ABRAXANE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Abraxane, and what generic alternatives are available?
Abraxane is a drug marketed by Abraxis Bioscience 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-one 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. Thirteen 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.
Summary for ABRAXANE
International Patents: | 241 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 85 |
Clinical Trials: | 422 |
Patent Applications: | 4,461 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Devalingam Mahalingam | Phase 1/Phase 2 |
Amgen | Phase 1/Phase 2 |
CSPC Ouyi Pharmaceutical Co., Ltd. | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for ABRAXANE
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 and two FDA Regulatory Exclusivities.
Patents protecting ABRAXANE
Combinations and modes of administration of therapeutic agents and combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compositions and methods of delivery of pharmacological agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compositions and methods of delivery of pharmacological agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Combinations and modes of administration of therapeutic agents and combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compositions and methods of delivery of pharmacological agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Combinations and modes of administration of therapeutic agents and combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compositions and methods of delivery of pharmacological agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Combinations and modes of administration of therapeutic agents and combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods of treating cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods of treating pancreatic cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods of treating cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting ABRAXANE
ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abraxis Bioscience | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Abraxis Bioscience | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Abraxis Bioscience | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | 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 ABRAXANE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abraxis Bioscience | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | See Plans and Pricing | See Plans and Pricing |
Abraxis Bioscience | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | See Plans and Pricing | See Plans and Pricing |
Abraxis Bioscience | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ABRAXANE
See the table below for patents covering ABRAXANE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5926724 | See Plans and Pricing | |
Japan | 2018087235 | 膵臓がんの処置方法 (METHODS OF TREATING PANCREATIC CANCER) | See Plans and Pricing |
Japan | 2020011999 | 組成物及び薬物送達方法 (COMPOSITION AND METHOD OF DELIVERY OF PHARMACOLOGICAL AGENT) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ABRAXANE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0961612 | 300417 | Netherlands | See Plans and Pricing | PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114 |
0961612 | 09C0050 | France | See Plans and Pricing | PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111 |
1853250 | 300673 | Netherlands | See Plans and Pricing | PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |