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, 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, Gland, Maia Pharms Inc, and Shilpa. and is included in twenty-eight 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-five 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:	24
NDAs:	28
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	1,053
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
Andrew Hantel, MD	PHASE1
PrECOG, LLC.	PHASE3
Massachusetts General Hospital	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	215331-001	Jul 27, 2022		DISCN	Yes	No
Accord Hlthcare	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215441-001	Jul 26, 2022		DISCN	Yes	No
Accord Hlthcare	BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS	215441-002	Jul 26, 2022		DISCN	Yes	No
Accord Hlthcare	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	204405-001	Jul 26, 2022		DISCN	No	No
Shuangcheng	BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	216528-001	Dec 17, 2025	AP	RX	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
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

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

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	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 (Velcade) 2024–2029: Sales Trends, Pricing Pressure, Generic and Biosimilar Risk, and Patent-Expiry Timeline

Last updated: June 20, 2026

Bortezomib (marketed as Velcade by Janssen Biotech, a Johnson & Johnson company) is in a mature, high-payer-exposure oncology niche. Demand is sustained by use in multiple myeloma and mantle cell lymphoma regimens, but long-run growth is constrained by (1) post-patent pricing competition for subcutaneous (SC) and intravenous (IV) presentations, (2) penetration of combination regimens and next-generation proteasome inhibitors, and (3) episodic uptake driven by guideline cycles and reimbursement patterns. Financial trajectory is shaped more by erosion in branded pricing and share than by new regimen-led blockbuster expansion.

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What is the bortezomib market size and how is demand evolving by geography and indication?

Bottom line: The bortezomib addressable market is dominated by multiple myeloma, with additional contribution from mantle cell lymphoma, while geographic demand concentrates in the US and EU with slower adoption curves in emerging markets.

Multiple myeloma is the core demand driver

• Bortezomib is used across stages of multiple myeloma treatment, including induction, consolidation, and relapse settings.
• Real-world use is influenced by regimen preferences (proteasome inhibitor backbone), renal-function considerations, and neuropathy management protocols that affect the relative uptake of SC dosing.

Mantle cell lymphoma contributes but is secondary

• Mantle cell lymphoma uptake is regimen dependent and typically smaller than multiple myeloma volume.
• Clinical sequencing is shaped by BTK inhibitors and chemoimmunotherapy frameworks, which can compress proteasome-inhibitor share.

Geography: pricing and access define net sales more than volume

• In the US and Western Europe, branded pricing and payer formulary status drive net price and rebate intensity.
• In countries with faster generic penetration, net revenue is pressured earlier.

Indication-by-indication commercial exposure

Because bortezomib is a mature oncology product, growth tends to be “mix-driven” rather than “new-patient driven.” The key mix levers are:

• IV versus SC utilization (SC generally used to reduce peripheral neuropathy risk)
• line of therapy shift (relapse usage can be stable, but incidence-driven new diagnosis growth is slower)
• combination regimen inclusion or substitution

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How have bortezomib sales and pricing changed over time, and what are the main drivers of financial erosion?

Bottom line: The financial trajectory has been dominated by branded net price compression, rebate pressure, and formulation or delivery-channel substitution as competitors entered.

Pricing pressure: net-to-gross compression is the main P&L channel

For mature branded injectable oncology:

• list price holds longer than net price
• rebates increase after competitor entries
• payer management shifts patients to preferred products and dosing forms

Share pressure: SC/IV preference and supportive-care protocols

• SC dosing is frequently used to manage neuropathy and improve tolerability.
• If payer formularies or procurement contracts favor specific manufacturers by presentation, utilization can shift even when active ingredient is the same.

Competition from next-generation proteasome and pathway options

• Treatment planning increasingly includes regimen backbones built around other proteasome inhibitors and immunotherapies.
• This does not eliminate bortezomib, but it can reduce incremental growth and increase “duration of use” volatility when patients switch at relapse.

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What patents protect bortezomib and how strong is the patent estate for Velcade?

Bottom line: Bortezomib’s patent moat is largely exhausted at the active-ingredient level; the practical remaining protection is usually tied to formulations, manufacturing, specific dosing schedules, or delivery forms such as SC.

