ANI Pharmaceuticals Announces the Launch of Acebutolol Hydrochloride Capsules USP

Rhea-AI Summary

ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) has launched Acebutolol Hydrochloride Capsules, the generic equivalent of Sectral®. The U.S. market for this medication is valued at approximately $10 million annually, according to IQVIA/IMS Health. CEO Nikhil Lalwani emphasized the company's focus on addressing patient needs and its successful track record in reintroducing older ANDAs. The firm aims for growth through innovation in generics and branded products while navigating potential risks such as competition and regulatory approvals.

Positive

• Launch of Acebutolol Hydrochloride Capsules, entering a limited-competition market.
• Estimated $10 million annual market for Acebutolol Hydrochloride Capsules.
• Strong track record in bringing back older ANDAs to market.

Negative

• Risks associated with competition from other products.
• Potential delays or failures in obtaining FDA approvals.

BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced the launch of Acebutolol Hydrochloride Capsules.

ANI’s Acebutolol Hydrochloride Capsules are the generic version of the Reference Listed Drug (RLD) Sectral^®. The current annual U.S. market for Acebutolol Hydrochloride Capsules is approximately $10.0 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"We are pleased to announce the launch and immediate commercialization of Acebutolol Hydrochloride Capsules, marking another entry into a limited-competition market. Keeping patient and customer needs top of mind, ANI has built a successful track record of bringing back to market older ANDAs from its library of those already approved,” 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; 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.

Source: ANI Pharmaceuticals, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220803005175/en/

Investor Relations:

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

T: 212-452-2793

E: lwilson@insitecony.com

Media Contact:

Faith Pomeroy-Ward, ANI Pharmaceuticals

T: 817-807-8044

E: Faith.pomeroyward@anipharmaceuticals.com

Source: ANI Pharmaceuticals, Inc.

FAQ

What is the recent product launched by ANI Pharmaceuticals?

ANI Pharmaceuticals recently launched Acebutolol Hydrochloride Capsules, a generic version of Sectral®.

What is the market size for Acebutolol Hydrochloride Capsules?

The annual U.S. market for Acebutolol Hydrochloride Capsules is approximately $10 million.

What are the potential risks mentioned in ANI Pharmaceuticals' press release?

Potential risks include competition from other products and delays in obtaining FDA approvals.

How does ANI Pharmaceuticals plan to grow its business?

ANI Pharmaceuticals aims for growth through innovations in generics and strengthening its branded product offerings.