Assyro AI

Orange Book product · Brand (NDA)

MAVYRET

GLECAPREVIR; PIBRENTASVIR

Brand (NDA)NDA 209394RX ABBVIE

At a glance

Aug 03, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

30

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 03, 2017

    9 yr ago

  2. Exclusivity ends · ODE-232

    Orphan-drug exclusivity (7 years)

    Apr 30, 2026

    2 mo ago

  3. Exclusivity ends · ODE-233

    Orphan-drug exclusivity (7 years)

    Apr 30, 2026

    2 mo ago

  4. Today

  5. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Oct 30, 2026

    in 4 mo

  6. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Oct 30, 2026

    in 4 mo

  7. Exclusivity ends · I-967

    New indication exclusivity (3 years)

    Jun 10, 2028

    in 2 yr

  8. Exclusivity ends · ODE-372

    Orphan-drug exclusivity (7 years)

    Jun 10, 2028

    in 2 yr

  9. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Dec 10, 2028

    in 2 yr 6 mo

  10. Patent 10028937 expires

    Listed method-of-use patent (U-4206) expiration.

    Jun 10, 2030

    in 4 yr

  11. Patent 10028937 expires

    Listed method-of-use patent (U-2141) expiration.

    Jun 10, 2030

    in 4 yr

  12. Patent 10028937 expires

    Listed method-of-use patent (U-3237) expiration.

    Jun 10, 2030

    in 4 yr

  13. Patent 10039754 expires

    Listed method-of-use patent (U-2141) expiration.

    Jun 10, 2030

    in 4 yr

  14. Patent 10039754 expires

    Listed method-of-use patent (U-4206) expiration.

    Jun 10, 2030

    in 4 yr

  15. Patent 10039754 expires

    Listed method-of-use patent (U-3237) expiration.

    Jun 10, 2030

    in 4 yr

  16. Patent 9586978 expires

    Listed method-of-use patent (U-4206) expiration.

    Nov 06, 2030

    in 4 yr 5 mo

  17. Patent 9586978 expires

    Listed method-of-use patent (U-3237) expiration.

    Nov 06, 2030

    in 4 yr 5 mo

  18. Patent 9586978 expires

    Listed method-of-use patent (U-2141) expiration.

    Nov 06, 2030

    in 4 yr 5 mo

  19. Patent 10028937*PED expires

    Listed listed patent expiration.

    Dec 10, 2030

    in 4 yr 7 mo

  20. Patent 10039754*PED expires

    Listed listed patent expiration.

    Dec 10, 2030

    in 4 yr 7 mo

  21. Patent 9586978*PED expires

    Listed listed patent expiration.

    May 06, 2031

    in 4 yr 11 mo

  22. Patent 8648037 expires

    Listed drug substance patent expiration.

    Jan 19, 2032

    in 5 yr 8 mo

  23. Patent 8648037 expires

    Listed drug substance patent expiration.

    Jan 19, 2032

    in 5 yr 8 mo

  24. Patent 8648037 expires

    Listed drug substance patent expiration.

    Jan 19, 2032

    in 5 yr 8 mo

  25. Patent 8937150 expires

    Listed drug substance patent expiration.

    May 18, 2032

    in 6 yr

  26. Patent 8648037*PED expires

    Listed listed patent expiration.

    Jul 19, 2032

    in 6 yr 2 mo

  27. Patent 8937150*PED expires

    Listed listed patent expiration.

    Nov 18, 2032

    in 6 yr 6 mo

  28. Patent 10286029 expires

    Listed method-of-use patent (U-4206) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  29. Patent 10286029 expires

    Listed method-of-use patent (U-3237) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  30. Patent 11484534 expires

    Listed method-of-use patent (U-4206) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  31. Patent 11484534 expires

    Listed method-of-use patent (U-3237) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  32. Patent 10286029*PED expires

    Listed listed patent expiration.

    Sep 14, 2034

    in 8 yr 4 mo

  33. Patent 11484534*PED expires

    Listed listed patent expiration.

    Sep 14, 2034

    in 8 yr 4 mo

  34. Patent RE48923 expires

    Listed drug substance patent expiration.

    May 08, 2035

    in 9 yr

  35. Patent 9321807 expires

    Listed drug substance patent expiration.

    Jun 05, 2035

    in 9 yr 1 mo

  36. Patent RE48923*PED expires

    Listed listed patent expiration.

    Nov 08, 2035

    in 9 yr 6 mo

  37. Patent 9321807*PED expires

    Listed listed patent expiration.

    Dec 05, 2035

    in 9 yr 7 mo

  38. Patent 11246866 expires

    Listed drug product patent expiration.

    Jun 24, 2036

    in 10 yr 2 mo

  39. Patent 11246866*PED expires

    Listed listed patent expiration.

    Dec 24, 2036

    in 10 yr 8 mo

Pharmaceutical detail

Active ingredient

GLECAPREVIR; PIBRENTASVIR

Strength

100MG;40MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 209394

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (7)

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

    Apr 30, 2026

    2 mo ago

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

    Apr 30, 2026

    2 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Oct 30, 2026

    in 4 mo

  • PEDPediatric exclusivity (adds 6 months)

    Oct 30, 2026

    in 4 mo

  • 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

Listed patents (30)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10028937Jun 10, 2030in 4 yr
U-4206
10028937Jun 10, 2030in 4 yr
U-2141
10028937Jun 10, 2030in 4 yr
U-3237
10039754Jun 10, 2030in 4 yr
U-2141
10039754Jun 10, 2030in 4 yr
U-4206
10039754Jun 10, 2030in 4 yr
U-3237
9586978Nov 06, 2030in 4 yr 5 mo
U-4206
9586978Nov 06, 2030in 4 yr 5 mo
U-3237
9586978Nov 06, 2030in 4 yr 5 mo
U-2141
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-2141
8648037Jan 19, 2032in 5 yr 8 mo
SubstanceProductU-4206
8648037Jan 19, 2032in 5 yr 8 mo
SubstanceProductU-3237
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
10286029Mar 14, 2034in 7 yr 10 mo
U-3237
11484534Mar 14, 2034in 7 yr 10 mo
U-4206
11484534Mar 14, 2034in 7 yr 10 mo
U-3237
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
Substance
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
Agent CTA Background

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