VENCLEXTA Drug Patent Profile

Which patents cover Venclexta, and when can generic versions of Venclexta launch?

Venclexta is a drug marketed by Abbvie and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and sixty-four patent family members in forty-three countries.

The generic ingredient in VENCLEXTA is venetoclax. One supplier is listed for this compound. Additional details are available on the venetoclax profile page.

DrugPatentWatch^® Generic Entry Outlook for Venclexta

Venclexta was eligible for patent challenges on April 11, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 23, 2032. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (venetoclax), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VENCLEXTA

International Patents:	264
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	190
Patent Applications:	4,843
Drug Prices:	Drug price information for VENCLEXTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VENCLEXTA
What excipients (inactive ingredients) are in VENCLEXTA?	VENCLEXTA excipients list
DailyMed Link:	VENCLEXTA at DailyMed

See drug prices for VENCLEXTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VENCLEXTA

Constraining patent/regulatory exclusivity:

11,369,599

NDA:

208573

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VENCLEXTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Antonio M Jimenez Jimenez	Phase 1
Montefiore Medical Center	Phase 1
Flamingo Therapeutics NV	Phase 1

See all VENCLEXTA clinical trials

Pharmacology for VENCLEXTA

Drug Class	BCL-2 Inhibitor
Mechanism of Action	P-Glycoprotein Inhibitors
Physiological Effect	Increased Cellular Death

Paragraph IV (Patent) Challenges for VENCLEXTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VENCLEXTA	Tablets	venetoclax	10 mg, 50 mg and 100 mg	208573	2	2020-04-13

US Patents and Regulatory Information for VENCLEXTA

VENCLEXTA is protected by fourteen US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,369,599.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes	11,590,128
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes

EU/EMA Drug Approvals for VENCLEXTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH Co. KG	Venclyxto	venetoclax	EMEA/H/C/004106Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Venclyxto monotherapy is indicated for the treatment of CLL:- in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or- in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.	Authorised	no	no	no	2016-12-04

International Patents for VENCLEXTA

When does loss-of-exclusivity occur for VENCLEXTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VENCLEXTA around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I501966
Uruguay	32668	AGENTES INDUCTORES DE LA APOPTOSIS PARA EL TRATAMIENTO DEL CÁNCER Y DE ENFERMEDADES INMUNES Y AUTOINMUNES
Lithuania	2643322

Supplementary Protection Certificates for VENCLEXTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435432	SPC/GB17/032	United Kingdom		PRODUCT NAME: VENETOCLAX; REGISTERED: UK EU/1/16/1138 (NI) 20161207; UK PLGB 41042/0035 20161207; UK PLGB 41042/0036 20161207; UK PLGB 41042/0037 20161207
2435432	2017023	Norway		PRODUCT NAME: VENETOKLAKS, DVS. 4-(4-(2-(4-; REG. NO/DATE: EU/1/16/1138 20161213
2435432	17C1018	France		PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207

Market Dynamics and Financial Trajectory for VENCLEXTA: A Comprehensive Analysis

Last updated: December 29, 2025

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Summary

VENCLEXTA (venetoclax) has established itself as a pivotal agent in the treatment landscape for hematologic malignancies, notably chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). This analysis examines the current market landscape, key drivers, competitive environment, regulatory factors, and financial projections shaping VENCLEXTA’s trajectory. The drug's robust approval pathway, expanding indications, and strategic collaborations forecast significant growth, while competitive pressures and market saturation pose potential challenges.

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What Are the Core Market Drivers for VENCLEXTA?

1. Expanding Indications and Label Approvals

VENCLEXTA, developed by AbbVie in collaboration with Genentech, initially secured FDA approval in 2016 for CLL with 17p deletion. Subsequent approvals include:

Approval Year	Indication	Regulatory Body	Key Conditions
2016	CLL with 17p deletion	FDA	Combination with rituximab
2018	AML (via accelerated approval)	FDA	Monotherapy for relapsed/refractory AML
2020	First-line CLL in combination with obinutuzumab	FDA
2022	Additional AML indications for newly approved subsets	FDA

The expansion into AML signifies a pivotal step, owing to the high unmet medical need for effective treatments in relapsed/refractory AML.

