VELCADE Drug Patent Profile

Which patents cover Velcade, and what generic alternatives are available?

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-four 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
Deutsche Studiengruppe Multiples Myelom (DSMM)	Phase 3
KKS Netzwerk	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
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 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
Austria	501157
Switzerland	0788360
Israel	133831	PHARMACEUTICAL COMPOSITIONS CONTAINING PROTEASOME INHIBITORS
Cyprus	1117484
Denmark	1355910

Supplementary Protection Certificates for VELCADE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788360	91083	Luxembourg		91083, EXPIRES: 20190426
0788360	SPC008/2004	Ireland		SPC008/2004: 20050504, EXPIRES: 20190425
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	CA 2004 00012	Denmark
0788360	300151	Netherlands		300151, 20151027, EXPIRES: 20190425