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FDA Orange Book · active-ingredient family

Glecaprevir; pibrentasvir

Glecaprevir; pibrentasvir is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:MAVYRET · NDA 215110

2

Brand (NDA)

0

Generics (ANDA)

20

Listed patents

10

Exclusivity periods

Brand (NDA) products · pellets, tablet

ProductApplicantApplicationTEApproved
MAVYRETRLDABBVIENDA 215110—Jun 10, 2021
MAVYRETRLDABBVIENDA 209394—Aug 03, 2017

Marketing exclusivity (10)

  • I-967New indication exclusivity (3 years)

    Jun 10, 2028

    in 2 yr

  • ODE-372Orphan-drug exclusivity (7 years)

    Jun 10, 2028

    in 2 yr

  • PEDPediatric exclusivity (adds 6 months)

    Dec 10, 2028

    in 2 yr 6 mo

  • I-967New indication exclusivity (3 years)

    Jun 10, 2028

    in 2 yr

  • ODE-232Orphan-drug exclusivity (7 years)

    Apr 30, 2026

    2 mo ago

  • ODE-233Orphan-drug exclusivity (7 years)

    Apr 30, 2026

    2 mo ago

  • ODE-372Orphan-drug exclusivity (7 years)

    Jun 10, 2028

    in 2 yr

  • PEDPediatric exclusivity (adds 6 months)

    Oct 30, 2026

    in 4 mo

  • PEDPediatric exclusivity (adds 6 months)

    Oct 30, 2026

    in 4 mo

  • PEDPediatric exclusivity (adds 6 months)

    Dec 10, 2028

    in 2 yr 6 mo

Listed patents (20)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10039754Jun 10, 2030in 4 yr
U-4206
10028937Jun 10, 2030in 4 yr
U-4206
9586978Nov 06, 2030in 4 yr 5 mo
U-4206
10028937*PEDDec 10, 2030in 4 yr 7 mo
10039754*PEDDec 10, 2030in 4 yr 7 mo
9586978*PEDMay 06, 2031in 4 yr 11 mo
8648037Jan 19, 2032in 5 yr 8 mo
SubstanceProductU-4206
8937150May 18, 2032in 6 yr
SubstanceProduct
8648037*PEDJul 19, 2032in 6 yr 2 mo
8937150*PEDNov 18, 2032in 6 yr 6 mo
10286029Mar 14, 2034in 7 yr 10 mo
U-4206
11484534Mar 14, 2034in 7 yr 10 mo
U-4206
10286029*PEDSep 14, 2034in 8 yr 4 mo
11484534*PEDSep 14, 2034in 8 yr 4 mo
RE48923May 08, 2035in 9 yr
Substance
9321807Jun 05, 2035in 9 yr 1 mo
SubstanceProduct
RE48923*PEDNov 08, 2035in 9 yr 6 mo
9321807*PEDDec 05, 2035in 9 yr 7 mo
11246866Jun 24, 2036in 10 yr 2 mo
Product
11246866*PEDDec 24, 2036in 10 yr 8 mo

Glecaprevir; pibrentasvir — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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