pregabalin · Upjohn · NDA 021446, 022488
Lyrica
Earliest generic entry, as listed · earliest of 9 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
- 25 Oct 2026Generic approved · 021446-00124 Feb 2026
- 25 Oct 2026Generic approved · 021446-00130 Apr 2026
Products covered · 9
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021446 · 001 · RLD | capsule, oral | 25MG | open |
| 021446 · 002 · RLD | capsule, oral | 50MG | open |
| 021446 · 003 · RLD | capsule, oral | 75MG | open |
| 021446 · 004 · RLD | capsule, oral | 100MG | open |
| 021446 · 005 · RLD | capsule, oral | 150MG | open |
| 021446 · 006 · RLD | capsule, oral | 200MG | open |
| 021446 · 007 · RLD | capsule, oral | 225MG | open |
| 021446 · 008 · RLD | capsule, oral | 300MG | open |
| 022488 · 001 · RLD | solution, oral | 20MG/ML | open |