ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Dexamethasone Tablets USP

Rhea-AI Summary

ANI Pharmaceuticals, Inc. received FDA approval for its Dexamethasone Tablets USP in 1.5mg, 4mg, and 6mg dosages, entering a market valued at approximately $59.8 million. This approval underscores ANI's commitment to delivering generic products with limited competition. ANI ranked sixth among companies for ANDA approvals in the past year, highlighting its robust R&D capabilities. The launch of Dexamethasone Tablets is anticipated to bolster revenue and market presence.

Positive

• FDA approval for Dexamethasone Tablets opens access to a $59.8 million market.
• Ranked sixth in ANDA approvals over the past year, indicating strong R&D performance.

Negative

• None.

BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Dexamethasone Tablets USP 1.5mg, 4mg and 6mg.

ANI’s Dexamethasone Tablets USP 1.5mg, 4mg and 6mg are the generic version of the Reference Listed Drug (RLD) Decadron^®. The current annual U.S. market for Dexamethasone Tablets USP 1.5mg, 4mg and 6mg is approximately $59.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"The FDA approval and imminent launch of Dexamethasone Tablets further demonstrates our commitment to serve patients in need by bringing limited competition products to market. Our R&D team continues to build on their strong track record and we ranked sixth among all companies in terms of the number of ANDA approvals received in the past 12 months,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

About ANI

ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin^® Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.

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, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, 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; competition from other products; acquisitions; contract manufacturing arrangements; delays or failure in obtaining and maintaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development and commercialization; 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 (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. 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.

All brand names listed are the registered trademarks of their respective owners.

Source: ANI Pharmaceuticals, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220816005393/en/

Investor Relations:

Lisa M. Wilson, In-Site Communications, Inc.

212-452-2793

lwilson@insitecony.com

Media:

Faith Pomeroy-Ward, ANI Pharmaceuticals, Inc.

817-807-8044

Faith.pomeroyward@anipharmaceuticals.com

Source: ANI Pharmaceuticals, Inc.

FAQ

What is the significance of ANI Pharmaceuticals receiving FDA approval for Dexamethasone Tablets?

The approval allows ANI to market its Dexamethasone Tablets in three dosages, capturing a portion of the $59.8 million U.S. market.

What potential sales can ANI Pharmaceuticals expect from the Dexamethasone Tablets launch?

Given the annual market value of approximately $59.8 million, ANI could see significant revenue growth from this product.

How does the approval of Dexamethasone Tablets impact ANI Pharmaceuticals' market position?

The approval enhances ANI's product portfolio and strengthens its competitive edge in the generics market.

When will ANI Pharmaceuticals launch the Dexamethasone Tablets?

The company has indicated an imminent launch following FDA approval.