Lupin Expands Branded Play
MUMBAI and BALTIMORE, August 7, 2013 /PRNewswire/ –
Announces Acquisition of Exclusive US Rights to Alinia(R) for Oral Suspension
Pharmaceutical Major, Lupin Ltd. and its US subsidiary, Lupin Pharmaceuticals Inc.
(collectively Lupin) announced today that it has signed a strategic licensing agreement
with US pharmaceutical company Romark Laboratories, L.C. (Romark) which grants Lupin
exclusive rights to promote, distribute and market Alinia(R) (nitazoxanide) for Oral
Suspension in the US.
Alinia(R) (nitazoxanide) is the first thiazolide approved by the FDA for the treatment
of diarrhea caused by Cryptosporidium and Giardia and is the only FDA-approved treatment
for Cryptosporidium. Alinia(R) for Oral Suspension is indicated for the treatment of
diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 1 year of age and
older. These are the two most common protozoal causes of diarrhea in the developed and
Use of Alinia(R) suspension in children is facilitated by relatively simple dosing and
administration; a strawberry flavored suspension given twice a day for three days (100mg
BID for ages 1 – 3 and 200mg BID for ages 4 – 11).
According to the Centers of Disease Control & Prevention (CDC) it is estimated that
there are 1.2 million cases of Giardiasis and 750,000 cases of Cryptosporidiosis in the US
annually, although many cases go undiagnosed. Cryptosporidium is one of the most frequent
causes of waterborne disease among humans in the United States. Pediatric diarrhea is a
major complaint in more than 10% of office visits for children less than 3 years of age,
says the American Academy of Pediatrics (AAP). Over 300,000 children under five years of
age are hospitalized with gastroenteritis annually. Pediatric diarrhea is often left
untreated based on limited treatment options (no other product is indicated for children <
3 years of age). Older children are sometimes treated with flouroquinolones (e.g., CIPRO),
cephalosporins (e.g., SUPRAX) and metronidazole. The cost of care for diarrhea-related
illness exceeds USD 2 billion each year according to AAP.
Alinia(R) for Oral Suspension will not only enable Lupin to strengthen its existing
Brand portfolio but also expand its offering specifically, but not limited to the US
Pediatrics segment. Key prescribers for Alinia(R) include pediatricians, pediatric,
gastroenterologists and primary care physicians which are strategic customer groups for
Lupin, so we are well positioned to capitalize on this opportunity. Lupin’s current 160+
strong brands sales force will promote Alinia(R) for Oral suspension in the US market. The
product will be marketed along with Lupin’s Suprax(R) and Antara(R).
“We are very excited with the addition of Alinia(R) for Oral Suspension to our Brands
portfolio. The agreement demonstrates Lupin’s commitment to grow its brand franchise in
the US and bring meaningful products to the Pediatric community. Our sales and marketing
efforts will commence immediately and we are optimistic that Alinia will contribute to our
growth and profitability in the coming quarters and years.” said Vinita Gupta, CEO, Lupin
Pharmaceuticals Inc. and Group President, Lupin Limited.
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical
company producing and developing a wide range of branded and generic formulations and APIs
globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma,
Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions
in the Anti-TB and Cephalosporin segment.
Lupin is the 5th largest and fastest growing top 5 generics player in the US (5.3%
market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical
company by sales. The Company is also the fastest growing top 10 generic pharmaceutical
players in Japan and South Africa (IMS).
For the financial year ended March 2013, Lupin’s Consolidated turnover and Profit
after Tax were Rs. 94,616 million (USD 1.74 billion) and Rs. 13,142 million (USD 242
million) respectively. Please visit http://www.lupinworld.com for more information.
Lupin Pharmaceuticals, Inc. is the wholly owned U.S. subsidiary of Lupin Limited.
Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to
delivering high-quality, affordable generic medicines and branded formulations trusted by
healthcare professionals and patients across geographies. For more information, visit
For further information or queries please contact - Shamsher Gorawara Head - Corporate Communications Lupin Limited Ph: +91-98-20-338-555 Email: email@example.com
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SOURCE Lupin Ltd