ANI Pharmaceuticals Announces the FDA Approval and Launch of Ketoconazole Shampoo, 2%
ANI Pharmaceuticals has announced the FDA approval and launch of Ketoconazole Shampoo, 2%, a generic version of Nizoral®. This approval marks another competition product for ANI, aligning with their strategic priority to launch new products addressing patient needs. The company's R&D team has been credited for this achievement.
Nikhil Lalwani, President and CEO of ANI, expressed pride in the approval and commercialization of the product. According to IQVIA data from July 2024, the U.S. annual sales for Ketoconazole Shampoo, 2% total approximately $69.2 million. This launch represents ANI's entry into a significant market segment, potentially boosting the company's revenue and market position in the pharmaceutical industry.
ANI Pharmaceuticals ha annunciato l'
Nikhil Lalwani, Presidente e CEO di ANI, ha espresso orgoglio per l'approvazione e la commercializzazione del prodotto. Secondo i dati IQVIA di luglio 2024, le vendite annuali negli Stati Uniti per lo Shampoo al Ketoconazolo, 2% ammontano a circa 69,2 milioni di dollari. Questo lancio rappresenta l'ingresso di ANI in un segmento di mercato significativo, potenzialmente aumentando le entrate e la posizione di mercato dell'azienda nell'industria farmaceutica.
ANI Pharmaceuticals ha anunciado la aprobación de la FDA y el lanzamiento del champú de Ketoconazol, 2%, una versión genérica de Nizoral®. Esta aprobación marca otro producto competitivo para ANI, alineándose con su prioridad estratégica de lanzar nuevos productos que aborden las necesidades de los pacientes. El equipo de I+D de la empresa ha sido acreditado por este logro.
Nikhil Lalwani, Presidente y CEO de ANI, expresó su orgullo por la aprobación y comercialización del producto. Según los datos de IQVIA de julio de 2024, las ventas anuales en EE. UU. del champú de Ketoconazol, 2% totalizan aproximadamente 69,2 millones de dólares. Este lanzamiento representa la entrada de ANI en un segmento de mercado significativo, lo que podría impulsar los ingresos y la posición de mercado de la empresa en la industria farmacéutica.
ANI 제약회사는 FDA의 승인과 2% 케토코나졸 샴푸의 출시를 발표했습니다. 이는 Nizoral®의 복제약입니다. 이번 승인은 ANI의 경쟁 제품의 또 다른 사례로, 환자의 필요를 충족하기 위해 새로운 제품을 출시하려는 전략적 우선 사항과 일치합니다. 회사의 R&D 팀은 이 성과에 대한 공로를 인정받았습니다.
ANI의 회장 겸 CEO인 Nikhil Lalwani는 제품의 승인과 상용화에 대한 자부심을 표명했습니다. 2024년 7월의 IQVIA 데이터에 따르면, 미국에서의 2% 케토코나졸 샴푸의 연간 판매액은 약 6920만 달러에 달합니다. 이번 출시로 ANI는 중요한 시장 세그먼트에 진입하게 되어, 회사의 수익 및 제약 산업 내 시장 입지를 높일 수 있습니다.
ANI Pharmaceuticals a annoncé l'
Nikhil Lalwani, Président et CEO d'ANI, a exprimé sa fierté pour l'approbation et la commercialisation du produit. Selon les données IQVIA de juillet 2024, les ventes annuelles aux États-Unis pour le shampoing au kétoconazole, 2% s'élèvent à environ 69,2 millions de dollars. Ce lancement représente l'entrée d'ANI dans un segment de marché significatif, potentiellement renforçant les revenus et la position de marché de l'entreprise dans l'industrie pharmaceutique.
ANI Pharmaceuticals hat die FDA-Zulassung und den Launch des Ketoconazol-Shampoos, 2% bekannt gegeben, eine generische Version von Nizoral®. Diese Zulassung markiert ein weiteres Wettbewerbsprodukt für ANI und entspricht deren strategischer Priorität, neue Produkte zu lancieren, die den Bedürfnissen der Patienten gerecht werden. Das R&D-Team des Unternehmens wurde für diesen Erfolg anerkannt.
Nikhil Lalwani, Präsident und CEO von ANI, äußerte Stolz über die Zulassung und Kommerzialisierung des Produkts. Laut IQVIA-Daten von Juli 2024 belaufen sich die jährlichen Verkäufe in den USA für das Ketoconazol-Shampoo, 2% auf insgesamt etwa 69,2 Millionen Dollar. Dieser Launch stellt den Eintritt von ANI in ein bedeutendes Marktsegment dar, was potenziell die Einnahmen und die Marktposition des Unternehmens in der Pharmaindustrie steigern könnte.
- FDA approval and launch of Ketoconazole Shampoo, 2%
- Entry into a market with annual sales of approximately $69.2 million
- competition product, potentially leading to higher profit margins
- Alignment with company's strategic priority to launch new products
- None.
Insights
The FDA approval and launch of Ketoconazole Shampoo, 2% by ANI Pharmaceuticals is a significant development for the company. This generic version of Nizoral® enters a market with annual sales of approximately
The launch aligns with ANI's strategic focus on expanding its product portfolio and addressing patient needs. For investors, this represents potential for increased market share and revenue growth. However, the actual impact will depend on ANI's ability to capture market share from the branded product and compete with other generic versions if present.
It's worth noting that while the market size is significant, the company's ability to penetrate and the potential profit margins will be key factors to watch. Generic drug pricing can be competitive, so ANI's manufacturing efficiency and distribution strategy will play important roles in determining the financial impact of this launch on the company's bottom line.
The launch of Ketoconazole Shampoo, 2% positions ANI Pharmaceuticals in a niche market with competition. This strategic move could potentially boost the company's revenue and market presence. With a market size of
Investors should consider the following factors:
- Market penetration rate and speed
- Pricing strategy compared to the branded version
- Production costs and potential profit margins
- Any exclusivity period for the generic version
The success of this product could serve as a proof of concept for ANI's R&D capabilities and strategy, potentially leading to increased investor confidence in the company's pipeline and future growth prospects. However, it's important to monitor how quickly ANI can ramp up production and distribution to capitalize on this opportunity before potential competitors enter the market.
PRINCETON, N.J., Sept. 26, 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 Ketoconazole Shampoo,
"We are proud to announce the FDA approval and commercialization of Ketoconazole Shampoo,
U.S. annual sales for Ketoconazole Shampoo,
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
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, including but not limited to, ILUVIEN, YUTIQ and Cortrophin Gel, 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, including ILUVIEN, YUTIQ and Cortrophin Gel, (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.
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