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Vincristine sulfate - Generic Drug Details
What are the generic sources for vincristine sulfate and what is the scope of patent protection?
Vincristine sulfate
is the generic ingredient in six branded drugs marketed by Acrotech, Lilly, Teva Parenteral, Bristol Myers Squibb, Abic, Abraxis Pharm, Fresenius Kabi Usa, Hospira, and Teva Pharms Usa, and is included in thirteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Vincristine sulfate has forty-six patent family members in sixteen countries.
There are thirteen drug master file entries for vincristine sulfate. Four suppliers are listed for this compound.
Summary for vincristine sulfate
| International Patents: | 46 |
| US Patents: | 3 |
| Tradenames: | 6 |
| Applicants: | 9 |
| NDAs: | 13 |
| Drug Master File Entries: | 13 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 35 |
| Clinical Trials: | 132 |
| Patent Applications: | 7,523 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for vincristine sulfate |
| DailyMed Link: | vincristine sulfate at DailyMed |
Recent Clinical Trials for vincristine sulfate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AIDS Malignancy Consortium | Early Phase 1 |
| National Cancer Institute (NCI) | Early Phase 1 |
| University of Washington | Phase 1 |
Recent Litigation for vincristine sulfate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Pharmacia & Upjohn v. Sicor Inc. | 2004-07-08 |
Pharmacology for vincristine sulfate
| Drug Class | Vinca Alkaloid |
Medical Subject Heading (MeSH) Categories for vincristine sulfate
Synonyms for vincristine sulfate
| 068V782 |
| 2068-78-2 |
| 22-oxovincaleukoblastine sulfate |
| AB0105888 |
| AB48730 |
| AC1L6O8Q |
| AI3-52944 |
| AK206276 |
| AKOS015895862 |
| Alkaloid extracted from Vinca rosea Linn |
| AQTQHPDCURKLKT-JKDPCDLQSA-N |
| C13974 |
| C46H56N4O10.H2O4S |
| CCRIS 2583 |
| CHEBI:79401 |
| CHEMBL501867 |
| D02197 |
| DTXSID8044331 |
| EINECS 218-190-0 |
| I06-1238 |
| KB-276095 |
| Kyocristine |
| l)-6-formyl-5-hydroxy-8-methoxy-3a,3a1,4,5,5a,6,11,12-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate sulfate |
| LCR |
| Leurocristine |
| Leurocristine sulfate |
| Leurocristine sulfate (1:1) |
| Leurocristine sulfate (1:1) (salt) |
| Leurocristine, sulfate |
| Leurocristine, sulfate (1:1) (salt) |
| Lilly 37231 |
| LS-87932 |
| Marqibo (TN) |
| MLS002702994 |
| MolPort-006-069-042 |
| NSC 67574 |
| NSC-67574 |
| NSC67574 |
| Oncovin |
| Oncovin (Lilly) |
| Oncovin (TN) |
| Onkovin |
| SCHEMBL3710 |
| VCR |
| VCR sulfate |
| Vincaleukoblastine, 22-oxo-, sulfate (1:1) (salt) |
| Vincasar (TN) |
| Vincasar PFS |
| Vincrex |
| Vincrex (TN) |
| Vincristine sulfate (JP17/USP) |
| Vincristine sulfate [USAN:JAN] |
| vincristine sulfate liposomes |
| Vincristine Sulfate PFS |
| Vincristine sulphate |
| Vincristine, sulfate |
| Vincristinsulfat [German] |
| Vincrisul |
| Z-3315 |
Paragraph IV (Patent) Challenges for VINCRISTINE SULFATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ONCOVIN | INJECTABLE;INJECTION | vincristine sulfate | 014103 |
US Patents and Regulatory Information for vincristine sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abic | VINCRISTINE SULFATE | vincristine sulfate | INJECTABLE;INJECTION | 070873-001 | Feb 19, 1987 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Abraxis Pharm | VINCRISTINE SULFATE | vincristine sulfate | INJECTABLE;INJECTION | 070411-001 | Sep 10, 1986 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Lilly | ONCOVIN | vincristine sulfate | INJECTABLE;INJECTION | 014103-003 | Mar 7, 1984 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Acrotech | MARQIBO KIT | vincristine sulfate | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 202497-001 | Aug 9, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Hospira | VINCRISTINE SULFATE | vincristine sulfate | INJECTABLE;INJECTION | 071559-001 | Apr 11, 1988 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Acrotech | MARQIBO KIT | vincristine sulfate | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 202497-001 | Aug 9, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Hospira | VINCRISTINE SULFATE PFS | vincristine sulfate | INJECTABLE;INJECTION | 071484-001 | Apr 19, 1988 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| >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 vincristine sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Acrotech | MARQIBO KIT | vincristine sulfate | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 202497-001 | Aug 9, 2012 | Start Trial | Start Trial |
| Lilly | ONCOVIN | vincristine sulfate | INJECTABLE;INJECTION | 014103-003 | Mar 7, 1984 | Start Trial | Start Trial |
| Acrotech | MARQIBO KIT | vincristine sulfate | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 202497-001 | Aug 9, 2012 | Start Trial | Start Trial |
| Acrotech | MARQIBO KIT | vincristine sulfate | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 202497-001 | Aug 9, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for vincristine sulfate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2015071631 | Start Trial |
| European Patent Office | 2266537 | Start Trial |
| Israel | 145720 | Start Trial |
| Brazil | PI0009448 | Start Trial |
| Germany | 60115045 | Start Trial |
| Canada | 2366787 | Start Trial |
| Spain | 2524141 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.