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Last Updated: March 28, 2024

BORTEZOMIB - Generic Drug Details


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What are the generic drug sources for bortezomib and what is the scope of patent protection?

Bortezomib is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Mylan Labs Ltd, Pharmascience Inc, Qilu Pharm Hainan, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Waverley Pharma Inc, Zydus Pharms, Takeda Pharms Usa, and Maia Pharms Inc, and is included in twenty-four NDAs. There are three 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 suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for BORTEZOMIB

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Recent Clinical Trials for BORTEZOMIB

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

SponsorPhase
Stanford UniversityPhase 1/Phase 2
Dong-A University HospitalPhase 2
Pediatric Oncology Experimental Therapeutics Investigators' ConsortiumPhase 1/Phase 2

See all BORTEZOMIB clinical trials

Generic filers with tentative approvals for BORTEZOMIB
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial3.5MG/1.4MLINJECTABLE; INJECTION
⤷  Try a Trial⤷  Try a Trial2.5MG/MLINJECTABLE; 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 ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
Medical Subject Heading (MeSH) Categories for BORTEZOMIB
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
Maia Pharms Inc BORTEZOMIB bortezomib SOLUTION;INTRAVENOUS 215331-002 Jul 27, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Maia Pharms Inc BORTEZOMIB bortezomib SOLUTION;INTRAVENOUS 215331-001 Jul 27, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Maia Pharms Inc BORTEZOMIB bortezomib SOLUTION;INTRAVENOUS 215331-001 Jul 27, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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/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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for BORTEZOMIB

Country Patent Number Title Estimated Expiration
European Patent Office 2624818 FORMULATIONS DE BORTÉZOMIB STABILISÉES PAR DE L'ACIDE BORIQUE (BORTEZOMIB FORMULATIONS STABILISED WITH BORIC ACID) ⤷  Try a Trial
Australia 2011312264 Bortezomib formulations stabilised with boric ⤷  Try a Trial
Canada 2813003 FORMULATIONS DE BORTEZOMIB STABILISEES PAR DE L'ACIDE BORIQUE (BORTEZOMIB FORMULATIONS STABILISED WITH BORIC ACID) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BORTEZOMIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0788360 04C0014 France ⤷  Try a Trial PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
0788360 SPC/GB04/021 United Kingdom ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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