pregabalin · Upjohn · NDA 209501
Lyrica Cr
Earliest generic entry, as listed · earliest of 3 marketed strengths
2 May 2027
Blocked by patent: US 10022447 (pediatric extension), US 8945620 (pediatric extension), US 9144559 (pediatric extension).
Listed patents · 3 unexpired
8 Orange Book listing rows for 3 patents, including 3 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10022447 | use U-2136, U-2137 | 2 May 2027 |
| US 10022447 listing row | use U-2136 | 2 Nov 2026 |
| US 10022447 listing row | use U-2137 | 2 Nov 2026 |
| US 10022447 listing row | pediatric extension · sets the listed date | 2 May 2027 |
| US 8945620 | drug product, use U-2136, U-2137 | 2 May 2027 |
| US 8945620 listing row | drug product, use U-2136 | 2 Nov 2026 |
| US 8945620 listing row | drug product, use U-2137 | 2 Nov 2026 |
| US 8945620 listing row | pediatric extension · sets the listed date | 2 May 2027 |
| US 9144559 | drug product | 2 May 2027 |
| US 9144559 listing row | drug product | 2 Nov 2026 |
| US 9144559 listing row | pediatric extension · sets the listed date | 2 May 2027 |
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
- Enters 12-month window basis: patent · 209501-003Listed date 2 May 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 209501-002Listed date 2 May 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 209501-001Listed date 2 May 2027Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209501 · 001 · RLD | tablet, extended release, oral | 82.5MG | 2 May 2027 |
| 209501 · 002 · RLD | tablet, extended release, oral | 165MG | 2 May 2027 |
| 209501 · 003 · RLD | tablet, extended release, oral | 330MG | 2 May 2027 |