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 44 .
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 2 of 2 · 80 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 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…2021-03-12 10:30 UTC 2021-03 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 e64feba35796…2022-09-29 23:25 UTC 2022-09 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 15 · 587 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N211765-001 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 9833448 2031-11-10 U-2718 2020-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 10117836 2035-01-30 Drug product 2020-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 11925709 2035-01-30 Drug product 2024-04-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 12168004 2035-01-30 Drug product 2025-01-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 12220408 2035-01-30 Drug product 2025-03-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 12310953 2035-01-30 Drug product 2025-06-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 12458632 2035-01-30 Drug product 2025-11-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 12458633 2035-01-30 Drug product 2025-11-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 11717515 2041-12-22 U-3677 2023-09-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 11857542 2041-12-22 U-3786 2024-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 12194030 2041-12-22 U-4121 2025-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 12194030 2041-12-22 U-4122 2025-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-001 12329750 2041-12-22 U-4213 2025-07-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 9833448 2031-11-10 U-2718 2020-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 10117836 2035-01-30 Drug product 2020-01-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 11925709 2035-01-30 Drug product 2024-04-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 12168004 2035-01-30 Drug product 2025-01-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 12220408 2035-01-30 Drug product 2025-03-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 12310953 2035-01-30 Drug product 2025-06-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 12458632 2035-01-30 Drug product 2025-11-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 12458633 2035-01-30 Drug product 2025-11-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211765-002 12070450 2041-12-22 U-3992 2024-09-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211765-001 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 9833448 2031-11-10 U-2718 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 10117836 2035-01-30 Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 11925709 2035-01-30 Drug product 2024-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12168004 2035-01-30 Drug product 2025-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12220408 2035-01-30 Drug product 2025-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12310953 2035-01-30 Drug product 2025-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12458632 2035-01-30 Drug product 2025-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12458633 2035-01-30 Drug product 2025-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 11717515 2041-12-22 U-3677 2023-09-07 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 62 observed states.
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 · 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