bupivacaine; meloxicam · Heron Theraps Inc · NDA 211988
Zynrelef Kit
Earliest generic entry, as listed · earliest of 2 marketed strengths
21 Apr 2036
Blocked by patent: US 11844837. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 16 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11844837 | use U-3417 | 21 Apr 2036 |
| US 10098957 | use U-3118 | 20 Apr 2035 |
| US 10213510 | product, use U-3118 | 20 Apr 2035 |
| US 10632199 | product, use U-3118 | 20 Apr 2035 |
| US 10898575 | product, use U-3118 | 20 Apr 2035 |
| US 10980886 | product | 20 Apr 2035 |
| US 11083730 | product, use U-3118 | 20 Apr 2035 |
| US 11083797 | product, use U-3118 | 20 Apr 2035 |
| US 11413350 | use U-3417 | 20 Apr 2035 |
| US 9694079 | product, use U-3118 | 20 Apr 2035 |
| US 9801945 | product, use U-3118 | 20 Apr 2035 |
| US 10398686 | product | 13 Mar 2034 |
| US 11253504 | use U-3118 | 13 Mar 2034 |
| US 9592227 | product, use U-3118 | 13 Mar 2034 |
| US 9744163 | product | 13 Mar 2034 |
| US 9913909 | use U-3118 | 13 Mar 2034 |
Exclusivities · 1 unexpired
| I-933 | new indication (3 years) | 23 Jan 2027 |
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 2026Exclusivity expires within 90 days I-933 · 211988-00423 Jan 2027
- 25 Oct 2026Exclusivity expires within 90 days I-933 · 211988-00323 Jan 2027
- 25 Oct 2026Exclusivity expires within 90 days I-933 · 211988-00223 Jan 2027
- 25 Oct 2026Exclusivity expires within 90 days I-933 · 211988-00123 Jan 2027
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211988 · 001 · RLD · discontinued | solution, extended release, periarticular | 60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) | 21 Apr 2036 |
| 211988 · 002 · RLD | solution, extended release, periarticular | 200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) | 21 Apr 2036 |
| 211988 · 003 · RLD · discontinued | solution, extended release, periarticular | 300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) | 21 Apr 2036 |
| 211988 · 004 · RLD | solution, extended release, periarticular | 400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) | 21 Apr 2036 |