Orange Book product · Brand (NDA)
MAVYRET
GLECAPREVIR; PIBRENTASVIR
At a glance
Aug 03, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
30
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 03, 2017
9 yr ago
Exclusivity ends · ODE-232
Orphan-drug exclusivity (7 years)
Apr 30, 2026
2 mo ago
Exclusivity ends · ODE-233
Orphan-drug exclusivity (7 years)
Apr 30, 2026
2 mo ago
Today
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Oct 30, 2026
in 4 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Oct 30, 2026
in 4 mo
Exclusivity ends · I-967
New indication exclusivity (3 years)
Jun 10, 2028
in 2 yr
Exclusivity ends · ODE-372
Orphan-drug exclusivity (7 years)
Jun 10, 2028
in 2 yr
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Dec 10, 2028
in 2 yr 6 mo
Patent 10028937 expires
Listed method-of-use patent (U-4206) expiration.
Jun 10, 2030
in 4 yr
Patent 10028937 expires
Listed method-of-use patent (U-2141) expiration.
Jun 10, 2030
in 4 yr
Patent 10028937 expires
Listed method-of-use patent (U-3237) expiration.
Jun 10, 2030
in 4 yr
Patent 10039754 expires
Listed method-of-use patent (U-2141) expiration.
Jun 10, 2030
in 4 yr
Patent 10039754 expires
Listed method-of-use patent (U-4206) expiration.
Jun 10, 2030
in 4 yr
Patent 10039754 expires
Listed method-of-use patent (U-3237) expiration.
Jun 10, 2030
in 4 yr
Patent 9586978 expires
Listed method-of-use patent (U-4206) expiration.
Nov 06, 2030
in 4 yr 5 mo
Patent 9586978 expires
Listed method-of-use patent (U-3237) expiration.
Nov 06, 2030
in 4 yr 5 mo
Patent 9586978 expires
Listed method-of-use patent (U-2141) expiration.
Nov 06, 2030
in 4 yr 5 mo
Patent 10028937*PED expires
Listed listed patent expiration.
Dec 10, 2030
in 4 yr 7 mo
Patent 10039754*PED expires
Listed listed patent expiration.
Dec 10, 2030
in 4 yr 7 mo
Patent 9586978*PED expires
Listed listed patent expiration.
May 06, 2031
in 4 yr 11 mo
Patent 8648037 expires
Listed drug substance patent expiration.
Jan 19, 2032
in 5 yr 8 mo
Patent 8648037 expires
Listed drug substance patent expiration.
Jan 19, 2032
in 5 yr 8 mo
Patent 8648037 expires
Listed drug substance patent expiration.
Jan 19, 2032
in 5 yr 8 mo
Patent 8937150 expires
Listed drug substance patent expiration.
May 18, 2032
in 6 yr
Patent 8648037*PED expires
Listed listed patent expiration.
Jul 19, 2032
in 6 yr 2 mo
Patent 8937150*PED expires
Listed listed patent expiration.
Nov 18, 2032
in 6 yr 6 mo
Patent 10286029 expires
Listed method-of-use patent (U-4206) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 10286029 expires
Listed method-of-use patent (U-3237) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 11484534 expires
Listed method-of-use patent (U-4206) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 11484534 expires
Listed method-of-use patent (U-3237) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 10286029*PED expires
Listed listed patent expiration.
Sep 14, 2034
in 8 yr 4 mo
Patent 11484534*PED expires
Listed listed patent expiration.
Sep 14, 2034
in 8 yr 4 mo
Patent RE48923 expires
Listed drug substance patent expiration.
May 08, 2035
in 9 yr
Patent 9321807 expires
Listed drug substance patent expiration.
Jun 05, 2035
in 9 yr 1 mo
Patent RE48923*PED expires
Listed listed patent expiration.
Nov 08, 2035
in 9 yr 6 mo
Patent 9321807*PED expires
Listed listed patent expiration.
Dec 05, 2035
in 9 yr 7 mo
Patent 11246866 expires
Listed drug product patent expiration.
Jun 24, 2036
in 10 yr 2 mo
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 familyThis 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)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10028937 | Jun 10, 2030 | in 4 yr | U-4206 |
| 10028937 | Jun 10, 2030 | in 4 yr | U-2141 |
| 10028937 | Jun 10, 2030 | in 4 yr | U-3237 |
| 10039754 | Jun 10, 2030 | in 4 yr | U-2141 |
| 10039754 | Jun 10, 2030 | in 4 yr | U-4206 |
| 10039754 | Jun 10, 2030 | in 4 yr | U-3237 |
| 9586978 | Nov 06, 2030 | in 4 yr 5 mo | U-4206 |
| 9586978 | Nov 06, 2030 | in 4 yr 5 mo | U-3237 |
| 9586978 | Nov 06, 2030 | in 4 yr 5 mo | U-2141 |
| 10028937*PED | Dec 10, 2030 | in 4 yr 7 mo | |
| 10039754*PED | Dec 10, 2030 | in 4 yr 7 mo | |
| 9586978*PED | May 06, 2031 | in 4 yr 11 mo | |
| 8648037 | Jan 19, 2032 | in 5 yr 8 mo | SubstanceProductU-2141 |
| 8648037 | Jan 19, 2032 | in 5 yr 8 mo | SubstanceProductU-4206 |
| 8648037 | Jan 19, 2032 | in 5 yr 8 mo | SubstanceProductU-3237 |
| 8937150 | May 18, 2032 | in 6 yr | SubstanceProduct |
| 8648037*PED | Jul 19, 2032 | in 6 yr 2 mo | |
| 8937150*PED | Nov 18, 2032 | in 6 yr 6 mo | |
| 10286029 | Mar 14, 2034 | in 7 yr 10 mo | U-4206 |
| 10286029 | Mar 14, 2034 | in 7 yr 10 mo | U-3237 |
| 11484534 | Mar 14, 2034 | in 7 yr 10 mo | U-4206 |
| 11484534 | Mar 14, 2034 | in 7 yr 10 mo | U-3237 |
| 10286029*PED | Sep 14, 2034 | in 8 yr 4 mo | |
| 11484534*PED | Sep 14, 2034 | in 8 yr 4 mo | |
| RE48923 | May 08, 2035 | in 9 yr | Substance |
| 9321807 | Jun 05, 2035 | in 9 yr 1 mo | Substance |
| RE48923*PED | Nov 08, 2035 | in 9 yr 6 mo | |
| 9321807*PED | Dec 05, 2035 | in 9 yr 7 mo | |
| 11246866 | Jun 24, 2036 | in 10 yr 2 mo | Product |
| 11246866*PED | Dec 24, 2036 | in 10 yr 8 mo |

