FDA Orange Book
Generic for Venclexta
Venclexta contains venetoclax. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Venclexta is venetoclax. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Venclexta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 10MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 50MG | Marketed (Rx) | AB | 1 | AB |
NDA 208573, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic venetoclax
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 214733 | AB (A-rated, therapeutically equivalent) | May 15, 2026 | 100MG, 10MG, 50MG |
Venclexta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9174982 | May 26, 2030 | Method of use | U-2537 | 208573 |
| 9174982 | May 26, 2030 | Method of use | U-2445 | 208573 |
| 9174982 | May 26, 2030 | Method of use | U-2323 | 208573 |
| 9174982 | May 26, 2030 | Method of use | U-2446 | 208573 |
| 8546399 | June 27, 2031 | Drug substance, Drug product | None | 208573 |
| 10730873 | November 21, 2031 | Drug substance | None | 208573 |
| 8722657 | January 29, 2032 | Drug substance | None | 208573 |
| 11369599 | May 23, 2032 | Drug product | None | 208573 |
| 11413282 | September 6, 2033 | Method of use | U-3412 | 208573 |
| 11590128 | September 6, 2033 | Method of use | U-3548 | 208573 |
| 9539251 | September 6, 2033 | Method of use | U-2538 | 208573 |
| 10993942 | September 6, 2033 | Method of use | U-3114 | 208573 |
| 11110087 | September 6, 2033 | Method of use | U-3222 | 208573 |
| 11110087 | September 6, 2033 | Method of use | U-3223 | 208573 |
Venclexta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-239 | Orphan drug exclusivity | May 15, 2026 | 208573 |
Venclexta NDC codes
Questions
Is there a generic for Venclexta?
Yes. The generic name for Venclexta is venetoclax. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Venclexta?
The active ingredient in Venclexta is venetoclax, per the FDA Orange Book.
When does the Venclexta patent expire?
The last patent listed for Venclexta in the Orange Book expires September 6, 2033. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.