Teva Wants Copaxone Generics Blocked Until Sept. 1

Teva is asking a federal court to bar any generic versions of Copaxone from entering the market until the last of the blockbuster MS drug’s patents expires in September.

The only thing now stopping generic entry from ANDA filers like Sandoz and Mylan is final approval from the FDA, Teva said in a Jan. 30 filing in the U.S. District Court for the Southern District of New York. Sandoz and Mylan have said publicly they would launch as soon as they receive FDA approval.

The Israeli drugmaker argues, however, that the Supreme Court’s Jan. 20 ruling that reversed an appellate court’s rejection of Copaxone’s (glatiramer acetate) ‘808 patent means generic versions should be forcibly blocked until the patent expires Sept. 1. That ruling sent the case back to the lower courts.

Teva has been fighting for years to protect Copaxone, a drug that brought in $1.4 billion in the third quarter of 2014 and accounts for half of its revenue. To help forestall a collapse in sales, the company has managed to switch more than half of Copaxone’s patients to a newer, 40 mg dose that enjoys patent protection until 2030.

Novartis, Sandoz’ parent company, declined to comment. Mylan did not respond to a request for comment by press time. — Bryan Koenig