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 42.

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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215383-001	NCE	2026-08-13
N215383-001	I-931	2026-12-14
N215383-001	I-968	2028-05-14
N215383-001	ODE-364	2028-08-13
N215383-001	I-994	2029-06-12

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	RLD / RS	Approval date	Source SHA-256
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 · 122 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	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…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215383-001	RE49948	2034-09-05	U-4195	Drug substance, Drug product	2024-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215383-001	RE49948	2034-09-05	U-4176	Drug substance, Drug product	2024-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215383-001	RE49948	2034-09-05	U-3201	Drug substance, Drug product	2024-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215383-001	12358870	2042-06-30		Drug product	2025-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215383-001	9908845	2034-09-05	U-4195	Drug substance, Drug product	2021-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215383-001	9908845	2034-09-05	U-3201	Drug substance, Drug product	2021-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215383-001	9908845	2034-09-05	U-4176	Drug substance, Drug product	2021-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215383-001	RE49948	2034-09-05	U-4195	Drug substance, Drug product	2024-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215383-001	RE49948	2034-09-05	U-4176	Drug substance, Drug product	2024-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215383-001	RE49948	2034-09-05	U-3201	Drug substance, Drug product	2024-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215383-001	12358870	2042-06-30		Drug product	2025-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215383-001	9908845	2034-09-05	U-3201	Drug substance, Drug product	2021-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215383-001	9908845	2034-09-05	U-3780	Drug substance, Drug product	2021-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215383-001	RE49948	2034-09-05	U-3201	Drug substance, Drug product	2024-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215383-001	RE49948	2034-09-05	U-3780	Drug substance, Drug product	2024-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215383-001	9908845	2034-09-05	U-3201	Drug substance, Drug product	2021-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215383-001	9908845	2034-09-05	U-3780	Drug substance, Drug product	2021-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215383-001	RE49948	2034-09-05	U-3201	Drug substance, Drug product	2024-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215383-001	RE49948	2034-09-05	U-3780	Drug substance, Drug product	2024-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215383-001	9908845	2034-09-05	U-3201	Drug substance, Drug product	2021-09-09	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 91 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215383-001	NCE	2026-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215383-001	I-931	2026-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215383-001	I-968	2028-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215383-001	ODE-364	2028-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215383-001	I-994	2029-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215383-001	NCE	2026-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215383-001	I-931	2026-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215383-001	I-968	2028-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215383-001	ODE-364	2028-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215383-001	NCE	2026-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215383-001	I-931	2026-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215383-001	I-968	2028-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215383-001	ODE-364	2028-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215383-001	NCE	2026-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215383-001	I-931	2026-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215383-001	I-968	2028-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215383-001	ODE-364	2028-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215383-001	NCE	2026-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215383-001	I-931	2026-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215383-001	ODE-364	2028-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215383-001	NCE	2026-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215383-001	I-931	2026-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215383-001	ODE-364	2028-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215383-001	NCE	2026-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215383-001	I-931	2026-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215383-001	ODE-364	2028-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215383-001	NCE	2026-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215383-001	I-931	2026-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215383-001	ODE-364	2028-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215383-001	NCE	2026-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215383-001	I-931	2026-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215383-001	ODE-364	2028-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215383-001	NCE	2026-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215383-001	I-931	2026-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215383-001	ODE-364	2028-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215383-001	NCE	2026-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215383-001	I-931	2026-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215383-001	ODE-364	2028-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215383-001	NCE	2026-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215383-001	I-931	2026-12-14	`79d66fd596c7…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WELIREG	BELZUTIFAN	Merck Sharp & Dohme LLC	13e15ee0-d679-4fa9-9430-e2e2170474da	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215383 application number: NDA215383 ndc (product): 0006-5331

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85859	SUPPL	2026-05-11
82302	SUPPL	2025-05-23
82243	SUPPL	2025-05-14
82242	SUPPL	2025-05-14
81961	SUPPL	2025-04-24
81960	SUPPL	2025-04-24
81932	SUPPL	2025-04-21
81931	SUPPL	2025-04-21
77633	SUPPL	2024-03-12
77630	SUPPL	2024-03-12
76857	SUPPL	2023-12-15
76841	SUPPL	2023-12-15
76840	SUPPL	2023-12-15
68566	ORIG	2021-09-10
68375	ORIG	2021-08-16
68366	ORIG	2021-08-13
68363	ORIG	2021-08-13