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Generic Launch Calendar - III
Teva loses TriCor, Dr Reddy’s files Valcyte
We provide updated chronology of upcoming generic
launches in US market for key Indian players
2012 will be peak period for generics launches; we remain
positive on overall US generics opportunities
We highlight new filings across our coverage universe and key litigation updates on
existing product pipeline. Please see below for detailed launch calendar.
New ANDA filings and litigations
Dr Reddy’s Labs (DRRD IN)
Valcyte (valganciclovir): DRRD got sued on Roche’s Valcyte, which is indicated for
cytomegalovirus infections in organ transplant patients and has annual sales of
cUSD400mn. DRRD’s 30-month stay will expire on Jun-14. Ranbaxy, Sandoz, Endo,
Apotex were also sued on this product by innovator Roche; Ranbaxy which is the FTF
(first-to-file) has settled for Mar-13 launch.
Lupin (LPC IN)
Generess (ethinyl estradiol + norethindrone): Lupin got sued on Warner’s Generess Fe
(oral contraceptive) where Mylan is FTF. Given the small size this is not a meaningful
opportunity. Lupin now has 9 active litigations in oral contraceptives space aside from 2
launches – gFemcon Fe and gNor QD. gLo Seasonique recently got final approval but
launch is not yet visible.
Lumigan (bimatoprost): Lumigan (0.01% ophthalmic solution) is fourth filing in
ophthalmic space for Lupin; Sandoz is FTF on this product. Teva and Sandoz earlier had
also filed on 0.03% solution. Brand size is cUSD400mn and generic launch can be
expected after ‘819 patent expiry in Aug-14.
Sun Pharma (SUNP IN)
Ortho Tricyclen Lo (ethinyl estradiol + norgestimate): Sun was sued for second oral
contraceptive ANDA on OrthoTricyclen Lo after first filing on Bayer’s Yaz. Teva,
Watson, Sandoz, Mylan and Lupin are other known filers for this product. Teva was FTF
and had launched earlier but later settled for re-entry in Dec-15. With annual brand sales
of cUSD450mn, this filing is big but may have atleast 5 players at time of launch post
Teva’s exclusivity.
Angiomax (bivalirudin): Sun has also filed ANDA for anticoagulant Angiomax which has brand sales of
cUSD400mn. Teva is FTF and has settled for a launch in June 2019 which makes this a very late
opportunity. Other filers include Hospira, Fresenius, Mylan and Dr Reddy’s.
Cadila Healthcare (CDH IN)
Asacol HD (mesalamine): Asacol HD 800mg is Cadila’s second focused filing for ulcerative colitis after
Lialda, and Cadila is FTF. Asacol HD 800mg was launched in the US in Jun-09 and has current annual
sales of cUSD70mn. Innovator Warner Chilcot is actively moving patients from Asacol 400mg to Asacol
HD 800mg as part of its life-cycle extension strategy. We believe, the market for Asacol will gradually
shift from 400mg to 800mg strength as Warner is anticipating generic entry in 400mg strength (though
recent grant of citizen petition delays generic in lower strength as well). We believe this a very strong
filing in terms of expected limited competition and sustainable sales.
Zegerid/+OTC (omeprazole + sodium bicarbonate) Cadila filed ANDA for both prescription and OTC
Zegerid. Innovator Santarus has stopped promoting brand post generic entry in 2010. Par is the FTF on
the product and Prasco the authorized generic. Generic sales for the product are cUSD85mn with brand at
cUSD30mn.
Other key updates
TriCor (fenofibrate): Teva yesterday commented that it doesn’t see a launch on gTricor in 2012. Teva
was FTF on this product and has forfeited its exclusivity due to lack of tentative approval before
30months of filing. Thus Tricor will be an open market for all the filers including Lupin, Biovail, Impax,
Wockhardt and Ranbaxy. Both Lupin and Ranbaxy have settled with innovator Abbott. We have
currently anticipated launch in mid 2012 of generics in TriCor.
