P-IV filing: Dr reddy’s sued for filing of P-IV to Mozobil®

Genzyme Corporation, a fully-owned subsidiary of drug major Sanofi-Aventis filed a suit against Dr. Reddy's Laboratories for ANDA filing to Plerixafor (Mozobil®).

Genzyme is the holder of New Drug Application (“NDA”) No. 022311, which relates to Plerixafor solution 20 mg/mL for subcutaneous injection. On December 15, 2008, the FDA approved the marketing of the drug product described in NDA No. 022311 for use in combination with granulocyte-colony stimulating factor (“G-CSF”) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

Letter dated July 19, 2013, DRL notified Genzyme that DRL had submitted ANDA No. 205182 to the FDA (21 U.S.C. § 355(j)) seeking approval to engage in the commercial manufacture, importation, use, and sale of 20 mg/mL Plerixafor injection (“Plerixafor ANDA Injection Product”) as a generic version of Genzyme’s Mobozil® drug product.

 

the Notice Letter, DRL notified Genzyme that its ANDA contained a “paragraph IV” certification that in DRL’s opinion the ‘152 patent, and ‘590 patent, and the ‘102 patent are invalid or will not be infringed by the commercial manufacture, use, sale, offer to sell, or importation of DRL’s Plerixafor ANDA Injection Product.

Genzyme also filed suit against Teva and Sandoz for the P-IV filing to Plerixafor.