FDA Orange Book
Generic for Copaxone
Copaxone contains glatiramer acetate. 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 Copaxone is glatiramer acetate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Copaxone products the Orange Book lists.
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Copaxone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, subcutaneous | 20MG/VIAL | Discontinued | None | 0 | None |
| injectable, subcutaneous | 20MG/ML | Marketed (Rx) | AP | 6 | AP |
| injectable, subcutaneous | 40MG/ML | Marketed (Rx) | AP | 6 | AP |
NDA 020622, held by TEVA PHARMACEUTICALS USA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic glatiramer acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 090218 | AP (A-rated, therapeutically equivalent) | April 16, 2015 | 20MG/ML |
| MYLAN PHARMACEUTICALS INC | 091646 | AP (A-rated, therapeutically equivalent) | October 3, 2017 | 20MG/ML |
| MYLAN PHARMACEUTICALS INC | 206936 | AP (A-rated, therapeutically equivalent) | October 3, 2017 | 40MG/ML |
| SANDOZ INC | 206921 | AP (A-rated, therapeutically equivalent) | February 12, 2018 | 40MG/ML |
| SYNTHON BV | 203857 | AP (A-rated, therapeutically equivalent) | September 25, 2024 | 20MG/ML |
| SYNTHON BV | 206873 | AP (A-rated, therapeutically equivalent) | September 25, 2024 | 40MG/ML |
| CHEMI SPA | 208468 | AP (A-rated, therapeutically equivalent) | May 7, 2025 | 20MG/ML, 40MG/ML |
| SCINOPHARM TAIWAN LTD | 214741 | AP (A-rated, therapeutically equivalent) | December 31, 2025 | 20MG/ML, 40MG/ML |
| HYBIO PHARMACEUTICAL CO LTD | 213382 | AP (A-rated, therapeutically equivalent) | February 11, 2026 | 20MG/ML |
| HYBIO PHARMACEUTICAL CO LTD | 214022 | AP (A-rated, therapeutically equivalent) | February 11, 2026 | 40MG/ML |
Copaxone NDC codes
Questions
Is there a generic for Copaxone?
Yes. The generic name for Copaxone is glatiramer acetate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Copaxone products the Orange Book lists.
What is the generic name for Copaxone?
The active ingredient in Copaxone is glatiramer acetate, 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.
More on Copaxone and Glatiramer Acetate
- What is Copaxone used for?FDA label uses
- Is Copaxone a controlled substance?Federal schedule
- What is Glatiramer Acetate used for?FDA label uses
- Is Glatiramer Acetate a controlled substance?Federal schedule
- Copaxone Medicare Part D coverageBy plan and state
- NDC 68546-317Copaxone NDC record
- NDC 68546-325Copaxone NDC record