CABAZITAXEL Drug Patent Profile
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When do Cabazitaxel patents expire, and when can generic versions of Cabazitaxel launch?
Cabazitaxel is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, and Mylan Labs Ltd. and is included in six NDAs.
The generic ingredient in CABAZITAXEL is cabazitaxel. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabazitaxel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cabazitaxel
A generic version of CABAZITAXEL was approved as cabazitaxel by ACCORD HLTHCARE on December 29th, 2021.
Summary for CABAZITAXEL
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 126 |
| Patent Applications: | 2,473 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CABAZITAXEL |
| DailyMed Link: | CABAZITAXEL at DailyMed |
Recent Clinical Trials for CABAZITAXEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundacion Oncosur | Phase 2 |
| MacroGenics | Phase 2/Phase 3 |
| Peter MacCallum Cancer Centre, Australia | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for CABAZITAXEL
Paragraph IV (Patent) Challenges for CABAZITAXEL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| JEVTANA KIT | Injection | cabazitaxel | 60 mg/1.5 mL | 201023 | 8 | 2014-06-17 |
US Patents and Regulatory Information for CABAZITAXEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207949-001 | Dec 29, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Breckenridge | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207619-001 | Jun 23, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Accord Hlthcare | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207693-001 | Oct 26, 2022 | 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 CABAZITAXEL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Accord Healthcare S.L.U. | Cabazitaxel Accord | cabazitaxel | EMEA/H/C/005178 Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. |
Authorised | yes | no | no | 2020-08-28 | |
| Sanofi Winthrop Industrie | Jevtana | cabazitaxel | EMEA/H/C/002018 Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. |
Authorised | no | no | no | 2011-03-17 | |
| Teva B.V. | Cabazitaxel Teva | cabazitaxel | EMEA/H/C/004951 Treatment of prostate cancer |
Refused | no | no | no | 2019-07-11 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
