diclofenac sodium · Nuvo Pharms Inc · NDA 020947, 204623
Pennsaid
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8546450. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 19 unexpired
21 Orange Book listing rows for 19 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8546450 | use U-1435, U-1436 | 9 Aug 2030 |
| US 8546450 listing row | use U-1435 · sets the listed date | 9 Aug 2030 |
| US 8546450 listing row | use U-1436 · sets the listed date | 9 Aug 2030 |
| US 8217078 | use U-1248, U-1477 | 10 Jul 2029 |
| US 8217078 listing row | use U-1248 | 10 Jul 2029 |
| US 8217078 listing row | use U-1477 | 10 Jul 2029 |
| US 8618164 | use U-1477 | 10 Jul 2029 |
| US 8741956 | use U-1435 | 10 Jul 2029 |
| US 9370501 | use U-1614 | 10 Jul 2029 |
| US 9375412 | use U-1614 | 10 Jul 2029 |
| US 9415029 | use U-1614 | 10 Jul 2029 |
| US 8252838 | drug product, use U-1489 | 21 Apr 2028 |
| US 8563613 | drug product, use U-1488 | 17 Oct 2027 |
| US 8871809 | use U-1614 | 17 Oct 2027 |
| US 9066913 | drug product, use U-1488 | 17 Oct 2027 |
| US 9101591 | drug product, use U-1488 | 17 Oct 2027 |
| US 9132110 | use U-1488 | 17 Oct 2027 |
| US 9168304 | drug product | 17 Oct 2027 |
| US 9168305 | use U-1488 | 17 Oct 2027 |
| US 9220784 | use U-1488 | 17 Oct 2027 |
| US 9339551 | use U-1488 | 17 Oct 2027 |
| US 9339552 | drug product, use U-1488 | 17 Oct 2027 |
| US 9539335 | use U-1614 | 17 Oct 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020947 · 001 · RLD · discontinued | solution, topical | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 9 Aug 2030 |
| 204623 · 001 · RLD · discontinued | solution, topical | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 9 Aug 2030 |