FDA Orange Book · active-ingredient family
Glatiramer acetate
Glatiramer acetate is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COPAXONE · NDA 020622
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COPAXONERLD×3 | TEVA PHARMS USA | NDA 020622 | — | Dec 20, 1996 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GLATIRAMER ACETATE | HYBIO | ANDA 213382 | AP | Feb 11, 2026 | |
| GLATIRAMER ACETATE | HYBIO | ANDA 214022 | AP | Feb 11, 2026 | |
| GLATIRAMER ACETATE×2 | SCINOPHARM TAIWAN | ANDA 214741 | AP | Dec 31, 2025 | |
| GLATIRAMER ACETATE×2 | CHEMI SPA | ANDA 208468 | AP | May 07, 2025 | |
| GLATIRAMER ACETATE | SYNTHON PHARMS INC | ANDA 203857 | AP | Sep 25, 2024 | |
| GLATIRAMER ACETATE | SYNTHON PHARMS INC | ANDA 206873 | AP | Sep 25, 2024 | |
| GLATOPA | SANDOZ | ANDA 206921 | AP | Feb 12, 2018 | |
| GLATIRAMER ACETATE | MYLAN | ANDA 091646 | AP | Oct 03, 2017 | |
| GLATIRAMER ACETATE | MYLAN | ANDA 206936 | AP | Oct 03, 2017 | |
| GLATOPA | SANDOZ | ANDA 090218 | AP | Apr 16, 2015 |
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.
Glatiramer acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
