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Re: AngeloFoca post# 38439

Wednesday, 02/20/2019 3:24:35 PM

Wednesday, February 20, 2019 3:24:35 PM

Post# of 38634
Ranexa has 5 tentative and 1 Lupin approval. Lupin got final approval in 2010 and agreed to a settlement launch on February 27, 2019. When the patent runs out May 27, 2019, I assume the FDA will give final approval to all the tentatively approved ANDAs. FDA can give IPCI's Ranexa ANDA final approval without giving tentative approval first.

Seroquel XR ANDA and two doses of Focalin XR ANDA are the only two drugs that have been approved on time. So I guess most wont be surprised if IPCI's Ranexa ANDA gets delayed.

Ranolazine in FDA Drug Database:
Lupin Approved
TEVA Tentative
Actavis Tentative
Aurobindo Tentative
Ajanta Tentative
Cipla Tentative

So key dates are:
February 27, 2019 Lupin allowed to launch generic Ranexa.
May 27, 2019 Patent expires and others allowed to launch.
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