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Last Updated: June 25, 2022

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 Inc and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for glecaprevir; pibrentasvir
International Patents:514
US Patents:9
Tradenames:1
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Clinical Trials: 28
DailyMed Link:glecaprevir; pibrentasvir at DailyMed
Recent Clinical Trials for glecaprevir; pibrentasvir

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

SponsorPhase
NYU Langone HealthEarly Phase 1
Kirby InstituteN/A
Mayo ClinicPhase 4

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 Inc MAVYRET glecaprevir; pibrentasvir PELLETS;ORAL 215110-001 Jun 10, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc MAVYRET glecaprevir; pibrentasvir PELLETS;ORAL 215110-001 Jun 10, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc MAVYRET glecaprevir; pibrentasvir PELLETS;ORAL 215110-001 Jun 10, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for glecaprevir; pibrentasvir

Country Patent Number Title Estimated Expiration
Australia 2018201011 Methods for treating HCV See Plans and Pricing
Dominican Republic P2019000218 See Plans and Pricing
Australia 2020239679 Crystal forms See Plans and Pricing
Ecuador SP11010937 COMPUESTOS ANTIVIRALES See Plans and Pricing
Mexico 2018002707 DERIVADOS DE TETRAHIDROFURANO ANTIVIRALES. (ANTI-VIRAL TETRAHYDROFURANE DERIVATIVES.) See Plans and Pricing
Mexico 343275 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for glecaprevir; pibrentasvir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2368890 639 Finland See Plans and Pricing
2692346 300901 Netherlands See Plans and Pricing PRODUCT NAME: PIBRENTASVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2618831 2017056 Norway See Plans and Pricing PRODUCT NAME: GLEKAPREVIR ELLER ET; REG. NO/DATE: EU/1/17/1213 20170807
2692346 CR 2017 00049 Denmark See Plans and Pricing PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2692346 1790050-7 Sweden See Plans and Pricing PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2618831 PA2017034,C2618831 Lithuania See Plans and Pricing PRODUCT NAME: GLEKAPREVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; 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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