Indian Pharma Majors Cipla And Meda Sue Apotex Over Dymista Patent Rights

Indian pharma major Cipla Ltd along with Meda Pharmaceuticals Inc, a subsidiary of Swedish specialty drug maker Meda AB, has filed a lawsuit against Canadian pharma company Apotex Inc and Apotex Corp to protect its Dymista patents in the Federal District Court in Delaware.

The companies have sued Apotex following the drug maker’s (Apotex) application to the US Food and Drug Administration (FDA), in which they had sought approval to sell a generic version of Meda’s Dymista in the market, even before the expiration of the patents.

“The Complaint was filed within 45 days of receiving Apotex’s Paragraph IV certification notice, thus triggering an automatic stay preventing the FDA from approving Apotex’s ANDA for 30 months from receipt of the notice, unless ordered otherwise by a district court,” said Cipla in a letter dated December 3, 2014, to the NSE.

It should be noted that Meda has the right over Dymista patents till 2026 and also possesses the New Drug Application (NDA) to produce and market the drug in the US market.

"Meda will vigorously enforce the Dymista patent rights against Apotex and any other company who challenges these patents", stated Dr Jorg Thomas Dierks, CEO of Meda Pharmaceuticals.

Cipla and Meda Pharmaceuticals had entered into partnership to manufacture the Dymista while Meda had exclusive rights to market it in other countries. Later, Cipla too acquired the right to sell drugs in a few countries.

Representational Image: Indiatimes.com