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Federal Trade Commission
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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208261

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NDA 208261 describes ZEPATIER, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ZEPATIER profile page.

The generic ingredient in ZEPATIER is elbasvir; grazoprevir. One supplier is listed for this compound. Additional details are available on the elbasvir; grazoprevir profile page.
Summary for 208261
Tradename:ZEPATIER
Applicant:Merck Sharp Dohme
Ingredient:elbasvir; grazoprevir
Patents:2
Suppliers and Packaging for NDA: 208261
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261 NDA Merck Sharp & Dohme Corp. 0006-3074 N 0006-3074-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;100MG
Approval Date:Jan 28, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 28, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Jul 24, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS
Patent:➤ Sign UpPatent Expiration:May 4, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS

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