2. Market Size and Demographics

The global hematologic malignancies market is valued at approximately $25 billion (2022), with key segments:

Segment	2022 Market Value	Growth Rate (CAGR 2022-2027)	Notes
CLL	$8.4 billion	6.2%	Leading subsegment targeted by VENCLEXTA
AML	$4.5 billion	7.0%	Increasing, driven by unmet needs
Multiple Myeloma & Others	$12.1 billion	5.8%	Competitive landscape

VENCLEXTA’s position as a first-in-class BCL-2 inhibitor and its flexibility in combination therapies bolsters its market appeal.

3. Clinical Efficacy and Safety Profile

Clinical trials underpin its market expansion:

Trial Name	Indication	Results Summary
M13-982 (CLL)	CLL	ORR (overall response rate): 85%; extended PFS (progression-free survival)
VIALE-A (AML)	AML	Median OS of 14.7 months vs. 7.4 months with placebo
HO425/AZA-001 (AML)	AML (combination)	CR (complete response): 37% with venetoclax+Azacitidine vs. 16% alone

Efficacy, combined with manageable safety, underpins reimbursement and clinician confidence.

4. Competitive Landscape: Key Players and Differentiators

Competitor	Mechanism	Indications	Market Share (Preliminary)	Differentiators
VENCLEXTA (AbbVie)	BCL-2 inhibitor	CLL, AML, crossover	~50% (hematology segment)	First-in-class, broad label approval
Cytarabine & Daunorubicin	Chemotherapy agents	AML	High	Standard of care, not targeted therapy
Magrolimab (Etlapgd)	Anti-CD47 antibody	AML, MDS	Emerging	Novel mechanism, early trials

VENCLEXTA benefits from its well-established efficacy, but newer mechanisms threaten future dominance.

5. Regulatory and Policy Environment

• The FDA’s continued support for targeted therapies enhances VENCLEXTA’s prospects.
• Orphan drug designation for certain AML subsets facilitates accelerated approval.
• Pricing and reimbursement policies influence access and profitability.

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What Is the Financial Trajectory for VENCLEXTA?

1. Current Revenue Performance

Fiscal Year	Global Sales (USD millions)	Growth Rate	Notable Markets
2021	$2,150	+40%	U.S., EU
2022	$3,020	+40.9%	U.S., EU, Asia-Pacific

2. Revenue Forecast (2023-2027)

Year	Projected Global Sales (USD millions)	CAGR (2023-2027)	Key Growth Drivers
2023	$3,950	34.5%	Expanded AML indications, new combinations
2024	$5,280		Broader label, increased penetration
2025	$6,930		New market entries, introducing biosimilars
2026	$8,420		Patent expiry approaches, pipeline growth
2027	$9,900		Expected market share stabilization

Note: These forecasts assume successful regulatory approvals, market uptake, and pricing strategies.

3. Profitability and Pricing Strategy

Pricing Element	USD per unit	Notes
Wholesale Acquisition Price (WAC)	$8,620 per 28-day pack	Variable by region and indication
Reimbursement Status	Broad in US/EU	Favorable, with coverage driven by efficacy data
Cost Structure	Moderate for AbbVie	R&D, manufacturing, marketing

AbbVie’s strategic focus is on maintaining premium pricing supported by clinical efficacy and regulatory exclusivity.

4. R&D Pipeline and Future Revenue Streams

Pipeline Summary:

Candidate	Indication	Phase	Potential Impact
Venetoclax + Durvalumab	Solid tumors (e.g., NSCLC)	Phase 1	Diversifying revenue beyond hematology
Venetoclax + Obinutuzumab	CLL (First-line)	Approved	Sustains sales growth in existing indications
New formulations (e.g., subcutaneous)	Hematologic cancers	Early	Improved patient compliance and market share

Implications: Diversification reduces dependency risk and enhances long-term growth.

