ANI Pharmaceuticals Announces the FDA Approval and Launch of L-Glutamine Oral Powder
ANI Pharmaceuticals (Nasdaq: ANIP) has announced the FDA approval and launch of L-Glutamine Oral Powder, the first AA-rated generic version of Endari®. This approval showcases the company's strong R&D capabilities and execution. The product aims to provide patients and healthcare providers with access to high-quality therapeutics.
Key points:
- L-Glutamine Oral Powder is an Abbreviated New Drug Application (ANDA)
- U.S. annual sales for the product are approximately $20.1 million (based on May 2024 IQVIA data)
- The launch demonstrates ANI's commitment to expanding its product portfolio and addressing market needs
- FDA approval and launch of L-Glutamine Oral Powder, the first AA-rated generic version of Endari®
- Potential revenue opportunity with U.S. annual sales for L-Glutamine Oral Powder at approximately $20.1 million
- Demonstration of strong R&D capabilities and execution
- None.
Insights
The FDA approval and subsequent launch of L-Glutamine Oral Powder by ANI Pharmaceuticals signifies an important milestone for the company's revenue stream. Approval for a generic version of a reference drug, especially one that is AA-rated, suggests that ANI’s product is therapeutically equivalent to Endari®. With this product entering the market, ANI stands to potentially capture a significant share of the
From an investment perspective, this approval may enhance ANI's market position and contribute positively to its earnings. However, it's important to consider the competitive landscape. The presence of other generic manufacturers could pressure ANI on pricing and market share. Investors should also monitor ANI's ability to ramp up production and distribution efficiently.
Long-term implications include the potential for ANI to leverage this success in obtaining approvals for additional generic medications, thus diversifying and strengthening their product portfolio.
For investors, the launch of L-Glutamine Oral Powder into a market with
However, market dynamics should be carefully observed. The introduction of a generic variant often leads to pricing adjustments to stay competitive. This could influence the overall market size and ANI’s revenue share. Moreover, the ability of ANI to secure market penetration through effective marketing and distribution will be a key determinant of their success in this endeavor.
In the short term, the news could positively affect ANI’s stock price due to the perceived immediate revenue prospects. In the long term, it offers a growth potential based on the company's ability to maintain or expand its market share in this category.
PRINCETON, N.J., July 15, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI’s L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari®.
"The approval and launch of L-Glutamine Oral Powder, the first AA-rated approved generic to Endari®, continues to demonstrate the strong capabilities and execution of our R&D team. We remain focused on ensuring that patients in need, and the providers who care for them, have access to our high-quality therapeutics,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
U.S. annual sales for L-Glutamine Oral Powder total approximately
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 is the newly approved product by ANI Pharmaceuticals (ANIP)?
What is the market potential for ANI Pharmaceuticals' (ANIP) L-Glutamine Oral Powder?
When did ANI Pharmaceuticals (ANIP) launch L-Glutamine Oral Powder?
What type of application did ANI Pharmaceuticals (ANIP) submit for L-Glutamine Oral Powder?
