ANI Pharmaceuticals Announces the Launch of Misoprostol Tablets

Rhea-AI Summary

ANI Pharmaceuticals has launched Misoprostol Tablets in 100 mcg and 200 mcg strengths, positioned as the generic counterpart to Cytotec®.

The U.S. market for these tablets is valued at approximately $15.3 million. The product holds an AB rating, ensuring its bioequivalence to the reference drug, which enhances its competitive edge amidst a recent market shortage.

ANI aims to fulfill the demand for limited market competition in generics, emphasizing its commitment to patient needs and sustainable growth.

Positive

• Launch of Misoprostol Tablets, potentially increasing revenue from a market worth $15.3 million.
• AB rating indicates strong market positioning and therapeutic equivalence to Cytotec®.
• Addresses recent drug shortages, enhancing company reputation and patient outreach.

Negative

• None.

BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced the launch of Misoprostol Tablets, 100 mcg and 200 mcg.

ANI’s Misoprostol Tablets are the generic version of the Reference Listed Drug (RLD) Cytotec^®. The current annual U.S. market for Misoprostol Tablets, 100 mcg and 200 mcg is approximately $15.3 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"We are pleased to announce the launch of AB rated Misoprostol Tablets. The AB rating indicates that our product meets necessary bioequivalence requirements, thus is therapeutically equivalent to the RLD. This rating provides us with an advantage versus other available generics. In light of the recent drug shortage, the commercialization of Misoprostol Tablets highlights our commitment to rapidly bringing limited market competition generic products to our patients in need and to our customers,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

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 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220411005212/en/

Investor Relations:

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

T: 212-452-2793

E: lwilson@insitecony.com

Media Contact:

Angela Salerno-Robin

dna Communications

T: 212-445-8219

E: ASalerno-Robin@dna-comms.com

Source: ANI Pharmaceuticals, Inc.

FAQ

What is the significance of ANI's launch of Misoprostol Tablets for investors?

The launch opens access to an estimated $15.3 million U.S. market, potentially boosting revenue for ANI.

What does the AB rating of Misoprostol Tablets mean for ANI?

The AB rating confirms bioequivalence to Cytotec®, giving ANI a competitive edge in the market.

How does the recent drug shortage impact ANI Pharmaceuticals?

The launch of Misoprostol Tablets aims to mitigate the effects of a drug shortage, potentially positioning ANI favorably in the market.

What is the expected market size for Misoprostol Tablets?

The current annual U.S. market for Misoprostol Tablets is approximately $15.3 million.

How does this product launch fit into ANI's strategic goals?

The launch supports ANI's commitment to developing generic products to meet patient needs and drive sustainable growth.