Viewing data from:

WELIREG

NDA

BELZUTIFAN | N215383 | MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC

1 strength4 unique patents5 unique exclusivities

Patent Timeline

4 unique patents, 5 exclusivities by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Sep. 5, 2034

Sep. 5, 2034

Apr. 14, 2036

Jun. 30, 2042

NCE

Aug. 13, 2026

I-931

Dec. 14, 2026

I-968

May. 14, 2028

ODE-364

Aug. 13, 2028

I-994

Jun. 12, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

22 trials from ClinicalTrials.gov — 10 recruiting, 11 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)NCT02861573	Phase 1/2	Active	Merck Sharp & Dohme LLC	1,200	2016-11-17 → 2028-07-24
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study NCT05899049	Phase 3	Active	Merck Sharp & Dohme LLC	251	2022-07-27 → 2027-04-22
Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)NCT04626518	Phase 1/2	Active	Merck Sharp & Dohme LLC	370	2020-12-17 → 2026-08-21
Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)NCT04626479	Phase 1/2	Active	Merck Sharp & Dohme LLC	400	2020-12-16 → 2026-08-21
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)NCT05468697	Phase 1/2	Active	Merck Sharp & Dohme LLC	60	2022-08-10 → 2026-10-22
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)NCT04736706	Phase 3	Active	Merck Sharp & Dohme LLC	1,854	2021-04-14 → 2027-04-22
A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)NCT04195750	Phase 3	Active	Merck Sharp & Dohme LLC	755	2020-02-27 → 2026-09-17
A Phase 2 Study of Belzutifan (PT2977, MK-6482) for the Treatment of Von Hippel Lindau (VHL) Disease-Associated Renal Cell Carcinoma (RCC) (MK-6482-004)NCT03401788	Phase 2	Active	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	50	2018-05-02 → 2027-04-29
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)NCT03634540	Phase 2	Active	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	118	2018-09-27 → 2027-02-26
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)NCT06428396	Phase 2	Active	Merck Sharp & Dohme LLC	120	2024-11-27 → 2028-12-25

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$22508.03

Highest Price

$29476.72

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00006-5331-01WELIREG 40MG TAB	$29476.72	FSS	Merck Sharp & Dohme LLC	05/31/2030
00006-5331-01WELIREG 40MG TAB	$22508.03	Big4	Merck Sharp & Dohme LLC	05/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Welireg (2024)

Total Spending

$205.5M

Total Claims

7,964

Beneficiaries

1,896

Avg Cost/Unit

$323.85

Spending Trend

$4.0M(2021)→$29.7M(2022)→$59.8M(2023)→$205.5M(2024)

YoY Change:-0.5%

5yr CAGR:+1.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

VALARY LAB PRIVATE LTDBELZUTIFAN

DMF 414232025

MSN LABORATORIES PRIVATE LTDBELZUTIFAN

DMF 414692025

APICORE LLCBELZUTIFAN

DMF 415152025

HETERO LABS LTDBELZUTIFAN PREMIX

DMF 419122025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 16, 2026	SUPPL -15	View Letter (PDF)
May 23, 2025	SUPPL -12	View Letter (PDF)
Apr 21, 2025	SUPPL -11	View Letter (PDF)
Apr 21, 2025	SUPPL -10	View Letter (PDF)
Mar 12, 2024	SUPPL -7	View Letter (PDF)
Dec 15, 2023	SUPPL -6	View Letter (PDF)
Aug 16, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

RLD

4 patents5 exclusivities▴

TABLET;ORAL | Approved: Aug 13, 2021

Patents (4) · 9 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE49948Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Sep 5, 2034	—	Yes	Yes		—
9908845Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Sep 5, 2034	—	Yes	Yes		—
10335388Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Apr 14, 2036	—	—	—		—
12358870	Jun 30, 2042	—	—	Yes	—	—

Exclusivities (5)

Code	Date	Status
I-931	Dec 14, 2026	< 1 year
I-968	May 14, 2028	Active
NCE	Aug 13, 2026	Expired
ODE-364	Aug 13, 2028	Active
I-994Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Jun 12, 2029	Active

Change History (1)

Recent changes detected for this application.

ADDED8/28/2026

Merck Sharp Dohme's WELIREG (belzutifan) received an orphan drug exclusivity designation (I-994) expiring Jun 2029, establishing a seven-year regulatory exclusivity period from FDA approval.

New: WELIREG (BELZUTIFAN) — exclusivity I-994 exp 06/12/2029