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Elite Pharmaceuticals Announces Commercial Launch of Oxycodone and Acetaminophen Tablets

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Elite Pharmaceuticals has announced the commercial launch of its generic version of Percocet (oxycodone hydrochloride and acetaminophen tablets, USP CII) in three different strengths: 5mg/325mg, 7.5mg/325mg, and 10mg/325mg.

The medication is specifically indicated for the treatment of moderate to moderately severe pain. This strategic product launch targets a significant market opportunity, as IQVIA reported annual sales of approximately $317 million for this product in 2024.

As a specialty pharmaceutical company focused on developing niche generic products, Elite's entry into this market represents a significant milestone in their product portfolio expansion. The company trades on the OTCQB market under the symbol ELTP.

Elite Pharmaceuticals ha annunciato il lancio commerciale della sua versione generica di Percocet (compresse di ossicodone cloridrato e acetaminofene, USP CII) in tre diverse dosi: 5mg/325mg, 7,5mg/325mg e 10mg/325mg.

Il farmaco è specificamente indicato per il trattamento del dolore da moderato a moderatamente grave. Questo lancio strategico mira a cogliere un'importante opportunità di mercato, poiché IQVIA ha riportato vendite annuali di circa 317 milioni di dollari per questo prodotto nel 2024.

Come azienda farmaceutica specializzata nello sviluppo di prodotti generici di nicchia, l'ingresso di Elite in questo mercato rappresenta un traguardo significativo nell'espansione del loro portafoglio prodotti. La società è quotata sul mercato OTCQB con il simbolo ELTP.

Elite Pharmaceuticals ha anunciado el lanzamiento comercial de su versión genérica de Percocet (tabletas de clorhidrato de oxicodona y acetaminofén, USP CII) en tres diferentes concentraciones: 5mg/325mg, 7.5mg/325mg y 10mg/325mg.

El medicamento está específicamente indicado para el tratamiento del dolor moderado a moderadamente intenso. Este lanzamiento estratégico apunta a una oportunidad de mercado significativa, ya que IQVIA reportó ventas anuales de aproximadamente 317 millones de dólares para este producto en 2024.

Como empresa farmacéutica especializada en el desarrollo de productos genéricos de nicho, la entrada de Elite en este mercado representa un hito importante en la expansión de su portafolio de productos. La compañía cotiza en el mercado OTCQB bajo el símbolo ELTP.

엘리트 제약사(Elite Pharmaceuticals)퍼코셋(Percocet)의 제네릭 버전(옥시코돈 하이드로클로라이드 및 아세트아미노펜 정제, USP CII)을 세 가지 용량인 5mg/325mg, 7.5mg/325mg, 10mg/325mg으로 상업 출시했다고 발표했습니다.

이 약물은 중등도에서 중증도에 이르는 통증 치료에 특별히 적응증이 있습니다. 이 전략적 제품 출시는 IQVIA가 2024년 이 제품의 연간 매출액을 약 3억 1,700만 달러로 보고한 점을 고려할 때 중요한 시장 기회를 겨냥하고 있습니다.

니치 제네릭 제품 개발에 주력하는 전문 제약회사인 엘리트의 이번 시장 진입은 제품 포트폴리오 확장에 있어 중요한 이정표를 의미합니다. 회사는 OTCQB 시장에서 ELTP라는 심볼로 거래되고 있습니다.

Elite Pharmaceuticals a annoncé le lancement commercial de sa version générique de Percocet (comprimés d'oxycodone chlorhydrate et d'acétaminophène, USP CII) en trois dosages différents : 5mg/325mg, 7,5mg/325mg et 10mg/325mg.

Le médicament est spécifiquement indiqué pour le traitement de la douleur modérée à modérément sévère. Ce lancement stratégique vise une opportunité de marché importante, IQVIA ayant rapporté des ventes annuelles d'environ 317 millions de dollars pour ce produit en 2024.

En tant que société pharmaceutique spécialisée dans le développement de génériques de niche, l'entrée d'Elite sur ce marché représente une étape majeure dans l'expansion de son portefeuille de produits. La société est cotée sur le marché OTCQB sous le symbole ELTP.

Elite Pharmaceuticals hat die Markteinführung seiner Generikaversion von Percocet (Tabletten mit Oxycodon-Hydrochlorid und Paracetamol, USP CII) in drei verschiedenen Stärken angekündigt: 5mg/325mg, 7,5mg/325mg und 10mg/325mg.

Das Medikament ist speziell zur Behandlung von mäßig bis mäßig starken Schmerzen indiziert. Dieser strategische Produkteinführung zielt auf eine bedeutende Marktchance ab, da IQVIA für dieses Produkt im Jahr 2024 einen Jahresumsatz von etwa 317 Millionen US-Dollar meldete.

Als spezialisiertes Pharmaunternehmen, das sich auf die Entwicklung von Nischen-Generika konzentriert, stellt der Markteintritt von Elite einen wichtigen Meilenstein in der Erweiterung ihres Produktportfolios dar. Das Unternehmen wird am OTCQB-Markt unter dem Symbol ELTP gehandelt.

Positive
  • Commercial launch of generic Percocet across three dosage strengths
  • Entering market worth $317M in annual sales (2024 IQVIA data)
  • Expanding product portfolio in pain management segment
Negative
  • Entering highly competitive generic market with potential price pressure
  • Operating in regulated opioid market with associated risks

Northvale, New Jersey--(Newsfile Corp. - April 30, 2025) - 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 Percocet® (oxycodone hydrochloride and acetaminophen tablets, USP CII) 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Oxycodone HCl and acetaminophen is indicated for the relief of moderate to moderately severe pain.

IQVIA reported 2024 annual sales of approximately $317 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/250318

FAQ

What new generic drug did Elite Pharmaceuticals (ELTP) launch in April 2025?

Elite Pharmaceuticals launched a generic version of Percocet (oxycodone hydrochloride and acetaminophen tablets) in three strengths: 5mg/325mg, 7.5mg/325mg, and 10mg/325mg.

How big is the market for Elite Pharmaceuticals' new oxycodone and acetaminophen tablets?

According to IQVIA data, the annual sales for this product were approximately $317 million in 2024.

What medical conditions will Elite Pharmaceuticals' new generic Percocet treat?

The oxycodone HCl and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.

What strengths of generic Percocet is Elite Pharmaceuticals (ELTP) offering?

Elite Pharmaceuticals is offering their generic Percocet in three strengths: 5mg/325mg, 7.5mg/325mg, and 10mg/325mg tablets.

When did Elite Pharmaceuticals (ELTP) begin commercial sales of generic Percocet?

Elite Pharmaceuticals launched their generic version of Percocet commercially on April 30, 2025.
Elite Pharmaceuticals Inc

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