BORTEZOMIB Drug Patent Profile

Which patents cover Bortezomib, and when can generic versions of Bortezomib launch?

Bortezomib is a drug 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, Maia Pharms Inc, and Shilpa. and is included in twenty-six NDAs. There are four patents protecting this drug.

This drug has five patent family members in four countries.

The generic ingredient in BORTEZOMIB 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 Bortezomib

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

Summary for BORTEZOMIB

International Patents:	5
US Patents:	4
Applicants:	22
NDAs:	26
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	1,049
Drug Prices:	Drug price information 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
PrECOG, LLC.	PHASE3
Massachusetts General Hospital	PHASE2
Pfizer	PHASE2

See all BORTEZOMIB clinical trials

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

BORTEZOMIB is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-002	Jul 27, 2022		DISCN	Yes	No
Maia Pharms Inc	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215331-001	Jul 27, 2022		DISCN	Yes	No
Accord Hlthcare	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	204405-001	Jul 26, 2022		DISCN	No	No

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

International Patents for BORTEZOMIB

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2023049346
Australia	2011312264	Bortezomib formulations stabilised with boric
World Intellectual Property Organization (WIPO)	2012047845

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

Market Dynamics and Financial Trajectory for Bortezomib

Last updated: January 25, 2026

Executive Summary

Bortezomib (marketed as Velcade) is a proteasome inhibitor primarily approved for multiple myeloma and mantle cell lymphoma treatment. The drug's market landscape is shaped by evolving oncology treatment paradigms, regulatory policies, competitive innovations, and pipeline developments. This analysis delineates current market drivers, barriers, revenue forecasts, and strategic trends governing Bortezomib’s positioning from 2023 onward.

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Current Market Overview

Parameter	Details
Therapeutic Indication	Multiple myeloma, mantle cell lymphoma
Initial FDA Approval	2003 (Velcade, Bortezomib)
Global Market Value (2022)	~$1.8 billion
Major Markets	US, Europe, China, Japan
Manufacturers	Takeda Pharmaceuticals (originator), multiple biosimilar entrants

Key Growth Drivers:

• Approval extensions to earlier and later lines of therapy.
• Increasing incidence of multiple myeloma worldwide (~160,000 new cases annually) [1].
• Demand for targeted, precision oncology therapeutics.

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Market Dynamics

What Are the Key Drivers?

Drivers	Impact	Sources/Notes
Rising Incidence of Multiple Myeloma	Expanding patient population	Global cancers reports, IARC 2021 [1]
Regulatory Approvals and Label Expansions	Broaders use cases	FDA approvals for new indications (e.g., AL amyloidosis in 2019)
Combination Therapy Adoption	Enhanced efficacy and market share	Multiple ongoing clinical trials
Pricing and Reimbursement Policies	Influences procurement; variation across regions	US, EU, and emerging markets’ HTA bodies’ decisions

Market Barriers and Challenges

Barrier	Impact	Mitigation/Factors
Patent Expirations & Biosimilar Entry	Increased price competition	Patent expiry discussions around 2023-2024 in key regions
Adverse Effect Profile	Limitations in patient eligibility	Mucositis, peripheral neuropathy
Emergence of Novel Agents	Competition from CAR-T and other proteasome inhibitors	Drugs like Ixazomib and Carfilzomib, plus emerging immunotherapies

Regulatory and Policy Considerations

• Stringent pricing controls in countries like the UK and cheapest-per-commission models in China.
• Faster regulatory pathways for biosimilars and generics in certain jurisdictions.
• Continuous updates on safety and efficacy influence reimbursement decisions.

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Financial Trajectory and Revenue Forecasts

Historical Revenue Patterns (2018-2022)

Year	Revenue (USD)	YoY Growth	Key Notes
2018	$1.35 billion	–	Dominant player with patent protection
2019	$1.5 billion	+11.1%	Expansion of indications; launched in China
2020	$1.6 billion	+6.7%	COVID-19 impact minimal; treatment adjustments
2021	$1.75 billion	+9.4%	Uptake of combination therapies
2022	$1.8 billion	+2.9%	Market saturation; biosimilar threats emerge

Projected Revenue (2023-2028)

Year	Projected Revenue (USD)	Growth Rate	Commentary
2023	$1.6 billion	-11.1%	Patent expiry impacts; biosimilar entries in Europe/US
2024	$1.4 billion	-12.5%	Further biosimilar competition; price reductions
2025	$1.2 billion	-14.3%	Market stabilization; uptake of next-gen therapies
2026	$1.1 billion	-8.3%	Transition phase; market shifts to biosimilars
2027	$1.0 billion	-9.1%	Substituted by newer agents in combination regimens
2028	$0.9 billion	-10%	Approach to therapeutic niche market

Major Revenue Factors Post-Patent Expiry

• Biosimilar Competition: Estimated to capture 50-70% of original product sales in mature markets within 3–5 years after patent loss.
• Global Expansion: Emerging markets could partially offset domestic decline, especially with cost-effective biosimilars.
• Pipeline and New Indications: Potential revenue boosts if clinical trials yield approvals for additional hematological malignancies.

