ANI Pharmaceuticals Announces the FDA Approval and Launch of Prucalopride Tablets with 180-Day CGT Exclusivity
ANI Pharmaceuticals (Nasdaq: ANIP) has received FDA approval and launched Prucalopride Tablets, the first generic version of Motegrity®. The company secured a Competitive Generic Therapy (CGT) designation with 180-day exclusivity for this product. This achievement reinforces ANI's position as the holder of the second-highest number of CGT approvals in the U.S. Generics market. According to IQVIA data from October 2024, the U.S. annual market for Prucalopride Tablets is approximately $168.0 million.
ANI Pharmaceuticals (Nasdaq: ANIP) ha ricevuto l'approvazione della FDA e ha lanciato Prucalopride Tablets, la prima versione generica di Motegrity®. L'azienda ha ottenuto una designazione di Competitive Generic Therapy (CGT) con un'esclusività di 180 giorni per questo prodotto. Questo traguardo rafforza la posizione di ANI come detentrice del secondo numero più alto di approvazioni CGT nel mercato dei generici negli Stati Uniti. Secondo i dati di IQVIA di ottobre 2024, il mercato annuale statunitense per le Prucalopride Tablets è di circa $168.0 milioni.
ANI Pharmaceuticals (Nasdaq: ANIP) ha recibido la aprobación de la FDA y ha lanzado Prucalopride Tablets, la primera versión genérica de Motegrity®. La compañía obtuvo una designación de Competitive Generic Therapy (CGT) con una exclusividad de 180 días para este producto. Este logro refuerza la posición de ANI como titular del segundo mayor número de aprobaciones CGT en el mercado de genéricos de EE. UU. Según datos de IQVIA de octubre de 2024, el mercado anual de Prucalopride Tablets en EE. UU. es de aproximadamente $168.0 millones.
ANI Pharmaceuticals (Nasdaq: ANIP)는 FDA 승인을 받고 Prucalopride Tablets를 출시했습니다. 이는 Motegrity®의 첫 번째 제네릭 버전입니다. 이 회사는 이 제품에 대해 180일 독점권을 가진 Competitive Generic Therapy (CGT) 지정을 확보했습니다. 이 성과는 ANI가 미국 제네릭 시장에서 두 번째로 많은 CGT 승인을 보유한 기업임을 강화합니다. 2024년 10월 IQVIA 데이터에 따르면, 미국 내 Prucalopride Tablets 연간 시장 규모는 약 $168.0 백만입니다.
ANI Pharmaceuticals (Nasdaq: ANIP) a reçu l'approbation de la FDA et a lancé Prucalopride Tablets, la première version générique de Motegrity®. L'entreprise a obtenu une désignation de Competitive Generic Therapy (CGT) avec une exclusivité de 180 jours pour ce produit. Cette réalisation renforce la position d'ANI en tant que détenteur du deuxième plus grand nombre d'approbations CGT sur le marché des génériques aux États-Unis. Selon des données d'IQVIA d'octobre 2024, le marché annuel des Prucalopride Tablets aux États-Unis est d'environ $168,0 millions.
ANI Pharmaceuticals (Nasdaq: ANIP) hat die FDA-Zulassung erhalten und Prucalopride Tablets auf den Markt gebracht, die erste generische Version von Motegrity®. Das Unternehmen hat für dieses Produkt eine Competitive Generic Therapy (CGT)-Bezeichnung mit 180-tägiger Exklusivität erhalten. Dieser Erfolg stärkt ANIs Position als Inhaber der zweithöchsten Anzahl an CGT-Zulassungen im US-Generika-Markt. Laut IQVIA-Daten von Oktober 2024 beträgt der jährliche Markt für Prucalopride Tablets in den USA etwa $168,0 Millionen.
- First generic approval for Motegrity® with 180-day market exclusivity
- Access to $168.0 million market opportunity
- Strengthens position in CGT approvals ranking
- None.
