BORTEZOMIB - Generic Drug Details
✉ Email this page to a colleague
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.
Summary for BORTEZOMIB
International Patents: | 5 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 20 |
NDAs: | 24 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 20 |
Raw Ingredient (Bulk) Api Vendors: | 121 |
Clinical Trials: | 988 |
Patent Applications: | 5,548 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
Recent Clinical Trials for BORTEZOMIB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Stanford University | Phase 1/Phase 2 |
Dong-A University Hospital | Phase 2 |
Pediatric Oncology Experimental Therapeutics Investigators' Consortium | Phase 1/Phase 2 |
Generic filers with tentative approvals for BORTEZOMIB
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 3.5MG/1.4ML | INJECTABLE; INJECTION |
⤷ Try a Trial | ⤷ Try a Trial | 2.5MG/ML | INJECTABLE; 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 Class | Proteasome 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 | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.