Home Applications 206038 Application 206038
Type NDA
Sponsor VERTEX PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORKAMBI IVACAFTOR; LUMACAFTOR TABLET;ORAL 125MG;200MG Yes Yes 002 ORKAMBI IVACAFTOR; LUMACAFTOR TABLET;ORAL 125MG;100MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206038-001 ORKAMBI IVACAFTOR; LUMACAFTOR 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 N206038-002 ORKAMBI IVACAFTOR; LUMACAFTOR 125MG;100MG TABLET / ORAL RLD 2016-09-28
Orange Book patents# Current patent rows page 1 of 2 · 94 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206038-001 7973038 2026-11-08 U-1973 2016-10-21 N206038-001 8741933 2026-11-08 U-1717 2015-07-22 N206038-001 8741933 2026-11-08 U-1909 2015-07-22 N206038-001 9216969 2026-11-08 Drug substance, Drug product 2016-03-15 N206038-001 8410274 2026-12-28 Drug product 2015-07-22 N206038-001 8754224 2026-12-28 Drug substance, Drug product 2015-07-22 N206038-001 9670163 2026-12-28 U-1911 Drug product 2017-07-05 N206038-001 9931334 2026-12-28 U-2276 Drug product 2018-05-02 N206038-001 7973038*PED 2027-05-08 Pediatric extension N206038-001 8741933*PED 2027-05-08 Pediatric extension N206038-001 9216969*PED 2027-05-08 Pediatric extension N206038-001 7495103 2027-05-20 Drug substance, Drug product 2015-07-22 N206038-001 8410274*PED 2027-06-28 Pediatric extension N206038-001 8754224*PED 2027-06-28 Pediatric extension N206038-001 9670163*PED 2027-06-28 Pediatric extension N206038-001 9931334*PED 2027-06-28 Pediatric extension N206038-001 8324242 2027-08-05 U-1311 2015-07-22 N206038-001 8324242 2027-08-05 U-1911 2015-07-22 N206038-001 7495103*PED 2027-11-20 Pediatric extension N206038-001 8324242*PED 2028-02-05 Pediatric extension N206038-001 10076513 2028-12-04 U-2411 Drug product 2018-10-18 N206038-001 10597384 2028-12-04 U-2777 Drug substance, Drug product 2020-04-23 N206038-001 11052075 2028-12-04 U-3181 Drug product 2021-08-04 N206038-001 12065432 2028-12-04 U-3984 2024-09-18 N206038-001 8653103 2028-12-04 Drug product 2015-07-22 N206038-001 9150552 2028-12-04 U-1908 2016-10-21 N206038-001 10076513*PED 2029-06-04 Pediatric extension N206038-001 10597384*PED 2029-06-04 Pediatric extension N206038-001 11052075*PED 2029-06-04 Pediatric extension N206038-001 12065432*PED 2029-06-04 Pediatric extension N206038-001 8653103*PED 2029-06-04 Pediatric extension N206038-001 9150552*PED 2029-06-04 Pediatric extension N206038-001 8846718 2029-07-02 U-1717 2015-07-22 N206038-001 8846718 2029-07-02 U-1908 2015-07-22 N206038-001 10646481 2029-08-13 Drug product 2020-06-11 N206038-001 11564916 2029-08-13 U-3529 2023-02-28 N206038-001 12458635 2029-08-13 U-4338 Drug product 2025-11-26 N206038-001 9192606 2029-09-29 U-1912 Drug product 2016-10-21 N206038-001 8846718*PED 2030-01-02 Pediatric extension N206038-001 10646481*PED 2030-02-13 Pediatric extension N206038-001 11564916*PED 2030-02-13 Pediatric extension N206038-001 12458635*PED 2030-02-13 Pediatric extension N206038-001 9192606*PED 2030-03-29 Pediatric extension N206038-001 8507534 2030-09-20 Drug substance, Drug product 2015-07-22 N206038-001 8716338 2030-09-20 U-1718 Drug product 2015-07-22 N206038-001 8716338 2030-09-20 U-1910 Drug product 2015-07-22 N206038-001 8993600 2030-12-11 Drug product 2015-07-22 N206038-001 8507534*PED 2031-03-20 Pediatric extension N206038-001 8716338*PED 2031-03-20 Pediatric extension N206038-001 8993600*PED 2031-06-11 Pediatric extension N206038-002 7973038 2026-11-08 U-1973 2016-10-21 N206038-002 8741933 2026-11-08 U-1909 2016-10-21 N206038-002 9216969 2026-11-08 Drug product 2016-10-21 N206038-002 8410274 2026-12-28 Drug product 2016-10-21 N206038-002 8754224 2026-12-28 Drug substance, Drug product 2016-10-21 N206038-002 9670163 2026-12-28 U-1911 Drug product 2017-07-05 N206038-002 9931334 2026-12-28 U-2276 Drug product 2018-05-02 N206038-002 7973038*PED 2027-05-08 Pediatric extension N206038-002 8741933*PED 2027-05-08 Pediatric extension N206038-002 9216969*PED 2027-05-08 Pediatric extension N206038-002 7495103 2027-05-20 Drug substance, Drug product 2016-10-21 N206038-002 8410274*PED 2027-06-28 Pediatric extension N206038-002 8754224*PED 2027-06-28 Pediatric extension N206038-002 9670163*PED 2027-06-28 Pediatric extension N206038-002 9931334*PED 2027-06-28 Pediatric extension N206038-002 8324242 2027-08-05 U-1911 2016-10-21 N206038-002 7495103*PED 2027-11-20 Pediatric extension N206038-002 8324242*PED 2028-02-05 Pediatric extension N206038-002 10597384 2028-12-04 U-2777 Drug substance, Drug product 2020-04-23 N206038-002 11052075 2028-12-04 U-3181 Drug product 2021-08-04 N206038-002 12065432 2028-12-04 U-3984 2024-09-18 N206038-002 8653103 2028-12-04 Drug product 2016-10-21 N206038-002 9150552 2028-12-04 U-1908 2016-10-21 N206038-002 10597384*PED 2029-06-04 Pediatric extension N206038-002 11052075*PED 2029-06-04 Pediatric extension N206038-002 12065432*PED 2029-06-04 Pediatric extension N206038-002 8653103*PED 2029-06-04 Pediatric extension N206038-002 9150552*PED 2029-06-04 Pediatric extension N206038-002 8846718 2029-07-02 U-1908 2016-10-21 N206038-002 10646481 2029-08-13 Drug product 2020-06-11
