ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Clorazepate Dipotassium Tablets USP

Rhea-AI Summary

ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has received FDA approval for its Clorazepate Dipotassium Tablets, a generic version of Tranxene^®. The U.S. market for this product is approximately $25.8 million, as reported by IQVIA/IMS Health. CEO Nikhil Lalwani highlighted this launch as part of ANI's commitment to expanding access to essential therapeutics. The Company continues to focus on sustainable growth through new product launches and strengthening its generics portfolio.

Positive

• FDA approval of Clorazepate Dipotassium Tablets enhances product portfolio.
• Launch could generate approximately $25.8 million in annual sales.
• Strengthening of generics business through new product launches.

Negative

• Potential competition from other generic products in the market.
• Risks associated with importing raw materials and obtaining regulatory approvals.

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 Clorazepate Dipotassium Tablets.

ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene^®. The current annual U.S. market for Clorazepate Dipotassium Tablets is approximately $25.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"We continue to strengthen our base business with new product launches. The imminent launch and commercialization of Clorazepate Dipotassium Tablets is another example of our ongoing commitment to ensuring that patients in need have access to important therapeutics,” 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 launch and commercialization and potential sales of Clorazepate Dipotassium Tablets and any additional product launches from the Company’s generic pipeline 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 risks that the Company may face with respect to: importing raw materials; competition from other products; 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 (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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220622005246/en/

Investor Relations:

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

212-452-2793

lwilson@insitecony.com

Media:

Angela Salerno-Robin

dna Communications

212-445-8219

ASalerno-Robin@dna-comms.com

Source: ANI Pharmaceuticals, Inc.

FAQ

What is the recent FDA approval by ANI Pharmaceuticals about?

ANI Pharmaceuticals received FDA approval for Clorazepate Dipotassium Tablets, a generic version of Tranxene^®.

How much is the U.S. market for Clorazepate Dipotassium Tablets?

The current annual U.S. market for Clorazepate Dipotassium Tablets is approximately $25.8 million.

What are the potential sales for ANI Pharmaceuticals after this product launch?

The launch of Clorazepate Dipotassium Tablets could generate significant revenue, estimated at around $25.8 million annually.

What are the risks associated with the launch of Clorazepate Dipotassium Tablets?

Risks include competition from other generic products and uncertainties in importing raw materials and regulatory approvals.