Vinorelbine tartrate - Generic Drug Details
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What are the generic drug sources for vinorelbine tartrate and what is the scope of patent protection?
Vinorelbine tartrate
is the generic ingredient in two branded drugs marketed by Pierre Fabre, Actavis Totowa, Dr Reddys, Ebewe Pharma, Fresenius Kabi Usa, Hikma, Hospira, Jiangsu Hansoh Pharm, Novast Labs, Rising, and Teva Pharms Usa, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.There are fourteen drug master file entries for vinorelbine tartrate. Two suppliers are listed for this compound.
Summary for vinorelbine tartrate
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 11 |
NDAs: | 12 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 75 |
Clinical Trials: | 81 |
Patent Applications: | 7,577 |
What excipients (inactive ingredients) are in vinorelbine tartrate? | vinorelbine tartrate excipients list |
DailyMed Link: | vinorelbine tartrate at DailyMed |
Recent Clinical Trials for vinorelbine tartrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Shanghai Yizhong Pharmaceutical Co., Ltd. | Phase 3 |
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Phase 3 |
Qilu Pharmaceutical Co., Ltd. | Phase 3 |
Pharmacology for vinorelbine tartrate
Drug Class | Vinca Alkaloid |
Anatomical Therapeutic Chemical (ATC) Classes for vinorelbine tartrate
US Patents and Regulatory Information for vinorelbine tartrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rising | VINORELBINE TARTRATE | vinorelbine tartrate | INJECTABLE;INJECTION | 200148-001 | Aug 31, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ebewe Pharma | VINORELBINE TARTRATE | vinorelbine tartrate | INJECTABLE;INJECTION | 078408-001 | Feb 13, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Jiangsu Hansoh Pharm | VINORELBINE TARTRATE | vinorelbine tartrate | INJECTABLE;INJECTION | 091106-001 | Sep 26, 2012 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | VINORELBINE TARTRATE | vinorelbine tartrate | INJECTABLE;INJECTION | 075992-001 | Jun 10, 2003 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Actavis Totowa | VINORELBINE TARTRATE | vinorelbine tartrate | INJECTABLE;INJECTION | 078011-001 | Jul 22, 2009 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | VINORELBINE TARTRATE | vinorelbine tartrate | INJECTABLE;INJECTION | 076028-001 | Feb 3, 2003 | DISCN | 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 vinorelbine tartrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pierre Fabre | NAVELBINE | vinorelbine tartrate | INJECTABLE;INJECTION | 020388-001 | Dec 23, 1994 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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