Venclexta is a drug owned by Abbvie Inc. It is protected by 10 US drug patents filed from 2016 to 2023 out of which none have expired yet. Venclexta's patents have been open to challenges since 11 April, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 06, 2033. Details of Venclexta's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8722657 | Salts and crystalline forms of an apoptosis-inducing agent |
Jan, 2032
(7 years from now) | Active |
| US10730873 | Salts and crystalline forms of an apoptosis-inducing agent |
Nov, 2031
(6 years from now) | Active |
| US8546399 | Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases |
Jun, 2031
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9539251 | Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor |
Sep, 2033
(8 years from now) | Active |
| US10993942 | Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor |
Sep, 2033
(8 years from now) | Active |
| US11413282 | Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor |
Sep, 2033
(8 years from now) | Active |
| US11590128 | Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor |
Sep, 2033
(8 years from now) | Active |
| US11110087 | Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor |
Sep, 2033
(8 years from now) | Active |
| US11369599 | Melt-extruded solid dispersions containing an apoptosis-inducing agent |
May, 2032
(7 years from now) | Active |
| US9174982 | Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases |
May, 2030
(5 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Venclexta's patents.
Latest Legal Activities on Venclexta's Patents
Given below is the list of recent legal activities going on the following patents of Venclexta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail O.P. Petition Decision | 19 Jul, 2024 | US11369599 |
| Email Notification Critical | 19 Jul, 2024 | US11369599 |
| Mail-Petition Decision - Denied | 16 Jul, 2024 | US11369599 |
| Mail-Petition Decision - Granted | 16 Jul, 2024 | US11369599 |
| Petition Decision - Denied | 15 Jul, 2024 | US11369599 |
| O.P. Petition Decision | 15 Jul, 2024 | US11369599 |
| Petition Decision - Granted Critical | 15 Jul, 2024 | US11369599 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jun, 2024 | US9539251 |
| Electronic Review Critical | 07 Jun, 2024 | US11369599 |
| Petition Entered | 30 Apr, 2024 | US11369599 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Venclexta and ongoing litigations to help you estimate the early arrival of Venclexta generic.
Venclexta's Litigations
Venclexta been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 03, 2022, against patent number US10993942. The petitioner Dr. Reddy's Laboratories, Inc. et al., challenged the validity of this patent, with Genentech, Inc. et al. as the respondent. Click below to track the latest information on how companies are challenging Venclexta's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11110087 | October, 2022 |
Final Written Decision - Appealed
(16 Apr, 2024) | Genentech, Inc. et al. | Dr. Reddy's Laboratories, Inc. et al. |
| US10993942 | February, 2022 |
Final Written Decision - Appealed
(10 Aug, 2023) | Genentech, Inc. et al. | Dr. Reddy's Laboratories, Inc. et al. |
FDA has granted some exclusivities to Venclexta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Venclexta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Venclexta.
Exclusivity Information
Venclexta holds 11 exclusivities out of which 8 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Venclexta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 11, 2021 |
| New Indication(I-782) | Jun 08, 2021 |
| M(M-228) | Jun 08, 2021 |
| New Indication(I-789) | Nov 21, 2021 |
| New Indication(I-795) | May 15, 2022 |
| Orphan Drug Exclusivity(ODE) | Apr 11, 2023 |
| Orphan Drug Exclusivity(ODE-114) | Apr 11, 2023 |
| M(M-265) | Oct 16, 2023 |
| Orphan Drug Exclusivity(ODE-185) | Jun 08, 2025 |
| Orphan Drug Exclusivity(ODE-211) | Nov 21, 2025 |
| Orphan Drug Exclusivity(ODE-239) | May 15, 2026 |
Several oppositions have been filed on Venclexta's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Venclexta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Venclexta patents.
Venclexta's Oppositions Filed in EPO
Venclexta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 30, 2018, by Generics (U.K.) Limited. This opposition was filed on patent number EP11791401A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP11791401A | May, 2018 | Generics (U.K.) Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Venclexta is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Venclexta's family patents as well as insights into ongoing legal events on those patents.
Venclexta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Venclexta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 06, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Venclexta Generics:
There are no approved generic versions for Venclexta as of now.
How can I launch a generic of Venclexta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Venclexta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Venclexta's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Venclexta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 50 mg and 100 mg | 13 Apr, 2020 | 2 | 29 Jan, 2032 |
About Venclexta
Venclexta is a drug owned by Abbvie Inc. It is used for treating various forms of leukemia, particularly acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), in adults with certain conditions or as subsequent therapy. Venclexta uses Venetoclax as an active ingredient. Venclexta was launched by Abbvie in 2016.
Approval Date:
Venclexta was approved by FDA for market use on 11 April, 2016.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Venclexta is 11 April, 2016, its NCE-1 date is estimated to be 11 April, 2020.
Active Ingredient:
Venclexta uses Venetoclax as the active ingredient. Check out other Drugs and Companies using Venetoclax ingredient
Treatment:
Venclexta is used for treating various forms of leukemia, particularly acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), in adults with certain conditions or as subsequent therapy.
Dosage:
Venclexta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |