Home Applications 212608 Application 212608
Type NDA
Sponsor BLUEPRINT MEDICINES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AYVAKIT AVAPRITINIB TABLET;ORAL 100MG Yes No 002 AYVAKIT AVAPRITINIB TABLET;ORAL 200MG Yes No 003 AYVAKIT AVAPRITINIB TABLET;ORAL 300MG Yes Yes 004 AYVAKIT AVAPRITINIB TABLET;ORAL 25MG Yes No 005 AYVAKIT AVAPRITINIB TABLET;ORAL 50MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212608-001 AYVAKIT AVAPRITINIB 100MG TABLET / ORAL RLD 2020-01-09 N212608-002 AYVAKIT AVAPRITINIB 200MG TABLET / ORAL RLD 2020-01-09 N212608-003 AYVAKIT AVAPRITINIB 300MG TABLET / ORAL RLD, RS 2020-01-09 N212608-004 AYVAKIT AVAPRITINIB 25MG TABLET / ORAL RLD 2021-06-16 N212608-005 AYVAKIT AVAPRITINIB 50MG TABLET / ORAL RLD 2021-06-16
Orange Book patents# Current patent rows page 1 of 1 · 39 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212608-001 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-001 9200002 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-001 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-001 9944651 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-001 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-001 9994575 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-001 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 N212608-001 11999744 2040-04-10 U-3168 2024-06-05 N212608-001 12060354 2042-03-08 U-2726 2024-08-14 N212608-002 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-002 9200002 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-002 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-002 9944651 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-002 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-002 9994575 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 N212608-002 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 N212608-002 11999744 2040-04-10 U-3168 2024-06-05 N212608-002 12060354 2042-03-08 U-2726 2024-08-14 N212608-003 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-003 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-003 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 N212608-003 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 N212608-003 12060354 2042-03-08 U-2726 2024-08-14 N212608-004 11827642 2034-10-15 U-3506 Drug substance, Drug product 2023-12-21 N212608-004 9200002 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-004 9200002 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 N212608-004 9944651 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-004 9944651 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 N212608-004 9994575 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-004 9994575 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 N212608-004 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 N212608-004 11999744 2040-04-10 U-3168 2024-06-05 N212608-004 11999744 2040-04-10 U-3506 2024-06-05 N212608-004 12252494 2040-04-10 U-3506 2025-04-16 N212608-005 9200002 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-005 9944651 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-005 9994575 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 N212608-005 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 N212608-005 11999744 2040-04-10 U-3168 2024-06-05
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 16 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 5 · 187 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 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212608-001 AYVAKIT 100MG TABLET / ORAL RLD 2020-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212608-002 AYVAKIT 200MG TABLET / ORAL RLD 2020-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212608-003 AYVAKIT 300MG TABLET / ORAL RLD, RS 2020-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212608-004 AYVAKIT 25MG TABLET / ORAL RLD 2021-06-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212608-005 AYVAKIT 50MG TABLET / ORAL RLD 2021-06-16 03ed91905a0d…
Observed Orange Book patent history# Patent history page 1 of 27 · 1,069 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 N212608-001 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 9200002 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 9944651 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 9994575 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 11999744 2040-04-10 U-3168 2024-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-001 12060354 2042-03-08 U-2726 2024-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9200002 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9944651 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 9994575 2034-10-15 U-3168 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 11999744 2040-04-10 U-3168 2024-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-002 12060354 2042-03-08 U-2726 2024-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 9944651 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 9994575 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-003 12060354 2042-03-08 U-2726 2024-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 11827642 2034-10-15 U-3506 Drug substance, Drug product 2023-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9200002 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9200002 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9944651 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9944651 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9994575 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 9994575 2034-10-15 U-3506 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 11999744 2040-04-10 U-3168 2024-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 11999744 2040-04-10 U-3506 2024-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-004 12252494 2040-04-10 U-3506 2025-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 9200002 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 9944651 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 9994575 2034-10-15 U-3168 Drug substance, Drug product 2021-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 11964980 2040-04-10 Drug substance, Drug product 2024-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212608-005 11999744 2040-04-10 U-3168 2024-06-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212608-001 9200002 2034-10-15 U-2726 Drug substance, Drug product 2020-02-05 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 22 · 860 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 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72064-110 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-110 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-110 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-120 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-120 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-120 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-125 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-125 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-130 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-130 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-130 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-150 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current 72064-150 Ayvakit avapritinib Blueprint Medicines Corporation NDA Current