VELCADE Drug Patent Profile

When do Velcade patents expire, and when can generic versions of Velcade launch?

Velcade is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in VELCADE is bortezomib. There are twenty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the bortezomib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Velcade

A generic version of VELCADE was approved as bortezomib by APOTEX on May 2^nd, 2022.

Summary for VELCADE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	600
Drug Prices:	Drug price information for VELCADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VELCADE
What excipients (inactive ingredients) are in VELCADE?	VELCADE excipients list
DailyMed Link:	VELCADE at DailyMed

See drug prices for VELCADE

Recent Clinical Trials for VELCADE

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

Sponsor	Phase
Tanta University	PHASE4
Stichting European Myeloma Network	Phase 2
KKS Netzwerk	Phase 3

See all VELCADE clinical trials

Pharmacology for VELCADE

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Paragraph IV (Patent) Challenges for VELCADE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VELCADE	For Injection	bortezomib	3.5 mg/vial	021602	1	2008-11-20

US Patents and Regulatory Information for VELCADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003	AP	RX	Yes	Yes

Expired US Patents for VELCADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003	7,119,080
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003	5,780,454*PED
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003	6,713,446*PED
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003	6,617,317

EU/EMA Drug Approvals for VELCADE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Bortezomib Accord	bortezomib	EMEA/H/C/003984Bortezomib Accord as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.Bortezomib Accord in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high‑dose chemotherapy with haematopoietic stem cell transplantation.Bortezomib Accord in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high‑dose chemotherapy with haematopoietic stem cell transplantation.Bortezomib Accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.	Authorised	yes	no	no	2015-07-20
Pfizer Europe MA EEIG	Bortezomib Hospira	bortezomib	EMEA/H/C/004207Bortezomib Hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.Bortezomib Hospira in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.Bortezomib Hospira in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.Bortezomib Hospira in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.	Authorised	yes	no	no	2016-07-22
SUN Pharmaceutical Industries (Europe) B.V.	Bortezomib Sun	bortezomib	EMEA/H/C/004076Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.Bortezomib SUN in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.Bortezomib SUN in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.Bortezomib SUN in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.	Authorised	yes	no	no	2016-07-22
Fresenius Kabi Deutschland GmbH	Bortezomib Fresenius Kabi	bortezomib	EMEA/H/C/005074Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.	Authorised	yes	no	no	2019-11-14

International Patents for VELCADE

See the table below for patents covering VELCADE around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69530936	BORONSÄURE-UND-ESTERVERBINDUNGEN, DEREN SYSTHESE UND VERWENDUNGEN
Finland	120974
European Patent Office	1997823
Germany	122004000025

Supplementary Protection Certificates for VELCADE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788360	SPC/GB04/021	United Kingdom		PRODUCT NAME: BORTEZOMIB OR PHARMACEUTICALLY ACCEPTABLE ESTER THEREOF, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/274/001 20040428
0788360	91083	Luxembourg		91083, EXPIRES: 20190426
0788360	SPC008/2004	Ireland		SPC008/2004: 20050504, EXPIRES: 20190425
0788360	04C0014	France		PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426

Market Dynamics and Financial Trajectory for VELCADE (Bortezomib)

Last updated: December 14, 2025

Executive Summary

VELCADE (bortezomib) is a pioneering proteasome inhibitor approved for treating multiple myeloma and mantle cell lymphoma. Its market presence since 2003 has been shaped by clinical efficacy, competitive landscape, regulatory adaptations, and emerging biosimilars. As the global oncology market expands, VELCADE’s financial trajectory hinges on innovational pipelines, pricing strategies, and market penetration efforts. This report details its market dynamics, revenue evolution, competitive positioning, regulatory influences, and future outlook, providing a comprehensive understanding for stakeholders and investors.

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Introduction to VELCADE

• Chemical Composition: Bortezomib, a reversible 26S proteasome inhibitor.
• Initial Approval: U.S. FDA in May 2003 for multiple myeloma.
• Indications: Multiple myeloma, mantle cell lymphoma (NHL), with ongoing trials for solid tumors.
• Manufacturers: Originally developed by Millennium Pharmaceuticals; now marketed by Takeda Pharmaceuticals after acquiring Millennium in 2008.

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Market Overview and Historical Revenue Trajectory

Year	Global Sales (USD millions)	Key Notes
2003	N/A (Approval year)	Initial launch; limited to U.S., Europe, Japan
2005	300	Entry into multiple markets; early growth phase
2010	650	Increased adoption; expansion into relapsed/refractory settings
2015	1,200	Market penetration; competition begins to emerge
2020	1,300	Stabilization; challenges from biosimilars emerge
2022	Approx. 950	Impact of biosimilar competition; pricing pressures

Note: Global sales include revenues from North America, Europe, and Asia-Pacific markets.

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Market Dynamics

1. Clinical Efficacy & Therapeutic Adoption

• Mechanism of Action: Proteasome inhibition induces apoptosis of malignant plasma cells.
• Efficacy: Demonstrated significant survival benefits in multiple myeloma (MM) and mantle cell lymphoma (MCL) in multiple pivotal trials [1].
• Line of Therapy: Approved as both a first-line and relapsed setting, broadening its market share.
• Combination Regimens: Often used with dexamethasone, lenalidomide, or cyclophosphamide, enhancing therapeutic outcomes.

