sheff /
29 August 2014Americas

FDA accepts generic applications for three-times-weekly Copaxone

The US Food and Drug Administration (FDA) has accepted applications by generic drug makers Mylan and Novartis subsidiary Sandoz for a three-times-weekly version of blockbuster drug Copaxone (glatiramer acetate), it was announced yesterday.

Sandoz intends to develop and commercialise the Copaxone three-times-weekly generic with Massachusetts-based Momenta Pharmaceuticals, whose chief executive and president Craig Wheeler said yesterday: “We are pleased to announce the acceptance of the ANDA [Abbreviated New Drug Application] for our three-times-a-week generic Copaxone for review.”

Teva has been pulling out all the stops in preparation for the expiry of its US patent covering the original once-daily formulation of the multiple sclerosis drug in May. The launch of the three-times-weekly formulation in January was its last ditch attempt at retaining its share in the market.

In July, Teva reported that more than half of all Copaxone prescriptions in the US were for its new three-times-weekly formulation.

Earlier this month, Teva received a notice that Indian pharmaceutical company Dr. Reddy’s intended to make a generic version of the three-times-weekly formulation of Copaxone, which is protected by two patents due to expire in 2030.

In a statement Teva said that it will continue to vigorously defend its IP rights whenever they are challenged, and that it intended to file a lawsuit against Dr. Reddy’s within the 45 day period provided under the Hatch-Waxman Act.

In the six months up to June 30 this year, Copaxone generated sales of $2 billion, down 6% on the same period last year.

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