,879 (‘879).

In agreeing to the stipulation, Both MSN and Aurobindo have waived their right to appeal the order, which will “finally resolve” the action between Allergan and the two generics companies.

Case history

Litigation over Fetzima generics started when Forest Laboratories, which later merged with Allergan, filed a lawsuit against several generic’s manufacturers who had submitted ANDA’s to manufacture Fetzima variants in January 2018.

MSN and Aurobindo were the last of the generics manufacturers targetted by Forest to settle, with Amneal Pharmaceuticals, Princeton Pharmaceuticals, Torrent Pharmaceuticals and Hikma Pharmaceuticals having settled with Allergan between December 2018 and March 2020.

The case was assigned to Allergan in January 2021 after the pharmaceutical giant merged with Forest in January 2021.

According to Bloomberg, bench trial had initially been set to begin on September 7 prior to the submission of the stipulation.

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