oxymorphone hydrochloride · Endo Operations · NDA 021610, 201655
Opana Er
Earliest generic entry, as listed · earliest of 14 marketed strengths
22 Nov 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8871779.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8871779 | substance | 22 Nov 2029 |
| US 7851482 | substance | 10 Jul 2029 |
| US 8808737 | use U-1598 | 21 Jun 2027 |
| US 8808737 | use U-3085 | 21 Jun 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 · 14
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021610 · 001 · RLD · discontinued | tablet, extended release, oral | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 22 Nov 2029 |
| 021610 · 002 · RLD · discontinued | tablet, extended release, oral | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 22 Nov 2029 |
| 021610 · 003 · RLD · discontinued | tablet, extended release, oral | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 22 Nov 2029 |
| 021610 · 004 · RLD · discontinued | tablet, extended release, oral | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 22 Nov 2029 |
| 021610 · 005 · RLD · discontinued | tablet, extended release, oral | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 22 Nov 2029 |
| 021610 · 006 · RLD · discontinued | tablet, extended release, oral | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 22 Nov 2029 |
| 021610 · 007 · RLD · discontinued | tablet, extended release, oral | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 22 Nov 2029 |
| 201655 · 001 · RLD · discontinued | tablet, extended release, oral | 5MG | 22 Nov 2029 |
| 201655 · 002 · RLD · discontinued | tablet, extended release, oral | 7.5MG | 22 Nov 2029 |
| 201655 · 003 · RLD · discontinued | tablet, extended release, oral | 10MG | 22 Nov 2029 |
| 201655 · 004 · RLD · discontinued | tablet, extended release, oral | 15MG | 22 Nov 2029 |
| 201655 · 005 · RLD · discontinued | tablet, extended release, oral | 20MG | 22 Nov 2029 |
| 201655 · 006 · RLD · discontinued | tablet, extended release, oral | 30MG | 22 Nov 2029 |
| 201655 · 007 · RLD · discontinued | tablet, extended release, oral | 40MG | 22 Nov 2029 |