BORTEZOMIB - Generic Drug Details

What are the generic drug sources for bortezomib and what is the scope of patent protection?

Bortezomib is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, 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, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Vilin Bio Med, Zydus Pharms, Takeda Pharms Usa, Maia Pharms Inc, and Shilpa, and is included in twenty-seven 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:	23
NDAs:	27
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	1,043
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
Children's Oncology Group	PHASE2
UNC Lineberger Comprehensive Cancer Center	PHASE2
Qilu Pharmaceutical Co., Ltd.	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
Fresenius Kabi Usa	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	209659-001	May 2, 2022	AP	RX	No	No
Fresenius Kabi Usa	BORTEZOMIB	bortezomib	POWDER;INTRAVENOUS	205004-001	Nov 6, 2017		DISCN	No	No			Y
Apotex	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	205533-001	May 2, 2022	AP	RX	No	No
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-001	Jul 27, 2022		DISCN	Yes	No
Jiangsu Hansoh Pharm	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	215011-001	Jul 26, 2022	AP	RX	No	No
Accord Hlthcare	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215441-002	Jul 26, 2022		DISCN	Yes	No

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
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
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 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
Canada	2813003	FORMULATIONS DE BORTEZOMIB STABILISEES PAR DE L'ACIDE BORIQUE (BORTEZOMIB FORMULATIONS STABILISED WITH BORIC ACID)
World Intellectual Property Organization (WIPO)	2012047845
World Intellectual Property Organization (WIPO)	2023049346
Australia	2011312264	Bortezomib formulations stabilised with boric
European Patent Office	2624818	FORMULATIONS DE BORTÉZOMIB STABILISÉES PAR DE L'ACIDE BORIQUE (BORTEZOMIB FORMULATIONS STABILISED WITH BORIC ACID)

Supplementary Protection Certificates for BORTEZOMIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788360	04C0014	France		PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
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

Market Dynamics and Financial Trajectory for Bortezomib

Last updated: September 22, 2025

Introduction

Bortezomib, commercially known as Velcade, is a pioneering proteasome inhibitor used predominantly in oncology treatments, notably multiple myeloma and mantle cell lymphoma. Since its FDA approval in 2003, Bortezomib has reshaped hematologic cancer management and remains a focal point for industry stakeholders. Analyzing its market dynamics and financial prospects offers insight into therapeutic innovations, competitive positioning, and future growth avenues within a rapidly evolving pharmaceutical landscape.

Market Overview and Therapeutic Landscape

Bortezomib’s initial market penetration was driven by its novel mechanism, disrupting protein degradation pathways critical for cancer cell survival. As of 2022, the global multiple myeloma treatment market was valued at approximately USD 10 billion and is projected to grow at a compound annual growth rate (CAGR) of roughly 7% through 2030. This growth is underpinned by increasing disease prevalence, advances in combination therapies, and expanded indications.

The evolution of the therapeutic landscape includes the advent of second-generation proteasome inhibitors, such as carfilzomib and ixazomib, which challenge Bortezomib’s market dominance. Nonetheless, Bortezomib maintains a significant market share, particularly due to its established efficacy, extensive clinical data, and widespread clinical adoption. Its role as a backbone agent in multiple myeloma therapy ensures sustained demand.

Market Drivers

1. Rising Incidence of Hematologic Cancers

The global burden of multiple myeloma and other hematologic malignancies is expanding, propelled by aging populations and enhanced diagnostic capabilities. According to the Global Cancer Observatory, multiple myeloma incidence is rising worldwide, especially in North America, Europe, and Asia-Pacific, creating a persistent demand for effective therapies like Bortezomib.

2. Treatment Paradigm Shifts

Combination regimens that include Bortezomib—paired with immunomodulatory drugs (IMiDs) and corticosteroids—have demonstrably improved patient outcomes, including higher response rates and survival prolongation. Ongoing clinical trials exploring Bortezomib-based combinations aim to further solidify its therapeutic positioning.

3. Extended Indications and Patent Strategies

While initially indicated for relapsed/refractory multiple myeloma, Bortezomib’s potential in multiple myeloma front-line settings and other hematological malignancies bolsters its market longevity. Patent expirations, primarily in generic markets, introduce pricing pressures but also broaden access, especially in lower-income regions.

4. Biosimilar and Generic Competition

The expiration of Bortezomib’s primary patents in the late 2010s has catalyzed biosimilar entry. Companies like Sandoz and Dr. Reddy’s launched biosimilar versions, exerting downward pressure on prices but expanding market penetration, particularly in cost-sensitive markets.

Market Challenges

1. Competition from Second-Generation Proteasome Inhibitors

Carfilzomib (Kyprolis) and ixazomib (Ninlaro) offer alternative mechanisms, potentially with improved safety profiles or easier administration (oral formulations). This elevates competitive pressure, particularly for maintenance therapy or in patients intolerant to Bortezomib.

