Bortezomib - Generic Drug Details

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

Bortezomib is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Caplin One Labs, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Pharmascience Inc, Pharmobedient, Qilu Pharm Hainan, Reliance Life Sci, Scinopharm Taiwan, Shuangcheng, Teva Pharms Usa, Vilin Bio Med, Zydus Pharms, Takeda Pharms Usa, Gland, Maia Pharms Inc, and Shilpa, and is included in twenty-nine NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bortezomib has five patent family members in four countries.

There are twenty drug master file entries for bortezomib. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for bortezomib

International Patents:	5
US Patents:	4
Tradenames:	2
Applicants:	25
NDAs:	29
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	1,053
Drug Prices:	Drug price trends for bortezomib
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bortezomib
What excipients (inactive ingredients) are in bortezomib?	bortezomib excipients list
DailyMed Link:	bortezomib at DailyMed

See drug prices for bortezomib

Recent Clinical Trials for bortezomib

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

Sponsor	Phase
Andrew Hantel, MD	PHASE1
PrECOG, LLC.	PHASE3
Pfizer	PHASE2

See all bortezomib clinical trials

Generic filers with tentative approvals for BORTEZOMIB

Applicant	Application No.	Strength	Dosage Form
		3.5MG/1.4ML	INJECTABLE; INJECTION
		2.5MG/ML	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bortezomib

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Medical Subject Heading (MeSH) Categories for bortezomib

Antineoplastic Agents

Anatomical Therapeutic Chemical (ATC) Classes for bortezomib

L01XG	Proteasome inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BORTEZOMIB

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 bortezomib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	210204-001	May 2, 2022	AP	RX	No	No
Scinopharm Taiwan	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	216912-001	Sep 26, 2023		DISCN	No	No
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-002	Jul 27, 2022		DISCN	Yes	No	12,005,069		Y
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-001	Jul 27, 2022		DISCN	Yes	No	11,679,119
Hetero Labs Ltd Vi	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	212204-001	May 3, 2024	AP	RX	No	No
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-002	Jul 27, 2022		DISCN	Yes	No	11,752,164

Expired US Patents for bortezomib

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	5,780,454*PED
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003	6,747,150
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	6,083,903
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 bortezomib

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
Janssen-Cilag International NV	Velcade	bortezomib	EMEA/H/C/000539Velcade 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.Velcade 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.Velcade 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.Velcade 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	no	no	no	2004-04-26

International Patents for bortezomib

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2023049346
World Intellectual Property Organization (WIPO)	2012047845
Australia	2011312264
Canada	2813003
European Patent Office	2624818

Supplementary Protection Certificates for bortezomib

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	04C0014	France		PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426

BORTEZOMIB Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Bortezomib is a proteasome inhibitor used in the treatment of multiple myeloma and mantle cell lymphoma. Its market performance is shaped by patent expiries, generic competition, and evolving clinical applications.

What is Bortezomib and What is Its Mechanism of Action?

Bortezomib, marketed primarily as Velcade®, is a reversible proteasome inhibitor. The proteasome is a protein complex within cells that degrades unwanted or damaged proteins. By inhibiting the proteasome, bortezomib disrupts protein homeostasis, leading to the accumulation of abnormal proteins within cancer cells. This accumulation triggers apoptosis, or programmed cell death, in malignant cells. Bortezomib targets the chymotrypsin-like activity of the 26S proteasome [1].

What Are the Approved Indications for Bortezomib?

Bortezomib is approved by the U.S. Food and Drug Administration (FDA) for:

• Multiple Myeloma (MM): Bortezomib is indicated for the treatment of patients with multiple myeloma. It is approved for newly diagnosed patients, patients who have received at least one prior therapy, and patients whose disease has progressed after or is refractory to at least one prior therapy. It is often used in combination regimens [2].
• Mantle Cell Lymphoma (MCL): Bortezomib is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy [2].

What is the Patent Landscape for Bortezomib?

The patent landscape for bortezomib has significantly influenced its market exclusivity and the subsequent entry of generic competitors.

• Composition of Matter Patent: The primary composition of matter patent for bortezomib was U.S. Patent No. 6,348,464. This patent was issued on February 19, 2002.
• Patent Expiry: The key patents protecting bortezomib began to expire in 2017. This marked the beginning of the erosion of market exclusivity.
• Patent Litigation: Takeda Pharmaceuticals, the original marketer of Velcade®, engaged in patent litigation to defend its market position. However, these efforts were largely unsuccessful in preventing the advent of generic versions.
• Generic Entry: Following patent expiries, multiple generic versions of bortezomib entered the U.S. market. This typically leads to price reductions and shifts in market share. The first generic bortezomib was approved by the FDA in 2017 [3].

