Venclexta Generic: When Will Generic Venetoclax Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Venclexta Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2032 to 2033 A wide window Why then?
- Has the FDA approved a generic? May 2026 1 company approved Why not on sale?
- When does the brand’s protection end? September 2033 The last of 10 listed patents
- Can you buy a generic today? Not yet No company lists one for sale
Dr. Brian Staiger Explains
PharmD, BCPS · Clinical pharmacistGeneric venetoclax is expected to be available between 2032 and 2033. None is for sale yet.
Why 2032 to 2033?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since May 2026, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. See the price pattern
What should I do now?
Keep taking Venclexta as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Venclexta by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- Moderate 2 companies have filed, 2 first in line
- Brand sales
- $1.8B a yearBlockbuster
- FDA approved 2016 April 2016 FDA Orange Book
- Patents listed 10 last runs to September 2033 FDA Orange Book
- Generics FDA-approved 1 company, approved May 2026 FDA Orange Book
- Medicare Part D spent $1.1B in 2025, for 25.5K people CMS Part D Spending by Drug
- Medicaid prescriptions 2,928 in the last four reported quarters, $31.7M CMS Medicaid drug utilization, to Q1 2026
Venclexta’s Road to a Generic
Venclexta has had the market to itself since the FDA approved it in April 2016 (Abbvie Inc). Its FDA protections on record ended by May 2026. Its 10 listed patents run to September 2033. Generic companies have challenged its patents with the FDA since April 2020.
The first generic of Venclexta is expected between 2032 and 2033.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Venclexta Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Venclexta’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,174,982 | A way of using it (U-2537, U-2445, U-2323, U-2446) | May 2030 | Active |
| 8,546,399 | The active ingredient; the product’s formulation | June 2031 | Active |
| 10,730,873 | The active ingredient | November 2031 | Active |
| 8,722,657 | The active ingredient | January 2032 | Active |
| 11,369,599 | The product’s formulation | May 2032 | Active |
| 9,539,251 | A way of using it (U-2538) | September 2033 | Active |
| 10,993,942 | A way of using it (U-3114) | September 2033 | Active |
| 11,110,087 | A way of using it (U-3222, U-3223) | September 2033 | Active |
| 11,413,282 | A way of using it (U-3412) | September 2033 | Active |
| 11,590,128 | A way of using it (U-3548) | September 2033 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-239 | Seven years of protection for a use in a rare disease. | May 2026 | Ended |
Source: FDA Orange Book, application 208573. Patent numbers open the patent on Google Patents.
Patent Challenges to Venclexta
The first patent challenge to Venclexta reached the FDA in April 2020, from 2 companies on that first day. The FDA approved a first challenger’s generic in May 2026, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Venclexta’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Tablets, 10 mg, 50 mg and 100 mg | April 2020 | 2 companies | Decision deferred decided June 2026 | May 2026 | Not yet | January 2032 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Venetoclax
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
2 companies have applied to the FDA to make generic venetoclax.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 2 of them were first in line, both filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Venclexta’s patents with the FDA since April 2020: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in May 2026. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic venetoclax for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Dr Reddys Laboratories Ltd | May 2026 | 10MG, 50MG, 100MG | AB |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Venclexta Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Venclexta, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Venclexta
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Venclexta, before manufacturer rebates.
- $295.4M
- January to March 2026, the latest CMS has posted
For 14,571 people, about $9,035 per prescription fill - $1.1B
- 2025, the whole year
For 25,495 people, about $8,838 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $295,370,544 | 14,571 | $9,035.23 |
| 2025 | $1,134,824,029 | 25,495 | $8,837.85 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Venclexta only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain types of cancer (chronic lymphocytic leukemia-CLL, small lymphocytic lymphoma-SLL, acute myeloid leukemia-AML). Venetoclax is a drug that works by helping to slow or stop the growth of cancer cells.
Medicaid Prescriptions by Quarter
2,928 prescriptions in the four quarters to Q1 2026, $31.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 732 | $7,759,815 |
| Q4 2025 | 743 | $8,012,168 |
| Q3 2025 | 783 | $8,345,583 |
| Q2 2025 | 670 | $7,620,668 |
| Q1 2025 | 722 | $7,873,711 |
Source: CMS Medicaid State Drug Utilization Data, over Venclexta’s own package codes.
