morphine sulfate · Hikma · NDA 019916, 019917, 020631, 022195, 022207, 201517, 202515, 204223
Morphine Sulfate
10 of 13 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 9072781, US 9192608, US 9192608, US 9248229.
FDA has approved 1 generic application (ANDA) for Morphine Sulfate, though its earliest generic-entry date is 12 Mar 2034 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9072781 | product | 12 Mar 2034 |
| US 9192608 | use U-43 | 12 Mar 2034 |
| US 9192608 | use U-55 | 12 Mar 2034 |
| US 9248229 | product | 12 Mar 2034 |
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 · 022195-0017 Jul 2026
Products covered · 23
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019916 · 001 · RLD · discontinued | injectable, injection | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019916 · 002 · RLD · discontinued | injectable, injection | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019917 · 001 · discontinued | injectable, injection | 0.5MG/ML | open |
| 020631 · 001 · discontinued | injectable, injection | 1MG/ML | open |
| 020631 · 002 · discontinued | injectable, injection | 2MG/ML | open |
| 022195 · 001 · RLD | solution, oral | 10MG/5ML | open |
| 022195 · 002 · RLD | solution, oral | 20MG/5ML | open |
| 022195 · 003 · RLD | solution, oral | 100MG/5ML | open |
| 022207 · 001 · RLD | tablet, oral | 15MG | open |
| 022207 · 002 · RLD | tablet, oral | 30MG | open |
| 201517 · 001 · discontinued | solution, oral | 100MG/5ML | open |
| 202515 · 001 · RLD | injectable, injection | 2MG/ML | open |
| 202515 · 002 · RLD | injectable, injection | 4MG/ML | open |
| 202515 · 003 · RLD | injectable, injection | 8MG/ML | open |
| 202515 · 004 · RLD | injectable, injection | 10MG/ML | open |
| 202515 · 005 · RLD · discontinued | injectable, injection | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 202515 · 006 · RLD | injectable, injection | 50MG/ML | open |
| 204223 · 001 · RLD | solution, intramuscular, intravenous | 2MG/ML (2MG/ML) | 12 Mar 2034 |
| 204223 · 002 · RLD | solution, intramuscular, intravenous | 4MG/ML (4MG/ML) | 12 Mar 2034 |
| 204223 · 003 · RLD · discontinued | solution, intramuscular, intravenous | 5MG/ML (5MG/ML) | 12 Mar 2034 |
| 204223 · 004 · RLD · discontinued | solution, intramuscular, intravenous | 8MG/ML (8MG/ML) | 12 Mar 2034 |
| 204223 · 005 · RLD | solution, intramuscular, intravenous | 10MG/ML (10MG/ML) | 12 Mar 2034 |
| 204223 · 006 · RLD · discontinued | solution, intramuscular, intravenous | 1MG/0.5ML (1MG/0.5ML) | open |