Shilpa filed 4 DMFs during Q3CY2015 (July – September) and now has filed 24 DMFs in the US market. For H1FY16, the company has filed 5 DMFs in total and is a sharp increase compared to 3 DMFs filed in FY15. The brief details of these 4 DMFs is give below:
- PEMETREXED DIPOTASSIUM (gAlimta, innovator – Eli Lily): Filed on September 14, 2015. Exclusivity expiry – Oct 17, 2015 & Patent Expiry – July 24, 2016. Used for initial treatment of advanced nonsquamous non-small cell lung cancer. ANDA – Tentative approval – App (Teva subsidiary), Accord, Hospira, Glenmark (also filed for ANDA). DMF Filers – Teva, Chongquing, DRL, Sun, MSN,Emcure, Chemwerth, Reliance, Glan, Neuland. US Sales of USD 1.23 billion and worldwide sales of USD 2.79 billion (2014). It seems to be a big product.
- ANASTROZOLE (gArimidex, innovator – AstraZeneca): Filed on September 18, 2015. Patent has expired. Used a non-steroidal aromatase-inhibiting drug approved for treatment of breast cancer after surgery, as well as for metastasis in both pre and post-menopausal women. Approved ANDAs – Accord, Apotex, Cipla, DRL, Fresenius Kabi, Mylan, Natco, Roxane, Sandoz, Santos Biotech, Sun, Teva, Zydus. Seems to be a me too product with lot of players already in the market.
- DIMETHYL FUMARATE (gTecfidera; innovator – Biogen): Filed on September 19, 2015. Exclusivity Expiry – March 27, 2018 & Patent Expiry – April 1, 2018. Used in treatment of multiple sclerosis. DMF Filers – DMF Filers – Glenmark,Arevipharma, Yabao Pharmaceutical , Mylan, MSN, Biophore, DRL, Honour Lab, Chongqing Huapont. US Sales of USD 2.40 billion (2014). Its a blockbuster product but there are quiet a few DMF filers.
- CLOFARABINE (gClolar; innovator – Genzyme [acquired by Sanofi]): Filed on September 25, 2015. Exclusivity expired Patent expiry – Jan 14, 2018. Used for treatment of treating relapsed or refractory acute lymphoblastic leukaemia. DMF Filers – Apicore, Olon, Scinopharm, Emcure, MSN, Biophore, Synbias. Sales of USD 80 million (ICICI Report). Seems DRL has filed ANDA has a para IV litigation was filed against it. It seems a small but limited competition product.
Out of the four DMF filing done by the company during the last quarter, two are multibillion dollar opportunities. The company seems to have developed a good pipeline for the US market. However, it all depends on execution now as and when it gets USFDA approval for its API and formulation plant.
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