FDA Orange Book
Generic for Mirapex ER
Mirapex ER 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 ER is pramipexole. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mirapex ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 0.375MG | Discontinued | None | 8 | AB |
| tablet, extended release, oral | 0.75MG | Discontinued | None | 8 | AB |
| tablet, extended release, oral | 1.5MG | Discontinued | None | 7 | AB |
| tablet, extended release, oral | 2.25MG | Discontinued | None | 5 | AB |
| tablet, extended release, oral | 3.75MG | Discontinued | None | 5 | AB |
| tablet, extended release, oral | 3MG | Discontinued | None | 7 | AB |
| tablet, extended release, oral | 4.5MG | Discontinued | None | 7 | AB |
NDA 022421, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. 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 |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 202353 | AB (A-rated, therapeutically equivalent) | December 4, 2014 | 0.375MG, 0.75MG, 1.5MG, 3MG, 4.5MG |
| DR REDDYS LABORATORIES LTD | 203354 | AB (A-rated, therapeutically equivalent) | August 7, 2015 | 0.375MG, 0.75MG, 1.5MG, 3MG, 4.5MG |
| ACTAVIS ELIZABETH LLC | 201963 | AB (A-rated, therapeutically equivalent) | April 21, 2016 | 0.375MG, 0.75MG, 1.5MG, 3MG, 4.5MG |
| MACLEODS PHARMACEUTICALS LTD | 206156 | AB (A-rated, therapeutically equivalent) | June 24, 2016 | 0.375MG, 0.75MG, 1.5MG, 2.25MG, 3.75MG, 3MG, 4.5MG |
| ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 203615 | AB (A-rated, therapeutically equivalent) | October 14, 2016 | 2.25MG, 3.75MG |
| ZYDUS PHARMACEUTICALS USA INC | 202891 | AB (A-rated, therapeutically equivalent) | December 12, 2017 | 0.375MG, 0.75MG, 1.5MG, 2.25MG, 3.75MG, 3MG, 4.5MG |
| ALEMBIC PHARMACEUTICALS LTD | 204518 | AB (A-rated, therapeutically equivalent) | January 2, 2019 | 0.375MG, 0.75MG, 1.5MG, 2.25MG, 3.75MG, 3MG, 4.5MG |
| XIAMEN LP PHARMACUETICAL CO LTD | 212797 | AB (A-rated, therapeutically equivalent) | June 11, 2021 | 0.375MG, 0.75MG |
| NOVAST LABORATORIES LTD | 213444 | AB (A-rated, therapeutically equivalent) | February 3, 2022 | 0.375MG, 0.75MG, 1.5MG, 2.25MG, 3.75MG, 3MG, 4.5MG |
Mirapex ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7695734 | April 26, 2028 | Drug product | None | 022421 |
| 8679533 | September 8, 2029 | Drug product | U-219 | 022421 |
Questions
Is there a generic for Mirapex ER?
Yes. The generic name for Mirapex ER is pramipexole. 9 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 Mirapex ER?
The active ingredient in Mirapex ER is pramipexole, per the FDA Orange Book.
When does the Mirapex ER patent expire?
The last patent listed for Mirapex ER in the Orange Book expires September 8, 2029. A listed patent expiry date is not a generic launch date.
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.