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Lupin (LPC)
Pharmaceuticals
Lupin denied FTF status on Combivir. Lupin’s citizen’s petition requesting FDA to
deny Teva its 180-day exclusivity for Combivir (US$315 mn sales in US) was turned
down on May 25. This resulted in Teva getting final approval for Combivir; however,
Teva has settled for a launch date in 4Q2011 as per its 2010 agreement with GSK. We
believe Teva will launch latest by November 15, 2011, as FDA is scheduled to approve
all pending ANDAs by May 15, 2012. However, the competitive scenario post the 180-
day exclusivity is not clear yet. In case Lupin is the only other filer, this may turn out to
be at least a US$10 mn product for Lupin in FY2013E, although that translates into only
2.8% of US generic sales for it. We await final approval of Fortamet ER (US$85 mn),
where Lupin is the sole FTF. Maintain ADD, PT at Rs500 (20X FY2013E EPS).
Lupin CP denied—FTF status continues to be held by Teva
FDA on May 25 denied Lupin’s citizen’s petition filed in January 2011, challenging Teva’s FTF
status. FDA thereby granted FTF status to Teva and has approved its ANDA. FDA’s decision was
based on the argument that Teva was the first to file a complete ANDA with Para IV certification
for ‘021 patent (expiring in May 12, 2012), regardless of whether it challenged the later expiring
patent ‘082 on the same day. As per a settlement agreement with the innovator, Teva will launch
the product in 4Q2011. We believe Teva will launch latest by November 15 to enjoy its 180-day
exclusivity, as Teva is likely to lose its FTF status (as per the forfeiture clause) by May 15, 2012, the
day the ‘021 patent expires, and FDA is likely to approve all other pending ANDAs.
However, competitive scenario post 180-day exclusivity is not clear
We believe the exact contours of the likely competition post the 180-day exclusivity is not known
since there are no other filers which have received tentative approvals, including Lupin. In case
Lupin is the only other filer, this may turn out to be at least a US$10 mn product (assuming 80%
erosion, 20% market share) for Lupin in FY2013E. However, this translates into only 2.8% of likely
FY2013E US generic sales for Lupin.
We await final approval for Fortamet ER (sales of US$85 mn)—Lupin is sole FTF
We believe Fortamet ER in 2011 and Glumetza in 2012 are key sole FTFs for Lupin. (1) Recently
Lupin got tentative approval for Fortamet ER and we await final approval. (2) The 30-month stay
for Glumetza (sales of US$40-50 mn) expires in mid-2012E; however, the patent challenge case
has not been heard. SUN had filed a Para IV for Glumetza in May 2011. SUN is the second filer for
Glumetza.
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
Lupin (LPC)
Pharmaceuticals
Lupin denied FTF status on Combivir. Lupin’s citizen’s petition requesting FDA to
deny Teva its 180-day exclusivity for Combivir (US$315 mn sales in US) was turned
down on May 25. This resulted in Teva getting final approval for Combivir; however,
Teva has settled for a launch date in 4Q2011 as per its 2010 agreement with GSK. We
believe Teva will launch latest by November 15, 2011, as FDA is scheduled to approve
all pending ANDAs by May 15, 2012. However, the competitive scenario post the 180-
day exclusivity is not clear yet. In case Lupin is the only other filer, this may turn out to
be at least a US$10 mn product for Lupin in FY2013E, although that translates into only
2.8% of US generic sales for it. We await final approval of Fortamet ER (US$85 mn),
where Lupin is the sole FTF. Maintain ADD, PT at Rs500 (20X FY2013E EPS).
Lupin CP denied—FTF status continues to be held by Teva
FDA on May 25 denied Lupin’s citizen’s petition filed in January 2011, challenging Teva’s FTF
status. FDA thereby granted FTF status to Teva and has approved its ANDA. FDA’s decision was
based on the argument that Teva was the first to file a complete ANDA with Para IV certification
for ‘021 patent (expiring in May 12, 2012), regardless of whether it challenged the later expiring
patent ‘082 on the same day. As per a settlement agreement with the innovator, Teva will launch
the product in 4Q2011. We believe Teva will launch latest by November 15 to enjoy its 180-day
exclusivity, as Teva is likely to lose its FTF status (as per the forfeiture clause) by May 15, 2012, the
day the ‘021 patent expires, and FDA is likely to approve all other pending ANDAs.
However, competitive scenario post 180-day exclusivity is not clear
We believe the exact contours of the likely competition post the 180-day exclusivity is not known
since there are no other filers which have received tentative approvals, including Lupin. In case
Lupin is the only other filer, this may turn out to be at least a US$10 mn product (assuming 80%
erosion, 20% market share) for Lupin in FY2013E. However, this translates into only 2.8% of likely
FY2013E US generic sales for Lupin.
We await final approval for Fortamet ER (sales of US$85 mn)—Lupin is sole FTF
We believe Fortamet ER in 2011 and Glumetza in 2012 are key sole FTFs for Lupin. (1) Recently
Lupin got tentative approval for Fortamet ER and we await final approval. (2) The 30-month stay
for Glumetza (sales of US$40-50 mn) expires in mid-2012E; however, the patent challenge case
has not been heard. SUN had filed a Para IV for Glumetza in May 2011. SUN is the second filer for
Glumetza.
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