Insights
The FDA approval of ANI's generic Prucalopride represents a major revenue opportunity with the potential to significantly boost ANI's financial performance. With
The CGT designation is particularly valuable as it grants ANI sole generic market access for 6 months. Considering typical generic pricing at
The timing of this approval, at the start of 2025, positions ANI to potentially exceed analyst expectations for Q1 and Q2 earnings. The company's track record with CGT approvals indicates strong execution capabilities in complex generic development, suggesting effective commercialization of this opportunity.
Prucalopride's approval marks a strategic advancement in the chronic constipation treatment market. As the first generic version of Motegrity®, this launch addresses a significant medical need while potentially reducing treatment costs for patients. The drug's mechanism as a selective serotonin type 4 receptor agonist offers an important alternative in the constipation therapy landscape.
The exclusivity period provides ANI a important window to establish market presence and build relationships with healthcare providers and pharmacy benefit managers. This timing coincides with increasing healthcare cost consciousness, which should drive rapid adoption of this more affordable alternative. The successful development of this complex generic further validates ANI's R&D capabilities and positions them favorably for future complex generic approvals.
PRINCETON, N.J., Jan. 02, 2025 (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 has launched Prucalopride Tablets. ANI’s Prucalopride Tablets is the generic version of the reference listed drug (RLD) Motegrity®.
"We are delighted to build momentum early in 2025 with the approval of the first generic for Motegrity®, once again highlighting our superior R&D capabilities. The FDA has granted our Prucalopride Tablets 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,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
U.S. annual sales for Prucalopride Tablets total approximately
About ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) 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&D expertise, operational excellence, and U.S.-based manufacturing; and its Established Brands business. For more information, visit www.anipharmaceuticals.com.
Forward-Looking Statements
This press release contains not only historical information, but also forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s expectations or beliefs concerning future events, including statements regarding the benefits of the acquisition of Alimera Sciences. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “continue,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “shall,” “would” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties.
The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the ability to implement business plans, forecasts, and other expectations in connection with the acquisition and integration of Alimera Sciences, Inc. (“Alimera”) and identify and realize additional opportunities and, in particular, the possibility that the Company is unable to achieve anticipated synergies, (ii) costs and regulatory requirements relating to contract manufacturing arrangements, (iii) costs or delays associated with manufacturing (including the sources and any changes in sources thereof) of the Company’s products, (iv) delays or failures in retaining and obtaining continuing and future product approvals from the FDA, and other regulatory issues relating to the Company's business and products, (v) market trends for the Company’s products, , and the ability to achieve anticipated sales for such products, (vi) risks that the acquisition of Alimera may disrupt current plans and operations of the Company and potential difficulties of the Company in retaining employees of Alimera and/or maintaining business relationships of Alimera, (vii) the impact of any litigation to which the Company is, or may become, a party, including in connection with the acquisition and integration thereof, (viii) volatility in the Company’s stock price, including as a result of the acquisition, (ix) changes in competitive and regulated industries in which the Company operates, variations in operating performance across competitors, changes in laws and regulations affecting the Company’s business, and changes in the Company’s capital structure as a result of the acquisition, (x) regulatory and other approvals relating to product development and manufacturing, (xi) 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/or the Company and its products, (xii) costs incurred in connection with the acquisition of Alimera and the possibility that the Company is unable to realize anticipated benefits of the acquisition or to realize estimated pro forma results and underlying assumptions, (xiii) delays in production, increased costs and potential loss of revenues if there is a change in manufacturers or manufacturing processes due to the limited number of suppliers for the Company’s raw materials, active pharmaceutical ingredients, excipients and other materials, (xiv) the Company’s reliance on single source third-party contract manufacturing supply for certain of its key products, , (xv) changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration, and other regulatory agencies, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions, (xvi) the impact of legislative or regulatory reform on the pricing for the Company’s products, (xvii) the Company’ ability to maintain the services of its key executives and other personnel, and (xviii) general business and economic conditions, such as inflationary pressures, geopolitical conditions including, but not limited to, the conflict between Russia and the Ukraine, the conflict between Israel and Gaza, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies. 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
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