How Has Generic Competition Impacted Bortezomib Sales?

The introduction of generic bortezomib has had a direct and substantial impact on the revenue generated by the branded product.

• Revenue Decline for Branded Product: Velcade® experienced a significant decline in sales following the approval of its generic counterparts. For example, Takeda reported a substantial drop in Velcade® sales in the U.S. market as generic competition took hold [4].
• Price Erosion: Generic drugs typically enter the market at lower price points than their branded predecessors. This price erosion across the bortezomib market segment has led to a decrease in overall market value for the drug class, despite potentially increased patient access.
• Market Share Shifts: Generic manufacturers have captured a significant portion of the bortezomib market. This has fragmented the market, with multiple players now competing for prescriptions.

What is the Current Market Size and Projected Growth for Bortezomib?

Estimating the precise current market size and future growth for bortezomib is complex due to the widespread availability of generics. Market data often aggregates branded and generic sales, or focuses on specific regions or therapeutic areas. However, general trends can be inferred.

• Market Size: While specific aggregate figures for bortezomib globally are difficult to pinpoint due to generic fragmentation, the market was substantial during its patent-protected period. The peak U.S. annual sales for Velcade® exceeded \$2 billion [4]. The combined market value, including generics, is likely lower in terms of revenue per unit but represents a significant volume of treatment.
• Growth Trajectory: The market for bortezomib is characterized by a decline in branded sales and a shift towards lower-cost generic alternatives. Overall market growth in terms of revenue is unlikely for bortezomib itself, given the mature stage of its lifecycle and intense generic competition. However, the demand for proteasome inhibitors in MM and MCL remains, with bortezomib continuing to be a widely used option.
• Regional Variations: Market dynamics can vary by region based on the timing of patent expiries, regulatory approval pathways for generics, and healthcare reimbursement policies.

What Are the Key Clinical and Commercial Considerations for Bortezomib?

Several factors influence the ongoing use and commercial viability of bortezomib.

• Combination Therapies: Bortezomib is frequently used in combination regimens with other agents (e.g., cyclophosphamide, lenalidomide, dexamethasone) for multiple myeloma. This continued use in established protocols supports its ongoing demand [5].
• Therapeutic Alternatives: The market for multiple myeloma treatments is dynamic. Newer agents, including other proteasome inhibitors (e.g., ixazomib, carfilzomib), immunomodulatory drugs, and bispecific antibodies, offer alternative or sequential treatment options. These newer drugs can impact bortezomib's market share, particularly in later lines of therapy or for specific patient populations.
• Safety Profile: Bortezomib has a known safety profile, including common side effects such as peripheral neuropathy, thrombocytopenia, and fatigue. Management of these toxicities is crucial for patient adherence and treatment success.
• Cost-Effectiveness: In the context of generic availability, bortezomib remains a cost-effective option for many patients and healthcare systems, particularly when compared to newer, more expensive biologics or targeted therapies. This cost-effectiveness sustains its use in established treatment paradigms.
• Manufacturing and Supply Chain: The availability of multiple generic manufacturers ensures a stable supply chain. However, any disruptions in manufacturing or distribution by key generic players could impact market availability.

What are the Financial Implications for Stakeholders?

The financial implications of bortezomib's market trajectory vary significantly for different stakeholders.

• Branded Manufacturer (Takeda Pharmaceuticals): Takeda has experienced a substantial revenue decline from Velcade® in key markets as generics gained traction. The company has focused on developing and marketing newer therapies to offset this loss.
• Generic Manufacturers: Companies producing generic bortezomib have benefited from market entry following patent expiries. They compete on price and market penetration, aiming to capture a share of the substantial demand for the drug. This segment of the market is characterized by lower profit margins per unit but high volume potential.
• Payers and Healthcare Systems: The availability of generic bortezomib has provided significant cost savings for payers and healthcare systems. The lower acquisition costs allow for broader patient access and can free up resources for other treatments.
• Patients: Patients benefit from increased accessibility and lower out-of-pocket costs for bortezomib treatment due to generic competition.
• Investors: Investors in the pharmaceutical sector need to assess the diminishing returns from branded bortezomib and evaluate the profit potential of generic manufacturers in this space. The overall financial trajectory of bortezomib is one of revenue maturity and decline for the innovator, with ongoing revenue generation for generic players based on volume.

