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Last Updated: May 10, 2024

Elbasvir; grazoprevir - Generic Drug Details

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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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Sponsor	Phase
Cairo University	Phase 4
University of Pennsylvania	Phase 4
Austin Hospital, Melbourne Australia	Phase 3

See all elbasvir; grazoprevir clinical trials

Pharmacology for elbasvir; grazoprevir

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A Inhibitors HCV NS3/4A Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for elbasvir; grazoprevir

US Patents and Regulatory Information for elbasvir; grazoprevir

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Glossary

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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				⤷ 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	Y	Y		⤷ 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

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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

International Patents for elbasvir; grazoprevir

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Country	Patent Number	Title	Estimated Expiration
Lithuania	C2410844		⤷ Try a Trial
Luxembourg	C00002		⤷ Try a Trial
France	16C1027		⤷ Try a Trial
Morocco	33209	مثبطات نسخ فيروس التهاب الكبد c	⤷ Try a Trial
Hungary	S1700002		⤷ Try a Trial
South Korea	20110036627	MACROCYCLIC QUINOXALINE COMPOUNDS AS HCV NS3 PROTEASE INHIBITORS	⤷ Try a Trial
Serbia	53420	KOMBINACIJE MAKROCIKLIČNOG JEDINJENJA HINOKSALINA KOJE JE INHIBITOR HCV NS3 PROTEAZE SA DRUGIM HCV SREDSTVIMA (COMBINATIONS OF A MACROCYCLIC QUINOXALINE COMPOUND WHICH IS AN HCV NS3 PROTEASE INHIBITOR WITH OTHER HCV AGENTS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for elbasvir; grazoprevir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2410844	1/2017	Austria	⤷ Try a Trial	PRODUCT NAME: ELBASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1119 (MITTEILUNG) 20160726
2310095	PA2016049	Lithuania	⤷ Try a Trial	PRODUCT NAME: GRAZOPREVIRAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; NAT. REGISTRATION NO/DATE: CH/65861 01 20160401; FIRST REGISTRATION: EU/1/16/1119 20160722
2310095	2016C/078	Belgium	⤷ Try a Trial	PRODUCT NAME: GRAZOPREVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/16/1119 20160726
2410844	SPC/GB17/013	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/16/1119 20160726; UK PLGB 53095/0082 20160726
2310095	122017000002	Germany	⤷ Try a Trial	PRODUCT NAME: GRAZOPREVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/16/1119 20160722
2310095	132017000002002	Italy	⤷ Try a Trial	PRODUCT NAME: GRAZOPREVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZEPATIER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1119, 20160726
2310095	CA 2016 00070	Denmark	⤷ Try a Trial	PRODUCT NAME: GRAZOPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 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.