Orange Book product · Brand (NDA)
COPAXONE
GLATIRAMER ACETATE
At a glance
Dec 20, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 20, 1996
29 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
GLATIRAMER ACETATE
Strength
20MG/VIAL
Dosage form
FOR SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 020622
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
