India Pharmaceuticals:1QCY16Drug Master File (DMF)update

　　India DMF share was 52% in 1QCY16: India’s share of overall DMF was 52% in1QCY16, higher than the 42% seen in the previous quarter. After India, Chinaregained second position with a share of 17% while the US slipped to third positionwith a c14% share in 1QCY16. In terms of absolute numbers, total DMF filings at 153remain at a similar level to the previous quarter.

　　Good number of filings from key players: Glenmark filed for 4 DMFs, AurobindoPharma for 3 DMFs, Dr Reddy’s, Cipla, Cadila Healthcare and Sun Pharma (1 fromTaro) each had 2 DMFs while Lupin and Biocon had 1 DMF each. Among smallplayers, MSN Lab stands out again with 12 DMFs in 1QCY16 (vs 7 in 4Q15). Divi’sfiled one DMF but this was a repeat filing for levetiracetam.

　　Key filings in the quarter: Sun Pharma and Aurobindo Pharma filed for the penemdrug, ertapenem. Aurobindo also filed for peptide desmopressin. With these filings,Aurobindo has 3 peptide filings and 4 penem filings. Taro Pharma (Sun Pharma’ssubsidiary) filed for derma product dapsone (brand Aczone). Lupin stepped up itsrespiratory DMFs with a filing on tiotropium bromide indicating a potential ANDA filingfor Spiriva. Multiple filers included Dr Reddy’s for carfilzomib (Brand Kyprolis), whichis a relatively new drug for treatment in multiple myeloma (approved in 2012).

　　Aurobindo and Biocon filed for the multiple sclerosis drug, teriflunomide (BrandAubagio). Glenmark has a DMF on azelaic acid (Brand: Finacea), which could befrom another site and will be part of a FY19 launch. Additionally, Glenmark andCadila Healthcare filed for mirabegron (brand Myrbetriq, sales USD400m). GlenmarkPharma filed for a new diabetes treatment from gliptin class, aloglpitin (Brand:Nesina). Cipla filed for new HIV drug dolutegravir (brand Tivicay) and an oncologyproduct, bortezomib. MSN Lab stands out with 12 DMFs during 1QCY16 with filingson many new products including apremilast, axitinib, bexarotene, bosutinib,dapagliflozin, dasatinib and enzalutamide. Hetero filed a DMF on anti-viral oseltamivir(brand Tamiflu), which is expected to go generic next year with Natco’s first launchfollowed by Lupin. Hetero’s earlier than expected approval could affect theopportunity for Natco and Lupin.