Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: November 22, 2019

DrugPatentWatch Database Preview

ZEPATIER Drug Profile

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Which patents cover Zepatier, and when can generic versions of Zepatier launch?

Zepatier is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and three patent family members in forty-two countries.

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 ZEPATIER
International Patents:103
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Clinical Trials: 23
Drug Prices: Drug price information for ZEPATIER
DailyMed Link:ZEPATIER at DailyMed
Drug patent expirations by year for ZEPATIER
Drug Prices for ZEPATIER

See drug prices for ZEPATIER

Generic Entry Opportunity Date for ZEPATIER
Generic Entry Date for ZEPATIER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ZEPATIER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Radboud UniversityPhase 1
King's College Hospital NHS TrustPhase 4
Albert Einstein Healthcare NetworkPhase 4

See all ZEPATIER clinical trials

Synonyms for ZEPATIER
Elbasvir / grazoprevir
Elbasvir and grazoprevir
Elbasvir mixture with grazoprevir
S900006960

US Patents and Regulatory Information for ZEPATIER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261-001 Jan 28, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261-001 Jan 28, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261-001 Jan 28, 2016 RX Yes 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

Supplementary Protection Certificates for ZEPATIER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2410844 C20160050 00207 Estonia   Start Trial PRODUCT NAME: ELBASVIIR;REG NO/DATE: EU/1/16/1119 26.07.2016
2410844 C20160050 Estonia   Start Trial (93) SZ 65861 01, 01.04.2016 (93) CH 65861 01, 01.04.2016
2410844 PA2016048 Lithuania   Start Trial PRODUCT NAME: ELBASVIRAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; NAT. REGISTRATION NO/DATE: CH/65861 01 20160401; FIRST REGISTRATION: EU/1/16/1119 20160722
2410844 122017000001 Germany   Start Trial PRODUCT NAME: ELBASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1119 20160722
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Baxter
Mallinckrodt
Colorcon
Medtronic

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.