Home Applications 215206 Application 215206
Type NDA
Sponsor ABBVIE INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QULIPTA ATOGEPANT TABLET;ORAL 10MG Yes No 002 QULIPTA ATOGEPANT TABLET;ORAL 30MG Yes No 003 QULIPTA ATOGEPANT TABLET;ORAL 60MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N215206-001 QULIPTA ATOGEPANT 10MG TABLET / ORAL RLD 2021-09-28 N215206-002 QULIPTA ATOGEPANT 30MG TABLET / ORAL RLD 2021-09-28 N215206-003 QULIPTA ATOGEPANT 60MG TABLET / ORAL RLD, RS 2021-09-28
Orange Book patents# Current patent rows page 1 of 1 · 22 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215206-001 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 N215206-001 9850246 2033-03-13 Drug substance 2021-10-26 N215206-001 10117836 2035-01-30 Drug product 2021-10-26 N215206-001 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 N215206-001 12383545 2039-06-06 U-3534 2025-09-09 N215206-001 12090148 2041-07-29 U-3534 2025-09-09 N215206-001 12465598 2042-09-27 U-4355 2025-12-10 N215206-001 12622897 2042-09-27 U-4536 2026-06-09 N215206-001 12350259 2043-02-27 U-4234 2025-08-06 N215206-002 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 N215206-002 9850246 2033-03-13 Drug substance 2021-10-26 N215206-002 10117836 2035-01-30 Drug product 2021-10-26 N215206-002 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 N215206-002 12383545 2039-06-06 U-3534 2025-09-09 N215206-002 12090148 2041-07-29 U-3534 2025-09-09 N215206-002 12622897 2042-09-27 U-4536 2026-06-09 N215206-003 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 N215206-003 9850246 2033-03-13 Drug substance 2021-10-26 N215206-003 10117836 2035-01-30 Drug product 2021-10-26 N215206-003 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 N215206-003 12383545 2039-06-06 U-3534 2025-09-09 N215206-003 12090148 2041-07-29 U-3534 2024-10-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 · 102 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 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 12 · 451 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 N215206-001 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 9850246 2033-03-13 Drug substance 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 10117836 2035-01-30 Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 12383545 2039-06-06 U-3534 2025-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 12090148 2041-07-29 U-3534 2025-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 12465598 2042-09-27 U-4355 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 12622897 2042-09-27 U-4536 2026-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 12350259 2043-02-27 U-4234 2025-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 9850246 2033-03-13 Drug substance 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 10117836 2035-01-30 Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 12383545 2039-06-06 U-3534 2025-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 12090148 2041-07-29 U-3534 2025-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 12622897 2042-09-27 U-4536 2026-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 9850246 2033-03-13 Drug substance 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 10117836 2035-01-30 Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 12383545 2039-06-06 U-3534 2025-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 12090148 2041-07-29 U-3534 2024-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215206-001 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 8754096 2032-07-19 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 9850246 2033-03-13 Drug substance 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 10117836 2035-01-30 Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 12383545 2039-06-06 U-3534 2025-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 12090148 2041-07-29 U-3534 2025-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 12465598 2042-09-27 U-4355 2025-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 12350259 2043-02-27 U-4234 2025-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 8754096 2032-07-19 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 9850246 2033-03-13 Drug substance 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 10117836 2035-01-30 Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 12383545 2039-06-06 U-3534 2025-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 12090148 2041-07-29 U-3534 2025-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-003 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-003 8754096 2032-07-19 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-003 9850246 2033-03-13 Drug substance 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-003 10117836 2035-01-30 Drug product 2021-10-26 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 171 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0074-7094 Qulipta Atogepant AbbVie Inc. NDA Current 0074-7094 Qulipta Atogepant AbbVie Inc. NDA Current 0074-7094 Qulipta Atogepant AbbVie Inc. NDA Current 0074-7095 Qulipta Atogepant AbbVie Inc. NDA Current 0074-7095 Qulipta Atogepant AbbVie Inc. NDA Current 0074-7095 Qulipta Atogepant AbbVie Inc. NDA Current 0074-7096 Qulipta Atogepant AbbVie Inc. NDA Current 0074-7096 Qulipta Atogepant AbbVie Inc. NDA Current 0074-7096 Qulipta Atogepant AbbVie Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 83627 SUPPL 2025-10-02 83622 SUPPL 2025-10-01 82549 SUPPL 2025-06-12 82548 SUPPL 2025-06-12 82533 SUPPL 2025-06-11 81716 SUPPL 2025-03-25 81697 SUPPL 2025-03-24 74017 SUPPL 2023-04-19 69181 ORIG 2021-11-01 68802 ORIG 2021-09-29 68801 ORIG 2021-09-29