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ANI Pharmaceuticals Announces the FDA Approval and Launch of Indomethacin Oral Suspension, USP

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ANI Pharmaceuticals, Inc. received FDA approval for the Abbreviated New Drug Application for Indomethacin Oral Suspension, a generic version of the Reference Listed Drug Indocin® Oral Suspension. The U.S. market for Indomethacin OS is valued at $4.1 million annually. The FDA granted Indomethacin OS a Competitive Generic Therapy designation with 180-day exclusivity. ANI holds the second highest number of CGT approvals in the U.S. Generics market, showcasing their strong R&D capabilities.
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The FDA's approval of ANI Pharmaceuticals' ANDA for Indomethacin Oral Suspension is a significant milestone for the company, particularly as it comes with a Competitive Generic Therapy (CGT) designation. This designation not only underscores the company's strategic positioning within the generic drug market but also grants them a 180-day exclusivity period. During this time, ANI will be the sole provider of the generic version of Indocin® Oral Suspension, which could potentially lead to a temporary surge in revenue.

From a market perspective, the exclusivity period is a critical factor that can influence stock performance, as investors often view such FDA approvals as positive indicators of a company's growth potential. However, considering the current annual U.S. market for Indomethacin OS stands at approximately $4.1 million, the impact on ANI's overall financial performance may be moderate, given the relative size of this market segment in comparison to the broader pharmaceutical industry.

The CGT designation is a regulatory incentive created to encourage the development of generic drugs for products with inadequate competition. It is an important tool for reducing healthcare costs and improving access to medications. ANI's receipt of this designation signals not only a win for the company but also for the healthcare system in terms of cost savings and patient access. Yet, the economic impact of this approval should be analyzed in the context of the drug's market size and the duration of exclusivity.

While the exclusivity can lead to a temporary monopoly-like situation, allowing ANI to set the price without immediate generic competition, the long-term benefits will depend on how the company leverages this period to establish a strong market presence. Post-exclusivity, the price dynamics and market share will likely change as other generic competitors enter the market.

The generic pharmaceutical market is highly competitive and the successful launch of a generic product can be pivotal for a company's market share. ANI's track record of holding the second-highest number of CGT approvals is noteworthy and may be indicative of the company's ability to efficiently navigate the regulatory landscape and capitalize on market opportunities.

Market intelligence, such as that provided by IQVIA/IMS Health, plays a crucial role in understanding the potential revenue streams from new generic drug approvals. Investors and stakeholders should monitor how ANI's market strategy for Indomethacin OS unfolds, particularly how it manages production, distribution and marketing during the exclusivity period to maximize the potential benefits.

BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) --  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 Indomethacin Oral Suspension (OS), USP.

ANI’s Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension. The current annual U.S. market for Indomethacin OS is approximately $4.1 million, according to the latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider.

"With this approval, the FDA has granted Indomethacin OS a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity. ANI continues to hold the second highest number of CGT approvals in the U.S. Generics market, highlighting the strong capabilities and execution of our Generics R&D team. We are happy to leverage the CGT pathway to provide our customers and patients in need with expanded access to high quality generics for limited competition products,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.        

About ANI
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) 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 scaling up our Rare Disease business through the successful launch of our lead asset, Purified Cortrophin® Gel, strengthening our generics business with enhanced research and 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; delays or failure in obtaining and maintaining product approval from the U.S. Food and Drug Administration (“FDA”); changes in policy or actions taken by the FDA and other regulatory agencies, including drug recalls; the ability of our manufacturing partners to meet our product demands and timelines; acceptance of our products at levels that will allow us to achieve profitability; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; the impact of legislative or regulatory reform on the pricing for pharmaceuticals products; issues with product quality, manufacturing or supply, or patient safety issues; general business and economic conditions, including the ongoing impact of and uncertainties regarding the COVID-19 pandemic and inflationary pressures as well as geopolitical conditions, including the conflict between Russia and Ukraine.

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.

Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Source: ANI Pharmaceuticals, Inc.


ANI Pharmaceuticals, Inc. received FDA approval for the Abbreviated New Drug Application for Indomethacin Oral Suspension, a generic version of the Reference Listed Drug Indocin® Oral Suspension.

The current annual U.S. market for Indomethacin OS is approximately $4.1 million.

The FDA granted Indomethacin OS a Competitive Generic Therapy designation with 180-day exclusivity.

ANI holds the second highest number of CGT approvals in the U.S. Generics market, showcasing their strong R&D capabilities.
ANI Pharmaceuticals Inc

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About ANIP

ani pharmaceuticals is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals. we focus on niche and high barrier to entry opportunities including controlled substances, anti-cancer (oncolytics), hormones and steroids, and complex formulations. our two pharmaceutical manufacturing facilities located in baudette, minnesota are capable of producing oral solid dose products, as well as liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment. our objective is to create long term shareholder value by building a sustainable and growing base business in generic and mature brand pharmaceutical products while advancing an opportunity to re-commercialize cortrophin gel and cortrophin-zinc.