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How Do Market Dynamics Vary Across Key Regions?

Region	Market Size (USD billions)	Regulatory Environment	Reimbursement Landscape	Challenges
US	~12	Accelerated approvals, Orphan designations	Medicare/Medicaid coverage; high competition	Pricing pressure, patent cliffs
EU	~8	Similar to US; EMA approvals	National health services bargaining	slower market access, policy variability
Asia-Pacific	~$5	Growing regulatory rigor	Emerging reimbursement policies	Market heterogeneity, low penetration

Regional strategies, including localized clinical trials and pricing negotiations, influence revenue localization.

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What Are the Competitive and Regulatory Risks?

Risk Type	Impact	Mitigation Strategies
Patent Expiry	Revenue erosion	Diversify pipeline, develop biosimilars
Competitive drugs entering markets	Threat to market share	Accelerate label expansions, combination strategies
Regulatory hurdles in emerging markets	Limited access	Engage local stakeholders early
Clinical trial setbacks	Delays and additional costs	Robust trial design, interim analyses

Favorable regulatory decisions and patent protections are vital for maintaining financial momentum.

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Comparison of VENCLEXTA’s Market Trajectory to Similar Drugs

Drug	First Approval Year	Indications	Peak Sales (USD millions)	Time to Peak	Key Differentiator
VENCLEXTA (AbbVie)	2016	CLL, AML	~$4.1 billion (2022)	4-5 years	First-in-class, broad label
Imbruvica (AbbVie)	2013	Multiple B-cell malignancies	~$7.3 billion (2019)	6-7 years	Established market, multiple indications
Idhifa (AbbVie)	2017	AML (IDH2 mutation-positive)	~$600 million (2022)	3-4 years	Mutation-specific targeting

VENCLEXTA’s trajectory mirrors or exceeds these benchmarks, underpinned by its targeted mechanisms and indications.

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Key Takeaways

• VENCLEXTA’s significant market potential hinges on expanding its approved indications and ongoing registration trials, particularly in AML and solid tumors.
• The drug benefits from a strong clinical efficacy profile and regulatory support, positioning it as a leader in hematologic oncology.
• Global revenues are projected to grow at approximately 34-35% CAGR from 2023-2027, driven by market expansion and pipeline innovation.
• Competitive pressures, patent expiries, and emerging pipeline entrants require strategic navigation to sustain gains.
• Regional policy environments, reimbursement frameworks, and clinical adoption rates critically influence growth patterns.

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Frequently Asked Questions (FAQs)

Q1: What are the main factors driving VENCLEXTA’s growth?
A1: Expanded indications, clinical efficacy, regulatory approvals, strategic collaborations, and pipeline diversification are primary drivers.

Q2: How does VENCLEXTA compare to its closest competitors?
A2: VENCLEXTA holds a first-mover advantage with comprehensive hematological indications; competitors have varied mechanisms and market penetration levels.

Q3: What are the key risks to VENCLEXTA’s future financial performance?
A3: Patent cliffs, competitive drugs, regulatory delays, and pricing pressures could impact revenue growth.

Q4: How significant is the AML market for VENCLEXTA’s financial trajectory?
A4: Critical; AML’s high unmet need and recent approvals position VENCLEXTA to be a key player, with forecasts indicating rapid growth.

Q5: Will pipeline developments significantly influence VENCLEXTA’s market share?
A5: Yes. Successful clinical trials for new combinations and indications will help sustain and increase market share, especially as primary indications mature.

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References

[1] AbbVie. VENCLEXTA (venetoclax) prescribing information. 2022.
[2] MarketWatch. Hematologic malignancies market overview, 2022.
[3] FDA. Approval history and labeling updates for VENCLEXTA, 2016-2022.
[4] EvaluatePharma. Oncology drug sales forecast, 2022-2027.
[5] Clinical trial registries (clinicaltrials.gov).

Note: All figures are estimates based on publicly available data and market analysis as of 2022-2023.