Amneal Pharmaceuticals Receives FDA Approval for Generic Suboxone®

  Amneal Pharmaceuticals Receives FDA Approval for Generic Suboxone®

   Buprenorphine HCl and Naloxone HCl tablets for treating opioid addiction
                expected to save millions in healthcare costs

Business Wire

BRIDGEWATER, N.J. -- February 25, 2013

Amneal Pharmaceuticals, LLC, the 7^th largest generic drug manufacturer in the
U.S. market, has received U.S. FDA approval for one of the first generic
versions of Suboxone^® sublingual tablets for maintenance treatment of opioid
drug dependence. Generic buprenorphine hydrochloride (HCl) and naloxone HCl
dihydrate sublingual tablets are now available in 2 mg/0.5 mg and 8 mg/2 mg
strengths, both in 30-count bottles. The Amneal medication is bioequivalent to
Suboxone^® (a registered trademark of Reckitt Benckiser Healthcare (UK)
Limited (LSE:RB)). Annual U.S. sales of Suboxone^® in all dosage forms are
$1.5 billion, according to December 2012 IMS Health market data.

Amneal Pharmaceuticals buprenorphine HCl and naloxone HCl tablets in 2 mg/0.5
mg and 8 mg/2 mg stren ...

Amneal Pharmaceuticals buprenorphine HCl and naloxone HCl tablets in 2 mg/0.5
mg and 8 mg/2 mg strengths, 30-count (Photo: Business Wire)

Providing opioid-dependent patients with high quality generic buprenorphine
HCl and naloxone HCl through treatment in physicians’ offices, treatment
centers, or prescriptions filled at retail pharmacies offers tremendous cost
savings for both consumers and the U.S. healthcare system, while delivering
the same therapeutic effect as the brand medication. To help their patients
take advantage of this lower cost alternative, physicians should clearly
indicate “buprenorphine HCl and naloxone HCl tablets” or “Suboxone^® tablets”
when writing prescriptions to avoid confusion at the pharmacy. Patients
currently using any form of Suboxone^® should ask their doctors or dispensing
pharmacists for buprenorphine HCl and naloxone HCl sublingual tablets to get
the cost-saving generic version with a pleasant orange flavor.

In addition to patients and their prescribing physicians, a more
cost-effective opioid addiction treatment should be welcome news to insurance
companies, the Centers for Medicare and Medicaid Services, the Veterans Health
Administration and other payors, pharmacy benefits managers (PBMs), managed
care facilities, drug addiction and recovery organizations and treatment
advocacy groups as well. Generic drugs are saving the U.S. healthcare system
one billion dollars every other day, according to the Generic Pharmaceutical
Association.

“The FDA’s decision to approve the first generic equivalents to Suboxone^®
sublingual tablets will ensure that millions of patients in the U.S. who need
this product now have access to a high quality, low cost generic version,”
said Chirag Patel, President and Co-Chairman of Amneal. “Since the agency has
issued its opinion on Reckitt Benckiser’s September 2012 Citizen’s Petition in
favor of generic competition, Amneal’s buprenorphine HCl and naloxone HCl
tablets can offer consumers and physicians greater choice in opioid addiction
treatment. We are also pleased that the FDA has referred this matter to the
Federal Trade Commission to investigate and address Reckitt’s anticompetitive
business practices.”

“We appreciate the FDA’s thorough assessment of Reckitt’s Citizen’s Petition
and applaud their recent decision to deny it in its entirety,” said Chintu
Patel, Amneal CEO and Co-Chairman. “The FDA determined that Reckitt’s petition
did not raise valid scientific or regulatory issues associated with the
product, which Amneal contended in its comments on the petition. Physicians
should have no concerns in writing prescriptions for the generic tablet form
of the product.”

Manufactured in Amneal’s fully FDA-compliant Brookhaven, NY facility,
buprenorphine HCl and naloxone HCl tablets will be available through
wholesalers and distributors as well as directly to the trade. The product
received FDA approval under an approved Risk Evaluation and Mitigation
Strategy (REMS), known as the Buprenorphine-containing Transmucosal products
for Opioid Dependence (BTOD) REMS program, and will be distributed in
accordance with FDA and U.S. Drug Enforcement Administration (DEA) regulations
governing the handling of CIII controlled substances. The generic tablets will
be available to patients when the BTOD REMS program becomes operational in
early March.

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
amneal.com.

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Contact:

Amneal Pharmaceuticals, LLC
Jim Luce, Executive Vice President, Sales & Marketing
949-610-8018
jim@amneal.com
www.amneal.com
or
Cheryl Lechok Communications, LLC
Cheryl Lechok, President
203-961-9280
M: 203-613-1506
clechok@optonline.net
www.linkedin.com/in/clechok
 
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