FDA Orange Book
Generic for Requip XL
Requip XL contains ropinirole. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Requip XL is ropinirole. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 6 Requip XL products the Orange Book lists.
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Requip XL products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 12MG BASE | Discontinued | None | 7 | AB |
| tablet, extended release, oral | EQ 2MG BASE | Discontinued | None | 7 | AB |
| tablet, extended release, oral | EQ 3MG BASE | Discontinued | None | 0 | None |
| tablet, extended release, oral | EQ 4MG BASE | Discontinued | None | 7 | AB |
| tablet, extended release, oral | EQ 6MG BASE | Discontinued | None | 7 | AB |
| tablet, extended release, oral | EQ 8MG BASE | Discontinued | None | 7 | AB |
NDA 022008, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ropinirole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 090869 | AB (A-rated, therapeutically equivalent) | May 17, 2012 | EQ 12MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE, EQ 8MG BASE |
| DR REDDYS LABORATORIES LTD | 201576 | AB (A-rated, therapeutically equivalent) | June 6, 2012 | EQ 12MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE, EQ 8MG BASE |
| SANDOZ INC | 201047 | AB (A-rated, therapeutically equivalent) | June 6, 2012 | EQ 12MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE, EQ 8MG BASE |
| CHARTWELL RX SCIENCES LLC | 091395 | AB (A-rated, therapeutically equivalent) | August 27, 2012 | EQ 12MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE, EQ 8MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 202786 | AB (A-rated, therapeutically equivalent) | April 22, 2013 | EQ 12MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE, EQ 8MG BASE |
| PRINSTON PHARMACEUTICAL INC | 204413 | AB (A-rated, therapeutically equivalent) | May 11, 2022 | EQ 12MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE, EQ 8MG BASE |
| ELITE LABORATORIES INC | 217862 | AB (A-rated, therapeutically equivalent) | November 10, 2025 | EQ 12MG BASE, EQ 2MG BASE, EQ 4MG BASE, EQ 6MG BASE, EQ 8MG BASE |
Questions
Is there a generic for Requip XL?
Yes. The generic name for Requip XL is ropinirole. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 6 Requip XL products the Orange Book lists.
What is the generic name for Requip XL?
The active ingredient in Requip XL is ropinirole, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.