Elite Pharmaceuticals Receives FDA Approval for Generic Requip XL(R)
Elite Pharmaceuticals (OTCBB: ELTP) announced FDA approval on November 12, 2025 of an ANDA for a generic version of Requip XL (ropinirole XR) in 2 mg, 4 mg, 6 mg, 8 mg and 12 mg strengths.
The product will be marketed under the Elite Laboratories label. According to IQVIA, the branded product and equivalents had $10 million in U.S. sales for the 12 months ended September 2025, providing a measurable commercial reference for potential generic uptake.
Elite Pharmaceuticals (OTCBB: ELTP) ha comunicato l'approvazione FDA avvenuta il 12 novembre 2025 per un ANDA che riguarda una versione generica di Requip XL (ropinìrolo XR) in dosi di 2 mg, 4 mg, 6 mg, 8 mg e 12 mg.
Il prodotto sarà commercializzato con l'etichetta Elite Laboratories. Secondo IQVIA, il prodotto di marca e i corrispondenti avevano vendite negli Stati Uniti pari a 10 milioni di dollari nei 12 mesi terminati a settembre 2025, fornendo un riferimento commerciale concreto per il potenziale incremento di versioni generiche.
Elite Pharmaceuticals (OTCBB: ELTP) anunció la aprobación de la FDA el 12 de noviembre de 2025 de un ANDA para una versión genérica de Requip XL (ropinirolo XR) en presentaciones de 2 mg, 4 mg, 6 mg, 8 mg y 12 mg.
El producto se comercializará bajo la marca Elite Laboratories. Según IQVIA, el producto de marca y sus equivalentes registraron 10 millones de USD en ventas en EE. UU. para los 12 meses finalizados en septiembre de 2025, lo que proporciona una referencia comercial tangible para un posible crecimiento de genéricos.
Elite Pharmaceuticals (OTCBB: ELTP)는 2025년 11월 12일에 Requip XL (ropinirolo XR)의 제네릭 버전에 대한 ANDA를 승인받았다고 발표했습니다. 용량은 2 mg, 4 mg, 6 mg, 8 mg, 12 mg 입니다.
이 제품은 Elite Laboratories 라벨로 판매될 예정입니다. IQVIA에 따르면 브랜드 제품 및 동등 물질의 미국 매출은 2025년 9월까지 12개월 동안 1000만 달러였으며, 이는 제네릭 도입에 대한 실질적인 사업 참고가 됩니다.
Elite Pharmaceuticals (OTCBB: ELTP) a annoncé l'approbation par la FDA le 12 novembre 2025 d'un ANDA pour une version générique de Requip XL (ropinirole XR) en dosages de 2 mg, 4 mg, 6 mg, 8 mg et 12 mg.
Le produit sera commercialisé sous l'étiquette Elite Laboratories. Selon IQVIA, le produit de marque et ses équivalents ont réalisé 10 millions de dollars de ventes aux États‑Unis sur les 12 mois se terminant en septembre 2025, fournissant une référence commerciale tangible pour un éventuel uptake des génériques.
Elite Pharmaceuticals (OTCBB: ELTP) teilte die FDA-Zulassung am 12. November 2025 für einen ANDA für eine Generika-Version von Requip XL (Ropiniro XR) in den Stärken 2 mg, 4 mg, 6 mg, 8 mg und 12 mg mit.
Das Produkt wird unter dem Label Elite Laboratories vermarktet. Laut IQVIA erzielten das Markenprodukt und Äquivalente in den USA in den 12 Monaten bis September 2025 Umsätze von 10 Millionen USD, was einen messbaren kommerziellen Referenzwert für den potenziellen Generika-Uptake bietet.
Elite Pharmaceuticals (OTCBB: ELTP) أعلنت موافقة FDA في 12 نوفمبر 2025 على ANDA لإصدار جنيريك من Requip XL (ropinirole XR) بتركيزات 2 mg و4 mg و6 mg و8 mg و12 mg.
سيُسوَّق المنتج تحت علامة Elite Laboratories. وفقاً لـ IQVIA، حققت المنتج ذو الاسم التجاري ونظيره ما مقداره 10 ملايين دولار من المبيعات في الولايات المتحدة للـ12 شهراً المنتهية في سبتمبر 2025، مما يوفر مرجعاً تجارياً ملموساً لإمكان تسجيل الاعتماد على الجنيريك.
- FDA ANDA approval received on November 12, 2025
- Five tablet strengths (2, 4, 6, 8, 12 mg) cleared for marketing
- $10M trailing 12-month U.S. sales for the branded product (IQVIA)
- Addressable U.S. market shown at $10M trailing 12 months, indicating modest sales scale
Northvale, New Jersey--(Newsfile Corp. - November 12, 2025) - Elite Pharmaceuticals, Inc. (OTCBB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP), with strengths of 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg tablets. Ropinirole belongs to a class of drugs known as a non-ergoline dopamine agonist used to treat symptoms of Parkinson's disease. This product will be marketed and sold under the Elite Laboratories, Inc. label.
According to IQVIA, the branded product and its equivalents had total U.S. sales of
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/273940
FAQ
What did Elite Pharmaceuticals (ELTP) announce on November 12, 2025?
Which strengths of generic Requip XL did ELTP receive FDA approval for?
How large were U.S. sales for Requip XL and equivalents before Elite's approval?
Under what label will Elite sell the generic Requip XL (ELTP)?
What therapeutic use does ropinirole extended-release have?
