Application 209394

Type
NDA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAVYRETGLECAPREVIR; PIBRENTASVIRTABLET;ORAL100MG;40MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209394-001MAVYRETGLECAPREVIR; PIBRENTASVIR100MG;40MGTABLET / ORALRLD, RS2017-08-03

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209394-001100289372030-06-10U-21412018-08-24
N209394-001100289372030-06-10U-32372018-08-24
N209394-001100289372030-06-10U-42062018-08-24
N209394-001100397542030-06-10U-21412018-09-06
N209394-001100397542030-06-10U-32372018-09-06
N209394-001100397542030-06-10U-42062018-09-06
N209394-00195869782030-11-06U-21412017-08-29
N209394-00195869782030-11-06U-32372017-08-29
N209394-00195869782030-11-06U-42062017-08-29
N209394-00110028937*PED2030-12-10Pediatric extension
N209394-00110039754*PED2030-12-10Pediatric extension
N209394-0019586978*PED2031-05-06Pediatric extension
N209394-00186480372032-01-19U-2141Drug substance, Drug product2017-08-29
N209394-00186480372032-01-19U-3237Drug substance, Drug product2017-08-29
N209394-00186480372032-01-19U-4206Drug substance, Drug product2017-08-29
N209394-00189371502032-05-18Drug substance, Drug product2017-08-29
N209394-0018648037*PED2032-07-19Pediatric extension
N209394-0018937150*PED2032-11-18Pediatric extension
N209394-001102860292034-03-14U-32372019-05-31
N209394-001102860292034-03-14U-42062019-05-31
N209394-001114845342034-03-14U-32372022-11-30
N209394-001114845342034-03-14U-42062022-11-30
N209394-00110286029*PED2034-09-14Pediatric extension
N209394-00111484534*PED2034-09-14Pediatric extension
N209394-001RE489232035-05-08Drug substance2022-03-08
N209394-00193218072035-06-05Drug substance2017-08-29
N209394-001RE48923*PED2035-11-08Pediatric extension
N209394-0019321807*PED2035-12-05Pediatric extension
N209394-001112468662036-06-24Drug product2022-03-08
N209394-00111246866*PED2036-12-24Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 7 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N209394-001ODE-2322026-04-30
N209394-001ODE-2332026-04-30
N209394-001PED2026-10-30
N209394-001PED2026-10-30
N209394-001I-9672028-06-10
N209394-001ODE-3722028-06-10
N209394-001PED2028-12-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N209394-001MAVYRET100MG;40MGTABLET / ORALRLD, RS2017-08-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209394-001MAVYRET100MG;40MGTABLET / ORALRLD, RS2017-08-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209394-001MAVYRET100MG;40MGTABLET / ORALRLD, RS2017-08-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N209394-001MAVYRET100MG;40MGTABLET / ORALRLD, RS2017-08-03a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 25 · 969 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N209394-001100289372030-06-10U-42062018-08-24c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001100289372030-06-10U-21412018-08-24c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001100289372030-06-10U-32372018-08-24c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001100397542030-06-10U-21412018-09-06c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001100397542030-06-10U-42062018-09-06c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001100397542030-06-10U-32372018-09-06c2088c7a36db…
2026-10-15 13:18:302026-09N209394-00195869782030-11-06U-42062017-08-29c2088c7a36db…
2026-10-15 13:18:302026-09N209394-00195869782030-11-06U-32372017-08-29c2088c7a36db…
2026-10-15 13:18:302026-09N209394-00195869782030-11-06U-21412017-08-29c2088c7a36db…
2026-10-15 13:18:302026-09N209394-00110028937*PED2030-12-10Pediatric extensionc2088c7a36db…
2026-10-15 13:18:302026-09N209394-00110039754*PED2030-12-10Pediatric extensionc2088c7a36db…
2026-10-15 13:18:302026-09N209394-0019586978*PED2031-05-06Pediatric extensionc2088c7a36db…
2026-10-15 13:18:302026-09N209394-00186480372032-01-19U-2141Drug substance, Drug product2017-08-29c2088c7a36db…
2026-10-15 13:18:302026-09N209394-00186480372032-01-19U-4206Drug substance, Drug product2017-08-29c2088c7a36db…
2026-10-15 13:18:302026-09N209394-00186480372032-01-19U-3237Drug substance, Drug product2017-08-29c2088c7a36db…
2026-10-15 13:18:302026-09N209394-00189371502032-05-18Drug substance, Drug product2017-08-29c2088c7a36db…
2026-10-15 13:18:302026-09N209394-0018648037*PED2032-07-19Pediatric extensionc2088c7a36db…
2026-10-15 13:18:302026-09N209394-0018937150*PED2032-11-18Pediatric extensionc2088c7a36db…
2026-10-15 13:18:302026-09N209394-001102860292034-03-14U-42062019-05-31c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001102860292034-03-14U-32372019-05-31c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001114845342034-03-14U-42062022-11-30c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001114845342034-03-14U-32372022-11-30c2088c7a36db…
2026-10-15 13:18:302026-09N209394-00110286029*PED2034-09-14Pediatric extensionc2088c7a36db…
2026-10-15 13:18:302026-09N209394-00111484534*PED2034-09-14Pediatric extensionc2088c7a36db…
2026-10-15 13:18:302026-09N209394-001RE489232035-05-08Drug substance2022-03-08c2088c7a36db…
2026-10-15 13:18:302026-09N209394-00193218072035-06-05Drug substance2017-08-29c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001RE48923*PED2035-11-08Pediatric extensionc2088c7a36db…
