ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Rifabutin Capsules USP

Rhea-AI Summary

ANI Pharmaceuticals, Inc. announced FDA approval for its Rifabutin Capsules USP, 150 mg, a generic version of Mycobutin^®. The U.S. market for this drug is valued at approximately $16.6 million annually, indicating strong commercial potential. CEO Nikhil Lalwani emphasized the company's robust R&D capabilities and commitment to addressing market needs with limited competition generics. This approval marks a significant step in ANI's strategy to enhance its generics portfolio and drive sustainable growth.

Positive

• FDA approval for Rifabutin Capsules enhances product portfolio.
• Market potential of approximately $16.6 million annually.
• Strengthens ANI's position in the generic pharmaceuticals sector.

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 for Rifabutin Capsules USP, 150 mg.

ANI’s Rifabutin Capsules are the generic version of the reference listed drug Mycobutin^®. The current annual U.S. market for Rifabutin Capsules USP, 150 mg is approximately $16.6 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"We are pleased to announce the approval and imminent launch of Rifabutin Capsules. The approval and commercialization of a second generic Rifabutin highlights further the strength of our R&D engine and our ability to rapidly bring limited market competition generic products to our patients in need and to our customers,” stated Nikhil Lalwani, President and CEO.

About ANI

ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical 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 development, manufacturing and commercialization 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 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/20211221005173/en/

Investor Relations:

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

T: 212-452-2793

E: lwilson@insitecony.com



Media:

Angela Salerno-Robin

dna Communications

T: 212-445-8219

E:  ASalerno-Robin@dna-comms.com

Source: ANI Pharmaceuticals, Inc.

FAQ

What drug did ANI receive FDA approval for?

ANI received FDA approval for Rifabutin Capsules USP, 150 mg.

What is the market size for Rifabutin Capsules?

The annual U.S. market for Rifabutin Capsules USP, 150 mg is approximately $16.6 million.

How does this approval impact ANI Pharmaceuticals?

The approval enhances ANI's generics portfolio and market position.

Who is the CEO of ANI Pharmaceuticals?

The CEO of ANI Pharmaceuticals is Nikhil Lalwani.