Patent estate categories that typically matter for bortezomib commercialization

• formulation patents (stability, excipients, lyophilized or solution characteristics, container closure)
• method-of-treatment patents tied to dosing schedules or patient subgroups
• process/method-of-manufacture patents
• new dosage forms or route-of-administration patents
• combination use claims when tied to a specific regimen

How “estate strength” behaves once active-ingredient exclusivity ends

When bortezomib active-ingredient exclusivity is over:

• generics can rely on bioequivalence and abbreviated approval pathways where permitted
• remaining brand protection typically concentrates in narrower, higher-friction patent claims (formulation and method-of-use)
• litigation and settlements determine the actual launch timing more than the patent count

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When does bortezomib lose exclusivity and what are the key expiration checkpoints for generics?

Bottom line: Bortezomib’s exclusivity window at the molecule level has passed in key markets; the remaining exclusivity and blocking points are formulation- and method-linked patents plus regulatory exclusivities tied to specific labeled presentations.

Exclusivity vs patent expiration: why launch timing differs

• exclusivity (regulatory periods like orphan or new clinical investigations, where applicable) can block generic approval submissions
• patents block approval or force design-around until expiration or settlement

Launch-risk timeline framework (commercially actionable)

In matured injectables, the generic “event risk” typically comes in three phases:

1. approval submission and first signaling of paragraph IV challenges
2. litigation stay outcomes or settlement effective dates
3. label entry and procurement ramp, where net sales usually deteriorate further

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What is the Orange Book status of Velcade (bortezomib) and which patents are listed?

Bottom line: Orange Book protection for bortezomib is structured around specific NDA/BLA entries and listed patents, but the actionable question for investors and litigators is which listed patents are still “unexpired and not irrelevant” to each presentation (SC vs IV) and to each generic filing.

Orange Book listings: what to extract for decision-making

For each relevant Velcade presentation, extract:

• application number and dosage form mapping
• listed patent numbers (composition, formulation, and method-of-use)
• expiration dates
• exclusivity expiration, if separately listed
• generic applicants’ paragraph IV status (if present)

Litigation relevance: listed patents are not all equally “blocker-grade”

Not all Orange Book patents block generic market entry. The blockers tend to be:

• formulation patents that are hard to design around
• process claims that relate to stability or container compatibility
• method-of-use claims that overlap labeled dosing regimens

(Orange Book-specific tables require live Orange Book pulls, which are not available in the current input set.)

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How do paragraph IV challenges and patent litigation affect the timing of bortezomib generic entry?

Bottom line: Paragraph IV challenges and related settlements determine practical generic launch windows. For matured injectables, even after patent expiry, procurement ramp can delay full commercial erosion.

Commercial effect pattern after generic approval

Once generic supply enters:

• tender and pharmacy supply switches can be rapid if payers prefer lower acquisition cost
• some patients remain on branded due to perceived stability, handling experience, or contracting
• market share transition often accelerates when SC and IV both face competitive tenders

What to track in litigation outcomes

• settlement effective dates that control “first commercial sale” (market entry)
• stipulations on launch geography or presentation
• whether generics are allowed to launch “at risk” for non-blocking indications

(Precise litigation case mapping and dates are not included because the source dataset for case-level facts is not provided.)

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Are biosimilars relevant for bortezomib, and how does biologic competition compare with generic competition?

Bottom line: Bortezomib is a small-molecule drug. Biosimilars are not part of the competitive landscape in the way they are for biologic therapeutics. Competition is primarily via chemically identical generics and, where applicable, alternative manufacturers of the same drug substance with FDA-approved formulations.

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What formulations and delivery routes (IV vs subcutaneous) influence bortezomib competitiveness?

Bottom line: Delivery route and formulation are central to both payer uptake and litigation leverage. SC dosing is often treated as more tolerable, which can shift procurement preference.

Commercially important formulation differentiators

• SC versus IV availability in the market
• stability, handling time, and preparation workflow in oncology clinics
• packaging and labeling specific to dosing schedule compliance
• any formulation-level patents that create regulatory launch friction

Patent and regulatory interplay at the formulation layer

A formulation patent that covers stability or excipient behavior can force:

• different formulation composition or container closure
• design-around strategies that may slow generic approval
• litigation with specific claim construction around stability and delivery performance

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Which companies compete in bortezomib generics for Velcade and what is the competitive landscape?

Bottom line: The competitive landscape centers on generic injectables manufacturers that file FDA abbreviated applications for bortezomib. Competitive intensity depends on:

• how many FDA-approved ANDAs exist for each presentation
• supply reliability and wholesaler penetration
• pricing and rebate aggressiveness

(Company-by-company competitor lists and share allocations require a factual competitor dataset and are not present in the provided input.)

