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 three branded drugs marketed by Accord Hlthcare, Actavis Totowa, Alembic, Dash Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Norvium Bioscience, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Hq Spclt Pharma, Bristol-myers, Am Regent, Hengrui Pharma, and Teva Pharms Inc, and is included in twenty-one NDAs. There are eleven 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 forty-two patent family members in thirty-one countries.

There are sixty-nine drug master file entries for paclitaxel. Nineteen suppliers are listed for this compound.

Summary for paclitaxel

International Patents:	242
US Patents:	11
Tradenames:	3
Applicants:	19
NDAs:	21
Drug Master File Entries:	69
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	3,817
Patent Applications:	445
Drug Prices:	Drug price trends for paclitaxel
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for paclitaxel
What excipients (inactive ingredients) are in paclitaxel?	paclitaxel excipients list
DailyMed Link:	paclitaxel at DailyMed

See drug prices for paclitaxel

Recent Clinical Trials for paclitaxel

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Vall d'Hebron Institute of Oncology	Phase 2
Lee Ocuin, MD	Phase 2
NorthShore University HealthSystem	N/A

See all paclitaxel clinical trials

Pharmacology for paclitaxel

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for paclitaxel

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Anatomical Therapeutic Chemical (ATC) Classes for paclitaxel

L01CD	Taxanes
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PACLITAXEL

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 paclitaxel

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Gland Pharma Ltd	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	207326-001	Aug 23, 2016	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	⤷ Sign Up	⤷ Sign Up
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for paclitaxel

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Abraxane	paclitaxel	EMEA/H/C/000778 Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.	Authorised	no	no	no	2008-01-11
ratiopharm GmbH	Pazenir	paclitaxel	EMEA/H/C/004441 Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Pazenir in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.	Authorised	yes	no	no	2019-05-06
Inceptua AB	Apealea	paclitaxel	EMEA/H/C/004154 Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum‑sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.	Authorised	no	no	no	2018-11-20
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for paclitaxel

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Country	Patent Number	Title	Estimated Expiration
China	104940929	Nanoparticles of paclitaxel and albumin in combination with bevacizumab against cancer	⤷ Sign Up
South Korea	20130028728	METHODS OF TREATING CANCER	⤷ Sign Up
Canada	2509365	COMPOSITIONS ET METHODES D'ADMINISTRATION D'AGENTS PHARMACOLOGIQUES (COMPOSITIONS AND METHODS OF DELIVERY OF PHARMACOLOGICAL AGENTS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for paclitaxel

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	PA2014022	Lithuania	⤷ Sign Up	PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250	C300673	Netherlands	⤷ Sign Up	PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612	2009C/046	Belgium	⤷ Sign Up	PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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