Amneal Partners with Hanmi to Market Nexium® Alternative

  Amneal Partners with Hanmi to Market Nexium® Alternative

Business Wire

BRIDGEWATER, N.J. -- January 28, 2013

Amneal Pharmaceuticals, LLC today announced that it has entered into a license
and distribution agreement with South Korea-based Hanmi Pharmaceutical Co.,
Ltd to acquire exclusive distribution rights to Hanmi's new drug application
(NDA), currently under FDA review, for esomeprazole strontium delayed-release
capsules. Hanmi’s NDA was filed with the U.S. FDA pursuant to Section
505(b)(2) of the Food, Drug and Cosmetic Act including comparative
bioequivalence testing against AstraZeneca's Nexium^® (esomeprazole magnesium
delayed-release capsules). Originally submitted to the FDA in October 2010
with additional development data subsequently provided by Hanmi, the NDA has
been granted a revised Prescription Drug User Fee Act (PDUFA) date of April
29, 2013.

“We are very excited to enter into this partnership with Hanmi, as it gives
Amneal the opportunity to introduce a high quality, low cost esomeprazole
strontium product into the U.S. market, potentially before other generic
competitors,” said Chirag Patel, President of Amneal. Amneal expects the
product to obtain timely FDA approval, and subject to the favorable resolution
of ongoing litigation between Hanmi and AstraZeneca, Amneal anticipates a
potential commercial launch in 2013, prior to the expected entry of generic
versions of Nexium^®.

About Amneal Pharmaceuticals, LLC

Amneal Pharmaceuticals, LLC is a U.S.-based manufacturer of generic
pharmaceuticals. Known as “Generic’s New Generation,” Amneal prides itself on
its unwavering commitment to quality, meaningful business relationships, and
innovative approach to maximizing value for all stakeholders. Extensive
investment in R&D, an intelligently aggressive expansion strategy, and focus
on vertical integration are key contributors to the company’s impressive
growth over the past several years. Amneal is headquartered in Bridgewater,
New Jersey with manufacturing, R&D, packaging, sales and distribution
facilities throughout the U.S., as well as abroad. For more information, visit


Cheryl Lechok Communications, LLC
Cheryl Lechok, President
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