FDA Orange Book · active-ingredient family
Ropinirole hydrochloride
Ropinirole hydrochloride is approved as 2 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:REQUIP XL · NDA 022008
2
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REQUIP XLRLD×6 | GLAXOSMITHKLINE LLC | NDA 022008 | — | Jun 13, 2008 | |
| REQUIPRLD×7 | GLAXOSMITHKLINE LLC | NDA 020658 | — | Sep 19, 1997 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE×5 | ELITE LABS INC | ANDA 217862 | AB | Nov 10, 2025 | |
| ROPINIROLE HYDROCHLORIDE×5 | PRINSTON INC | ANDA 204413 | AB | May 11, 2022 | |
| ROPINIROLE HYDROCHLORIDE×7 | ACCORD HLTHCARE | ANDA 204022 | AB | Feb 28, 2017 | |
| ROPINIROLE HYDROCHLORIDE×5 | ALEMBIC | ANDA 202786 | AB | Apr 22, 2013 | |
| ROPINIROLE HYDROCHLORIDE×7 | ORBION PHARMS | ANDA 079229 | AB | Nov 28, 2012 | |
| ROPINIROLE HYDROCHLORIDE×6 | AUROBINDO PHARMA USA | ANDA 200462 | — | Oct 15, 2012 | |
| ROPINIROLE HYDROCHLORIDE×5 | CHARTWELL RX | ANDA 091395 | AB | Aug 27, 2012 | |
| ROPINIROLE HYDROCHLORIDE×5 | DR REDDYS LABS LTD | ANDA 201576 | AB | Jun 06, 2012 | |
| ROPINIROLE HYDROCHLORIDE×5 | SANDOZ INC | ANDA 201047 | AB | Jun 06, 2012 | |
| ROPINIROLE HYDROCHLORIDE×5 | WATSON LABS INC | ANDA 200431 | — | Jun 06, 2012 | |
| ROPINIROLE HYDROCHLORIDE×5 | ACTAVIS ELIZABETH | ANDA 090869 | AB | May 17, 2012 | |
| ROPINIROLE HYDROCHLORIDE×7 | MLV | ANDA 079165 | AB | Feb 07, 2012 | |
| ROPINIROLE HYDROCHLORIDE×7 | ALEMBIC LTD | ANDA 090429 | AB | Mar 24, 2010 | |
| ROPINIROLE HYDROCHLORIDE×7 | GLENMARK PHARMS LTD | ANDA 090135 | AB | Feb 25, 2010 | |
| ROPINIROLE HYDROCHLORIDE×7 | ZYDUS LIFESCIENCES | ANDA 090411 | AB | Jun 01, 2009 | |
| ROPINIROLE HYDROCHLORIDE×7 | CHARTWELL RX | ANDA 079050 | AB | May 29, 2008 | |
| ROPINIROLE HYDROCHLORIDE×7 | EPIC PHARMA LLC | ANDA 078230 | — | May 20, 2008 | |
| ROPINIROLE HYDROCHLORIDE×7 | COSETTE | ANDA 077460 | — | May 05, 2008 | |
| ROPINIROLE HYDROCHLORIDE×7 | HIKMA | ANDA 077852 | — | May 05, 2008 | |
| ROPINIROLE HYDROCHLORIDE×7 | PHARMOBEDIENT | ANDA 078881 | — | May 05, 2008 | |
| ROPINIROLE HYDROCHLORIDE×7 | PRINSTON INC | ANDA 078110 | AB | May 05, 2008 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Ropinirole hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
