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Last Updated: April 18, 2024

Glecaprevir; pibrentasvir - Generic Drug Details

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What are the generic drug sources for glecaprevir; pibrentasvir and what is the scope of freedom to operate?

Glecaprevir; pibrentasvir is the generic ingredient in one branded drug marketed by Abbvie and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glecaprevir; pibrentasvir has five hundred and thirty patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for glecaprevir; pibrentasvir

International Patents:	530
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	31
DailyMed Link:	glecaprevir; pibrentasvir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for glecaprevir; pibrentasvir

Generic Entry Dates for glecaprevir; pibrentasvir^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: TABLET;ORAL
Generic Entry Dates for glecaprevir; pibrentasvir^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: PELLETS;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 glecaprevir; pibrentasvir

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

Sponsor	Phase
White River Junction Veterans Affairs Medical Center	Phase 2
Peking University People's Hospital	Phase 4
White River Junction Veterans Affairs Medical Center	Phase 2/Phase 3

See all glecaprevir; pibrentasvir clinical trials

Pharmacology for glecaprevir; pibrentasvir

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 3A Inhibitors HCV NS3/4A Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for glecaprevir; pibrentasvir

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for glecaprevir; pibrentasvir

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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
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			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 glecaprevir; pibrentasvir

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH Co. KG	Maviret	glecaprevir, pibrentasvir	EMEA/H/C/004430 Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.Maviret coated granules is indicated for the treatment of chronic hepatitis C virus (HCV) infection in children 3 years and older.	Authorised	no	no	no	2017-07-26
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for glecaprevir; pibrentasvir

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3020723	DÉRIVÉS DE PROLINES MACROCYCLIQUES INHIBITEURS DE LA SÉRINE PROTÉASE DU VHC (MACROCYCLIC PROLINE DERIVED HCV SERINE PROTEASE INHIBITORS)	⤷ Try a Trial
Canada	2901810	COMBINAISON DE DEUX ANTIVIRAUX POUR LE TRAITEMENT DE L'HEPATITE C (COMBINATION OF TWO ANTIVIRALS FOR TREATING HEPATITIS C)	⤷ Try a Trial
Japan	2018518517	ＨＣＶを処置するための固体医薬組成物	⤷ Try a Trial
Japan	5911838		⤷ Try a Trial
European Patent Office	3140284	FORMES CRISTALLINES (CRYSTAL FORMS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for glecaprevir; pibrentasvir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368890	CR 2015 00015	Denmark	⤷ Try a Trial	PRODUCT NAME: OMBITASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/982 20150119
2618831	17C1039	France	⤷ Try a Trial	PRODUCT NAME: GLECAPREVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN ESTER DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2618831	300 50016-2017	Slovakia	⤷ Try a Trial	PRODUCT NAME: GLECAPREVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2368890	639	Finland	⤷ Try a Trial
2692346	2017/046	Ireland	⤷ Try a Trial	PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/17/1213 20170726
>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.