nintedanib esylate · Boehringer Ingelheim · NDA 205832
Ofev
Earliest generic entry, as listed · earliest of 2 marketed strengths
7 Dec 2029
Blocked by patent: US 9907756.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9907756 | — | 7 Dec 2029 |
| US 10105323 | — | 4 Dec 2029 |
| US 9907756 | product | 7 Jun 2029 |
| US 10105323 | product | 4 Jun 2029 |
Exclusivities · 1 unexpired
| PED | pediatric (6 months added) | 6 Mar 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 2026Generic tentatively approved · 205832-0014 Feb 2026
- 25 Oct 2026Generic approved · 205832-00119 Aug 2026
- 25 Oct 2026Generic approved · 205832-0019 Jul 2026
- 25 Oct 2026Generic approved · 205832-0013 Aug 2026
- 25 Oct 2026First generic approved · 205832-0012 Apr 2026
- 25 Oct 2026Generic approved · 205832-0012 Apr 2026
- 25 Oct 2026First generic approved · 205832-0012 Apr 2026
- 25 Oct 2026Generic approved · 205832-0012 Apr 2026
- 25 Oct 2026First generic approved · 205832-0012 Apr 2026
- 25 Oct 2026Generic approved · 205832-0012 Apr 2026
- 25 Oct 2026First generic approved · 205832-0012 Apr 2026
- 25 Oct 2026Generic approved · 205832-0012 Apr 2026
- 25 Oct 2026Generic approved · 205832-0019 Jul 2026
- 25 Oct 2026First generic approved · 205832-0012 Apr 2026
- 25 Oct 2026Generic approved · 205832-0012 Apr 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205832 · 001 · RLD | capsule, oral | EQ 100MG BASE | 7 Dec 2029 |
| 205832 · 002 · RLD | capsule, oral | EQ 150MG BASE | 7 Dec 2029 |
Expired or delisted (5)
- US 10154990 · — · 8 Jul 2026
- US 6762180 · — · 1 Apr 2026
- US 10154990 · use U-2620 · 8 Jan 2026
- US 6762180 · substance, product · 1 Oct 2025
- ODE-261 · 6 Sep 2026