venetoclax · Abbvie · NDA 208573
Venclexta
Blocked by patent: US 10993942, US 11110087, US 11413282, US 11590128, US 9539251. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
FDA has approved 1 generic application (ANDA) for Venclexta, though its earliest generic-entry date is 6 Sep 2033 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 · 10 unexpired
14 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10993942 | use U-3114 · sets the listed date | 6 Sep 2033 |
| US 11110087 | use U-3222, U-3223 | 6 Sep 2033 |
| US 11110087 listing row | use U-3222 · sets the listed date | 6 Sep 2033 |
| US 11110087 listing row | use U-3223 · sets the listed date | 6 Sep 2033 |
| US 11413282 | use U-3412 · sets the listed date | 6 Sep 2033 |
| US 11590128 | use U-3548 · sets the listed date | 6 Sep 2033 |
| US 9539251 | use U-2538 · sets the listed date | 6 Sep 2033 |
| US 11369599 | drug product | 23 May 2032 |
| US 8722657 | drug substance | 29 Jan 2032 |
| US 10730873 | drug substance | 21 Nov 2031 |
| US 8546399 | drug substance, drug product | 27 Jun 2031 |
| US 9174982 | use U-2323, U-2445, U-2446, U-2537 | 26 May 2030 |
| US 9174982 listing row | use U-2323 | 26 May 2030 |
| US 9174982 listing row | use U-2445 | 26 May 2030 |
| US 9174982 listing row | use U-2446 | 26 May 2030 |
| US 9174982 listing row | use U-2537 | 26 May 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 2026First generic approved · 208573-00115 May 2026
- 25 Oct 2026Generic approved · 208573-00115 May 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208573 · 001 · RLD | tablet, oral | 10MG | 6 Sep 2033 |
| 208573 · 002 · RLD | tablet, oral | 50MG | 6 Sep 2033 |
| 208573 · 003 · RLD | tablet, oral | 100MG | 6 Sep 2033 |
Expired or delisted (1)
- ODE-239 · 15 May 2026