Akorn Announces the Approval and Launch of Generic Prometrium®

  Akorn Announces the Approval and Launch of Generic Prometrium®

Business Wire

LAKE FOREST, Ill. -- October 24, 2012

Akorn, Inc. (NASDAQ: AKRX), a niche specialty pharmaceutical company, today
announced that its manufacturing and development partner, Sofgen
Pharmaceuticals, LLC, has received approval of its abbreviated new drug
application (ANDA) for Progesterone capsules, 100mg and 200mg. The approved
ANDA is for the generic of Abbott Laboratories’ Prometrium® capsules indicated
for the treatment of endometrial hyperplasia and secondary amenorrhea. Akorn
has exclusive marketing rights to Sofgen’s product in the U.S. and the Company
has begun distribution.

According to IMS Health, Progesterone capsules, 100mg and 200mg, had combined
sales of approximately $170 million in the U.S. based on annualizing the three
months ended August 31, 2012. IMS Health sales figures exclude certain
customary discounts and incentives.

About Akorn, Inc.

Akorn, Inc. is a niche specialty pharmaceutical company engaged in the
development, manufacture and marketing of multisource and branded
pharmaceuticals. Akorn has manufacturing facilities located in Decatur,
Illinois, Somerset, New Jersey, and Paonta Sahib, India where the Company
manufactures ophthalmic and injectable pharmaceuticals. Additional information
is available on the Company’s website at www.akorn.com.

About Sofgen Pharmaceuticals, LLC

Sofgen was established in Florida as a specialized developer and manufacturer
of niche pharmaceutical products with high barriers to entry. Sofgen is part
of the Procaps Group, which has a manufacturing network with facilities
throughout North and South America, with a wealth of experience in soft
capsules and related delivery technologies and serving customers within the
health sector in 50 different countries around the globe.

Forward Looking Statement

This press release includes statements that may constitute "forward-looking
statements", including projections of certain measures of Akorn's results of
operations, projections of certain charges and expenses, and other statements
regarding Akorn's goals, regulatory approvals and strategy. Akorn cautions
that these forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those indicated in the
forward-looking statements. These statements are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995.
Because such statements inherently involve risks and uncertainties, actual
future results may differ materially from those expressed or implied by such
forward-looking statements. You can identify these statements by the fact that
they do not relate strictly to historical or current facts. They use words
such as "anticipate," "estimate," "expect," "project," "intend," "plan,"
"believe," and other words and terms of similar meaning in connection with a
discussion of future operating or financial performance. Factors that could
cause or contribute to such differences include, but are not limited to:
statements relating to future steps we may take, prospective products, future
performance or results of current and anticipated products, sales efforts,
expenses, the outcome of contingencies such as legal proceedings, and
financial results. These cautionary statements should be considered in
connection with any subsequent written or oral forward-looking statements that
may be made by the company or by persons acting on its behalf and in
conjunction with its periodic SEC filings. You are advised, however, to
consult any further disclosures we make on related subjects in our reports
filed with the SEC. In particular, you should read the discussion in the
section entitled "Cautionary Statement Regarding Forward-Looking Statements"
in our most recent Annual Report on Form 10-K, as it may be updated in
subsequent reports filed with the SEC. That discussion covers certain risks,
uncertainties and possibly inaccurate assumptions that could cause our actual
results to differ materially from expected and historical results. Other
factors besides those listed there could also adversely affect our results.

Contact:

At the Company:
Akorn, Inc.
Tim Dick, Chief Financial Officer
(847) 279-6150
 
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