PRINCETON, N.J., April  20, 2026  (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced the launch of Pimozide Tablets 1 mg and 2 mg. ANI&#39;s Pimozide Tablets is the generic

ANIP

ANI Pharmaceuticals Announces the FDA Approval and Launch of Pimozide Tablets with 180 Day CGT Exclusivity

ANI Pharmaceuticals Launches Pimozide Tablets with 180-Day Exclusivity

<section class="insight" data-version="1">
  <section data-block="information">
    <h3>Information</h3>
    <p>PRINCETON, N.J., April  20, 2026  (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced the launch of Pimozide Tablets 1 mg and 2 mg. ANI&amp;#39;s Pimozide Tablets is the generic</p>
  </section>

  <section data-block="ai-summary-paragraph">
    <h3>AI Summary</h3>
    <p>ANI Pharmaceuticals has launched Pimozide Tablets, the generic version of Orap, with 180-day CGT exclusivity, amid U.S. sales totaling $3.1 million annually. This move enhances ANI&#039;s generics offering and could increase market share in a competitive landscape.</p>
  </section>

  <section data-block="ai-summary-bullets">
    <h3>Key Points</h3>
    <ul><li>ANI Pharmaceuticals launched Pimozide Tablets 1 mg and 2 mg.</li><li>The product has 180-day CGT exclusivity, limiting competition.</li><li>U.S. annual sales for Pimozide are approximately $3.1 million.</li><li>Launch supports ANI&#039;s generics strategy and market share growth.</li><li>Company emphasizes sustainability in its Rare Disease and Generics businesses.</li></ul>
  </section>

  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Otsuka Pharmaceutical Co., Ltd. (N/A)</strong>: Otsuka markets the branded Orap, facing competition from ANI&#039;s Pimozide.</li></ul>
  </section>

  <section data-block="category">
    <h3>Corporate Developments</h3>
    <p>This launch fits in the Corporate Developments category, highlighting ANI&#039;s strategic efforts to enhance its generics portfolio against competitive pressures.</p>
  </section>

  <section data-block="market-moving">
    <h3>Market-Moving</h3>
    <ul><li>180-day CGT exclusivity for Pimozide could significantly boost ANIP&#039;s sales.</li><li>Limited competition enhances ANIP&#039;s market position in the generics space.</li><li>Pimozide&#039;s $3.1 million sales potential reflects positive revenue impact.</li><li>Continued focus on sustainable growth could attract investor interest.</li></ul>
  </section>

  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>Pimozide launched on April 20, 2026.</li><li>The product is priced at 1 mg and 2 mg doses.</li><li>U.S. annual sales for the drug are approximately $3.1 million.</li><li>The company is operationally focused on rare diseases.</li><li>ANI emphasizes generic pharmaceuticals leveraging R&amp;D expertise.</li></ul>
  </section>

  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>Invest in ANIP for potential short-term growth driven by product launch success.</p>
  </section>
</section>


<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link><p align="justify">PRINCETON, N.J., April  20, 2026  (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ANIP">ANIP</a>) today announced the launch of Pimozide Tablets 1 mg and 2 mg. ANI's Pimozide Tablets is the generic version of the reference listed drug (RLD) Orap<sup>&#xAE;</sup>.</p>  <p align="justify">&#34;We are proud to announce the launch of Pimozide Tablets with 180-Day CGT exclusivity. We are excited to bring limited competition products to market and continue to provide generic alternatives to our customers and patients," stated Nikhil Lalwani, President and Chief Executive Officer of ANI. </p>  <p align="justify">U.S. annual sales for Pimozide Tablets total approximately $3.1 million, based on February 2026 moving annual total (MAT) IQVIA data.<br></br></p>  <p align="justify"><strong>About ANI Pharmaceuticals, Inc.</strong></p>  <p align="justify">ANI Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ANIP">ANIP</a>) is a diversified biopharmaceutical company committed to its mission of "Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&amp;D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit <a href="https://www.globenewswire.com/Tracker?data=3REMWjDsb4QCx762H0I7-iiyBlrhVm08RJbZte9P9cScTJiEK8YTnNETZKANHyjqPto_C81H3_hraRoQ5GJ0nUzSCL9QjRmxR2kI97W3DceLdCnIsUGwdS-HYMjjoQVE" rel="nofollow" target="_blank">www.anipharmaceuticals.com</a>.<br></br></p>  <p align="justify"><strong>Forward-Looking Statements</strong></p>  <p align="justify">To the extent any statements made in this release relate to 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, statements regarding the Company's strategy; its plans with respect to the commercialization and potential sales of the Company's products, including the launch of Pimozide Tablets; its efforts to bring limited-competition products to market and ensure that is high-quality products are readily accessible to its customers and patients in need; expansion plans for the Company's Rare Disease, Generics and Brands businesses; and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates.</p>  <p align="justify">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 ability of the Company's approved products to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; delays and disruptions in the production of the Company's approved products; delays or failure to obtain or maintain approvals by the FDA of the Company's products; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies; risks that the Company may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of the Company's products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of the Company's manufacturing partners to meet its product demands and timelines; the level of competition the Company faces and the legal, regulatory and/or legislative strategies employed by its competitors to prevent or delay competition from generic alternatives to branded products; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the Company's ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; and general business and economic conditions, such as inflationary pressures and geopolitical conditions.</p>  <p align="justify">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, and other periodic reports, 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.</p>  <p><strong>Investor Relations:</strong><br></br>Courtney Mogerley, Argot Partners<br></br>T: 646-368-8014<br></br>E: <a href="https://www.globenewswire.com/Tracker?data=1O62LPBcOmxQDOzmOrGGh0ZJbuap_Bkf-11b5XFx7ZUpG_eaewoDSW65cxYQzP3cSyzAHLNHnp0tLdKnyqGLlu6VN2vYUmZw3hoIa1umBcI=" rel="nofollow" target="_blank">ani@argotpartners.com</a> </p>  <p>Source: ANI Pharmaceuticals, Inc.</p> <img alt="" class="__GNW8366DE3E__IMG" src="https://www.globenewswire.com/newsroom/ti?nf=OTY5MjM1NCM3NTQyMjYxIzIwMTkyNjA="></img> <br></br><img alt="" src="https://ml.globenewswire.com/media/NGNjYTM5MTEtNDE2MC00ZWUxLTgzMmQtNDRiZmRjMTYwODNhLTEwMzA4MzMtMjAyNi0wNC0yMC1lbg==/tiny/ANI-Pharmaceuticals-Inc-.png" referrerpolicy="no-referrer-when-downgrade"></img><p><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/24d1d851-9075-4d6e-b22c-0c23a5ef0b36"><img src="https://ml.globenewswire.com/media/24d1d851-9075-4d6e-b22c-0c23a5ef0b36/small/ani-logo-png.png" border="0" width="150" height="63" alt="Primary Logo"></img></a></p>

ANI Pharmaceuticals has launched Pimozide Tablets, the generic version of Orap, with 180-day CGT exclusivity, amid U.S. sales totaling $3.1 million annually. This move enhances ANI's generics offering and could increase market share in a competitive landscape.

ANI Pharmaceuticals Announces the FDA Approval and Launch of Pimozide Tablets with 180 Day CGT Exclusivity

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