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
Generic Launch Calendar - III
Teva loses TriCor, Dr Reddy’s files Valcyte
We provide updated chronology of upcoming generic
launches in US market for key Indian players
2012 will be peak period for generics launches; we remain
positive on overall US generics opportunities
We highlight new filings across our coverage universe and key litigation updates on
existing product pipeline. Please see below for detailed launch calendar.
New ANDA filings and litigations
Dr Reddy’s Labs (DRRD IN)
Valcyte (valganciclovir): DRRD got sued on Roche’s Valcyte, which is indicated for
cytomegalovirus infections in organ transplant patients and has annual sales of
cUSD400mn. DRRD’s 30-month stay will expire on Jun-14. Ranbaxy, Sandoz, Endo,
Apotex were also sued on this product by innovator Roche; Ranbaxy which is the FTF
(first-to-file) has settled for Mar-13 launch.
Lupin (LPC IN)
Generess (ethinyl estradiol + norethindrone): Lupin got sued on Warner’s Generess Fe
(oral contraceptive) where Mylan is FTF. Given the small size this is not a meaningful
opportunity. Lupin now has 9 active litigations in oral contraceptives space aside from 2
launches – gFemcon Fe and gNor QD. gLo Seasonique recently got final approval but
launch is not yet visible.
Lumigan (bimatoprost): Lumigan (0.01% ophthalmic solution) is fourth filing in
ophthalmic space for Lupin; Sandoz is FTF on this product. Teva and Sandoz earlier had
also filed on 0.03% solution. Brand size is cUSD400mn and generic launch can be
expected after ‘819 patent expiry in Aug-14.
Sun Pharma (SUNP IN)
Ortho Tricyclen Lo (ethinyl estradiol + norgestimate): Sun was sued for second oral
contraceptive ANDA on OrthoTricyclen Lo after first filing on Bayer’s Yaz. Teva,
Watson, Sandoz, Mylan and Lupin are other known filers for this product. Teva was FTF
and had launched earlier but later settled for re-entry in Dec-15. With annual brand sales
of cUSD450mn, this filing is big but may have atleast 5 players at time of launch post
Teva’s exclusivity.
Angiomax (bivalirudin): Sun has also filed ANDA for anticoagulant Angiomax which has brand sales of
cUSD400mn. Teva is FTF and has settled for a launch in June 2019 which makes this a very late
opportunity. Other filers include Hospira, Fresenius, Mylan and Dr Reddy’s.
Cadila Healthcare (CDH IN)
Asacol HD (mesalamine): Asacol HD 800mg is Cadila’s second focused filing for ulcerative colitis after
Lialda, and Cadila is FTF. Asacol HD 800mg was launched in the US in Jun-09 and has current annual
sales of cUSD70mn. Innovator Warner Chilcot is actively moving patients from Asacol 400mg to Asacol
HD 800mg as part of its life-cycle extension strategy. We believe, the market for Asacol will gradually
shift from 400mg to 800mg strength as Warner is anticipating generic entry in 400mg strength (though
recent grant of citizen petition delays generic in lower strength as well). We believe this a very strong
filing in terms of expected limited competition and sustainable sales.
Zegerid/+OTC (omeprazole + sodium bicarbonate) Cadila filed ANDA for both prescription and OTC
Zegerid. Innovator Santarus has stopped promoting brand post generic entry in 2010. Par is the FTF on
the product and Prasco the authorized generic. Generic sales for the product are cUSD85mn with brand at
cUSD30mn.
Other key updates
TriCor (fenofibrate): Teva yesterday commented that it doesn’t see a launch on gTricor in 2012. Teva
was FTF on this product and has forfeited its exclusivity due to lack of tentative approval before
30months of filing. Thus Tricor will be an open market for all the filers including Lupin, Biovail, Impax,
Wockhardt and Ranbaxy. Both Lupin and Ranbaxy have settled with innovator Abbott. We have
currently anticipated launch in mid 2012 of generics in TriCor.
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