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, Norvium Bioscience, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Am Regent, Hengrui Pharma, and Teva Pharms Inc. and is included in nineteen NDAs.
The generic ingredient in PACLITAXEL is paclitaxel. There are sixty-nine drug master file entries for this compound. Nineteen 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.
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Summary for PACLITAXEL
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 19 |
| Finished Product Suppliers / Packagers: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 95 |
| Clinical Trials: | 3,817 |
| 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 075436-001 | Nov 12, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hengrui Pharma | PACLITAXEL | paclitaxel | POWDER;INTRAVENOUS | 212700-001 | Oct 8, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 207326-001 | Aug 23, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 216874-001 | Oct 20, 2022 | 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 |
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 |
