GLECAPREVIR; PIBRENTASVIR - Generic Drug Details

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What are the generic drug sources for glecaprevir; pibrentasvir and what is the scope of patent protection?

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-four patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for GLECAPREVIR; PIBRENTASVIR

International Patents:	534
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL
Generic Entry Dates for GLECAPREVIR; PIBRENTASVIR^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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	3456318	COMPOSITIONS SOLIDES (SOLID COMPOSITIONS)	⤷ Sign Up
Japan	2018520185	ＨＣＶを処置するための固体医薬組成物	⤷ Sign Up
Taiwan	I642436		⤷ Sign Up
Norway	2017057		⤷ Sign Up
Singapore	186251	SOLID COMPOSITIONS	⤷ Sign Up
Japan	2016128456	ＨＣＶ感染を治療するための抗ウィルス化合物 (ANTI-VIRAL COMPOUNDS FOR TREATING HCV INFECTION)	⤷ Sign Up
>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	2015/010	Ireland	⤷ Sign Up	PRODUCT NAME: OMBITASVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/982 20150115
2692346	C02692346/01	Switzerland	⤷ Sign Up	FORMER OWNER: ABBVIE BAHAMAS LTD., BS
2692346	299 50017-2017	Slovakia	⤷ Sign Up	PRODUCT NAME: PIBRENTASVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2618831	714	Finland	⤷ Sign Up
2368890	300731	Netherlands	⤷ Sign Up	PRODUCT NAME: OMBITASVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/982 20150119
2618831	50/2017	Austria	⤷ Sign Up	PRODUCT NAME: GLECAPREVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER ESTHER DAVON; REGISTRATION NO/DATE: EU/1/17/1213/001 (MITTEILUNG) 20170728
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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