glatiramer acetate · Teva Pharms Usa · NDA 020622
Copaxone
Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 213382, Hybio · 020622-002Approved 11 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214022, Hybio · 020622-002Approved 11 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214741, Scinopharm Taiwan · 020622-002Approved 31 Dec 2025Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020622 · 001 · RLD · discontinued | for solution, subcutaneous | 20MG/VIAL | open |
| 020622 · 002 · RLD | injectable, subcutaneous | 20MG/ML | open |
| 020622 · 003 · RLD | injectable, subcutaneous | 40MG/ML | open |