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How much revenue is at risk for bortezomib, and where is the highest financial exposure?

Bottom line: Revenue risk concentrates in markets with faster generic uptake and in channels where SC and IV presentations are tendered separately. Financial exposure is typically highest where:

• payers have strong formulary controls for oncology injectables
• hospitals prefer lowest net cost and standardized administration workflows
• tender schedules coincide with generic entry timing

Revenue at risk by channel

• hospital purchasing: sensitive to contract price and tender timing
• specialty pharmacies: sensitive to reimbursement and patient assistance dynamics
• wholesale distribution: affected by supply competition and allocation policies

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What generic entry scenarios are most likely for bortezomib, and what are the profit-impact ranges?

Bottom line: Entry scenarios are less about “if” and more about “how fast share migrates.” In mature injectables, profit impact is driven by:

• net price compression after multiple suppliers enter
• loss of branded exclusivity in a subset of presentations first (SC or IV)
• manufacturing scale-up and supply continuity

Scenario structure used in commercial planning

1. Single generic entrant: slower erosion, higher branded durability
2. Multiple entrants: faster net price collapse, higher margin pressure
3. Settlement-delayed entry: temporary protection followed by step-change erosion
4. Presentation-specific entry: partial erosion initially, full erosion later when both routes compete

(Profit-impact ranges require historical net sales baselines and pricing decks that are not provided.)

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How does bortezomib compare with other multiple myeloma proteasome inhibitors in market trajectory?

Bottom line: Bortezomib’s commercial trajectory is shaped by substitution within the proteasome-inhibitor class and by shifting regimen standards. Brand durability depends on clinical tolerability protocols and payer contracting more than on novelty.

Practical comparison axes

• dosing flexibility and regimen compatibility
• neuropathy management and SC uptake
• line-of-therapy inclusion and guideline emphasis
• availability across geographies and supplier capacity

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What FDA regulatory status and approval history affects bortezomib competition?

Bottom line: Competitive dynamics depend on labeled presentations (SC/IV), manufacturing changes, and whether generics can secure approval for the same route and dosing form without triggering formulation-related blocking.

Regulatory levers affecting market entry

• ANDA approval pathway eligibility
• bioequivalence demonstration scope
• ability to match formulation, strength, and route
• labeling alignment

(Precise FDA approvals and regulatory milestones by year require dossier-level inputs.)

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Key patent and exclusivity event timeline for bortezomib (framework)

Bottom line: For decision-making, organize timelines by (1) regulatory exclusivity, (2) listed patent expirations by presentation, and (3) litigation settlement effective dates that define “first sale” timing.

Timeline layer	What to anchor on	Why it matters for P&L
Regulatory exclusivity	NDA/BLA exclusivity end dates tied to specific presentations	Blocks abbreviated approvals or limits generic timelines
Listed patents	Composition/formulation/method patents linked to relevant dosage form	Controls “at-risk” launch feasibility and injunction risk
Litigation settlements	“Effective date” of settlement or stipulation of launch	Determines practical market entry window
Launch ramp	Hospital contracting cycles, tenders, formulary updates	Drives speed of net sales decline

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Key Takeaways

• Bortezomib (Velcade) is a mature oncology product where financial trajectory is dominated by branded net price erosion and formulation/presentation-specific competitive dynamics rather than by major pipeline-led growth.
• Market share risk concentrates around SC versus IV procurement and how quickly generic suppliers can match the same dosage forms and routes.
• Patent estate relevance shifts from molecule-level exclusivity to narrower formulation and method-of-use protections, with litigation and settlements often determining actual entry timing.
• Generic-biosimilar dynamics are not applicable because bortezomib is a small molecule; competition is driven by generics (ANDA) and supplier execution.

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FAQs

1. How does subcutaneous versus intravenous bortezomib dosing affect payer formularies and generic switching?
2. What Orange Book patent types typically block bortezomib generic entry: formulation, composition, or method-of-use?
3. Which multiple myeloma guideline changes most often impact bortezomib line-of-therapy utilization?
4. What settlement terms most commonly delay bortezomib generic launch in the US?
5. How does hospital tender timing influence the slope of bortezomib net sales decline after generic entry?

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via FDA Orange Book database).
2. FDA Drug Trials Snapshots for Velcade (bortezomib). U.S. Food and Drug Administration.
3. Janssen Biotech / Johnson & Johnson investor materials for Velcade (bortezomib) net sales disclosures. (Company filings and earnings presentations).

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