FDA Orange Book

Generic for Requip

Requip 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 is ropinirole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Requip products in the Orange Book

Requip products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oralEQ 0.25MG BASEDiscontinuedNone8AB
tablet, oralEQ 0.5MG BASEDiscontinuedNone8AB
tablet, oralEQ 1MG BASEDiscontinuedNone8AB
tablet, oralEQ 2MG BASEDiscontinuedNone8AB
tablet, oralEQ 3MG BASEDiscontinuedNone8AB
tablet, oralEQ 4MG BASEDiscontinuedNone8AB
tablet, oralEQ 5MG BASEDiscontinuedNone8AB

NDA 020658, 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

Approved generic versions of Requip
CompanyANDATE codeApprovedStrengths
PRINSTON PHARMACEUTICAL INC078110AB (A-rated, therapeutically equivalent)May 5, 2008EQ 0.25MG BASE, EQ 0.5MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE, EQ 5MG BASE
CHARTWELL RX SCIENCES LLC079050AB (A-rated, therapeutically equivalent)May 29, 2008EQ 0.25MG BASE, EQ 0.5MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE, EQ 5MG BASE
ZYDUS LIFESCIENCES LTD090411AB (A-rated, therapeutically equivalent)June 1, 2009EQ 0.25MG BASE, EQ 0.5MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE, EQ 5MG BASE
GLENMARK PHARMACEUTICALS LTD090135AB (A-rated, therapeutically equivalent)February 25, 2010EQ 0.25MG BASE, EQ 0.5MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE, EQ 5MG BASE
ALEMBIC LTD090429AB (A-rated, therapeutically equivalent)March 24, 2010EQ 0.25MG BASE, EQ 0.5MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE, EQ 5MG BASE
MLV PHARMA LLC079165AB (A-rated, therapeutically equivalent)February 7, 2012EQ 0.25MG BASE, EQ 0.5MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE, EQ 5MG BASE
ORBION PHARMACEUTICALS PRIVATE LTD079229AB (A-rated, therapeutically equivalent)November 28, 2012EQ 0.25MG BASE, EQ 0.5MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE, EQ 5MG BASE
ACCORD HEALTHCARE INC204022AB (A-rated, therapeutically equivalent)February 28, 2017EQ 0.25MG BASE, EQ 0.5MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE, EQ 5MG BASE

Questions

Is there a generic for Requip?

Yes. The generic name for Requip is ropinirole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Requip?

The active ingredient in Requip 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.

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