FDA Orange Book
Generic for Azilect
Azilect contains rasagiline. 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 Azilect is rasagiline. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Azilect products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 0.5MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | EQ 1MG BASE | Marketed (Rx) | AB | 10 | AB |
NDA 021641, held by TEVA NEUROSCIENCE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic rasagiline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ORBION PHARMACEUTICALS PRIVATE LTD | 201970 | AB (A-rated, therapeutically equivalent) | March 15, 2016 | EQ 0.5MG BASE, EQ 1MG BASE |
| AUROBINDO PHARMA USA INC | 201971 | AB (A-rated, therapeutically equivalent) | May 15, 2017 | EQ 0.5MG BASE, EQ 1MG BASE |
| ALKEM LABORATORIES LTD | 201889 | AB (A-rated, therapeutically equivalent) | October 30, 2017 | EQ 0.5MG BASE, EQ 1MG BASE |
| CHARTWELL RX SCIENCES LLC | 201892 | AB (A-rated, therapeutically equivalent) | July 27, 2018 | EQ 0.5MG BASE, EQ 1MG BASE |
| MICRO LABS LTD | 207004 | AB (A-rated, therapeutically equivalent) | March 29, 2019 | EQ 0.5MG BASE, EQ 1MG BASE |
| REGCON HOLDINGS LLC | 206153 | AB (A-rated, therapeutically equivalent) | October 4, 2019 | EQ 0.5MG BASE, EQ 1MG BASE |
| CARNEGIE PHARMACEUTICALS LLC | 201942 | AB (A-rated, therapeutically equivalent) | November 18, 2021 | EQ 0.5MG BASE, EQ 1MG BASE |
| RISING PHARMA HOLDINGS INC | 218163 | AB (A-rated, therapeutically equivalent) | April 9, 2024 | EQ 0.5MG BASE, EQ 1MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 208866 | AB (A-rated, therapeutically equivalent) | June 28, 2024 | EQ 0.5MG BASE, EQ 1MG BASE |
| TORRENT PHARMACEUTICALS LTD | 210150 | AB (A-rated, therapeutically equivalent) | May 5, 2025 | EQ 0.5MG BASE, EQ 1MG BASE |
Azilect patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7572834 | December 5, 2026 | Drug product | None | 021641 |
| 7815942 | August 27, 2027 | Drug substance, Drug product | U-219 | 021641 |
Azilect NDC codes
Questions
Is there a generic for Azilect?
Yes. The generic name for Azilect is rasagiline. 10 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 Azilect?
The active ingredient in Azilect is rasagiline, per the FDA Orange Book.
When does the Azilect patent expire?
The last patent listed for Azilect in the Orange Book expires August 27, 2027. 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.