Home Applications 207924 Application 207924
Type NDA
Sponsor ELI LILLY AND CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OLUMIANT BARICITINIB TABLET;ORAL 2MG Yes Yes 002 OLUMIANT BARICITINIB TABLET;ORAL 1MG Yes No 003 OLUMIANT BARICITINIB TABLET;ORAL 4MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207924-001 OLUMIANT BARICITINIB 2MG TABLET / ORAL AB RLD 2018-05-31 N207924-002 OLUMIANT BARICITINIB 1MG TABLET / ORAL AB RLD 2019-10-08 N207924-003 OLUMIANT BARICITINIB 4MG TABLET / ORAL AB RLD, RS 2022-05-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 17 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207924-001 8420629 2029-03-10 U-247 2018-06-20 N207924-001 11806555 2031-11-02 U-3500 2023-11-21 N207924-001 9737469 2031-11-02 U-3500 2023-01-09 N207924-001 8158616 2032-05-31 Drug substance, Drug product 2018-06-20 N207924-001 11045474 2032-11-30 U-3372 2022-05-26 N207924-001 9089574 2032-11-30 U-3372 2022-05-26 N207924-002 8420629 2029-03-10 U-247 2020-10-26 N207924-002 11806555 2031-11-02 U-3500 2023-11-21 N207924-002 9737469 2031-11-02 U-3500 2023-01-09 N207924-002 8158616 2032-05-31 Drug substance, Drug product 2020-10-26 N207924-002 11045474 2032-11-30 U-3372 2022-05-26 N207924-002 9089574 2032-11-30 U-3372 2022-05-26 N207924-003 11806555 2031-11-02 U-3500 2023-11-21 N207924-003 9737469 2031-11-02 U-3500 2023-01-09 N207924-003 8158616 2032-05-31 Drug substance, Drug product 2022-05-26 N207924-003 11045474 2032-11-30 U-3372 2022-05-26 N207924-003 9089574 2032-11-30 U-3372 2022-05-26
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 · 115 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 2026-09-14 22:38:34 2026-08 N207924-001 OLUMIANT 2MG TABLET / ORAL AB RLD 2018-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-002 OLUMIANT 1MG TABLET / ORAL AB RLD 2019-10-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-003 OLUMIANT 4MG TABLET / ORAL AB RLD, RS 2022-05-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207924-001 OLUMIANT 2MG TABLET / ORAL AB RLD 2018-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-002 OLUMIANT 1MG TABLET / ORAL AB RLD 2019-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-003 OLUMIANT 4MG TABLET / ORAL AB RLD, RS 2022-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207924-001 OLUMIANT 2MG TABLET / ORAL AB RLD 2018-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207924-002 OLUMIANT 1MG TABLET / ORAL AB RLD 2019-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207924-003 OLUMIANT 4MG TABLET / ORAL AB RLD, RS 2022-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207924-001 OLUMIANT 2MG TABLET / ORAL AB RLD 2018-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207924-002 OLUMIANT 1MG TABLET / ORAL AB RLD 2019-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207924-003 OLUMIANT 4MG TABLET / ORAL AB RLD, RS 2022-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207924-001 OLUMIANT 2MG TABLET / ORAL RLD 2018-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207924-002 OLUMIANT 1MG TABLET / ORAL RLD 2019-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207924-003 OLUMIANT 4MG TABLET / ORAL RLD, RS 2022-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207924-001 OLUMIANT 2MG TABLET / ORAL RLD 2018-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207924-002 OLUMIANT 1MG TABLET / ORAL RLD 2019-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207924-003 OLUMIANT 4MG TABLET / ORAL RLD, RS 2022-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207924-001 OLUMIANT 2MG TABLET / ORAL RLD 2018-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207924-002 OLUMIANT 1MG TABLET / ORAL RLD 2019-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207924-003 OLUMIANT 4MG TABLET / ORAL RLD, RS 2022-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207924-001 OLUMIANT 2MG TABLET / ORAL RLD 2018-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207924-002 OLUMIANT 1MG TABLET / ORAL RLD 2019-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207924-003 OLUMIANT 4MG TABLET / ORAL RLD, RS 2022-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207924-001 OLUMIANT 2MG TABLET / ORAL RLD 2018-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207924-002 OLUMIANT 1MG TABLET / ORAL RLD 2019-10-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207924-003 OLUMIANT 4MG TABLET / ORAL RLD, RS 2022-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207924-001 OLUMIANT 2MG TABLET / ORAL RLD 2018-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207924-002 OLUMIANT 1MG TABLET / ORAL RLD 2019-10-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207924-003 OLUMIANT 4MG TABLET / ORAL RLD, RS 2022-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207924-001 OLUMIANT 2MG TABLET / ORAL RLD 2018-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207924-002 OLUMIANT 1MG TABLET / ORAL RLD 2019-10-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207924-003 OLUMIANT 4MG TABLET / ORAL RLD, RS 2022-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207924-001 OLUMIANT 2MG TABLET / ORAL RLD 2018-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207924-002 OLUMIANT 1MG TABLET / ORAL RLD 2019-10-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207924-003 OLUMIANT 4MG TABLET / ORAL RLD, RS 2022-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207924-001 OLUMIANT 2MG TABLET / ORAL AB RLD 2018-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207924-002 OLUMIANT 1MG TABLET / ORAL AB RLD 2019-10-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207924-003 OLUMIANT 4MG TABLET / ORAL RLD, RS 2022-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207924-001 OLUMIANT 2MG TABLET / ORAL RLD 2018-05-31 301d65b070ca…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 13 · 519 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N207924-001 8420629 2029-03-10 U-247 2018-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-001 11806555 2031-11-02 U-3500 2023-11-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-001 9737469 2031-11-02 U-3500 2023-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-001 8158616 2032-05-31 Drug substance, Drug product 2018-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-001 11045474 2032-11-30 U-3372 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-001 9089574 2032-11-30 U-3372 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-002 8420629 2029-03-10 U-247 2020-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-002 11806555 