Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Mallinckrodt
Moodys
Harvard Business School
AstraZeneca

Last Updated: November 27, 2022

Bortezomib - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic sources for bortezomib and what is the scope of freedom to operate?

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, Pharmascience Inc, Qilu Pharm Hainan, Sandoz Inc, Teva Pharms Usa, Waverley Pharma Inc, Zydus Pharms, Takeda Pharms Usa, and Maia Pharms Inc, and is included in twenty-two 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 thirty-one patent family members in thirteen countries.

There are twenty drug master file entries for bortezomib. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for bortezomib

See drug prices for bortezomib

Recent Clinical Trials for bortezomib

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

SponsorPhase
Southwest Oncology GroupPhase 3
Janssen Research & Development, LLCPhase 2/Phase 3
Pharmacyclics LLC.Phase 2/Phase 3

See all bortezomib clinical trials

Generic filers with tentative approvals for BORTEZOMIB
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing3.5MG/1.4MLINJECTABLE; INJECTION
See Plans and PricingSee Plans and Pricing2.5MG/MLINJECTABLE; INJECTION
See Plans and PricingSee Plans and Pricing3.5MG/VIALINJECTABLE;INTRAVENOUS, SUBCUTANEOUS

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 Action Proteasome 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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira BORTEZOMIB bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 208460-001 Jul 26, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Meitheal BORTEZOMIB bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 212958-001 Jul 26, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 See Plans and Pricing See Plans and Pricing
>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

Supplementary Protection Certificates for bortezomib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0788360 04C0014 France See Plans and Pricing PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
0788360 SPC/GB04/021 United Kingdom See Plans and Pricing 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Moodys
Baxter
McKesson
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.