Momenta Pharmaceuticals reports that the US Food and Drug Administration (FDA) has accepted for review its abbreviated new drug application (ANDA) for a three-times-a-week generic Copaxone (glatiramer acetate injection, 40 mg/mL), submitted by Sandoz Inc., Momenta’s development and commercialization partner for this product candidate. The product is the generic version of Teva’s Copaxone 40-mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Momenta Pharmaceuticals is one of several companies contending for first-to-file status for generic glatiramer acetate injection, 40 mg/mL. Based on publicly-available information, Momenta believes that, should the ANDA be approved, it would be eligible for 180-day first-to-file exclusivity under Hatch-Waxman. The product could be on the market as early as the first quarter of 2017, assuming the Paragraph IV challenge is successful and adheres to customary Hatch-Waxman litigation timelines. Since the 40 mg/mL formulation contains the same drug substance as the 20 mg/mL ANDA currently under review by the FDA, Momenta anticipates the FDA review process can be completed within the same time frame.

Mylan also reported that its ANDA has been accepted by the FDA and said it believes itis one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval.

In August 2014, Teva Pharmaceutical Industries Ltd. reported it had received a Paragraph IV notice for its three-times-a-week Copaxone (glatiramer acetate) injection 40 mg/mL product from Dr. Reddy's Laboratories, Inc. In an August 7, 2014 press statement, Teva says it intends to file a lawsuit for patent infringement against Dr. Reddy's within the 45-day period provided under the Hatch-Waxman Act. The filing of the lawsuit will trigger a 30 month stay of FDA approval of Dr. Reddy's ANDA.

Teva reported that its Copaxone 40 mg/mL is protected by two Orange Book patents that expire in 2030. In January 2014, the FDA approved Teva’s supplemental new drug application for Copaxone 40 mg/mL administered three times a week. The new formulation allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of MS. The company also filed for marketing authorization in the European Union, Canada, Russia, Australia and other markets globally, with approvals expected over the next several months. The US Orange Book patents covering Copaxone (20 mg) expired in May 2014.

Copaxone, a drug to treat relapsing-remitting MS is Teva’s top-selling specialty medicine with 2013 sales of $4.328 billion, according to Teva’s annual financial filing. Copaxone 40 mg/mL had US sales of approximately $411.5 million for the 12 months ending June 30, 2014, according to information from IMS Health as reported by Mylan.

See related story, “Teva Plans Patent Infringement Lawsuit Against Dr. Reddy’s for Generic Copaxone” and “Mylan’s ANDA for Generic Version of Teva’s Copaxone Accepted by FDA”

Source: Momenta Pharmaceuticals