FDA Orange Book
Generic for Mirapex
Mirapex contains pramipexole. 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 Mirapex is pramipexole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 7 Mirapex products the Orange Book lists.
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Mirapex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.125MG | Discontinued | None | 7 | AB |
| tablet, oral | 0.25MG | Discontinued | None | 8 | AB |
| tablet, oral | 0.5MG | Discontinued | None | 8 | AB |
| tablet, oral | 0.75MG | Discontinued | None | 8 | AB |
| tablet, oral | 1.25MG | Discontinued | None | 0 | None |
| tablet, oral | 1.5MG | Discontinued | None | 8 | AB |
| tablet, oral | 1MG | Discontinued | None | 8 | AB |
NDA 020667, held by BOEHRINGER INGELHEIM. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pramipexole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 078920 | AB (A-rated, therapeutically equivalent) | July 6, 2010 | 0.125MG, 0.25MG, 0.5MG, 0.75MG, 1.5MG, 1MG |
| GLENMARK PHARMACEUTICALS LTD | 090781 | AB (A-rated, therapeutically equivalent) | October 8, 2010 | 0.125MG, 0.25MG, 0.5MG, 0.75MG, 1.5MG, 1MG |
| TORRENT PHARMACEUTICALS LTD | 090865 | AB (A-rated, therapeutically equivalent) | October 8, 2010 | 0.125MG, 0.25MG, 0.5MG, 0.75MG, 1.5MG, 1MG |
| PHARMOBEDIENT CONSULTING LLC | 090151 | AB (A-rated, therapeutically equivalent) | April 30, 2012 | 0.125MG, 0.25MG, 0.5MG, 0.75MG, 1.5MG, 1MG |
| AUROBINDO PHARMA LTD | 202633 | AB (A-rated, therapeutically equivalent) | October 26, 2012 | 0.125MG, 0.25MG, 0.5MG, 0.75MG, 1.5MG, 1MG |
| STRIDES PHARMA GLOBAL PTE LTD | 202702 | AB (A-rated, therapeutically equivalent) | June 3, 2014 | 0.125MG, 0.25MG, 0.5MG, 0.75MG, 1.5MG, 1MG |
| SCIEGEN PHARMACEUTICALS INC | 203855 | AB (A-rated, therapeutically equivalent) | October 28, 2014 | 0.125MG, 0.25MG, 0.5MG, 0.75MG, 1.5MG, 1MG |
| RISING PHARMA HOLDING INC | 211088 | AB (A-rated, therapeutically equivalent) | October 3, 2018 | 0.25MG, 0.5MG, 0.75MG, 1.5MG, 1MG |
Questions
Is there a generic for Mirapex?
Yes. The generic name for Mirapex is pramipexole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 7 Mirapex products the Orange Book lists.
What is the generic name for Mirapex?
The active ingredient in Mirapex is pramipexole, 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.