morphine sulfate; naltrexone hydrochloride · Alpharma Pharms · NDA 022321
Embeda
Earliest generic entry, as listed · earliest of 6 marketed strengths
7 Nov 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8623418. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8623418 | use U-1640 | 7 Nov 2029 |
| US 7815934 | product | 12 Dec 2027 |
| US 7682633 | use U-1510 | 19 Jun 2027 |
| US 7682634 | product | 19 Jun 2027 |
| US 8158156 | use U-1510 | 19 Jun 2027 |
| US 8846104 | product | 19 Jun 2027 |
| US 8877247 | product | 19 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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022321 · 001 · RLD · discontinued | capsule, extended release, oral | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Nov 2029 |
| 022321 · 002 · RLD · discontinued | capsule, extended release, oral | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Nov 2029 |
| 022321 · 003 · RLD · discontinued | capsule, extended release, oral | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Nov 2029 |
| 022321 · 004 · RLD · discontinued | capsule, extended release, oral | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Nov 2029 |
| 022321 · 005 · RLD · discontinued | capsule, extended release, oral | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Nov 2029 |
| 022321 · 006 · RLD · discontinued | capsule, extended release, oral | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 7 Nov 2029 |