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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 NDA: 208261

Tradename:
ZEPATIER
Applicant:
Merck Sharp Dohme
Ingredient:
elbasvir; grazoprevir
Patents:2

Pharmacology for NDA: 208261

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 0006-3074-02 2 DOSE PACK in 1 CARTON (0006-3074-02) > 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)

Summary 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:7,973,040Patent Expiration:Jul 24, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS
Patent:8,871,759Patent Expiration:May 4, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS


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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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