2026-10-15 13:18:302026-09N209394-0019321807*PED2035-12-05Pediatric extensionc2088c7a36db…
2026-10-15 13:18:302026-09N209394-001112468662036-06-24Drug product2022-03-08c2088c7a36db…
2026-10-15 13:18:302026-09N209394-00111246866*PED2036-12-24Pediatric extensionc2088c7a36db…
2026-09-14 22:38:342026-08N209394-001100289372030-06-10U-42062018-08-2484e616aacf4f…
2026-09-14 22:38:342026-08N209394-001100289372030-06-10U-21412018-08-2484e616aacf4f…
2026-09-14 22:38:342026-08N209394-001100289372030-06-10U-32372018-08-2484e616aacf4f…
2026-09-14 22:38:342026-08N209394-001100397542030-06-10U-21412018-09-0684e616aacf4f…
2026-09-14 22:38:342026-08N209394-001100397542030-06-10U-42062018-09-0684e616aacf4f…
2026-09-14 22:38:342026-08N209394-001100397542030-06-10U-32372018-09-0684e616aacf4f…
2026-09-14 22:38:342026-08N209394-00195869782030-11-06U-42062017-08-2984e616aacf4f…
2026-09-14 22:38:342026-08N209394-00195869782030-11-06U-32372017-08-2984e616aacf4f…
2026-09-14 22:38:342026-08N209394-00195869782030-11-06U-21412017-08-2984e616aacf4f…
2026-09-14 22:38:342026-08N209394-00110028937*PED2030-12-10Pediatric extension84e616aacf4f…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 10 · 376 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N209394-001ODE-2322026-04-30c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001ODE-2332026-04-30c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001PED2026-10-30c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001PED2026-10-30c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001I-9672028-06-10c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001ODE-3722028-06-10c2088c7a36db…
2026-10-15 13:18:302026-09N209394-001PED2028-12-10c2088c7a36db…
2026-09-14 22:38:342026-08N209394-001ODE-2322026-04-3084e616aacf4f…
2026-09-14 22:38:342026-08N209394-001ODE-2332026-04-3084e616aacf4f…
2026-09-14 22:38:342026-08N209394-001PED2026-10-3084e616aacf4f…
2026-09-14 22:38:342026-08N209394-001PED2026-10-3084e616aacf4f…
2026-09-14 22:38:342026-08N209394-001I-9672028-06-1084e616aacf4f…
2026-09-14 22:38:342026-08N209394-001ODE-3722028-06-1084e616aacf4f…
2026-09-14 22:38:342026-08N209394-001PED2028-12-1084e616aacf4f…
2026-08-18 06:07:402026-07N209394-001ODE-2322026-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07N209394-001ODE-2332026-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07N209394-001PED2026-10-30caaa826d4ba7…
2026-08-18 06:07:402026-07N209394-001PED2026-10-30caaa826d4ba7…
2026-08-18 06:07:402026-07N209394-001I-9672028-06-10caaa826d4ba7…
2026-08-18 06:07:402026-07N209394-001ODE-3722028-06-10caaa826d4ba7…
2026-08-18 06:07:402026-07N209394-001PED2028-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209394-001ODE-2322026-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209394-001ODE-2332026-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209394-001PED2026-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209394-001PED2026-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209394-001I-9672028-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209394-001ODE-3722028-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209394-001PED2028-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209394-001ODE-2322026-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209394-001ODE-2332026-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209394-001PED2026-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209394-001PED2026-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209394-001I-9672028-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209394-001ODE-3722028-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209394-001PED2028-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N209394-001ODE-2322026-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209394-001ODE-2332026-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209394-001PED2026-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209394-001PED2026-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209394-001I-9672028-06-106a471c1ec25d…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MavyretGLECAPREVIR AND PIBRENTASVIRAbbVie Inc.7bf99777-0401-9095-8645-16c6e907fcc02025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209394
application number: NDA209394
ndc (product): 0074-2625

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent
0074-2625MavyretGlecaprevir and PibrentasvirAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85649SUPPL 2026-04-07
85648SUPPL 2026-04-07
82544SUPPL 2025-06-12
82534SUPPL 2025-06-11
75973SUPPL 2023-10-27
75948SUPPL 2023-10-26
68862SUPPL2021-10-01
68804SUPPL2021-09-29
67778SUPPL2021-06-14
67768SUPPL2021-06-11
62548SUPPL2020-04-13
62544SUPPL2020-04-13
60205SUPPL2019-10-02
60204SUPPL2019-10-02
60142SUPPL2019-09-27
60141SUPPL2019-09-27
58503SUPPL2019-05-01
58484SUPPL2019-04-30
55130SUPPL2018-08-07
55124SUPPL2018-08-07
50719SUPPL2017-12-18
50676SUPPL2017-12-13
49723ORIG2017-09-13
49722ORIG2017-09-13
49257ORIG2017-08-07
49251ORIG2017-08-07
63051SUPPL1900-01-01
63049SUPPL1900-01-01
63048SUPPL1900-01-01
63047SUPPL1900-01-01
63046SUPPL1900-01-01