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Elite Pharmaceuticals Announces Commercial Launch of Acetaminophen and Hydrocodone Tablets

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Elite Pharmaceuticals (OTCQB: ELTP) has launched its generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets, USP CII) in four different strengths: 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg, and 10mg/325mg. The medication is indicated for managing severe pain requiring opioid analgesics when alternative treatments are inadequate. According to IQVIA, the annual sales for this product reached approximately $300 million for the twelve months ending September 2024.

Elite Pharmaceuticals (OTCQB: ELTP) ha lanciato la sua versione generica di Norco® (compresse di bitartrato di idrocodone e acetaminofene, USP CII) in quattro diverse concentrazioni: 2,5 mg/325 mg, 5 mg/325 mg, 7,5 mg/325 mg e 10 mg/325 mg. Il farmaco è indicato per la gestione del dolore severo che richiede analgesici oppioidi quando i trattamenti alternativi sono inadeguati. Secondo IQVIA, le vendite annuali per questo prodotto hanno raggiunto circa 300 milioni di dollari per i dodici mesi terminati a settembre 2024.

Elite Pharmaceuticals (OTCQB: ELTP) ha lanzado su versión genérica de Norco® (tabletas de bitartrato de hidrocodona y acetaminofén, USP CII) en cuatro diferentes presentaciones: 2,5 mg/325 mg, 5 mg/325 mg, 7,5 mg/325 mg y 10 mg/325 mg. El medicamento está indicado para el manejo del dolor severo que requiere analgésicos opioides cuando los tratamientos alternativos son insuficientes. Según IQVIA, las ventas anuales de este producto alcanzaron aproximadamente 300 millones de dólares en los doce meses que terminaron en septiembre de 2024.

엘리트 제약 (OTCQB: ELTP)는 노르코®(하이드로코돈 비타르타르트 및 아세트아미노펜 정제, USP CII)의 일반약 버전을 네 가지 다른 용량으로 출시했습니다: 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg 및 10mg/325mg. 이 약물은 대체 치료가 불충분할 때 오피오이드 진통제가 필요한 심한 통증 관리를 위해 사용됩니다. IQVIA에 따르면, 이 제품의 연간 판매액은 2024년 9월 종료된 12개월 동안 약 3억 달러에 달했습니다.

Elite Pharmaceuticals (OTCQB: ELTP) a lancé sa version générique de Norco® (comprimés de bitartrate d'hydrocodone et d'acétaminophène, USP CII) en quatre dosages différents : 2,5 mg/325 mg, 5 mg/325 mg, 7,5 mg/325 mg et 10 mg/325 mg. Ce médicament est indiqué pour la gestion de la douleur sévère nécessitant des analgésiques opioïdes lorsque les traitements alternatifs sont insuffisants. Selon IQVIA, les ventes annuelles de ce produit ont atteint environ 300 millions de dollars pour les douze mois se terminant en septembre 2024.

Elite Pharmaceuticals (OTCQB: ELTP) hat seine generische Version von Norco® (Hydrocodon-Bitartrat und Acetaminophen-Tabletten, USP CII) in vier verschiedenen Stärken auf den Markt gebracht: 2,5 mg/325 mg, 5 mg/325 mg, 7,5 mg/325 mg und 10 mg/325 mg. Das Medikament ist zur Behandlung von starken Schmerzen angezeigt, die Opioid-Analgetika erfordern, wenn alternative Behandlungen unzureichend sind. Laut IQVIA betrugen die jährlichen Verkaufszahlen für dieses Produkt etwa 300 Millionen Dollar für die zwölf Monate bis September 2024.

Positive
  • Entry into a market with $300 million annual sales potential
  • Launch of product in multiple dosage strengths, allowing broader market coverage
Negative
  • Entering a highly competitive generic market with established players
  • Product category (opioids) subject to strict regulatory oversight and potential liability risks

Northvale, New Jersey--(Newsfile Corp. - December 2, 2024) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, today announced that the company has launched Elite's generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Hydrocodone and acetaminophen is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

IQVIA reported annual sales for the twelve months ending September 2024 of approximately $300 million for this product.

About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and distributes niche generic products. Elite's product lines consist of immediate-release and controlled-release, solid oral dose products, which are marketed under the Elite Laboratories label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit www.elitepharma.com.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release. Readers are cautioned that such forward-looking statements involve, without limitation, risks, uncertainties, and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of products by the FDA and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/231899

FAQ

What new product did Elite Pharmaceuticals (ELTP) launch in December 2024?

Elite Pharmaceuticals launched its generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets) in four strengths: 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg, and 10mg/325mg.

What is the market size for Elite Pharmaceuticals' (ELTP) new hydrocodone and acetaminophen product?

According to IQVIA, the annual sales for this product were approximately $300 million for the twelve months ending September 2024.

What are the medical uses for Elite Pharmaceuticals' (ELTP) new generic product?

The product is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

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