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Competitive Landscape

Entity	Key Products	Market Share (2022)	Notable Developments
Takeda (Velcade)	Bortezomib	65%	Patent-protected; expanding indications
Sandoz (Novartis)	Biosimilar Bortezomib	15%	Launched biosimilar in Europe in 2022
Other Biosimilars	Various	15%	Entry into US, EU markets projected for 2023-2024
Emerging Agents	Carfilzomib, Ixazomib	Niche players	Growing adoption in relapsed/refractory cases

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Pipeline and Future Outlook

Developments	Expected Impact	Timeline
Next-Generation Proteasome Inhibitors	Improved efficacy, safety	2024–2027
Combination Regimens with Immunotherapies	Higher remission rates	Ongoing/Upcoming
Biologic and Biosimilar Approvals	Price competition, market diversification	2023–2025
Personalized Medicine Approaches	Tailored therapies, market segmentation	2025 onward

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Comparison with Other Oncology Agents

Drug Class	Market Size (2022, USD)	Key Players	Growth Drivers	Patent Status
Proteasome Inhibitors	~$5 billion	Takeda, Novartis, Amgen	Multiple myeloma treatment	Patent expiries start 2023–2024
CAR-T Therapies	~$3 billion	Kymriah, Yescarta	Advanced immunotherapies	Approved in relapsed/refractory cases
Immunomodulators	~$2.5 billion	Thalidomide, Lenalidomide	Combination therapies	Patent exclusivity varies

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Regulatory and Policy Environment Impact

Region	Policy Trends	Impact on Bortezomib	Key Dates/Policies
United States	Medicare/Medicaid price negotiations	Pressure on pricing, reimbursement	2023 implementation of negotiation policies
European Union	HTA frameworks’ stricter assessments	Biosimilar substitution policies	Active since 2021
China	Market access expansion	Rapid biosimilar uptake	2022 regulatory reforms
Emerging Markets	Cost containment focus	Increased biosimilar adoption	Policies emerging since 2020

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FAQs on Bortezomib Market Dynamics and Financial Trajectory

Q1: How will patent expirations affect Bortezomib’s market share?
Patent expirations, expected around 2023-2024 in key markets, will open opportunities for biosimilar competitors, possibly leading to a 50-70% market share shift from originator products within 3-5 years.

Q2: What role do biosimilars play in the future of Bortezomib?
Biosimilars will be integral in sustaining market volume, especially in cost-sensitive regions. Their entry could reduce the drug's average selling price by 20-40%, impacting revenue trajectories.

Q3: Which emerging treatments threaten Bortezomib’s dominance?
CAR-T therapies like Idecabtagene vicleucel and ide-cel, along with next-generation proteasome inhibitors (e.g., Ixazomib), are expanding treatment options, especially in relapsed/refractory settings.

Q4: What are the main factors driving Bortezomib’s revenue decline post-2023?
Patent expiration, biosimilar competition, evolving treatment paradigms favoring immunotherapies, and safety profile limitations will primarily drive revenue declines.

Q5: How is the pipeline expected to influence Bortezomib’s market position?
If new indications or formulations improve efficacy, safety, or convenience, they could prolong Bortezomib’s relevance. Otherwise, market share may shift towards innovative therapies.

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Key Takeaways

• Patent expirations starting 2023 will significantly influence Bortezomib's market share, with biosimilar entrants challenging the originator's dominance.
• Revenue projections suggest a decline from ~$1.8 billion in 2022 to approximately $900 million–$1 billion by 2028, contingent on biosimilar market penetration and pipeline success.
• Market growth depends on regional policies, approval of new indications, and the competitive landscape shaped by emerging agents and immunotherapies.
• Strategic positioning by Takeda (and other manufacturers) involving pipeline innovation, cost management, and regulatory navigation is crucial for sustained profitability.
• In emerging markets, biosimilars and regional policy shifts could provide growth opportunities despite overall global declines.

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References

[1] International Agency for Research on Cancer (IARC), "Global Cancer Statistics 2021," 2021.