2031-11-02 U-3500 2023-11-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-002 9737469 2031-11-02 U-3500 2023-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-002 8158616 2032-05-31 Drug substance, Drug product 2020-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-002 11045474 2032-11-30 U-3372 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-002 9089574 2032-11-30 U-3372 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-003 11806555 2031-11-02 U-3500 2023-11-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-003 9737469 2031-11-02 U-3500 2023-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-003 8158616 2032-05-31 Drug substance, Drug product 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-003 11045474 2032-11-30 U-3372 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207924-003 9089574 2032-11-30 U-3372 2022-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207924-001 8420629 2029-03-10 U-247 2018-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-001 11806555 2031-11-02 U-3500 2023-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-001 9737469 2031-11-02 U-3500 2023-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-001 8158616 2032-05-31 Drug substance, Drug product 2018-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-001 11045474 2032-11-30 U-3372 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-001 9089574 2032-11-30 U-3372 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-002 8420629 2029-03-10 U-247 2020-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-002 11806555 2031-11-02 U-3500 2023-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-002 9737469 2031-11-02 U-3500 2023-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-002 8158616 2032-05-31 Drug substance, Drug product 2020-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-002 11045474 2032-11-30 U-3372 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-002 9089574 2032-11-30 U-3372 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-003 11806555 2031-11-02 U-3500 2023-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-003 9737469 2031-11-02 U-3500 2023-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-003 8158616 2032-05-31 Drug substance, Drug product 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-003 11045474 2032-11-30 U-3372 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207924-003 9089574 2032-11-30 U-3372 2022-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207924-001 8420629 2029-03-10 U-247 2018-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207924-001 11806555 2031-11-02 U-3500 2023-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207924-001 9737469 2031-11-02 U-3500 2023-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207924-001 8158616 2032-05-31 Drug substance, Drug product 2018-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207924-001 11045474 2032-11-30 U-3372 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207924-001 9089574 2032-11-30 U-3372 2022-05-26 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 208 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207924-001 I-891 2025-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207924-001 I-890 2025-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207924-002 I-891 2025-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207924-002 I-890 2025-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207924-003 I-891 2025-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207924-003 I-890 2025-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207924-001 I-891 2025-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207924-001 I-890 2025-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207924-002 I-891 2025-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207924-002 I-890 2025-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207924-003 I-891 2025-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207924-003 I-890 2025-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207924-001 I-891 2025-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207924-001 I-890 2025-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207924-002 I-891 2025-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207924-002 I-890 2025-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207924-003 I-891 2025-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207924-003 I-890 2025-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207924-001 I-891 2025-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207924-001 I-890 2025-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207924-002 I-891 2025-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207924-002 I-890 2025-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207924-003 I-891 2025-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207924-003 I-890 2025-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207924-001 I-891 2025-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207924-001 I-890 2025-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207924-002 I-891 2025-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207924-002 I-890 2025-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207924-003 I-891 2025-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207924-003 I-890 2025-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207924-001 I-891 2025-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207924-001 I-890 2025-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207924-002 I-891 2025-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207924-002 I-890 2025-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207924-003 I-891 2025-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207924-003 I-890 2025-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207924-001 I-891 2025-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207924-001 I-890 2025-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207924-002 I-891 2025-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207924-002 I-890 2025-06-13 5bbf6a4d5a75…
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.
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 · 25 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4182 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4479 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4479 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current 0002-4732 Olumiant baricitinib Eli Lilly and Company NDA Current