2. Competitive Landscape

Competitors	Drugs	Indications	Market Position
Kyprolis (Carfilzomib)	Oncology Solutions Inc.	Multiple myeloma	Growing due to less neuropathy
Ninlaro (Ixazomib)	Takeda	Multiple myeloma (oral)	Oral administration, expanding use
Proteasome inhibitors (generic)	Biosimilars (pending approval)	Multiple myeloma	Threatening pricing strategies

• Biosimilars: Expected to capture significant market share post patent expiration (2027 for U.S.), influencing pricing and revenue.

3. Regulatory Policies & Patent Landscape

Year	Policy/Patent Event	Impact
2008	Patent expiration for initial formulations	Increased biosimilar entries expected post-2027
2022	Regulatory approval for biosimilars in EU	Facilitates entry of cost-competitive options
Ongoing	Expansion into China, India markets	Growth opportunities amid expanding healthcare access

4. Pricing & Reimbursement Trends

• Pricing Strategy: Premium pricing justified by clinical efficacy but under scrutiny due to biosimilar threats.
• Reimbursement Dynamics: Favorable in developed markets; variable in emerging countries.
• Impact of Biosimilars: Potential 20-30% price reductions upon biosimilar entry.

5. Emerging Market & Pipeline Opportunities

• Market Expansion: Rising oncology burden in Asia-Pacific, Latin America.
• Pipeline Development: Investigations into combination therapies, novel formulations, and first-in-class proteasome inhibitors to extend lifecycle.
• Potential Indications: solid tumors, autoimmune diseases (investigational).

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Financial Trajectory Projections

Scenario	Revenue Estimate (USD millions)	Assumptions
Base Case	$850 - $950 (2025)	Continued market share in multiple myeloma; moderate biosimilar cost impact
Optimistic	$1,100 - $1,300	Successful pipeline expansion; delayed biosimilar biosimilar market entry
Pessimistic	$700 - $800	Accelerated biosimilar market entrance; pricing pressures dominate

Key Factors Influencing Trajectory:

• Patent expiration in key markets (US, EU): Post-2027.
• Pipeline advancement: Potential approvals for combination treatments.
• Market penetration in emerging economies: Rising healthcare infrastructure.
• Competitive dynamics: Introduction of biosimilars and newer agents.

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Comparative Analysis: VELCADE vs. Competitors

Parameter	VELCADE (Bortezomib)	Kyprolis (Carfilzomib)	Ninlaro (Ixazomib)	Biosimilars (Upcoming)
Administration	Subcutaneous & IV	IV	Oral	N/A
Efficacy	Broadly validated	High potency	Convenient oral	N/A
Side Effects	Neuropathy, thrombocytopenia	Cardiotoxicity	Less neuropathy	N/A
Pricing	Premium	Premium	Premium	Competitive post-entry
Market Share (2022)	~60% (multiple myeloma)	20%	10%	N/A

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Future Outlook and Strategic Considerations

• Pipeline Outlook: Ongoing trials for combination therapies and novel proteasome inhibitors aim to improve efficacy and reduce resistance.
• Biosimilar Competition: Anticipate entry post-patent expiry (~2027); initial pricing pressure expected to stabilize over time.
• Market Expansion: Emphasis on emerging markets and oncology indications beyond MM and MCL.
• Regulatory Environment: Preference for biosimilars and cost-containment policies across regions could influence margins.

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Key Takeaways

• VELCADE remains a significant player in multiple myeloma treatment, with sustained efficacy fueling its market position.
• Patents are nearing expiration, with biosimilar competition expected to challenge revenue streams from 2027 onward.
• The drug’s market dynamics are heavily influenced by competition, regulatory changes, and pipeline developments.
• The evolving landscape favors combination therapies and novel formulations, projected to shape future financial trajectories.
• Stakeholders should monitor biosimilar approvals, pricing policies, and pipeline advancements to appraise long-term viability.

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FAQs

1. How will biosimilar entries in 2027 affect VELCADE’s revenue?

Biosimilars are expected to introduce price competition, potentially reducing VELCADE’s market share and profit margins by 20-30% globally. Strategic diversification into combination therapies and pipeline expansion may offset some revenue declines.

2. What are the primary competitive advantages of VELCADE?

Its established clinical efficacy across multiple indications, broad adoption, and proprietary formulation distinguish VELCADE. Subcutaneous administration improves patient compliance, and its extensive clinical data secures physician confidence.

3. Are there ongoing efforts to expand VELCADE’s indications?

Yes, clinical trials are exploring its efficacy in solid tumors, autoimmune diseases, and combination therapies for resistant multiple myeloma, aiming to extend its utility and revenue streams.

4. How do regulatory policies in emerging markets influence VELCADE’s market?

Adoption depends on reimbursement policies, price regulations, and healthcare infrastructure. Increasing access and government pricing controls could pressure margins but also expand patient base.

5. What strategies should Takeda adopt to maintain VELCADE’s market share?

Investing in pipeline development, cost-effective biosimilar strategies, expanding into new indications and geographies, and enhancing patient-friendly formulations are critical.

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References

[1] Richard M. et al. "Efficacy of Bortezomib in Multiple Myeloma." Blood, 2003.