2. Side-Effect Profile and Administration Challenges

Bortezomib’s adverse effects—peripheral neuropathy, thrombocytopenia, and gastrointestinal symptoms—limit its tolerability. Subcutaneous administration routes have mitigated some side effects, but tolerability remains a differentiator.

3. Global Access and Pricing Dynamics

Price sensitivity, especially in emerging markets, and regulatory hurdles hinder access. The proliferation of biosimilars aids affordability but challenges profit margins for innovator companies.

Financial Trajectory and Revenue Outlook

1. Revenue Trends

Global sales of Bortezomib peaked around USD 2.9 billion in 2018 but faced gradual declines owing to generic competition and emerging alternatives. Still, the drug reports stable revenues, driven by expansion in Asia-Pacific regions and off-label uses.

2. R&D and Pipeline Developments

Pharmaceutical companies are investing in next-generation proteasome inhibitors and novel delivery formulations. Clinical pipelines exploring Bortezomib in solid tumors and autoimmune diseases indicate potential revenue expansion if approved.

3. Market Expansion Opportunities

Expanding access through biosimilars, especially in emerging economies, offers growth prospects. Strategic licensing, collaborations, and regional launches are critical to capture underserved markets.

4. Strategic Pricing and Reimbursement

Price negotiations, value-based pricing, and inclusion in national formularies influence revenue streams. Demonstrating real-world effectiveness and cost-effectiveness will be pivotal in sustaining profitability.

Regulatory and Patent Outlook

While patents for Bortezomib expired in early 2020s in key markets, regulatory pathways for biosimilars and generics streamline market entry, further lowering prices. Patent litigations and exclusivity rights remain relevant considerations for future financial planning.

Future Trajectory and Industry Outlook

The long-term outlook for Bortezomib hinges on ongoing clinical validation, competitive positioning, and global access strategies. Despite challenges from newer agents and biosimilars, Bortezomib’s entrenched clinical role sustains its market relevance. Furthermore, innovations like subcutaneous administration, fixed-dose combinations, and new indications could rejuvenate growth.

Industry forecasts suggest a stabilized, albeit slightly decling, revenue trajectory in mature markets. Simultaneously, emerging markets and pipeline advancements present opportunities for extended revenue generation.

Key Takeaways

• Market resilience stems from Bortezomib’s proven efficacy and central role in hematologic cancer therapy, underpinning sustained demand despite evolving competitors.
• Biosimilar entry has mitigated pricing power, compelling companies to innovate operational and market strategies, focusing on regional expansion and new indications.
• Clinical advances in combination regimens and maintenance therapy reinforce the drug’s relevance, with ongoing research promising future revenue streams.
• Global access and affordability remain critical, with strategic collaborations and local manufacturing key to capturing emerging market share.
• Regulatory evolutions and patent expiries necessitate adaptive business models, balancing innovation with cost competitiveness to ensure long-term profitability.

FAQs

1. How does Bortezomib compare to its second-generation alternatives?
Second-generation inhibitors like carfilzomib and ixazomib often offer improved side-effect profiles and convenience—oral administration for ixazomib, less peripheral neuropathy with carfilzomib—but Bortezomib’s extensive clinical data and established efficacy sustain its prominent market position.

2. What impact have biosimilars had on Bortezomib’s global sales?
Biosimilars have exerted downward pricing pressure, especially in Europe and emerging markets, leading to revenue adjustments. However, increased access in low-income regions has expanded overall market size.

3. What are the primary therapeutic indications for Bortezomib?
It is primarily indicated for multiple myeloma and mantle cell lymphoma. Expanded investigations are underway into other hematologic and solid tumors, potentially broadening its therapeutic scope.

4. How significant is the patent expiry in influencing future revenue?
Patent expiries facilitate biosimilar entry, impacting prices and sales volume. Companies are adjusting strategies by developing next-generation compounds and exploring novel indications.

5. What are the key factors influencing Bortezomib’s future market trajectory?
Regulatory approvals, combination therapy guidelines, biosimilar adoption, global access initiatives, and ongoing clinical research will determine the future landscape.

References

1. Global Cancer Observatory. (2021). Multiple Myeloma Factsheet. International Agency for Research on Cancer.
2. MarketsandMarkets. (2022). Hematologic Cancer Therapeutics Market.
3. FDA. (2003). Velcade [Bortezomib] Prescribing Information.
4. Sandoz. (2020). Bortezomib biosimilar launched in Europe.
5. Kumar, S. K., et al. (2021). Advances in Multiple Myeloma Therapy: Focus on Proteasome Inhibitors. Journal of Hematology & Oncology.