ABRAXANE Drug Patent Profile
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Which patents cover Abraxane, and what generic alternatives are available?
Abraxane is a drug marketed by Bristol-myers and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and forty-two patent family members in thirty-one countries.
The generic ingredient in ABRAXANE is paclitaxel. There are sixty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Abraxane
A generic version of ABRAXANE was approved as paclitaxel by TEVA PHARMS on January 25th, 2002.
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Summary for ABRAXANE
| International Patents: | 242 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 95 |
| Clinical Trials: | 450 |
| Drug Prices: | Drug price information for ABRAXANE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABRAXANE |
| What excipients (inactive ingredients) are in ABRAXANE? | ABRAXANE excipients list |
| DailyMed Link: | ABRAXANE at DailyMed |
Recent Clinical Trials for ABRAXANE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| 280Bio Inc | Phase 1 |
| Alliance for Clinical Trials in Oncology | Phase 2/Phase 3 |
| Gruppo Oncologico del Nord-Ovest | Phase 2/Phase 3 |
Pharmacology for ABRAXANE
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
Paragraph IV (Patent) Challenges for ABRAXANE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ABRAXANE | For Injection Suspension | paclitaxel | 100 mg/vial | 021660 | 1 | 2015-12-11 |
US Patents and Regulatory Information for ABRAXANE
ABRAXANE is protected by eleven US patents.
Patents protecting ABRAXANE
Combinations and modes of administration of therapeutic agents and combination therapy
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Compositions and methods of delivery of pharmacological agents
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Compositions and methods of delivery of pharmacological agents
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Combinations and modes of administration of therapeutic agents and combination therapy
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Compositions and methods of delivery of pharmacological agents
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Combinations and modes of administration of therapeutic agents and combination therapy
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Compositions and methods of delivery of pharmacological agents
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Combinations and modes of administration of therapeutic agents and combination therapy
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Methods of treating cancer
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Methods of treating pancreatic cancer
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Methods of treating cancer
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | AB | 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 |
Expired US Patents for ABRAXANE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ABRAXANE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Bristol-Myers Squibb Pharma EEIG | Abraxane | paclitaxel | EMEA/H/C/000778 Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. |
Authorised | no | no | no | 2008-01-11 | |
| ratiopharm GmbH | Pazenir | paclitaxel | EMEA/H/C/004441 Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Pazenir in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. |
Authorised | yes | no | no | 2019-05-06 | |
| Inceptua AB | Apealea | paclitaxel | EMEA/H/C/004154 Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum‑sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. |
Authorised | no | no | no | 2018-11-20 | |
| Norton Healthcare Ltd. | Paxene | paclitaxel | EMEA/H/C/000216 Paxene is indicated for the treatment of patients with:• advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy;• metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy;• advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment;• metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment;• non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1). |
Withdrawn | no | no | no | 1999-07-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ABRAXANE
See the table below for patents covering ABRAXANE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | E028472 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2011123395 | ⤷ Sign Up | |
| Norway | 332166 | ⤷ Sign Up | |
| European Patent Office | 1944019 | Procédé pour la préparation des agents actifs stabilisés par protéine (Method for the preparation of protein stabilized pharmacologically active agents) | ⤷ Sign Up |
| Taiwan | I646959 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ABRAXANE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0961612 | 2009C/046 | Belgium | ⤷ Sign Up | PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111 |
| 0961612 | 300417 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114 |
| 1853250 | 300673 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 |
| 1853250 | 238 50005-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230 |
| 1853250 | 122014000065 | Germany | ⤷ Sign Up | PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220 |
| >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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