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Paclitaxel - Generic Drug Details
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What are the generic sources for paclitaxel and what is the scope of freedom to operate?
Paclitaxel
is the generic ingredient in four branded drugs marketed by Abraxis Bioscience, Gland Pharma Ltd, Accord Hlthcare, Actavis Totowa, Fresenius Kabi Usa, Hospira, MSN, Mylan, Mylan Labs Ltd, Pliva Lachema, Sandoz Inc, Teva Pharms, Teva Pharms Usa, West-ward Pharms Int, and Hq Spclt Pharma, and is included in seventeen NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Paclitaxel has three hundred and fifty-one patent family members in thirty-one countries.
There are sixty-nine drug master file entries for paclitaxel. Eleven suppliers are listed for this compound.
Summary for paclitaxel
International Patents: | 351 |
US Patents: | 12 |
Tradenames: | 4 |
Applicants: | 15 |
NDAs: | 17 |
Drug Master File Entries: | 69 |
Suppliers / Packagers: | 11 |
Bulk Api Vendors: | 84 |
Clinical Trials: | 3,039 |
Patent Applications: | 6,738 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for paclitaxel |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for paclitaxel |
DailyMed Link: | paclitaxel at DailyMed |
Recent Clinical Trials for paclitaxel
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
CSPC-NBP Pharmaceutical Co., Ltd. | Phase 2 |
Conjupro Biotherapeutics, Inc. | Phase 2 |
Ipsen | Phase 2 |
Pharmacology for paclitaxel
Drug Class | Microtubule Inhibitor |
Physiological Effect | Microtubule Inhibition |
Medical Subject Heading (MeSH) Categories for paclitaxel
Paragraph IV (Patent) Challenges for PACLITAXEL
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ABRAXANE | FOR SUSPENSION;IV (INFUSION) | paclitaxel | 021660 | 2015-12-11 |
TAXOL | INJECTABLE;INJECTION | paclitaxel | 020262 |
US Patents and Regulatory Information for paclitaxel
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pliva Lachema | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 077413-001 | Mar 12, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Msn | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 213434-001 | Aug 24, 2020 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Mylan | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 075278-001 | Jan 25, 2002 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Accord Hlthcare | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 205720-001 | Aug 17, 2018 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | Start Trial | Start Trial | 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 paclitaxel
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 |
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | Start Trial | Start Trial |
Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | Start Trial | Start Trial |
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | Start Trial | Start Trial |
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for paclitaxel
Country | Patent Number | Estimated Expiration |
---|---|---|
Russian Federation | 2452482 | Start Trial |
Japan | 2020012005 | Start Trial |
Australia | 718753 | Start Trial |
Norway | 20092179 | Start Trial |
Cyprus | 1120625 | Start Trial |
Japan | 2009185042 | Start Trial |
Russian Federation | 2005121569 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for paclitaxel
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1853250 | 122014000065 | Germany | Start Trial | PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220 |
0961612 | 2009C/046 | Belgium | Start Trial | PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111 |
0961612 | 09C0050 | France | Start Trial | PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111 |
1853250 | 132014902271575 | Italy | Start Trial | PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220 |
0961612 | 132009901771196 | Italy | Start Trial | PRODUCT NAME: PACLITAXEL(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/07/428/001, 20080114 |
0961612 | C00961612/01 | Switzerland | Start Trial | PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014 |
0961612 | CA 2009 00036 | Denmark | Start Trial | PRODUCT NAME: PACLITAXELALBUMIN |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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