ANI Pharmaceuticals Announces the FDA Approval of Colestipol Hydrochloride Tablets USP

Rhea-AI Summary

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has received FDA approval for its Abbreviated New Drug Application (ANDA) for Colestipol Hydrochloride Tablets USP, 1 g, a generic version of Colestid®.

This market is valued at approximately $81.3 million annually in the U.S., according to IQVIA/IMS Health. CEO Nikhil Lalwani noted the launch expands their generics portfolio, emphasizing the limited suppliers for this product.

ANI aims to enhance its growth through access to high-quality medicines and strengthening its generics business.

Positive

• FDA approval for Colestipol Hydrochloride Tablets opens access to a market worth approximately $81.3 million annually.
• Expansion of generics portfolio may lead to increased market share and revenue potential.

Negative

• None.

BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Colestipol Hydrochloride Tablets USP, 1 g.

ANI’s Colestipol Hydrochloride Tablets are the generic version of the Reference Listed Drug (RLD) Colestid^®. The current annual U.S. market for Colestipol Hydrochloride Tablets is approximately $81.3 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"We are pleased to expand our generics portfolio with the launch of Colestipol, bringing to market a product with a limited number of suppliers. We remain committed to providing patients access to high-quality medicines,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

About ANI

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) 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 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 and other ingredients and supplies necessary for manufacture of our products; 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, including the ongoing impact of and uncertainties regarding the COVID-19 pandemic and inflationary pressures; 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230404005060/en/

Investor Relations:

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

T: 212-452-2793

E: lwilson@insitecony.com

Source: ANI Pharmaceuticals, Inc.

FAQ

What is Colestipol Hydrochloride Tablets approved by FDA?

Colestipol Hydrochloride Tablets USP, 1 g is a generic medication approved by the FDA, serving as a treatment similar to the branded Colestid®.

What is the market potential for Colestipol Hydrochloride Tablets?

The annual U.S. market for Colestipol Hydrochloride Tablets is approximately $81.3 million, indicating significant revenue potential for ANI.

What does the FDA approval mean for ANI Pharmaceuticals?

The FDA approval allows ANI Pharmaceuticals to launch Colestipol Hydrochloride Tablets, expanding its generics portfolio and potentially increasing revenue.

How does ANI Pharmaceuticals plan to leverage the new product?

ANI aims to strengthen its generics business with the launch of Colestipol, focusing on providing high-quality medicines to patients with limited alternatives.