More Generics Makers Targeting Teva’s Copaxone 40 mg

Generics manufacturers Mylan, Momenta and Sandoz have joined Dr. Reddy’s Laboratories as some of the first to announce patent challenges against Teva’s blockbuster multiple sclerosis drug Copaxone in the newer 40 mg version.

Momenta said Aug. 28 that the FDA had accepted a Paragraph IV ANDA submitted by Sandoz, with whom it has partnered in developing a generic 40 mg Copaxone (glatiramer acetate). On the same day, Mylan said the FDA had accepted its own ANDA challenge against the 40 mg version.

Both Mylan and Momenta suggest they’re entitled to first-to-file status, although Teva said in early August that the first patent challenge notice it received came from Dr. Reddy’s. Teva vowed at the time it would file an infringement lawsuit that would trigger a 30 month stay of approval. No lawsuit has yet been filed, and Teva has 45 days from receiving notice of an ANDA to do so.

Challenges to the 40 mg Copaxone represent the latest chapter in Teva’s efforts to defend its flagship product. Teva has taken the defense of its older, 20 mg version all the way to the U.S. Supreme Court, which is due to hear arguments on patent challenges from Mylan and Sandoz in the fall.

Teva won approval of the 40 mg version in January, and since then has been trying to switch patients from the 20 mg version. The last of Teva’s patents on the 20 mg version expired in May, while two of the 40 mg dose’s protections run until 2030. The Israeli drugmaker said July 31 that it had switched 51 percent of Copaxone prescriptions in the U.S. to the 40 mg dose.

Since its launch through June 30, the 40 mg version earned Teva $411.5 million in the U.S., Mylan said quoting IMS Health data. Copaxone earned Teva $4.3 billion worldwide in 2013. — 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.