Application 207931

Type
NDA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TECHNIVIEOMBITASVIR; PARITAPREVIR; RITONAVIRTABLET;ORAL12.5MG;75MG;50MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N207931-001TECHNIVIEOMBITASVIR; PARITAPREVIR; RITONAVIR12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N207931-00186425382029-09-10U-1638Drug substance, Drug product2015-08-06
N207931-00190063872030-06-10U-16872015-08-06
N207931-00184205962031-04-10Drug substance, Drug product2015-08-06
N207931-00190444802031-04-10U-16382015-08-06
N207931-00186860262031-06-09Drug product2015-08-06
N207931-0018420596*PED2031-10-10Pediatric extension
N207931-00186919382032-04-13Drug substance, Drug product2015-08-06

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207931-001TECHNIVIE12.5MG;75MG;50MGTABLET / ORALRLD2015-07-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207931-001TECHNIVIE12.5MG;75MG;50MGTABLET / ORALRLD2015-07-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207931-001TECHNIVIE12.5MG;75MG;50MGTABLET / ORALRLD2015-07-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD2015-07-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207931-001TECHNIVIE12.5MG;75MG;50MGTABLET / ORALRLD2015-07-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N207931-001TECHNIVIE12.5MG;75MG;50MGTABLET / ORALRLD2015-07-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N207931-001TECHNIVIE12.5MG;75MG;50MGTABLET / ORALRLD2015-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207931-001TECHNIVIE12.5MG;75MG;50MGTABLET / ORALRLD2015-07-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N207931-001TECHNIVIE12.5MG;75MG;50MGTABLET / ORALRLD2015-07-243f01610625f2…
2019-09-15 20:21 UTC2019-09N207931-001TECHNIVIE12.5MG;75MG;50MGTABLET / ORALRLD2015-07-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N207931-001TECHNIVIE12.5MG;75MG;50MGTABLET / ORALRLD2015-07-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N207931-001TECHNIVIE12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2015-07-24cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 12 · 462 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207931-00186425382029-09-10U-1638Drug substance, Drug product2015-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207931-00190063872030-06-10U-16872015-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207931-00184205962031-04-10Drug substance, Drug product2015-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207931-00190444802031-04-10U-16382015-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207931-00186860262031-06-09Drug product2015-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207931-0018420596*PED2031-10-10Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207931-00186919382032-04-13Drug substance, Drug product2015-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-00182683492024-08-25Drug product2015-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-00183990152024-08-25Drug product2015-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-0018268349*PED2025-02-25Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-0018399015*PED2025-02-25Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-00186425382029-09-10U-1638Drug substance, Drug product2015-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-00190063872030-06-10U-16872015-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-00184205962031-04-10Drug substance, Drug product2015-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-00190444802031-04-10U-16382015-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-00186860262031-06-09Drug product2015-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-0018420596*PED2031-10-10Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207931-00186919382032-04-13Drug substance, Drug product2015-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N207931-0018268349*PED2025-02-25Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207931-0018399015*PED2025-02-25Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207931-00186425382029-09-10U-1638Drug substance, Drug product2015-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207931-00190063872030-06-10U-16872015-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207931-00184205962031-04-10Drug substance, Drug product2015-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207931-00190444802031-04-10U-16382015-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207931-00186860262031-06-09Drug product2015-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207931-0018420596*PED2031-10-10Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207931-00186919382032-04-13Drug substance, Drug product2015-08-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207931-0018268349*PED2025-02-25Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207931-0018399015*PED2025-02-25Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207931-00186425382029-09-10U-1638Drug substance, Drug product2015-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207931-00190063872030-06-10U-16872015-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207931-00184205962031-04-10Drug substance, Drug product2015-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207931-00190444802031-04-10U-16382015-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207931-00186860262031-06-09Drug product2015-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207931-0018420596*PED2031-10-10Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207931-00186919382032-04-13Drug substance, Drug product2015-08-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207931-0018268349*PED2025-02-25Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207931-0018399015*PED2025-02-25Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207931-00186425382029-09-10U-1638Drug substance, Drug product2015-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207931-00190063872030-06-10U-16872015-08-06b8a1b40f171c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N207931-001NCE2019-12-1974a2ff9319b5…
2019-12-14 00:12 UTC2019-12N207931-001NCE2019-12-193f01610625f2…
2019-09-15 20:21 UTC2019-09N207931-001NCE2019-12-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N207931-001NCE2019-12-19ea99ee380514…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3082TechnivieOmbitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent
0074-3082TechnivieOmbitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent
0074-3082TechnivieOmbitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61208SUPPL2019-12-10
61195SUPPL2019-12-09
61194SUPPL2019-12-09
55363SUPPL2018-08-29
55361SUPPL2018-08-29
54974SUPPL2018-07-25
50379SUPPL2017-11-13
47677SUPPL2017-03-24
47676SUPPL2017-03-24
47645SUPPL2017-03-23
47644SUPPL2017-03-23
47441SUPPL2017-03-03
47369SUPPL2017-02-28
47222SUPPL2017-02-15
47211SUPPL2017-02-15
40599SUPPL2016-06-23
10631SUPPL2016-06-23
43538ORIG2016-05-25
40598SUPPL2016-02-01
32865SUPPL2016-01-29
10630SUPPL2015-10-26
40597SUPPL2015-10-23
40596ORIG2015-07-24
10629ORIG2015-07-24