The USFDA has rejected a Citizen Petition by Innovator Teva w.r.t its blockbuster formulation Glatiramer acetate injection (Copaxone) against generic approvals.
Earlier in July, 2008, generic players like Momenta Pharma and Sandoz announced (as reported by IPPharmadoc Here) Para IV patent challenge on Glatiramer acetate injection. Subsequently, Teva sued the generic players in U.S. District Court of Manhattan, accordingly, ANDA approval process of generic companies was stayed for 30 months under Hatch-Waxman provisions.
Additionally, Teva filed a Citizen Petition on September 8, 2008 with the USFDA, wherein, Teva opined that designing around against this formulation would be extremely difficult and presents a significant challenge. Also, once injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult. Also, the mechanism of the drug product is not fully clear. Teva also requested in the citizen petition that generic players should carry out detailed clainical studies to establish quality, safety and efficacy of the generic product. Alternatively, Teva suggested USFDA that ANDA on Copaxone should be reviewed under 505 (b) (2) category.
In response to the citizen petition, USFDA refused to review the Citizen petition and communicated Teva that as ANDA review process is stayed till 30 months, it would be premature and inappropriate to address points raised by Teva before actual ANDA review process begins.
Glatiramer Acetate is the generic name for Copaxone or Copolymer. It is an immunomodulator, licensed in much of the world for reduced frequency of relapses in relapsing-remitting multiple sclerosis. Copaxone is administered by subcutaneous injection at a dose of 20 mg per day. It is a non-interferon and non steroidal medication.Glatiramer acetate was originally discovered by Professor Sela, Professor Arnon and Dr. Teitelbaum at the Weizmann Institute of Science in Israel. Teva got license on this molecule and subsequently commercialised this product.. Copaxone had $1.38 billion in US sales in 2008.
Also, another generic player Mylan has opposed the Citizen petition by Teva.
Link to Globes news Here
Link to Foxbusiness news Here
Earlier news of IPPharmdoc on Copaxone Here
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