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Last Updated: February 25, 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 twenty-nine patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for glecaprevir; pibrentasvir
International Patents:529
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  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 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

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 PA2015012,C2368890 Lithuania ⤷  Try a Trial PRODUCT NAME: OMBITASVIRAS; REGISTRATION NO/DATE: EU/1/14/982 20150115
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
2692346 PA2017033,C2692346 Lithuania ⤷  Try a Trial PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1213 20170726
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Medtronic
Johnson and Johnson
McKesson
Moodys

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