Home Applications 215383 Application 215383
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 WELIREG BELZUTIFAN TABLET;ORAL 40MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215383-001 WELIREG BELZUTIFAN 40MG TABLET / ORAL RLD, RS 2021-08-13
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 N215383-001 9908845 2034-09-05 U-4565 Drug substance, Drug product 2021-09-09 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 N215383-001 RE49948 2034-09-05 U-4565 Drug substance, Drug product 2024-05-28 N215383-001 10335388 2036-04-14 U-4565 2026-07-08 N215383-001 12358870 2042-06-30 Drug product 2025-07-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 5 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.
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 2026-10-15 13:18:30 2026-09 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 142 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 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215383-001 9908845 2034-09-05 U-4565 Drug substance, Drug product 2021-09-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215383-001 RE49948 2034-09-05 U-4565 Drug substance, Drug product 2024-05-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215383-001 10335388 2036-04-14 U-4565 2026-07-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 9908845 2034-09-05 U-4565 Drug substance, Drug product 2021-09-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 RE49948 2034-09-05 U-4565 Drug substance, Drug product 2024-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 10335388 2036-04-14 U-4565 2026-07-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-4565 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-4565 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 10335388 2036-04-14 U-4565 2026-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 3 of 3 · 101 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-5331 WELIREG belzutifan Merck Sharp & Dohme Corp. NDA Current 0006-5331 WELIREG belzutifan Merck Sharp & Dohme LLC NDA Current