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FDA accepts applications for three-times-weekly follow-on Copaxone Posted 05/09/2014

The US Food and Drug Administration (FDA) has accepted applications submitted by generics makers Dr Reddy’s, Sandoz (Momenta Pharmaceuticals’ development and commercialization partner), and Mylan for three-times-weekly follow-on versions of blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

The news comes as a blow to Teva Pharmaceuticals (Teva), which only received approval for the three-times-weekly formulation of Copaxone in January 2013 [1]. The 40 mg/mL allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis. The company was therefore hoping to switch patients from daily to weekly Copaxone to avoid generic erosion of the daily version (20 mg/mL), which became open to generics competition in May 2014.

On 28 August 2014, both Mylan and the Momenta/Sandoz collaboration announced that they had had abbreviated new drug applications (ANDAs) for their three-times-weekly follow-on glatiramer acetate injection 40 mg/mL products accepted for filing by FDA. The companies believe that they are the first to file a substantially complete ANDA containing a Paragraph IV certification for this product and expect to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval.

Teva responded by saying that it would ‘continue to vigorously defend its Copaxone intellectual property rights against infringement wherever they are challenged’. The company stated that it ‘intends to file a lawsuit for patent infringement’, adding that ‘Copaxone 40 mg/mL is protected by two Orange Book patents that expire in 2030’.

Copaxone 40 mg/mL had US sales of approximately US$411.5 million for the 12 months ending 30 June 2014, according to IMS Health.

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1.    GaBI Online - Generics and Biosimilars Initiative. Teva gains FDA approval for three-times-a-week Copaxone [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 5]. Available from: www.gabionline.net/Biosimilars/General/Teva-gains-FDA-approval-for-three-times-a-week-Copaxone

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Source: FDA, Momenta, Mylan

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