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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Colorcon
Cerilliant
Chubb
McKinsey
Covington
Novartis
Federal Trade Commission
Accenture

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203585

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NDA 203585 describes SYNRIBO, 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

Tradename:1
Applicant:1
Ingredient:1
Patents:2

Suppliers and Packaging for NDA: 203585

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585 NDA Cephalon, Inc. 63459-177 63459-177-14 1 VIAL, SINGLE-USE in 1 CARTON (63459-177-14) > 1 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrength3.5MG/VIAL
Approval Date:Oct 26, 2012TE: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:► SubscribePatent Expiration:Oct 26, 2026Product 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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Serving leading biopharmaceutical companies globally:

Covington
McKinsey
UBS
Healthtrust
Citi
AstraZeneca
Chinese Patent Office
Fish and Richardson
Farmers Insurance
Merck

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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