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India Pharmaceuticals
1QCY11 DMF filings update
Indian generics represent majority share in US DMF filings;
1QCY11 continues strong trend with 56% share of all filings
Dr Reddy’s and Cadila had a few interesting filings. But
momentum in some large generics seems to be slowing
down
We are positive on the sector given generic opportunity in
the US. Strong DMF filings suggest long-term earnings
potential
Indian DMFs constitute 56% of overall DMF filings in 1QCY11: Indian generics
continue robust trend of filing over half of the DMFs (drug master files) with USFDA,
with most filings coming from Dr Reddy’s Labs and Cadila Healthcare in the quarter. The
other notable filers include Sun Pharma, Jubilant, Emcure, Hetero and Alembic. Some of
the generic names with no new filings include Ranbaxy, Aurobindo and Cipla. MNC
generics filings were few, with Apotex’s filing on raloxifene (Lilly’s Evista) the only
noteworthy DMF.
Some of the interesting DMFs filed in the quarter included filings from Dr Reddy’s on
lacosamide (UCB’s Vimpat), Sun Pharma on sevelamer carbonate (Genzyme’s Renvela)
and bivalirudin (Medicines’ Angiomax), Cadila on diclofenac epolamine (Alpharma’s
Flector Patch), Natco on sorafenib (Bayer’s Nexavar), and Glenmark on choline
fenofibrate (Abbott’s TriLipix). Most of these filings are interesting because there is
limited competition in these products. Cadila’s filing on diclofenac epolamine is unique in
that it employs a patch-based (transdermal) drug delivery.
Nine first-time filings from Indian generics: Some of the molecules on which Indian
generics filed for the first time include lacosamide, mafenide, sorafenib, and fampridine.
Most of these new filings are on newly approved molecules (see Exhibit 4 below).
DRRD’s filing on Vimpat could be potential FTF (first to file): DRRD’s filing on
lacosamide is the first global filing to date and could suggest possible FTF status. Vimpat
currently posts USD100m in sales on the back of its recent approval in October 2008. The
base patent expires in FY15, when generic launch could be expected.
DMF filings likely to be strong with upcoming generic expiry wave in US: We expect
the filing rate to continue to be robust among Indian generics, though slackening
momentum among a few large players like Ranbaxy and Cipla is worrisome. We are
bullish on the upcoming generics opportunity in the US. Dr Reddy’s is likely to benefit in
the near term from US generic launches.
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
India Pharmaceuticals
1QCY11 DMF filings update
Indian generics represent majority share in US DMF filings;
1QCY11 continues strong trend with 56% share of all filings
Dr Reddy’s and Cadila had a few interesting filings. But
momentum in some large generics seems to be slowing
down
We are positive on the sector given generic opportunity in
the US. Strong DMF filings suggest long-term earnings
potential
Indian DMFs constitute 56% of overall DMF filings in 1QCY11: Indian generics
continue robust trend of filing over half of the DMFs (drug master files) with USFDA,
with most filings coming from Dr Reddy’s Labs and Cadila Healthcare in the quarter. The
other notable filers include Sun Pharma, Jubilant, Emcure, Hetero and Alembic. Some of
the generic names with no new filings include Ranbaxy, Aurobindo and Cipla. MNC
generics filings were few, with Apotex’s filing on raloxifene (Lilly’s Evista) the only
noteworthy DMF.
Some of the interesting DMFs filed in the quarter included filings from Dr Reddy’s on
lacosamide (UCB’s Vimpat), Sun Pharma on sevelamer carbonate (Genzyme’s Renvela)
and bivalirudin (Medicines’ Angiomax), Cadila on diclofenac epolamine (Alpharma’s
Flector Patch), Natco on sorafenib (Bayer’s Nexavar), and Glenmark on choline
fenofibrate (Abbott’s TriLipix). Most of these filings are interesting because there is
limited competition in these products. Cadila’s filing on diclofenac epolamine is unique in
that it employs a patch-based (transdermal) drug delivery.
Nine first-time filings from Indian generics: Some of the molecules on which Indian
generics filed for the first time include lacosamide, mafenide, sorafenib, and fampridine.
Most of these new filings are on newly approved molecules (see Exhibit 4 below).
DRRD’s filing on Vimpat could be potential FTF (first to file): DRRD’s filing on
lacosamide is the first global filing to date and could suggest possible FTF status. Vimpat
currently posts USD100m in sales on the back of its recent approval in October 2008. The
base patent expires in FY15, when generic launch could be expected.
DMF filings likely to be strong with upcoming generic expiry wave in US: We expect
the filing rate to continue to be robust among Indian generics, though slackening
momentum among a few large players like Ranbaxy and Cipla is worrisome. We are
bullish on the upcoming generics opportunity in the US. Dr Reddy’s is likely to benefit in
the near term from US generic launches.
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