ANI Pharmaceuticals Announces Two Generic Product Launches

Wednesday, March 27, 2019 Press Release
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BAUDETTE, Minn., March 27, 2019 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (Nasdaq: ANIP) today announced

the launch of 18mg and 27mg Methylphenidate Hydrochloride Extended-Release Tablets, indicated as a treatment for Attention Deficit Hyperactivity Disorder ("ADHD"). The current annual U.S. market for these two strengths of the product is approximately
$505 million, according to Iqvia.

Also today, ANI announced the launch of Erythromycin Ethylsuccinate for Oral Suspension 400mg/5mL, indicated as a treatment for various infections. The current annual U.S. market for this product is approximately $16 million, according to Iqvia.

After today's announced launches, ANI's generic commercial portfolio now consists of 33 products.

About Methylphenidate Hydrochloride Extended-Release Tablets

Methylphenidate Hydrochloride Extended-Release Tablets are a CNS stimulant indicated for the treatment of ADHD in children 6 years of age and older, adolescents, and adults up to the age of 65. For more information, including the complete list of indications and usages, please see the Full Prescribing Information.

About Erythromycin Ethylsuccinate for Oral SuspensionErythromycin Ethylsuccinate for Oral Suspension is indicated in the treatment of infections caused by susceptible strains of selected diseases. For more information, including the complete list of indications and usages, please see the Full Prescribing Information.

About ANI

ANI is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website

Forward-Looking Statements 

To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about price increases, the Company's future operations, products financial position, operating results and prospects , the Company's pipeline or potential markets therefor, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," other words of similar meaning, derivations of such words and the use of future dates. 

Uncertainties and risks may cause the Company's actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; increased competition; acquisitions; contract manufacturing arrangements; delays or failure in obtaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing.

More detailed information on these and additional factors that could affect the Company's actual results are described in the Company's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as its proxy statement. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company's current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information about ANI, please contact:Investor


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SOURCE ANI Pharmaceuticals, Inc.

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