Dr. Reddy's Files First Patent Challege Against Teva's Copaxone 40mg

Indian generics firm Dr. Reddy’s has filed the first patent challenge against Teva’s blockbuster multiple sclerosis drug Copaxone’s 40 mg, introducing a new chapter into the Israeli drugmaker’s efforts to protect its multibillion dollar product.

Teva confirmed receipt of a Dr. Reddy’s Paragraph IV ANDA Aug. 7, and said it would file a patent infringement lawsuit triggering a 30-month stay of approval under Hatch-Waxman.

Two of the Copaxone (glatiramer acetate) patents run until 2030, Teva said. However, those aren’t the patents the drugmaker is likely worried about. The rest of the drug’s patents expired in May, including all of the ones protecting its 20 mg version.

Teva has spent years fighting to protect Copaxone, which generated $4.3 billion last year. Those efforts have included a patent infringement lawsuit against a proposed generic of the Copaxone 20 mg version that is bound for the U.S. Supreme Court this fall.

In addition, Teva has filed seven different citizen petitions and even a lawsuit against the FDA seeking more stringent testing of would-be Copaxone copies, as well as efforts to shift patients from the 20 mg version to the 40 mg one. The lawsuit against the FDA was tossed last month. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.