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Serving leading biopharmaceutical companies globally:

Fuji
Chubb
US Army
Dow
Argus Health
UBS
Mallinckrodt
Novartis
Cerilliant
Covington

Generated: February 24, 2018

DrugPatentWatch Database Preview

Paclitaxel - Generic Drug Details

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What are the generic sources for paclitaxel and what is the scope of paclitaxel 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 Oncol, Hospira, 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 fifteen 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 two hundred and eighty-two patent family members in thirty-one countries.

There are sixty-eight drug master file entries for paclitaxel. Fourteen suppliers are listed for this compound.
Pharmacology for paclitaxel
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for paclitaxel

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
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pliva Lachema PACLITAXEL paclitaxel INJECTABLE;INJECTION 077413-001 Mar 12, 2008 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms PACLITAXEL paclitaxel INJECTABLE;INJECTION 075184-001 Jan 25, 2002 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa PACLITAXEL paclitaxel INJECTABLE;INJECTION 075297-001 Jan 25, 2002 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Actavis Totowa PACLITAXEL paclitaxel INJECTABLE;INJECTION 090130-001 Dec 9, 2009 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Try a Free Trial ➤ Try a Free Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for paclitaxel

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,665,382 Methods for the preparation of pharmaceutically active agents for in vivo delivery ➤ Try a Free Trial
5,508,021 Non-fluorinated polymeric shells for medical imaging ➤ Try a Free Trial
5,916,596 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof ➤ Try a Free Trial
8,846,771 Compositions and methods of delivery of pharmacological agents ➤ Try a Free Trial
6,749,868 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof ➤ Try a Free Trial
8,735,394 Combinations and modes of administration of therapeutic agents and combination therapy ➤ Try a Free Trial
5,498,421 Composition useful for in vivo delivery of biologics and methods employing same ➤ Try a Free Trial
5,512,268 Polymeric shells for medical imaging prepared from synthetic polymers, and methods for the use thereof ➤ Try a Free Trial
6,096,331 Methods and compositions useful for administration of chemotherapeutic agents ➤ Try a Free Trial
7,780,984 Methods and compositions for treating proliferative diseases ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for paclitaxel

Supplementary Protection Certificates for paclitaxel

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2014 Austria ➤ Try a Free Trial PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
00673 Netherlands ➤ Try a Free Trial PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0673 Netherlands ➤ Try a Free Trial PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
613 Luxembourg ➤ Try a Free Trial 91613, EXPIRES: 20220924
2014022 Lithuania ➤ Try a Free Trial PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
2014 00034 Denmark ➤ Try a Free Trial PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220
41/2009 Austria ➤ Try a Free Trial PRODUCT NAME: PACLITAXEL ALBUMIN
2014000065 Germany ➤ Try a Free Trial PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
1 Finland ➤ Try a Free Trial
0961612/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Accenture
Baxter
Moodys
McKesson
US Department of Justice
Deloitte
Fish and Richardson
Chinese Patent Office

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