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, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Norvium Bioscience, Pharmascience Inc, Qilu Pharm Hainan, Reliance Life Sci, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Zydus Pharms, Takeda Pharms Usa, Maia Pharms Inc, and Shilpa, and is included in twenty-six 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-four 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:	22
NDAs:	26
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	1,001
Patent Applications:	5,548
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
Alexion Pharmaceuticals, Inc.	Phase 4
Pfizer	Phase 3
Jin Lu, MD	N/A

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
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003	AP	RX	Yes	Yes
Fresenius Kabi Usa	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	209659-001	May 2, 2022	AP	RX	No	No
Zydus Pharms	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	210204-001	May 2, 2022	AP	RX	No	No
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-001	Jul 27, 2022		DISCN	Yes	No	11,752,164
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	7,119,080
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	6,617,317
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003	6,083,903

EU/EMA Drug Approvals for bortezomib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Velcade	bortezomib	EMEA/H/C/000539 Velcade 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
Accord Healthcare S.L.U.	Bortezomib Accord	bortezomib	EMEA/H/C/003984 Bortezomib 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
SUN Pharmaceutical Industries (Europe) B.V.	Bortezomib Sun	bortezomib	EMEA/H/C/004076 Bortezomib 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
Pfizer Europe MA EEIG	Bortezomib Hospira	bortezomib	EMEA/H/C/004207 Bortezomib 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
Fresenius Kabi Deutschland GmbH	Bortezomib Fresenius Kabi	bortezomib	EMEA/H/C/005074 Bortezomib 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 bortezomib

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

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

Market Overview

Bortezomib, a proteasome inhibitor, is a crucial drug in the treatment of blood cancers such as multiple myeloma and mantle cell lymphoma. The global bortezomib market is poised for significant growth, driven by several key factors.

Market Size and Growth Projections

The global bortezomib market is estimated to be valued at USD 24.54 million in 2024 and is expected to reach USD 33.15 million by 2031, exhibiting a compound annual growth rate (CAGR) of 4.4% from 2024 to 2031[2][4].

Drivers of Market Growth

Increasing Prevalence of Multiple Myeloma

The rising prevalence of multiple myeloma, which accounts for about 10% of all hematological cancers, is a major driver of the bortezomib market. As healthcare expenditure increases in developing nations, more patients are gaining access to bortezomib treatment[2][4].

Growing Adoption in Combination Therapy

Bortezomib's use as part of combination therapy and its approval for newer indications, such as maintenance therapy and in combination with immunomodulators, are boosting its adoption globally[2].

Robust Pipeline of Novel Drug Candidates

The robust pipeline of novel drug candidates and the increasing demand for more effective targeted therapies offer significant growth opportunities for market players[2].

Improving Healthcare Infrastructure

Enhanced healthcare facilities, increasing disposable income, and greater public awareness of cancer detection and treatment options in emerging economies are driving the demand for bortezomib[4].

Regional Market Dynamics

North America

North America currently dominates the bortezomib market, with a share of around 40.3% in 2024. The region's strong healthcare infrastructure, high incidence of multiple myeloma, and favorable reimbursement policies contribute to its dominance[2][4].

Asia Pacific

The Asia Pacific region, particularly China and India, is expected to be the fastest-growing segment during the forecast period. The region's steady economic growth, expanding healthcare access, and increasing healthcare expenditure are key factors driving this growth[2][4].

Europe

Europe's bortezomib market is driven by increasing cancer incidence, government initiatives promoting cancer care, and advanced medical technologies. The region's aging population also adds to the demand for cancer treatments[4].

Challenges and Constraints

Patent Expirations and Generic Competition

The patent for Velcade (bortezomib) expired in 2020, paving the way for generic versions. This has led to increased competition from cheaper generic alternatives, which can reduce the revenues of leading drug manufacturers[2].

Price Decline

The availability of generic versions can bring down the prices of bortezomib therapies, potentially reducing the market share and revenues of branded products[2].

Market Opportunities

Emerging Economies

Emerging economies in Asia Pacific and Latin America offer substantial commercialization possibilities due to rising healthcare budgets, greater medical awareness, and increasing health insurance penetration. These markets have less stringent regulations and price controls compared to developed markets[2].

Innovation and R&D

Continuous research and development to develop safer and more effective drugs through collaborations can drive market growth. Companies are actively working on expanding the approved indications of bortezomib and launching new drug delivery formats to differentiate their products from generics[2].

Key Market Players

Major companies operating in the bortezomib market include Takeda Pharmaceutical Company Limited, Pfizer Inc., Johnson & Johnson, Mylan Pharmaceuticals Inc., Novartis International AG, Bristol Myers Squibb, and Teva Pharmaceutical Industries Ltd.[4].

Financial Trajectory

The financial trajectory of the bortezomib market is influenced by several factors, including the growth in demand, competition from generics, and innovations in treatment options.

Revenue Growth

The market is expected to grow from USD 24.54 million in 2024 to USD 33.15 million by 2031, with a CAGR of 4.4% during this period[2].

Impact of Generic Competition

The entry of generic versions of bortezomib is expected to impact the revenues of branded products. However, companies are focusing on expanding indications and developing new delivery formats to maintain market share[2].

Regional Revenue Contributions

North America and Europe are expected to continue contributing significantly to the market revenue, while the Asia Pacific region is anticipated to show the fastest growth due to its expanding healthcare infrastructure and increasing demand for cancer treatments[2][4].

Key Takeaways

• The global bortezomib market is driven by the increasing prevalence of multiple myeloma and the growing adoption of bortezomib in combination therapy.
• Emerging economies in Asia Pacific and Latin America present significant growth opportunities.
• Patent expirations and generic competition pose challenges, but continuous R&D and innovation can mitigate these effects.
• North America and Europe are key revenue contributors, with the Asia Pacific region expected to be the fastest-growing segment.

FAQs

What is the current market size of the global bortezomib market?

The global bortezomib market is estimated to be valued at USD 24.54 million in 2024[2].

What is the expected CAGR of the global bortezomib market from 2024 to 2031?

The global bortezomib market is expected to exhibit a CAGR of 4.4% from 2024 to 2031[2].

Which region dominates the global bortezomib market?

North America currently dominates the global bortezomib market with a share of around 40.3% in 2024[2].

What are the main drivers of the bortezomib market growth?

The main drivers include the increasing prevalence of multiple myeloma, growing adoption in combination therapy, robust pipeline of novel drug candidates, and improving healthcare infrastructure in emerging economies[2][4].

How does the patent expiration of Velcade impact the bortezomib market?

The patent expiration of Velcade has led to the entry of generic versions, which can reduce the prices of bortezomib therapies and impact the revenues of branded products[2].