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Elite Pharmaceuticals Announces Commercial Launch of Acetaminophen and Codeine Phosphate Tablets

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Elite Pharmaceuticals (OTCQB: ELTP) has announced the commercial launch of its generic version of Tylenol with Codeine (acetaminophen and codeine phosphate) tablets. The product is available in three strengths: 300mg/15mg, 300mg/30mg, and 300mg/60mg. These tablets are indicated for managing mild to moderate pain where opioid treatment is appropriate and alternative treatments are inadequate.

The product is marketed and sold under the Elite Laboratories, Inc. label. According to IQVIA data, the total U.S. sales of acetaminophen and codeine in these strengths were approximately $47 million for the 12 months ended May 2024. This launch represents Elite's entry into a significant market segment for pain management medications.

Elite Pharmaceuticals (OTCQB: ELTP) ha annunciato il lancio commerciale della sua versione generica delle compresse di Tylenol con Codeina (paracetamolo e fosfato di codeina). Il prodotto è disponibile in tre dosaggi: 300mg/15mg, 300mg/30mg e 300mg/60mg. Queste compresse sono indicate per la gestione del dolore da lieve a moderato dove il trattamento con oppioidi è appropriato e le alternative terapeutiche sono insufficienti.

Il prodotto è commercializzato e venduto sotto l'etichetta di Elite Laboratories, Inc.. Secondo i dati di IQVIA, le vendite totali negli Stati Uniti di paracetamolo e codeina in questi dosaggi sono state di circa $47 milioni per i 12 mesi conclusi a maggio 2024. Questo lancio rappresenta l'ingresso di Elite in un segmento di mercato significativo per i farmaci per la gestione del dolore.

Elite Pharmaceuticals (OTCQB: ELTP) ha anunciado el lanzamiento comercial de su versión genérica de Tylenol con Codeína (acetaminofén y fosfato de codeína) en tabletas. El producto está disponible en tres concentraciones: 300mg/15mg, 300mg/30mg y 300mg/60mg. Estas tabletas están indicadas para la gestión de dolor leve a moderado donde el tratamiento con opioides es apropiado y los tratamientos alternativos son insuficientes.

El producto se comercializa y se vende bajo la etiqueta de Elite Laboratories, Inc.. Según los datos de IQVIA, las ventas totales en EE. UU. de acetaminofén y codeína en estas concentraciones fueron aproximadamente $47 millones para los 12 meses que terminaron en mayo de 2024. Este lanzamiento representa la entrada de Elite en un segmento de mercado significativo para los medicamentos de manejo del dolor.

엘리트 제약 (OTCQB: ELTP)는 타이레놀과 코데인 (아세트아미노펜 및 코데인 인산염) 정제의 제네릭 버전의 상업적 출범을 발표했습니다. 이 제품은 300mg/15mg, 300mg/30mg 및 300mg/60mg의 세 가지 농도로 제공됩니다. 이 정제는 경증에서 중등도 통증을 관리하는 데 적합하며, 강력한 진통제 치료가 필요한 경우 권장됩니다.

이 제품은 엘리트 연구소, Inc. 상표로 마케팅되고 판매됩니다. IQVIA 데이터에 따르면, 이러한 농도의 아세트아미노펜과 코데인의 총 미국 판매액은 2024년 5월까지의 12개월 동안 약 $47백만에 달했습니다. 이번 출시는 통증 관리 약물의 중요한 시장 부문에 대한 Elite의 진입을 나타냅니다.

Elite Pharmaceuticals (OTCQB: ELTP) a annoncé le lancement commercial de sa version générique de Tylenol avec Codéine (acétaminophène et phosphate de codéine) en comprimés. Le produit est disponible en trois dosages : 300mg/15mg, 300mg/30mg et 300mg/60mg. Ces comprimés sont destinés à gérer des douleurs légères à modérées lorsque le traitement aux opioïdes est approprié et que les traitements alternatifs sont insuffisants.

Le produit est commercialisé et vendu sous la marque Elite Laboratories, Inc.. Selon les données d'IQVIA, les ventes totales aux États-Unis d'acétaminophène et de codéine dans ces dosages ont été d'environ $47 millions pour les 12 mois se terminant en mai 2024. Ce lancement représente l'entrée d'Elite dans un segment de marché significatif pour les médicaments de gestion de la douleur.

Elite Pharmaceuticals (OTCQB: ELTP) hat die kommerzielle Einführung seiner generischen Version von Tylenol mit Codein (Paracetamol und Codeinphosphat) Tabletten bekannt gegeben. Das Produkt ist in drei Dosierungen erhältlich: 300mg/15mg, 300mg/30mg und 300mg/60mg. Diese Tabletten sind zur Behandlung von leichtem bis mäßigem Schmerz vorgesehen, wenn eine Opioidbehandlung angemessen ist und alternative Behandlungen unzureichend sind.

Das Produkt wird unter dem Label Elite Laboratories, Inc. vermarktet und verkauft. Laut IQVIA-Daten betrugen die Gesamverkäufe von Paracetamol und Codein in diesen Dosierungen in den USA etwa $47 Millionen für die 12 Monate bis Mai 2024. Dieser Launch markiert den Eintritt von Elite in einen bedeutenden Marktsegment für Schmerzmanagement-Medikamente.

Positive
  • Launch of generic version of Tylenol with Codeine, entering a $47 million market
  • Product available in three different strengths, potentially catering to various patient needs
  • Expansion of Elite's product portfolio in the pain management segment
Negative
  • None.

Northvale, New Jersey--(Newsfile Corp. - October 7, 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 Tylenol® with Codeine (acetaminophen and codeine phosphate) 300mg/15mg, 300mg/30mg, and 300mg/60mg tablets.

Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. This product is marketed and sold under the Elite Laboratories, Inc. label.

According to IQVIA, the total U.S. sales of acetaminophen and codeine, 300mg/15mg, 300mg/30mg, and 300mg/60mg, was approximately $47 million for the 12 months ended May 2024.

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/225787

FAQ

What new product has Elite Pharmaceuticals (ELTP) launched?

Elite Pharmaceuticals (ELTP) has launched a generic version of Tylenol with Codeine (acetaminophen and codeine phosphate) tablets in strengths of 300mg/15mg, 300mg/30mg, and 300mg/60mg.

What is the market size for acetaminophen and codeine tablets that Elite Pharmaceuticals (ELTP) is entering?

According to IQVIA data, the total U.S. sales of acetaminophen and codeine in the strengths Elite is launching were approximately $47 million for the 12 months ended May 2024.

What is the medical indication for Elite Pharmaceuticals' (ELTP) new acetaminophen and codeine phosphate tablets?

Elite's acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and alternative treatments are inadequate.

Under which label is Elite Pharmaceuticals (ELTP) marketing its new acetaminophen and codeine phosphate tablets?

The new acetaminophen and codeine phosphate tablets are being marketed and sold under the Elite Laboratories, Inc. label.

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