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 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206038-001 ORKAMBI 125MG;200MG TABLET / ORAL RLD, RS 2015-07-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206038-002 ORKAMBI 125MG;100MG TABLET / ORAL RLD 2016-09-28 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 53 · 2,118 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N206038-001 7973038 2026-11-08 U-1973 2016-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8741933 2026-11-08 U-1909 2015-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8741933 2026-11-08 U-1717 2015-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 9216969 2026-11-08 Drug substance, Drug product 2016-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8410274 2026-12-28 Drug product 2015-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8754224 2026-12-28 Drug substance, Drug product 2015-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 9670163 2026-12-28 U-1911 Drug product 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 9931334 2026-12-28 U-2276 Drug product 2018-05-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 7973038*PED 2027-05-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8741933*PED 2027-05-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 9216969*PED 2027-05-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 7495103 2027-05-20 Drug substance, Drug product 2015-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8410274*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8754224*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 9670163*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 9931334*PED 2027-06-28 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8324242 2027-08-05 U-1311 2015-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8324242 2027-08-05 U-1911 2015-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 7495103*PED 2027-11-20 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8324242*PED 2028-02-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 10076513 2028-12-04 U-2411 Drug product 2018-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 10597384 2028-12-04 U-2777 Drug substance, Drug product 2020-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 11052075 2028-12-04 U-3181 Drug product 2021-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 12065432 2028-12-04 U-3984 2024-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8653103 2028-12-04 Drug product 2015-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 9150552 2028-12-04 U-1908 2016-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 10076513*PED 2029-06-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 10597384*PED 2029-06-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 11052075*PED 2029-06-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 12065432*PED 2029-06-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8653103*PED 2029-06-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 9150552*PED 2029-06-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8846718 2029-07-02 U-1717 2015-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8846718 2029-07-02 U-1908 2015-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 10646481 2029-08-13 Drug product 2020-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 11564916 2029-08-13 U-3529 2023-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 12458635 2029-08-13 U-4338 Drug product 2025-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 9192606 2029-09-29 U-1912 Drug product 2016-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 8846718*PED 2030-01-02 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206038-001 10646481*PED 2030-02-13 Pediatric extension caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 118 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51167-700 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-700 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-700 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-700 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-700 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-700 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-809 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-809 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-809 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-809 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-809 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current 51167-809 ORKAMBI lumacaftor and ivacaftor Vertex Pharmaceuticals Incorporated NDA Current