Glatiramer acetate
Glatiramer acetate: 1 brand, 10 generics; first approved Dec 20, 1996; generic available.
Generic available: 10 ANDA applications approved.
Brand (NDA) products
- COPAXONERLDTEVA PHARMS USANDA 02062219963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/VIAL FOR SOLUTION SUBCUTANEOUS Discontinued — 20MG/ML INJECTABLE SUBCUTANEOUS Rx AP 40MG/ML INJECTABLE SUBCUTANEOUS Rx AP
Generic (ANDA) products (10)
- GLATIRAMER ACETATEHYBIOANDA 2133822026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE SUBCUTANEOUS Rx AP - GLATIRAMER ACETATEHYBIOANDA 2140222026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE SUBCUTANEOUS Rx AP - GLATIRAMER ACETATESCINOPHARM TAIWANANDA 21474120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE SUBCUTANEOUS Rx AP 40MG/ML INJECTABLE SUBCUTANEOUS Rx AP - GLATIRAMER ACETATECHEMI SPAANDA 20846820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE SUBCUTANEOUS Rx AP 40MG/ML INJECTABLE SUBCUTANEOUS Rx AP - GLATIRAMER ACETATESYNTHON BVANDA 2038572024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE SUBCUTANEOUS Rx AP - GLATIRAMER ACETATESYNTHON BVANDA 2068732024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE SUBCUTANEOUS Rx AP - SANDOZANDA 2069212018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE SUBCUTANEOUS Rx AP - GLATIRAMER ACETATEMYLANANDA 0916462017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE SUBCUTANEOUS Rx AP - GLATIRAMER ACETATEMYLANANDA 2069362017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE SUBCUTANEOUS Rx AP - SANDOZANDA 0902182015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE SUBCUTANEOUS Rx AP
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 1996–2026 across 11 FDA applications.
Glatiramer acetate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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