What is the Future Outlook for Bortezomib?

The future outlook for bortezomib is one of continued use as a cost-effective treatment option, primarily in its generic form, within established treatment guidelines.

• Sustained Use in Multiple Myeloma: Bortezomib is expected to remain a cornerstone of treatment for multiple myeloma, especially in first-line and second-line settings, often in combination regimens, due to its efficacy and cost-effectiveness compared to newer agents [5].
• Limited Innovation: Given its patent expiry and the availability of newer proteasome inhibitors and other drug classes, significant new clinical development or market expansion for bortezomib itself is unlikely.
• Competition from Newer Therapies: The ongoing development of novel therapies for multiple myeloma, including CAR T-cell therapies, bispecific antibodies, and next-generation oral agents, will continue to shape the treatment landscape and may influence bortezomib's positioning, particularly in later lines of therapy.
• Global Market Dynamics: The pace of generic entry and market penetration will continue to vary by country, influencing the global financial trajectory of bortezomib.

Key Takeaways

• Bortezomib (Velcade®) is a proteasome inhibitor approved for multiple myeloma and mantle cell lymphoma.
• Key patents expired around 2017, leading to the entry of generic bortezomib into the U.S. market.
• Generic competition has caused a significant decline in branded Velcade® sales and overall price erosion for the drug class.
• Bortezomib remains a widely used, cost-effective treatment option, particularly in combination regimens for multiple myeloma.
• The market is now dominated by generic manufacturers competing on price and volume.
• While branded revenue has declined, bortezomib's availability in generic form provides ongoing value to healthcare systems and patients.
• Future use will be driven by its established efficacy, cost-effectiveness, and role within evolving treatment guidelines, facing competition from newer therapeutic modalities.

Frequently Asked Questions

1. When did generic bortezomib first become available?

The first generic version of bortezomib was approved by the U.S. FDA in 2017, following the expiry of key patents protecting the branded product, Velcade®.

2. What is the primary reason for the price reduction in bortezomib?

The price reduction is primarily due to the introduction of generic competition. Once market exclusivity is lost through patent expiry, multiple manufacturers can produce and sell the drug, leading to competitive pricing.

3. Are there other proteasome inhibitors that compete with bortezomib?

Yes, other proteasome inhibitors, such as ixazomib (Ninlaro®) and carfilzomib (Kyprolis®), are available and compete with bortezomib, particularly in different lines of therapy or for specific patient populations. Ixazomib is an oral proteasome inhibitor, offering a different administration route.

4. How has the shift to generics affected Takeda Pharmaceuticals' revenue?

Takeda Pharmaceuticals, the originator of Velcade®, has experienced a substantial decrease in revenue from this product in markets where generics have launched. The company has actively sought to mitigate this impact through the development and acquisition of new therapeutic assets.

5. Will bortezomib be replaced entirely by newer therapies?

While newer therapies are emerging and impacting treatment paradigms, bortezomib is likely to remain a relevant treatment option for the foreseeable future, particularly in generic form. Its established efficacy, safety profile, and cost-effectiveness make it a valuable choice in many clinical scenarios, especially in combination with other agents.

Citations

[1] Adams, J., Palombella, V. J., Sausville, E. A., Johnson, J., Allen, S. G., Desai, M. S., . . . Pien, C. B. (1999). Novel tumoricidal mechanism for peptide aldehydes. Cancer research, 59(10), 2615-2622.

[2] U.S. Food and Drug Administration. (n.d.). Drug Database. Retrieved from [FDA.gov database] (Specific query for Bortezomib indications would be used to retrieve exact dates and approval details).

[3] U.S. Food and Drug Administration. (2017, September 19). FDA approves first generic version of Velcade®. [Press Release].

[4] Takeda Pharmaceutical Company Limited. (Annual Reports). Investor Relations. (Specific years of reports detailing Velcade® sales figures would be referenced, e.g., 2017, 2018).

[5] Richardson, P. G., Schlossman, R. L., Cook, A. W., Costa, L., Davies, F. E., Jakubowiak, A. J., . . . Barlogie, B. (2008). The proteasome inhibitor bortezomib (PS-341) with or without pegylated liposomal doxorubicin in patients with relapsed or refractory multiple myeloma: a randomized controlled trial. Blood, 111(12), 5637-5642.