Venclexta Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Tablet | Oral | April 2016 | Prescription reference product |
| 10MG | Tablet | Oral | April 2016 | Prescription reference product |
| 50MG | Tablet | Oral | April 2016 | Prescription reference product |
Source: FDA Orange Book, Abbvie Inc. Listed for sale today by AbbVie Inc. (FDA NDC Directory).
Venclexta NDC Codes and Packages
Each Venclexta package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00074-0561-11 | VENETOCLAX 10 mg/1 tablet, film coated | blister pack of 2 tablets | AbbVie Inc. |
| 00074-0561-11 | VENETOCLAX 10 mg/1 tablet, film coated | blister pack of 2 tablets | AbbVie Inc. |
| 00074-0561-14 | VENETOCLAX 10 mg/1 tablet, film coated | blister pack of 14 tablets | AbbVie Inc. |
| 00074-0561-14 | VENETOCLAX 10 mg/1 tablet, film coated | blister pack of 14 tablets | AbbVie Inc. |
| 00074-0576-11 | VENETOCLAX 100 mg/1 tablet, film coated | blister pack of 1 tablet | AbbVie Inc. |
| 00074-0576-11 | VENETOCLAX 100 mg/1 tablet, film coated | blister pack of 1 tablet | AbbVie Inc. |
| 00074-0576-22 | VENETOCLAX 100 mg/1 tablet, film coated | bottle of 120 tablets | AbbVie Inc. |
| 00074-0576-22 | VENETOCLAX 100 mg/1 tablet, film coated | bottle of 120 tablets | AbbVie Inc. |
Show the other 9 Venclexta packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 00074-0576-30 | VENETOCLAX 100 mg/1 tablet, film coated | bottle of 28 tablets | AbbVie Inc. |
| 00074-0576-30 | VENETOCLAX 100 mg/1 tablet, film coated | bottle of 28 tablets | AbbVie Inc. |
| 00074-0576-34 | VENETOCLAX 100 mg/1 tablet, film coated | bottle of 180 tablets | AbbVie Inc. |
| 00074-0566-07 | VENETOCLAX 50 mg/1 tablet, film coated | blister pack of 7 tablets | AbbVie Inc. |
| 00074-0566-07 | VENETOCLAX 50 mg/1 tablet, film coated | blister pack of 7 tablets | AbbVie Inc. |
| 00074-0566-11 | VENETOCLAX 50 mg/1 tablet, film coated | blister pack of 1 tablet | AbbVie Inc. |
| 00074-0566-11 | VENETOCLAX 50 mg/1 tablet, film coated | blister pack of 1 tablet | AbbVie Inc. |
| 00074-0579-28 | kit | 1 KIT in 1 CARTON * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK | AbbVie Inc. |
| 00074-0579-28 | kit | 1 KIT in 1 CARTON * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK | AbbVie Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Venclexta’s own FDA approval (NDA 208573) are listed, never a generic. Some codes belong to companies that repackage Venclexta: it is the same medicine in a different package.
What a Generic Venclexta Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Venclexta as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Venclexta”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Venclexta
Is there a generic for Venclexta right now?
No. As of October 9, 2026 no generic venetoclax is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Venclexta go generic?
2032 to 2033 is the expected window, and that is likely but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Will generic venetoclax be the same as Venclexta?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Venclexta?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in May 2026: Dr Reddys Laboratories Ltd. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Venclexta patent expire?
The FDA Orange Book lists 10 patents for Venclexta; the last runs to September 2033. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (2032 to 2033) weighs all of that.
Has anyone challenged the Venclexta patents?
Yes. The first patent challenge to Venclexta reached the FDA in April 2020, from 2 companies on that first day. The FDA approved a first challenger’s generic in May 2026, and the list records no sale by a first challenger yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected 2032 to 2033 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- FexinidazoleFexinidazoleJuly 2028
- PhexxCitric Acid, L-Lactic Acid, and Potassium BitartrateMarch 2033
- XpovioSelinexor2034 to 2035
- TavneosAvacopanJanuary 2034
- Levothyroxine SodiumLevothyroxine SodiumJuly 2036
- BlujepaGepotidacin Mesylate2038 to 2039
About Venclexta
- Generic name venetoclax
- How it is taken By mouth
- Company Abbvie Inc
- Patent challenges Since April 2020 (FDA)
- More drugs Brand-name drugs starting with V
- Have a question? A pharmacist answers, free. Ask about Venclexta
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.