Orange Book product · Brand (NDA)
COPAXONE
GLATIRAMER ACETATE
At a glance
Jan 28, 2014
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 28, 2014
12 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
GLATIRAMER ACETATE
Strength
40MG/ML
Dosage form
INJECTABLE
Route
SUBCUTANEOUS
TE code
AP
Application
NDA 020622
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026GLATIRAMER ACETATEGeneric (ANDA)
ANDA 213382 · HYBIO
- 2026GLATIRAMER ACETATEGeneric (ANDA)
ANDA 214022 · HYBIO
- 2025GLATIRAMER ACETATEGeneric (ANDA)
ANDA 214741 · SCINOPHARM TAIWAN
- 2025GLATIRAMER ACETATEGeneric (ANDA)
ANDA 208468 · CHEMI SPA
- 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.
