Orange Book product · Brand (NDA)
VENCLEXTA
VENETOCLAX
At a glance
Apr 11, 2016
Approved
Brand (NDA)
Application
AB
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 11, 2016
10 yr 4 mo ago
Exclusivity ends · ODE-239
Orphan-drug exclusivity (7 years)
May 15, 2026
1 mo ago
Today
Patent 9174982 expires
Listed method-of-use patent (U-2537) expiration.
May 26, 2030
in 4 yr
Patent 9174982 expires
Listed method-of-use patent (U-2445) expiration.
May 26, 2030
in 4 yr
Patent 9174982 expires
Listed method-of-use patent (U-2323) expiration.
May 26, 2030
in 4 yr
Patent 9174982 expires
Listed method-of-use patent (U-2446) expiration.
May 26, 2030
in 4 yr
Patent 8546399 expires
Listed drug substance patent expiration.
Jun 27, 2031
in 5 yr 1 mo
Patent 10730873 expires
Listed drug substance patent expiration.
Nov 21, 2031
in 5 yr 6 mo
Patent 8722657 expires
Listed drug substance patent expiration.
Jan 29, 2032
in 5 yr 8 mo
Patent 11369599 expires
Listed drug product patent expiration.
May 23, 2032
in 6 yr
Patent 10993942 expires
Listed method-of-use patent (U-3114) expiration.
Sep 06, 2033
in 7 yr 4 mo
Patent 11110087 expires
Listed method-of-use patent (U-3222) expiration.
Sep 06, 2033
in 7 yr 4 mo
Patent 11110087 expires
Listed method-of-use patent (U-3223) expiration.
Sep 06, 2033
in 7 yr 4 mo
Patent 11413282 expires
Listed method-of-use patent (U-3412) expiration.
Sep 06, 2033
in 7 yr 4 mo
Patent 11590128 expires
Listed method-of-use patent (U-3548) expiration.
Sep 06, 2033
in 7 yr 4 mo
Patent 9539251 expires
Listed method-of-use patent (U-2538) expiration.
Sep 06, 2033
in 7 yr 4 mo
Pharmaceutical detail
Active ingredient
VENETOCLAX
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 208573
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- ODE-239Orphan-drug exclusivity (7 years)
May 15, 2026
1 mo ago
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9174982 | May 26, 2030 | in 4 yr | U-2537 |
| 9174982 | May 26, 2030 | in 4 yr | U-2445 |
| 9174982 | May 26, 2030 | in 4 yr | U-2323 |
| 9174982 | May 26, 2030 | in 4 yr | U-2446 |
| 8546399 | Jun 27, 2031 | in 5 yr 1 mo | SubstanceProduct |
| 10730873 | Nov 21, 2031 | in 5 yr 6 mo | Substance |
| 8722657 | Jan 29, 2032 | in 5 yr 8 mo | Substance |
| 11369599 | May 23, 2032 | in 6 yr | Product |
| 10993942 | Sep 06, 2033 | in 7 yr 4 mo | U-3114 |
| 11110087 | Sep 06, 2033 | in 7 yr 4 mo | U-3222 |
| 11110087 | Sep 06, 2033 | in 7 yr 4 mo | U-3223 |
| 11413282 | Sep 06, 2033 | in 7 yr 4 mo | U-3412 |
| 11590128 | Sep 06, 2033 | in 7 yr 4 mo | U-3548 |
| 9539251 | Sep 06, 2033 | in 7 yr 4 mo | U-2538 |
