PACLITAXEL Drug Patent Profile
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Which patents cover Paclitaxel, and when can generic versions of Paclitaxel launch?
Paclitaxel is a drug marketed by Accord Hlthcare, Actavis Totowa, Alembic, Dash Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Mylan, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Am Regent, and Teva Pharms Inc. and is included in eighteen NDAs.
The generic ingredient in PACLITAXEL is paclitaxel. There are sixty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Paclitaxel
A generic version of PACLITAXEL was approved as paclitaxel by TEVA PHARMS on January 25th, 2002.
Summary for PACLITAXEL
US Patents: | 0 |
Applicants: | 16 |
NDAs: | 18 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 95 |
Clinical Trials: | 3,748 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
---|---|
Cancer Cures 4 Kids | Phase 1 |
Aston Sci. Inc. | Phase 2 |
Chengdu Seventh People's Hospital | Phase 2 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Accord Hlthcare | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 075436-001 | Nov 12, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Teva Pharms Inc | PACLITAXEL | paclitaxel | POWDER;INTRAVENOUS | 216338-001 | May 11, 2023 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Gland Pharma Ltd | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 207326-001 | Aug 23, 2016 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |