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Serving leading biopharmaceutical companies globally:

Healthtrust
Covington
AstraZeneca
Julphar
Novartis
Deloitte
Federal Trade Commission
Express Scripts
Merck
Argus Health

Generated: January 22, 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 thirteen 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-seven 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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Labs Ltd PACLITAXEL paclitaxel INJECTABLE;INJECTION 091540-001 Sep 29, 2011 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hospira PACLITAXEL paclitaxel INJECTABLE;INJECTION 076131-001 May 8, 2002 AP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pliva Lachema PACLITAXEL paclitaxel INJECTABLE;INJECTION 077413-001 Mar 12, 2008 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms Usa PACLITAXEL paclitaxel INJECTABLE;INJECTION 075297-001 Jan 25, 2002 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz Inc PACLITAXEL paclitaxel INJECTABLE;INJECTION 078167-001 Dec 26, 2007 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Subscribe ➤ Subscribe
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ➤ Subscribe ➤ Subscribe
Hq Spclt Pharma TAXOL paclitaxel INJECTABLE;INJECTION 020262-001 Dec 29, 1992 ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Subscribe ➤ Subscribe
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 ➤ Subscribe ➤ Subscribe
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
5,665,383 Methods for the preparation of immunostimulating agents for in vivo delivery ➤ Subscribe
6,506,405 Methods and formulations of cremophor-free taxanes ➤ Subscribe
5,650,156 Methods for in vivo delivery of nutriceuticals and compositions useful therefor ➤ Subscribe
5,362,478 Magnetic resonance imaging with fluorocarbons encapsulated in a cross-linked polymeric shell ➤ Subscribe
9,561,288 Combinations and modes of administration of therapeutic agents and combination therapy ➤ Subscribe
5,834,025 Reduction of intravenously administered nanoparticulate-formulation-induced adverse physiological reactions ➤ Subscribe
8,137,684 Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof ➤ Subscribe
9,012,519 Compositions and methods of delivery of pharmacological agents ➤ Subscribe
6,096,331 Methods and compositions useful for administration of chemotherapeutic agents ➤ Subscribe
6,749,868 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof ➤ Subscribe
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 ➤ Subscribe PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
41/2009 Austria ➤ Subscribe PRODUCT NAME: PACLITAXEL ALBUMIN
C0050 France ➤ Subscribe PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
0673 Netherlands ➤ Subscribe PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612/01 Switzerland ➤ Subscribe PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
2009 00036 Denmark ➤ Subscribe
2014000065 Germany ➤ Subscribe PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
2014022 Lithuania ➤ Subscribe PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
8 50005-2014 Slovakia ➤ Subscribe PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230
1 Finland ➤ Subscribe
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Covington
Colorcon
Dow
Citi
QuintilesIMS
McKesson
US Department of Justice
Chinese Patent Office
Fish and Richardson

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