Venetoclax - Generic Drug Details

What are the generic drug sources for venetoclax and what is the scope of freedom to operate?

Venetoclax is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Venetoclax has two hundred and fifty-nine patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for venetoclax

International Patents:	259
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	473
Patent Applications:	3,123
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for venetoclax
What excipients (inactive ingredients) are in venetoclax?	venetoclax excipients list
DailyMed Link:	venetoclax at DailyMed

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

Constraining patent/regulatory exclusivity:

11,369,599

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 venetoclax

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

Sponsor	Phase
Benjamin Tomlinson	Phase 1/Phase 2
Antonio M Jimenez Jimenez	Phase 1
Flamingo Therapeutics NV	Phase 1

See all venetoclax clinical trials

Pharmacology for venetoclax

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

Anatomical Therapeutic Chemical (ATC) Classes for venetoclax

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for VENETOCLAX

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 venetoclax

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	208573-001	Apr 11, 2016		RX	Yes	No	11,590,128
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-001	Apr 11, 2016		RX	Yes	No	10,730,873			Y
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No	9,174,982
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-001	Apr 11, 2016		RX	Yes	No	8,722,657			Y
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No	8,722,657			Y

EU/EMA Drug Approvals for venetoclax

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 venetoclax

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
Japan	6038195

Supplementary Protection Certificates for venetoclax

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
2435432	17C1018	France		PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207

Venetoclax Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Venetoclax

Introduction

Venetoclax, a potent BCL-2 inhibitor, has revolutionized the treatment of chronic lymphocytic leukemia (CLL) and other hematological cancers. Here, we delve into the market dynamics and financial trajectory of this critical drug.

Market Size and Growth

The global venetoclax market is experiencing robust growth. As of 2023, the market size was valued at USD 1.17 billion and is projected to reach USD 2.26 billion by 2032, growing at a CAGR of 12.92% during the forecast period (2024-2032)[1].

Regional Market Segmentation

The market is segmented into several regions, with North America dominating the global market due to its advanced healthcare sector and favorable government policies. Europe is expected to be the second leading region, driven by the strong presence of hospitals, clinics, and oncology centers, as well as the influence of pharmaceutical companies like AbbVie Inc.[1].

Asia Pacific is anticipated to be the fastest-growing region, driven by the high prevalence of CLL and a large population base. In contrast, Latin America and the Middle East & Africa are expected to experience sluggish growth due to poor healthcare infrastructure and low awareness about CLL[1].

Application and Distribution Channels

The Chronic Lymphocytic Leukemia (CLL) segment dominates the venetoclax market by application, due to the drug's proven efficacy in treating CLL, especially in patients who have relapsed or are refractory to other treatments. Venetoclax's ability to induce deep and durable remissions, often in combination with other therapies, has made it a cornerstone in CLL management[1].

In terms of distribution channels, hospital pharmacies hold the largest share. This is because venetoclax is a specialized oncology drug that requires close administration and monitoring, particularly during the initial phase of treatment. Hospital pharmacies provide a controlled environment for drug dispensing and monitoring, ensuring safer and more effective therapy[1].

Economic Impact and Cost Analysis

The economic impact of venetoclax is significant, particularly in the context of treatment sequences for CLL. Studies have shown that treatment sequences starting with first-line venetoclax plus obinutuzumab (V+O) result in lower cumulative costs compared to sequences starting with ibrutinib or acalabrutinib. For example, the 10-year cumulative costs for V+O sequences were estimated to be between $690,346 and $951,633, compared to $1,426,924 to $1,906,544 for ibrutinib or acalabrutinib sequences[2].

Cost Savings and Budget Impact

Introducing venetoclax-based treatment sequences can lead to substantial cost savings. In a hypothetical 1-million-member health plan, the total budget impact of introducing V+O sequences resulted in cost savings of $12.5 million and $56.4 million over 5 and 10 years, respectively[2].

Price Dynamics and Competition

Despite the entry of other oral targeted drugs like acalabrutinib and zanubrutinib, the net spending per 30-day supply of ibrutinib increased by 46% from 2014 to 2020. Venetoclax, however, has maintained a competitive price point, with a 30-day fill price of $7,787 in 2020, which is lower than many of its competitors[3].

Reduced Dose and Cost Effectiveness

Using a reduced dose of venetoclax can significantly lower the total cost of treatment. A study showed that reduced doses of venetoclax can decrease the economic burden by 50% or more, improving treatment adherence and reducing side effects in frail older adults. This approach could potentially allow for disease control while minimizing toxicity and healthcare costs[5].

Key Players and Market Strategies

The global venetoclax market is dominated by key players such as AbbVie Inc., Dr. Reddy's Laboratories, Cayman Chemical, and Teva. These companies are focusing on expanding the use of venetoclax into other hematological cancers and enhancing their market positions through strategic collaborations and geographic expansions[4].

Future Outlook and Emerging Trends

The future outlook for the venetoclax market is promising, driven by increasing demand for effective CLL treatments, expanding indications, and ongoing research to optimize dosing and reduce costs. The market is expected to benefit from advancements in healthcare infrastructure, especially in emerging regions, and from favorable regulatory environments[1][4].

Challenges and Limitations

Despite the positive trajectory, the venetoclax market faces challenges such as high treatment costs, which can be a barrier to access, especially in regions with poor healthcare infrastructure. Additionally, the market is influenced by complex factors such as prescriber practices, formulary negotiations, and financial incentives that can affect the adoption of cost-effective treatment sequences[3].

Key Takeaways

• Market Growth: The global venetoclax market is projected to grow from USD 1.17 billion in 2023 to USD 2.26 billion by 2032, with a CAGR of 12.92%.
• Regional Dominance: North America leads the market, followed by Europe, with Asia Pacific expected to be the fastest-growing region.
• Application and Distribution: CLL is the dominant application, and hospital pharmacies are the primary distribution channel.
• Cost Effectiveness: Venetoclax-based treatment sequences offer significant cost savings compared to other treatments.
• Reduced Dose: Using reduced doses of venetoclax can lower costs and improve treatment adherence.
• Key Players: AbbVie Inc., Dr. Reddy's Laboratories, Cayman Chemical, and Teva are key market players.

FAQs

Q: What is the current market size of the global venetoclax market? A: The global venetoclax market size was valued at USD 1.17 billion in 2023[1].

Q: What is the projected growth rate of the venetoclax market? A: The market is expected to grow at a CAGR of 12.92% from 2024 to 2032[1].

Q: Which region dominates the venetoclax market? A: North America dominates the global venetoclax market, followed by Europe[1].

Q: What is the primary application of venetoclax? A: The primary application of venetoclax is in the treatment of Chronic Lymphocytic Leukemia (CLL)[1].

Q: How can reduced doses of venetoclax impact treatment costs? A: Reduced doses of venetoclax can lower the total cost of treatment by 50% or more, improving treatment adherence and reducing side effects[5].

Cited Sources

1. Straits Research: "Venetoclax Market Size, Share, Trend and Forecast to 2032"
2. Analysis Group: "The Economic Impact of Treatment Sequences for Chronic Lymphocytic Leukemia in the United States: A Cost of Care and Budget Impact Model of Venetoclax Plus Obinutuzumab Sequences"
3. JAMA Network Open: "Trends in Medicare Spending on Oral Drugs for Chronic Lymphocytic Leukemia"
4. Analytic Insights Hub: "Global Venetoclax Market Size, Trends, Growth Forecast to 2031"
5. Blood: "Reduced-Dose Venetoclax Is Well Tolerated and Cost Effective for Chronic Lymphocytic Leukemia"