ropinirole hydrochloride · Glaxosmithkline Llc · NDA 022008
Requip Xl
Earliest generic entry, as listed · earliest of 6 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 217862, Elite Labs Inc · 022008-001Approved 10 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022008 · 001 · RLD · discontinued | tablet, extended release, oral | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 022008 · 002 · RLD · discontinued | tablet, extended release, oral | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 022008 · 003 · RLD · discontinued | tablet, extended release, oral | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 022008 · 004 · RLD · discontinued | tablet, extended release, oral | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 022008 · 005 · RLD · discontinued | tablet, extended release, oral | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 022008 · 006 · RLD · discontinued | tablet, extended release, oral | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |