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Last Updated: November 21, 2024

Glecaprevir; pibrentasvir - Generic Drug Details


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What are the generic 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*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for glecaprevir; pibrentasvir*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
White River Junction Veterans Affairs Medical CenterPhase 2
Peking University People's HospitalPhase 4
White River Junction Veterans Affairs Medical CenterPhase 2/Phase 3

See all glecaprevir; pibrentasvir clinical trials

US Patents and Regulatory Information for glecaprevir; pibrentasvir

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
>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

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

Supplementary Protection Certificates for glecaprevir; pibrentasvir

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
>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.