VELCADE Drug Patent Profile

When do Velcade patents expire, and when can generic versions of Velcade launch?

Velcade is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in VELCADE 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 Velcade

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

Summary for VELCADE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	598
Drug Prices:	Drug price information for VELCADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VELCADE
What excipients (inactive ingredients) are in VELCADE?	VELCADE excipients list
DailyMed Link:	VELCADE at DailyMed

See drug prices for VELCADE

Recent Clinical Trials for VELCADE

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

Sponsor	Phase
Stichting European Myeloma Network	Phase 2
KKS Netzwerk	Phase 3
Deutsche Studiengruppe Multiples Myelom (DSMM)	Phase 3

See all VELCADE clinical trials

Pharmacology for VELCADE

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Paragraph IV (Patent) Challenges for VELCADE

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 VELCADE

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

Expired US Patents for VELCADE

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	6,958,319*PED
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	6,713,446*PED
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 VELCADE

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/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
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
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
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
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

International Patents for VELCADE

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

Country	Patent Number	Title	Estimated Expiration
Japan	H10510245
European Patent Office	3078667	FORMULATION DE COMPOSÉS D'ACIDE BORONIQUE (FORMULATION OF BORONIC ACID COMPOUNDS)
Finland	114801
Portugal	1312609
Spain	2702732
China	1168633
Japan	2004517932

Supplementary Protection Certificates for VELCADE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788360	C00788360/01	Switzerland		FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0788360	300151	Netherlands		300151, 20151027, EXPIRES: 20190425
0788360	CA 2004 00012	Denmark
0788360	91083	Luxembourg		91083, EXPIRES: 20190426
0788360	SPC008/2004	Ireland		SPC008/2004: 20050504, EXPIRES: 20190425
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

VELCADE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VELCADE

Introduction

VELCADE, also known as bortezomib, is a proteasome inhibitor used primarily in the treatment of multiple myeloma and mantle cell lymphoma. The market dynamics and financial trajectory of VELCADE are influenced by several factors, including its efficacy, market competition, patent status, and geographical demand.

Market Size and Growth

The VELCADE market has seen significant fluctuations in recent years. As of 2018, VELCADE represented more than 54% of the overall volume in the proteasome inhibitors market, driven by advances in research and its ability to capture new patient pools[1].

However, the market size of VELCADE has been valued at USD 40 million in 2023 and is expected to grow at a CAGR of 7% from 2024 to 2031, reaching USD 68.73 million by 2031. This growth is largely attributed to the increasing prevalence of multiple myeloma and other hematological cancers[3].

Revenue Trends

Historically, VELCADE has been a significant revenue generator for its manufacturer, Takeda. In the fiscal year 2017, VELCADE brought in $1.25 billion, contributing substantially to Takeda's total revenue of $15.8 billion[2].

However, the revenue from VELCADE has been declining. The drug's sales were expected to plummet more than 30% due to the U.S. rollout of Fresenius Kabi’s alternative bortezomib formulation and the expiration of its patent protection in 2020. This decline has been a significant challenge for Takeda, impacting its core earnings by 18 percentage points in fiscal 2018[2].

Patent Expiry and Generic Competition

The patent expiry of VELCADE in 2020 has led to the entry of several generic versions of bortezomib into the market. This has resulted in increased competition and a potential reduction in prices, which could further reduce the revenues of leading drug manufacturers. The availability of cheaper generic alternatives poses a serious revenue and market share threat to established market players[4].

Geographical Market Dynamics

The North American market has been a significant contributor to the revenue of VELCADE, accounting for about 47% of the overall revenue in 2018. This is due to the high prevalence of multiple myeloma and non-Hodgkin’s lymphoma in this region[1].

However, emerging economies in Asia Pacific and Latin America are expected to offer growth opportunities. The increasing incidence of blood cancer indications, rising healthcare budgets, and greater medical awareness in these regions are driving the adoption of bortezomib. These markets offer less stringent regulations and price controls, making them attractive for market players[4].

Clinical Applications and Research

VELCADE's market potential is further enhanced by ongoing research and clinical trials. The drug is being explored for new administration methods and combination treatments, which can expand its clinical applications beyond multiple myeloma. For instance, its use as a maintenance therapy and in combination with immunomodulators are newer approved indications[3][4].

Competitive Landscape

The proteasome inhibitors market is competitive, with other drugs like KYPROLIS and NINLARO also vying for market share. KYPROLIS, for example, is expected to register a CAGR of more than 10% in terms of revenue from 2019 to 2023 due to its superior efficacy and target affinity[1].

NINLARO, another proteasome inhibitor, commanded over 11% of the volume share in 2018 and is expected to witness considerable growth during the forecast period, driven by diverse research on the drug[1].

Financial Impact of Market Changes

The decline in VELCADE sales has been mitigated to some extent by Takeda's acquisition of Shire, which nearly doubled Takeda's revenue guidance for 2018. However, the long-term financial impact of VELCADE's declining sales remains a challenge. Companies are focusing on expanding the approved indications of bortezomib and launching new drug delivery formats to differentiate their products from generics[2].

Patient Access and Healthcare Infrastructure

The market growth of VELCADE is also influenced by improvements in patient access to cancer medicines and innovations in healthcare infrastructure. As more individuals receive prescriptions for VELCADE due to its recognized efficacy and safety, the demand for the drug is increasing. Supportive care techniques and the creation of new treatment options further position VELCADE as an essential part of contemporary cancer treatment procedures[3].

Key Takeaways

• Market Size and Growth: VELCADE's market size is expected to grow at a CAGR of 7% from 2024 to 2031, reaching USD 68.73 million by 2031.
• Revenue Trends: Historically significant revenue generator, but sales are declining due to patent expiry and generic competition.
• Geographical Dynamics: North America is a major market, but emerging economies in Asia Pacific and Latin America offer growth opportunities.
• Clinical Applications: Ongoing research expands its applications beyond multiple myeloma.
• Competitive Landscape: Faces competition from KYPROLIS and NINLARO.
• Financial Impact: Decline in sales mitigated by Takeda's acquisition of Shire, but long-term challenges remain.

FAQs

What is the current market size of VELCADE?

The VELCADE market was valued at USD 40 million in 2023 and is expected to reach USD 68.73 million by 2031[3].

Why is the sales revenue of VELCADE declining?

The sales revenue of VELCADE is declining primarily due to the patent expiry in 2020 and the subsequent entry of generic versions into the market[2][4].

Which regions are driving the growth of the VELCADE market?

North America has been a significant contributor, but emerging economies in Asia Pacific and Latin America are expected to drive future growth[1][4].

What are the new clinical applications being explored for VELCADE?

VELCADE is being explored for new administration methods and combination treatments, including its use as a maintenance therapy and in combination with immunomodulators[3][4].

How has Takeda mitigated the decline in VELCADE sales?

Takeda's acquisition of Shire has helped mitigate the decline in VELCADE sales by nearly doubling Takeda's revenue guidance for 2018[2].

What are the challenges faced by VELCADE in the market?

VELCADE faces challenges such as patent expiry, generic competition, and high drug costs, particularly in low-income countries[2][4].

Sources

1. Proteasome Inhibitors Market Size Worth $1.7 Billion by 2023 - Biospace
2. Looming Velcade freefall shows why Takeda paid big for Shire - FiercePharma
3. Velcade Market Size and Projections - Market Research Intellect
4. Bortezomib Market - Share, Size and Industry Analysis - Coherent Market Insights