vasopressin · Ph Health · NDA 204485
Vasostrict
Blocked by patent: US 10010575, US 12186362, US 9375478, US 9687526, US 9744209, US 9744239, US 9750785, US 9919026, US 9925233, US 9925234, US 9937223, US 9962422, US 9968649, US 9974827, US 9981006.
FDA has approved 2 generic applications (ANDAs) for Vasostrict, though its earliest generic-entry date is 30 Jan 2035 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 · 15 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10010575 | use U-1857 | 30 Jan 2035 |
| US 12186362 | product | 30 Jan 2035 |
| US 9375478 | use U-1857 | 30 Jan 2035 |
| US 9687526 | use U-1857 | 30 Jan 2035 |
| US 9744209 | use U-1857 | 30 Jan 2035 |
| US 9744239 | use U-1857 | 30 Jan 2035 |
| US 9750785 | product | 30 Jan 2035 |
| US 9919026 | product | 30 Jan 2035 |
| US 9925233 | use U-1857 | 30 Jan 2035 |
| US 9925234 | use U-1857 | 30 Jan 2035 |
| US 9937223 | use U-1857 | 30 Jan 2035 |
| US 9962422 | use U-1857 | 30 Jan 2035 |
| US 9968649 | use U-1857 | 30 Jan 2035 |
| US 9974827 | use U-1857 | 30 Jan 2035 |
| US 9981006 | use U-1857 | 30 Jan 2035 |
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 · 204485-0016 May 2026
- 25 Oct 2026Generic approved · 204485-0016 May 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204485 · 001 · RLD | solution, intravenous | 20UNITS/ML (20UNITS/ML) | 30 Jan 2035 |
| 204485 · 002 · RLD | solution, intravenous | 200UNITS/10ML (20UNITS/ML) | 30 Jan 2035 |
| 204485 · 003 · RLD | solution, intravenous | 40UNITS/100ML (0.4UNITS/ML) | 30 Jan 2035 |
| 204485 · 004 · RLD · discontinued | solution, intravenous | 60UNITS/100ML (0.6UNITS/ML) | 30 Jan 2035 |
| 204485 · 005 · RLD | solution, intravenous | 20UNITS/100ML (0.2UNITS/ML) | 30 Jan 2035 |
| 204485 · 006 · RLD · discontinued | solution, intravenous | 50UNITS/50ML (1UNITS/ML) | 30 Jan 2035 |