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ABRAXANE Drug Profile
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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 twelve patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and fifty-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. Twelve suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
US ANDA 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: | 352 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 84 |
| Clinical Trials: | 348 |
| Patent Applications: | 4,280 |
| 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 |
|---|---|
| Shandong University | Phase 2 |
| Shandong Cancer Hospital and Institute | Phase 2 |
| CSPC Ouyi Pharmaceutical Co., Ltd. | Phase 2 |
Pharmacology for ABRAXANE
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
Paragraph IV (Patent) Challenges for ABRAXANE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ABRAXANE | FOR SUSPENSION;IV (INFUSION) | paclitaxel | 021660 | 2015-12-11 |
US Patents and Regulatory Information for ABRAXANE
| 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 | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 ABRAXANE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ABRAXANE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2685436 | Start Trial |
| Japan | 2015147814 | Start Trial |
| China | 100588396 | Start Trial |
| South Korea | 20190062506 | Start Trial |
| Costa Rica | 20120528 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ABRAXANE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1853250 | 238 50005-2014 | Slovakia | Start Trial | PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230 |
| 1853250 | C300673 | Netherlands | Start Trial | PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 |
| 0961612 | SZ 41/2009 | Austria | Start Trial | PRODUCT NAME: PACLITAXEL ALBUMIN |
| 1853250 | CA 2014 00034 | Denmark | Start Trial | PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: EU/1/07/428 C(2013)9835 20131230 |
| 0961612 | 132009901771196 | Italy | Start Trial | PRODUCT NAME: PACLITAXEL(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/07/428/001, 20080114 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
