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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 fifty-nine 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.

Indicators of Generic Entry

Summary for VENCLEXTA

International Patents:	259
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	189
Patent Applications:	1,225
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

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.

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
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
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes			Y	Y
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No				Y

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/004106 Venclyxto 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

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
Uruguay	33047	AGENTES INDUCTORES DE APOPTOSIS PARA EL TRATAMIENTO DEL CÁNCER Y DE ENFERMEDADES INMUNES Y AUTOINMUNES
Canada	2813985	DISPERSIONS SOLIDES EXTRUDEES EN FUSION CONTENANT UN AGENT INDUISANT L'APOPTOSE (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT)
Costa Rica	20180289	DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS (Divisional 2013-0224)
New Zealand	595708	Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
Singapore	189477	MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT
South Africa	201108616	APOPTOSIS-INDUCING AGENTS FOR THE TRATMENT OF CANCER AND IMMUNE AND AUTOIMMUNE DISEASES

Supplementary Protection Certificates for VENCLEXTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435432	1790021-8	Sweden		PRODUCT NAME: VENETOCLAX; REG. NO/DATE: EU/1/16/1138 20161207
2435432	21/2017	Austria		PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 (MITTEILUNG) 20161207
2435432	132017000054735	Italy		PRODUCT NAME: VENETOCLAX(VENCLYXTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1138, 20161207
2435432	300873	Netherlands		PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
2435432	122017000031	Germany		PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432	C201730016	Spain		PRODUCT NAME: VENETOCLAX; NATIONAL AUTHORISATION NUMBER: EU/1/16/1138; DATE OF AUTHORISATION: 20161205; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1138; DATE OF FIRST AUTHORISATION IN EEA: 20161205

VENCLEXTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VENCLEXTA

Introduction

VENCLEXTA (venetoclax), a BCL-2 inhibitor, has been a significant player in the oncology market since its approval for the treatment of certain blood cancers. Developed by AbbVie and Roche's Genentech unit, VENCLEXTA has shown promising growth and is poised to continue its impact in the cancer treatment landscape.

Mechanism of Action and Clinical Significance

VENCLEXTA works by inhibiting the BCL-2 protein, which is often overexpressed in cancer cells, particularly in chronic lymphocytic leukemia (CLL) and other hematologic malignancies. This inhibition leads to the apoptosis (programmed cell death) of cancer cells, providing a targeted approach to cancer treatment[3].

Regulatory Approvals and Designations

The drug received its first FDA approval in April 2016 for the treatment of relapsed or refractory CLL with a 17p deletion. Since then, it has received additional approvals and designations, including a breakthrough designation for the treatment of mantle-cell lymphoma in May 2024[1][3].

Market Performance and Revenue

VENCLEXTA has demonstrated strong financial performance. In 2023, it generated global sales of USD 2.2 billion, with a growth rate of approximately 14% year-over-year[1]. For the third quarter of 2024, global VENCLEXTA net revenues were $677 million, showing an increase of 14.8% on a reported basis and 18.2% on an operational basis[5].

Forecast and Growth Projections

The global venetoclax market is estimated to grow significantly, with a projected market size of USD 2.26 billion by 2032, up from USD 1.17 billion in 2023, at a CAGR of 12.92% during the forecast period (2024-2032)[4].

Regional Market Dynamics

North America dominates the global VENCLEXTA market, driven by a robust healthcare sector and rapid technological advancements. Europe is expected to be the second leading region, while Asia Pacific is anticipated to be the fastest-growing region due to the high prevalence of CLL and a large population base[4].

Competitive Landscape

VENCLEXTA faces competition from other oncology drugs, notably Imbruvica, which is also marketed by AbbVie. However, VENCLEXTA's unique mechanism of action and expanding indications are expected to strengthen AbbVie's presence in the oncology market[3].

Pipeline and Future Developments

Several BCL-2 inhibitors are in the pipeline, including Sonrotoclax (BGB-11417) and ICP-248, which are being developed by companies like BeiGene and innoCare, respectively. These developments are expected to further enhance the treatment options for hematologic malignancies[1].

Safety and Efficacy

One of the significant challenges in the development of VENCLEXTA was managing the risk of tumor lysis syndrome, a condition that arises from the rapid death of cancer cells. AbbVie implemented an escalating dose schedule to mitigate this risk, although adverse effects such as tumor lysis, pneumonia, and low blood cell counts were still reported in clinical trials[3].

Financial Impact on AbbVie

VENCLEXTA's success has been a key contributor to AbbVie's financial performance. The drug's growth has helped offset declines in other areas, such as the loss of exclusivity for Humira. In the full-year 2023 financial results, VENCLEXTA's net revenues increased by 14.3% on a reported basis, contributing significantly to AbbVie's overall revenue[2].

Market Expansion and Collaborations

To extend the use of VENCLEXTA into other hematological cancers, AbbVie and its partners are collaborating on various clinical trials. For instance, a combination of VENCLEXTA and Rituxan is being explored for the treatment of relapsed/refractory CLL[3].

Patient Impact and Market Demand

The demand for VENCLEXTA is driven by the increasing incidence of blood cancers. According to the Leukemia Research Foundation, over 201,870 new cases of blood cancer are expected in the U.S., highlighting the need for effective treatments like VENCLEXTA[4].

Conclusion

VENCLEXTA has established itself as a crucial drug in the treatment of blood cancers, with a strong financial trajectory and promising market dynamics. Its unique mechanism of action, expanding indications, and robust pipeline of related BCL-2 inhibitors position it for continued growth and impact in the oncology market.

Key Takeaways

• Strong Financial Performance: VENCLEXTA generated USD 2.2 billion in global sales in 2023 with a 14% year-over-year growth rate.
• Regulatory Approvals: Received breakthrough designation for mantle-cell lymphoma and approvals for CLL and other hematologic malignancies.
• Market Growth Projections: Expected to reach USD 2.26 billion by 2032 at a CAGR of 12.92%.
• Regional Dominance: North America leads, with Europe and Asia Pacific showing significant growth potential.
• Competitive Landscape: Faces competition from Imbruvica but maintains a strong position due to its unique mechanism.
• Pipeline Developments: Several BCL-2 inhibitors are in development, enhancing treatment options.
• Safety and Efficacy: Managed tumor lysis syndrome risk through an escalating dose schedule.

FAQs

Q: What is the primary mechanism of action of VENCLEXTA? A: VENCLEXTA works by inhibiting the BCL-2 protein, leading to the apoptosis of cancer cells.

Q: What were the global sales of VENCLEXTA in 2023? A: VENCLEXTA generated global sales of USD 2.2 billion in 2023.

Q: What is the projected market size of VENCLEXTA by 2032? A: The global venetoclax market is estimated to reach USD 2.26 billion by 2032.

Q: Which regions are expected to drive the growth of the VENCLEXTA market? A: North America, Europe, and Asia Pacific are expected to be key drivers of market growth.

Q: What are some of the challenges faced during the development of VENCLEXTA? A: Managing the risk of tumor lysis syndrome was a significant challenge, addressed through an escalating dose schedule.

Sources

1. GlobeNewswire - Game-Changing BCL-2 Inhibitors Set to Revolutionize Cancer Treatment Market[1].
2. AbbVie Investors - AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results[2].
3. BioPharma Dive - Inside the development of Venclexta, AbbVie's new leukemia drug[3].
4. Straits Research - Venetoclax Market Size, Share, Trend and Forecast to 2032[4].
5. AbbVie Investors - AbbVie Reports Third-Quarter 2024 Financial Results[5].