BORTEZOMIB Drug Patent Profile
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Which patents cover Bortezomib, and what generic alternatives are available?
Bortezomib is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Norvium Bioscience, Pharmascience Inc, Qilu Pharm Hainan, Reliance Life Sci, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Zydus Pharms, Maia Pharms Inc, and Shilpa. and is included in twenty-five NDAs. There are four patents protecting this drug.
This drug has five patent family members in four countries.
The generic ingredient in BORTEZOMIB 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 Bortezomib
A generic version of BORTEZOMIB was approved as bortezomib by APOTEX on May 2nd, 2022.
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Summary for BORTEZOMIB
| International Patents: | 5 |
| US Patents: | 4 |
| Applicants: | 21 |
| NDAs: | 25 |
| Finished Product Suppliers / Packagers: | 23 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 1,001 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Alexion Pharmaceuticals, Inc. | Phase 4 |
| Pfizer | Phase 3 |
| Jin Lu, MD | N/A |
Pharmacology for BORTEZOMIB
| Drug Class | Proteasome Inhibitor |
| Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for BORTEZOMIB
Anatomical Therapeutic Chemical (ATC) Classes 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
BORTEZOMIB is protected by six US patents.
Patents protecting BORTEZOMIB
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Bortezomib formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | 215331-001 | Jul 27, 2022 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Maia Pharms Inc | BORTEZOMIB | bortezomib | SOLUTION;INTRAVENOUS | 215331-002 | Jul 27, 2022 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Accord Hlthcare | BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 204405-001 | Jul 26, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms Usa | BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 205857-001 | May 2, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Accord Hlthcare | BORTEZOMIB | bortezomib | SOLUTION;INTRAVENOUS | 215441-001 | Jul 26, 2022 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hetero Labs Ltd Vi | BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 212204-001 | May 3, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Shilpa | BORTEZOMIB | bortezomib | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 212782-001 | Aug 26, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 | |
| 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for BORTEZOMIB
See the table below for patents covering BORTEZOMIB around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2011312264 | Bortezomib formulations stabilised with boric | ⤷ Sign Up |
| European Patent Office | 2624818 | FORMULATIONS DE BORTÉZOMIB STABILISÉES PAR DE L'ACIDE BORIQUE (BORTEZOMIB FORMULATIONS STABILISED WITH BORIC ACID) | ⤷ Sign Up |
| Canada | 2813003 | FORMULATIONS DE BORTEZOMIB STABILISEES PAR DE L'ACIDE BORIQUE (BORTEZOMIB FORMULATIONS STABILISED WITH BORIC ACID) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2023049346 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2012047845 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BORTEZOMIB
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0788360 | SPC/GB04/021 | United Kingdom | ⤷ Sign Up | 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 | 04C0014 | France | ⤷ Sign Up | PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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