A complaint for infringement of patents with regard to drug for treatment of acne has been filed against Zydus Pharmaceuticals USA, Inc, a fully owned subsidiary of Ahmedabad-based pharma major Cadila Healthcare Ltd (Zydus Cadila) in a district court of US.
This complaint petition has been filed by one Arizona-based Medicis Pharmaceutical Corporation (MPC).
Zydus USA has been accused of seeking approval from the United States Food and Drug Administration (FDA) to commercially manufacture, use, and selling of a generic version of Solodyn minocycline hydrochloride and extended release tablets, before the drug’s patents which is with MPC, expires.
MPC has accused Zydus USA and its parent company Zydus Cadila in India of infringement of its patents for method of treatment of acne, and manufacture of minocycline oral dosage forms for the treatment of acne.
It has further stated in its complaint to the district court of Delaware, that if Zydus USA was not restricted from infringing on its patents, it would cause ‘irreparably harm’ to MPC.
MPC is a leading independent specialty pharmaceutical company in the United States focusing on the treatment of dermatological conditions including acne which is a common skin disease that causes pimples when hair follicles under the skin clog up.
The US-based company filed the complaint in the court last week after Zydus Cadila through its subsidiary there filed Abbreviated New Drug Application (ANDA) in under the Federal Food, Drug, and Cosmetic Act to obtain approval for commercial manufacture and selling of generic minocycline hydrochloride extended release tablets in different strengths for the treatment of acne. Zydus Cadila had filed the ANDA under the contention that the patent of MPC was invalid and had expired. It had also sent a notice to MPC regarding its ANDA.
MPC has sought direction from the court for permanent injunction restricting Zydus USA from infringing on its patents, and manufacture, use, sale, or distribution of any current or future versions of the product described its ANDA.
An email query to Zydus in Ahmedabad did not elicit any response.
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