Home Applications 211765 Application 211765
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 UBRELVY UBROGEPANT TABLET;ORAL 50MG Yes No 002 UBRELVY UBROGEPANT TABLET;ORAL 100MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N211765-001 UBRELVY UBROGEPANT 50MG TABLET / ORAL RLD 2019-12-23 N211765-002 UBRELVY UBROGEPANT 100MG TABLET / ORAL RLD, RS 2019-12-23
Orange Book patents# Current patent rows page 1 of 1 · 28 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211765-001 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 N211765-001 9833448 2031-11-10 U-2718 2020-01-21 N211765-001 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 N211765-001 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 N211765-001 10117836 2035-01-30 Drug product 2020-01-21 N211765-001 11925709 2035-01-30 Drug product 2024-04-10 N211765-001 12168004 2035-01-30 Drug product 2025-01-15 N211765-001 12220408 2035-01-30 Drug product 2025-03-12 N211765-001 12310953 2035-01-30 Drug product 2025-06-25 N211765-001 12458632 2035-01-30 Drug product 2025-11-04 N211765-001 12458633 2035-01-30 Drug product 2025-11-04 N211765-001 11717515 2041-12-22 U-3677 2023-09-07 N211765-001 11857542 2041-12-22 U-3786 2024-01-31 N211765-001 12194030 2041-12-22 U-4121 2025-02-11 N211765-001 12194030 2041-12-22 U-4122 2025-02-11 N211765-001 12329750 2041-12-22 U-4213 2025-07-16 N211765-002 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 N211765-002 9833448 2031-11-10 U-2718 2020-01-21 N211765-002 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 N211765-002 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 N211765-002 10117836 2035-01-30 Drug product 2020-01-21 N211765-002 11925709 2035-01-30 Drug product 2024-04-10 N211765-002 12168004 2035-01-30 Drug product 2025-01-15 N211765-002 12220408 2035-01-30 Drug product 2025-03-12 N211765-002 12310953 2035-01-30 Drug product 2025-06-25 N211765-002 12458632 2035-01-30 Drug product 2025-11-04 N211765-002 12458633 2035-01-30 Drug product 2025-11-04 N211765-002 12070450 2041-12-22 U-3992 2024-09-25
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 · 74 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 2026-02-19 14:30 UTC 2026-02 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 13 · 503 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211765-001 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 9833448 2031-11-10 U-2718 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 10117836 2035-01-30 Drug product 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 11925709 2035-01-30 Drug product 2024-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 12168004 2035-01-30 Drug product 2025-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 12220408 2035-01-30 Drug product 2025-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 12310953 2035-01-30 Drug product 2025-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 12458632 2035-01-30 Drug product 2025-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 12458633 2035-01-30 Drug product 2025-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 11717515 2041-12-22 U-3677 2023-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 11857542 2041-12-22 U-3786 2024-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 12194030 2041-12-22 U-4121 2025-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 12194030 2041-12-22 U-4122 2025-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-001 12329750 2041-12-22 U-4213 2025-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 9833448 2031-11-10 U-2718 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 10117836 2035-01-30 Drug product 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 11925709 2035-01-30 Drug product 2024-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 12168004 2035-01-30 Drug product 2025-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 12220408 2035-01-30 Drug product 2025-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 12310953 2035-01-30 Drug product 2025-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 12458632 2035-01-30 Drug product 2025-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 12458633 2035-01-30 Drug product 2025-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 12070450 2041-12-22 U-3992 2024-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 9833448 2031-11-10 U-2718 2020-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 10117836 2035-01-30 Drug product 2020-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 11925709 2035-01-30 Drug product 2024-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 12168004 2035-01-30 Drug product 2025-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 12220408 2035-01-30 Drug product 2025-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 12310953 2035-01-30 Drug product 2025-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 12458632 2035-01-30 Drug product 2025-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 12458633 2035-01-30 Drug product 2025-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 11717515 2041-12-22 U-3677 2023-09-07 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 62 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 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-6498 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6498 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6498 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6498 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6498 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6498 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6498 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6498 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6501 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6501 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6501 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6501 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6501 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6501 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6501 UBRELVY ubrogepant Allergan, Inc. NDA Current 0023-6501 UBRELVY ubrogepant Allergan, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82554 SUPPL 2025-06-13 82477 SUPPL 2025-06-06 81712 SUPPL 2025-03-25 81699 SUPPL 2025-03-24 73578 SUPPL 2023-02-21 73555 SUPPL 2023-02-17 66481 SUPPL 2021-03-04 61608 ORIG 2020-01-22 61456 ORIG 2019-12-26 61434 ORIG 2019-12-23