tolvaptan · Otsuka · NDA 204441
Jynarque
Earliest generic entry, as listed · earliest of 5 marketed strengths
7 Apr 2030
Blocked by patent: US 10905694.
FDA has approved 3 generic applications (ANDAs) for Jynarque, though its earliest generic-entry date is 7 Apr 2030 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 · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10905694 | drug product · sets the listed date | 7 Apr 2030 |
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 · 204441-00121 Apr 2026
- 25 Oct 2026Generic approved · 204441-00121 Jul 2026
- 25 Oct 2026Generic approved · 204441-00110 Nov 2025
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204441 · 001 · RLD | tablet, oral | 15MG | 7 Apr 2030 |
| 204441 · 002 · RLD | tablet, oral | 30MG | 7 Apr 2030 |
| 204441 · 003 · RLD | tablet, oral | 45MG | 7 Apr 2030 |
| 204441 · 004 · RLD | tablet, oral | 60MG | 7 Apr 2030 |
| 204441 · 005 · RLD | tablet, oral | 90MG | 7 Apr 2030 |
Expired or delisted (1)
- US 8501730 · substance · 1 Sep 2026