Generated: December 15, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203585
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, which is a drug marketed by Teva Pharms Intl and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SYNRIBO profile page.
The generic ingredient in SYNRIBO is omacetaxine mepesuccinate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the omacetaxine mepesuccinate profile page.
Summary for 203585
Suppliers and Packaging for NDA: 203585
||National Drug Code
||1 VIAL, SINGLE-USE in 1 CARTON (63459-177-14) > 1 mL in 1 VIAL, SINGLE-USE
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Summary for product number 001
|Approval Date:||Oct 26, 2012||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Oct 26, 2017
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Oct 26, 2019
|Regulatory Exclusivity Use:||ORPHAN DRUG EXCLUSIVITY|
|Patent:||► Subscribe||Patent Expiration:||Oct 26, 2026||Product Flag?||Substance Flag?||Delist Request?|
|Patented Use:||TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML)|
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