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-five 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
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003

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

International Patents for VELCADE

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

Country	Patent Number	Title	Estimated Expiration
Israel	133831	PHARMACEUTICAL COMPOSITIONS CONTAINING PROTEASOME INHIBITORS
World Intellectual Property Organization (WIPO)	02059130
Finland	971746

Supplementary Protection Certificates for VELCADE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788360	C00788360/01	Switzerland		FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0788360	300151	Netherlands		300151, 20151027, EXPIRES: 20190425
0788360	CA 2004 00012	Denmark

Market Dynamics and Financial Trajectory for VELCADE (Bortezomib)

Last updated: November 20, 2025

Introduction

VELCADE (bortezomib) represents a pivotal advance in oncology pharmacotherapy, particularly for multiple myeloma and mantle cell lymphoma. Since its FDA approval in 2003, VELCADE has revolutionized proteasome inhibition therapy, establishing a robust commercial presence that continues to evolve amid shifting market dynamics. This analysis delineates the factors influencing VELCADE’s market trajectory, examines its financial performance, and forecasts future growth amidst technological, competitive, and regulatory landscapes.

Overview of VELCADE: Product Profile and Indications

VELCADE is a first-in-class proteasome inhibitor developed by Millennium Pharmaceuticals, subsequently acquired by Takeda Pharmaceutical Company. Its mechanism involves disrupting proteasome activity, inducing apoptosis in malignant cells. The primary indications include:

• Relapsed/refractory multiple myeloma (R/R MM)
• Newly diagnosed multiple myeloma (in combination therapies)
• Mantle cell lymphoma (MCL)

In response to evolving therapeutic landscapes, VELCADE's formulation has expanded from intravenous administration to subcutaneous delivery, enhancing patient convenience and adherence.

Market Dynamics

1. Market Penetration and Adoption

VELCADE captured rapid adoption within hematology-oncology fields owing to its novel mechanism and clinical efficacy. The initial success was bolstered by the approval of combination regimens such as VELCADE plus dexamethasone, and later, combinations with immunomodulatory agents like lenalidomide. As a result, VELCADE's market share grew substantially, especially in the U.S. and Europe.

2. Competitive Landscape

The advent of alternative proteasome inhibitors, notably ixazomib (Ninlaro) and carfilzomib (Kyprolis), has introduced competition, impacting VELCADE’s market share. While these agents offer differing administration routes and side-effect profiles, VELCADE maintains a significant position due to established efficacy and clinician familiarity.

3. Regulatory and Pricing Factors

Pricing strategies and reimbursement policies influence VELCADE’s accessibility. Its inclusion in various treatment guidelines enhances uptake, yet price pressures in key markets exert downward influence on revenues.

4. Technological Innovations

The transition to subcutaneous VELCADE has reduced administration costs and side effects, improving market acceptance. Ongoing research into triplet and quadruplet regimens is expected to further augment VELCADE's usage.

5. Global Market Expansion

While initial sales concentrated in North America and Europe, VELCADE's approval in emerging markets presents significant growth opportunities. Gaining market share in Asia, Latin America, and the Middle East necessitates strategic partnerships, differential pricing, and localized clinical data.

Financial Trajectory

1. Historical Revenue Performance

Takeda’s filings reveal that VELCADE has maintained a strong revenue stream. In FY2022, VELCADE generated approximately $1.0 billion in global sales, reflecting market resilience despite competitive pressures[1].

2. Revenue Drivers

• Patent protections: The expiration of certain patents in key markets prompts revenue diversification strategies.
• Combination therapy approvals: The inclusion of VELCADE in frontline treatment protocols enhances volume.
• Biosimilar entry: Although biosimilars for VELCADE are less prevalent than for other monoclonal antibodies, potential future biosimilar competition could impact margins.

3. Profitability and Cost Considerations

The high-cost manufacturing process for proteasome inhibitors underpins premium pricing. However, rising competition and price erosion challenge profit margins, prompting investments in cost-efficiency and lifecycle management.

Future Outlook and Market Trends

1. Pipeline and Line Extensions

Takeda is exploring next-generation proteasome inhibitors and combination regimens, aiming to extend VELCADE’s lifecycle. Clinical trials assessing subcutaneous delivery, fixed-dose combinations, and maintenance therapy could bolster market presence.

2. Regulatory Environment

Regulatory agencies remain vigilant about biosimilar proliferation and value-based pricing. Strategies encompassing patent filings, data exclusivity, and clinical evidence are crucial for market sustainment.

3. Market Challenges

• Generic and biosimilar competition: These can reduce VELCADE’s market share and exert downward pressure on prices.
• Therapeutic evolution: Emergence of CAR-T cell therapies and monoclonal antibodies may redefine multiple myeloma treatment paradigms, potentially limiting VELCADE’s growth.

4. Growth Opportunities

• Expanding indications: Ongoing trials for solid tumors and other hematological malignancies may open new revenue streams.
• Global access: Pricing and partnership strategies in emerging markets are vital for capturing incremental growth.
• Patient-centric formulations: Improved formulations and administration protocols will likely sustain market relevance.

Conclusion

VELCADE’s trajectory remains robust but is inherently sensitive to competitive, regulatory, and technological developments. Its market strength depends on continuous innovation, strategic adaptation to biosimilar threats, and expansion into underserved territories. As the hematology-oncology landscape morphs with novel therapies, VELCADE’s ongoing relevance hinges on its integration into combination regimens and lifecycle management strategies.

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Key Takeaways

• VELCADE has established a durable market position through early clinical efficacy, combination therapies, and formulation advancements.
• The advent of biosimilars and alternative therapies pose future challenges to its revenue streams.
• Global expansion, especially in emerging markets, presents significant growth potential if managed with tailored strategies.
• Innovation in delivery and new indications could prolong its market viability.
• Stakeholders should monitor regulatory trends, competitive threats, and pipeline developments to optimize investment decisions.

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FAQs

1. What are the primary drivers of VELCADE’s revenue growth?
Market expansion into new geographic regions, integration into standard-of-care combination regimens, and innovative formulations (e.g., subcutaneous administration) drive revenue growth.

2. How does biosimilar competition impact VELCADE?
Potential biosimilar entrants could lower prices and erode market share, prompting Takeda to focus on lifecycle management strategies such as new combinations and expanded indications.

3. Are there upcoming pipeline developments that could affect VELCADE’s market?
Yes, clinical trials exploring new formulations, maintenance protocols, and additional indications (e.g., solid tumors) could reinforce VELCADE’s market relevance.

4. How significant is global market expansion for VELCADE’s future?
Highly significant. Emerging markets offer substantial growth, provided pricing and regulatory strategies align with local healthcare systems’ needs.

5. What strategic actions can Takeda undertake to sustain VELCADE’s market position?
Investing in lifecycle management, expanding indications, reducing costs, and establishing strategic partnerships globally are key actions to ensure sustained success.

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Sources:

[1] Takeda Annual Report 2022.