>INDIAN PHARMACEUTICALS: 4Q CY11 Drug Master Files (DMF) filings update

• Indian DMF share recovers to c46% of overall DMF filings in 4QCY11, breaking out of the recent slowing trend in filings
• Large generics filings seem to be stagnating; small players more aggressive registering an increase on yoy basis
• DRRD sole DMF on Prasugrel (potential FTF), Lupin files ophthalmic brimonidine

■ Indian DMFs share jumped to c46 %( +22% yoy) of overall DMF filings in 4Q CY11 after witnessing a slower rate over the last few quarters. For the full year CY2011, Indian DMFs share in overall DMFs filings remained at similar 50% level as in CY2010 (c9% yoy growth). China’s DMFs share of total DMFs fell from 20% in 4Q10 (18% in CY2010) to 16% in 4Q11 and CY2011. Global DMFs increased by c10% for CY2011.


■ Indian large cap generics filings seem to be stagnating: Barring DRRD which increased its filings in CY2011, most players’ filings stagnated for the year as a whole. The number of filings from CIPLA and RBXY actually declined materially. DRRD CY2011 filings were strong at 14; SUNP and LPC filed 6 each, CDH 8, RBXY had 2 and CIPLA 0. TRP and IPCA each filed three DMF during the year. Small players like Hetero Lab, Alembic were the most active with DMF filings of c12-13.


■ 4QCY11 noteworthy filings include Dr Reddy’s sole filing on Eli Lilly’s antithrombotic
drug Effient (prasugrel), which has cUSD100mn sales in the US. This could be a potential first-to-file opportunity given no other DMF yet (though ANDA can only be filed after July 2013). Lupin continued its filing momentum in ophthalmics with a recent filing on brimonidine (Alphagan-P) used in glaucoma. Among mid caps, Ipca’s filing on primaquine, Cadila’s on erlotinib (Tarceva) and Torrent’s on darfenacin (Enablex) are noteworthy. Other small players’ filings including Hetero’s DMF on etravirine (Intelence) and Gland Pharma’s filing on agratroban and dalteparin (Fragmin) are the sole Indian DMF filings and hence potentially strong. Reliance Life Science filed two niche products including loteprednol etabonate (ophthalmic corticosteroid) and injectable nandrolone. Among MNCs, Apotex’s filing on lansoprazole hints at a possible increase in competition in Prevacid generic (currently four players only). Mylan’s filing on iloperidone (Fanapt) is also worth mentioning.


To read full report: INDIAN PHARMACEUTICALS
RISH TRADER