Paclitaxel - Generic Drug Details
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What are the generic drug 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 |
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 |
Pharmacology for paclitaxel
Drug Class | Microtubule Inhibitor |
Physiological Effect | Microtubule Inhibition |
Medical Subject Heading (MeSH) Categories for paclitaxel
Anatomical Therapeutic Chemical (ATC) Classes for paclitaxel
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 076233-001 | Aug 1, 2002 | DISCN | No | No | ⤷ 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 | ⤷ Sign Up | |||
Msn | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 213434-001 | Aug 24, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Am Regent | PACLITAXEL | paclitaxel | POWDER;INTRAVENOUS | 211875-001 | Jul 27, 2022 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fresenius Kabi Usa | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 077574-001 | Nov 27, 2006 | AP | RX | No | No | ⤷ 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 | ||
>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 |
---|---|---|---|---|---|---|---|
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 |
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
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 |
Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for paclitaxel
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 | |
Norton Healthcare Ltd. | Paxene | paclitaxel | EMEA/H/C/000216 Paxene is indicated for the treatment of patients with:• advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy;• metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy;• advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment;• metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment;• non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1). |
Withdrawn | no | no | no | 1999-07-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for paclitaxel
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E038768 | ⤷ Sign Up | |
European Patent Office | 2301531 | COMBINAISONS ET MODES D'ADMINISTRATION D'AGENTS THERAPEUTIQUES ET TRAITEMENT COMBINE (COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY) | ⤷ Sign Up |
New Zealand | 560879 | Combinations and modes of administration of therapeutic agents and combination therapy | ⤷ Sign Up |
South Korea | 101894689 | ⤷ Sign Up | |
South Korea | 20140016402 | COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY | ⤷ Sign Up |
Mexico | 2012011072 | METODOS PARA TRATAR EL CANCER. (METHODS OF TREATING CANCER.) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for paclitaxel
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1853250 | 238 50005-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230 |
1853250 | 122014000065 | Germany | ⤷ Sign Up | PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220 |
1853250 | CA 2014 00034 | Denmark | ⤷ Sign Up | PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: EU/1/07/428 C(2013)9835 20131230 |
0961612 | SZ 41/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: PACLITAXEL ALBUMIN |
0961612 | 300417 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114 |
0961612 | 09C0050 | France | ⤷ Sign Up | PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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