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ANI Pharmaceuticals Announces the FDA Approval and Launch of Naproxen Delayed-Release Tablets, USP

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ANI Pharmaceuticals has announced the FDA approval and launch of Naproxen Delayed-Release Tablets, USP, which is a generic version of EC-Naprosyn®. This product received first-cycle approval, allowing ANI to quickly commercialize it.

The U.S. market for Naproxen Delayed-Release Tablets is valued at approximately $36.7 million annually, based on April 2024 IQVIA data. Nikhil Lalwani, President and CEO of ANI, emphasized the company's commitment to growth through effective new product launches.

Positive
  • FDA approval for Naproxen Delayed-Release Tablets, allowing market entry.
  • First-cycle approval, indicating efficient regulatory submission.
  • Market potential of $36.7 million annually in the U.S., enhancing revenue opportunities.
Negative
  • None.

The approval and subsequent launch of Naproxen Delayed-Release Tablets by ANI Pharmaceuticals is notable from a financial perspective. The U.S. annual sales for the generic equivalent of EC-Naprosyn® are approximately $36.7 million, offering ANI a substantial revenue opportunity. First-cycle FDA approval is particularly significant as it indicates the product met regulatory standards quickly, minimizing any potential delay in market entry. This efficiency can translate to quicker revenue generation and further solidifies ANI's capability in navigating the regulatory landscape.

However, it's essential to consider that the generic drug market is highly competitive with thin profit margins. ANI’s ability to capture and sustain market share against other generics will be crucial. Pricing strategies and production efficiencies will play a significant role in determining the financial performance of this product.

From a market research perspective, the entry of ANI's Naproxen Delayed-Release Tablets into the market will likely impact not just ANI but also its competitors. With U.S. annual sales at $36.7 million, there is an evident demand for this type of medication. The swift FDA approval suggests that ANI has robust regulatory compliance mechanisms, which can be a competitive advantage.

However, the market for generic medications often experiences price erosion due to multiple entrants. ANI's success will depend on their marketing strategy, distribution efficiency and pricing competitiveness. Additionally, patient and physician adoption will be critical – ANI must ensure that their product is perceived as a viable and trusted alternative to the branded version. This launch also aligns well with ANI's broader strategy of expanding their portfolio with high-demand generics, potentially improving their market positioning.

PRINCETON, N.J., July 02, 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) and launched Naproxen Delayed-Release Tablets, USP. ANI’s Naproxen Delayed-Release Tablets is the generic version of the reference listed drug (RLD) EC-Naprosyn®.

"We are pleased to announce the first cycle FDA approval and commercialization of Naproxen Delayed-Release Tablets. ANI remains committed to driving growth through superior new product launch execution, in keeping with our purpose of ‘Serving Patients, Improving Lives,’” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

U.S. annual sales for Naproxen Delayed-Release Tablets total approximately $36.7 million, based on April 2024 moving annual total (MAT) IQVIA data.

About ANI Pharmaceuticals, Inc.

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. The Company is focused on delivering sustainable growth by scaling up its Rare Disease business through its lead asset Purified Cortrophin® Gel, strengthening its Generics business with enhanced research and development capabilities, delivering innovation in Established Brands, and leveraging its U.S. based manufacturing footprint. For more information, visit 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: acquisitions and other investments could disrupt our business and harm our financial position and operating results; the limited number of suppliers for our active pharmaceutical ingredients could result in lengthy delays in production if we need to change suppliers; the risk that the Company may face with respect to importing raw materials and other ingredients and supplies necessary for manufacture of its products from both domestic and overseas sources due to supply chain disruptions or any other reason; delays or failure in obtaining and maintaining product approval from the U.S. Food and Drug Administration (“FDA”) of the products we sell; changes in policy, guidelines or actions taken by the FDA and other regulatory agencies, including drug recalls; the ability of the Company’s 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; our ability to protect our intellectual property rights; our ability to retain the services of our key executives and other personnel; 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 but not limited to the conflict between Russia and Ukraine, the conflict between Israel and Gaza, or conflicts relating to attacks on cargo ships in the Red Sea.

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.


FAQ

What product did ANI Pharmaceuticals receive FDA approval for in July 2024?

ANI Pharmaceuticals received FDA approval for Naproxen Delayed-Release Tablets, USP in July 2024.

What is the market value for Naproxen Delayed-Release Tablets, USP?

The market value for Naproxen Delayed-Release Tablets, USP is approximately $36.7 million annually in the U.S.

How did ANI Pharmaceuticals describe the FDA approval for Naproxen Delayed-Release Tablets?

ANI Pharmaceuticals described the FDA approval for Naproxen Delayed-Release Tablets as a first-cycle approval, highlighting quick commercialization.

Who announced ANI Pharmaceuticals' commitment to growth through new product launches?

Nikhil Lalwani, President and CEO of ANI Pharmaceuticals, announced the company's commitment to growth through new product launches.

What is the generic version of EC-Naprosyn® launched by ANI Pharmaceuticals?

ANI Pharmaceuticals launched Naproxen Delayed-Release Tablets, USP as the generic version of EC-Naprosyn®.

ANI Pharmaceuticals, Inc.

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