Elite Pharmaceuticals Receives FDA Approval for Generic Requip XL(R)
Rhea-AI Summary
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.
Positive
- 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)
Negative
- Addressable U.S. market shown at $10M trailing 12 months, indicating modest sales scale
News Market Reaction 1 Alert
On the day this news was published, ELTP gained 3.33%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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?
