Orange Book product · Generic (ANDA)
GLATIRAMER ACETATE
GLATIRAMER ACETATE
At a glance
May 07, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 07, 2025
1 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
GLATIRAMER ACETATE
Strength
20MG/ML
Dosage form
INJECTABLE
Route
SUBCUTANEOUS
TE code
AP
Application
ANDA 208468
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GLATIRAMER ACETATE
- 1996COPAXONEBrand (NDA)
NDA 020622 · TEVA PHARMS USA
- 2026GLATIRAMER ACETATEGeneric (ANDA)
ANDA 213382 · HYBIO
- 2026GLATIRAMER ACETATEGeneric (ANDA)
ANDA 214022 · HYBIO
- 2025GLATIRAMER ACETATEGeneric (ANDA)
ANDA 214741 · SCINOPHARM TAIWAN
- 2024GLATIRAMER ACETATEGeneric (ANDA)
ANDA 203857 · SYNTHON PHARMS INC
- 2024GLATIRAMER ACETATEGeneric (ANDA)
ANDA 206873 · SYNTHON PHARMS INC
- 2018GLATOPAGeneric (ANDA)
ANDA 206921 · SANDOZ
- 2017GLATIRAMER ACETATEGeneric (ANDA)
ANDA 091646 · MYLAN
- 2017GLATIRAMER ACETATEGeneric (ANDA)
ANDA 206936 · MYLAN
- 2015GLATOPAGeneric (ANDA)
ANDA 090218 · SANDOZ
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.
