You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Elbasvir; grazoprevir - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for elbasvir; grazoprevir and what is the scope of freedom to operate?

Elbasvir; grazoprevir is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elbasvir; grazoprevir has one hundred and twelve patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for elbasvir; grazoprevir
International Patents:112
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 62
DailyMed Link:elbasvir; grazoprevir at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for elbasvir; grazoprevir
Generic Entry Date for elbasvir; grazoprevir*:
Constraining patent/regulatory exclusivity:
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 elbasvir; grazoprevir

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

SponsorPhase
Cairo UniversityPhase 4
University of PennsylvaniaPhase 4
Austin Hospital, Melbourne AustraliaPhase 3

See all elbasvir; grazoprevir clinical trials

US Patents and Regulatory Information for elbasvir; grazoprevir

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

EU/EMA Drug Approvals for elbasvir; grazoprevir

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Zepatier elbasvir, grazoprevir EMEA/H/C/004126
ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
Authorised no no no 2016-07-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for elbasvir; grazoprevir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2410844 C02410844/01 Switzerland ⤷  Try a Trial FUSION; FORMER OWNER: MERCK SHARP AND DOHME CORP., US
2410844 C20160050 00207 Estonia ⤷  Try a Trial PRODUCT NAME: ELBASVIIR;REG NO/DATE: EU/1/16/1119 26.07.2016
2410844 C20160050 Estonia ⤷  Try a Trial (93) SZ 65861 01, 01.04.2016 (93) CH 65861 01, 01.04.2016
2310095 PA2016049,C2310095 Lithuania ⤷  Try a Trial PRODUCT NAME: GRAZOPREVIRAS ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1119 20160722
2410844 122017000001 Germany ⤷  Try a 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

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.