Generic Version of Copaxone, the Most-Used MS Drug, Receives FDA Approval

The 20 mg generic version of the drug could be labeled ‘substitutable’, meaning prescriptions for Copaxone could be automatically switched to the generic.

The Food and Drug Administration (FDA) has approved the lower-cost version of Copaxone, the most-used drug for multiple sclerosis.

Teva Pharmaceutical Industries Ltd manufactures Copaxone. The generic drug, Glatopa, was developed collaboratively by Sandoz, a unit of Swiss drugmaker Novartis AG, and Momenta Pharmaceuticals Inc, for treating patients with relapsing forms of the chronic neurodegenerative disease.

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However, the companies are still engaged with the patent litigation. Sreejit Mohan, spokesman of Sandoz, said the company would not comment on commercial launch plans.

Sources with Momenta said the 20 mg generic version of the blockbuster drug could be labeled ‘substitutable’, meaning prescriptions for Copaxone could be automatically switched to the generic.

Teva’s U.S. sales of Copaxone totaled $3.1 billion in fiscal 2014. The company has been working to switch patients to a 40 mg formulation of the drug that still has patent protection.

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Source-Medindia

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