Drybench Patent.
BELZUTIFAN, NDA 215383
The patents and exclusivities FDA's Orange Book lists for NDA 215383 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
Listed protection
Listed dates run from 13 Aug 2026 to 30 Jun 2042, each by its own rule; no one date stands for this product.
- Earliest listed date
- 13 Aug 2026NCE exclusivityRule R3 · Product 001 · exclusivity.txt line 1,557
- Latest listed date
- 30 Jun 2042US 12,358,870, product patentRule R1 · Product 001 · patent.txt line 16,819
- Latest substance patent
- 5 Sep 2034US RE49948, substance and product and use patentRule R1 · Product 001 · patent.txt line 16,827
- Latest listed patent
- 30 Jun 2042US 12,358,870, product patentRule R1 · Product 001 · patent.txt line 16,819
- Latest exclusivity
- 12 Jun 2029I-994 exclusivityRule R3 · Product 001 · exclusivity.txt line 1,556
9 use-code patents, blocking the coded use only
This page shows only the dates FDA lists. The app also shows NCE-1, the one date it computes, with its qualifications. Open in the app
Products
Each product number FDA lists under NDA 215383, as listed. The sections below name products by these numbers.
Product 001 · WELIREG
- Dosage form; route
- TABLET;ORAL
- Strength
- 40MG
- Approval date as listed
- 13 Aug 2021
- Type as listed
- RX
- Applicant as listed
- MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC
Listed patents
Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.
10 entries from 10 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 9,908,845, substance and product and use patent
patent.txt line 16,820- Expiry as listed
- 5 Sep 2034
- Rule
- R1
- Flags
- substance · product · use code U-3201
- Product numbers
- 001
US 9,908,845, substance and product and use patent
patent.txt line 16,821- Expiry as listed
- 5 Sep 2034
- Rule
- R1
- Flags
- substance · product · use code U-4176
- Product numbers
- 001
US 9,908,845, substance and product and use patent
patent.txt line 16,822- Expiry as listed
- 5 Sep 2034
- Rule
- R1
- Flags
- substance · product · use code U-4195
- Product numbers
- 001
US 9,908,845, substance and product and use patent
patent.txt line 16,823- Expiry as listed
- 5 Sep 2034
- Rule
- R1
- Flags
- substance · product · use code U-4565
- Product numbers
- 001
US RE49948, substance and product and use patent
patent.txt line 16,824- Expiry as listed
- 5 Sep 2034
- Rule
- R1
- Flags
- substance · product · use code U-3201
- Product numbers
- 001
US RE49948, substance and product and use patent
patent.txt line 16,825- Expiry as listed
- 5 Sep 2034
- Rule
- R1
- Flags
- substance · product · use code U-4176
- Product numbers
- 001
US RE49948, substance and product and use patent
patent.txt line 16,826- Expiry as listed
- 5 Sep 2034
- Rule
- R1
- Flags
- substance · product · use code U-4195
- Product numbers
- 001
US RE49948, substance and product and use patent
patent.txt line 16,827- Expiry as listed
- 5 Sep 2034
- Rule
- R1
- Flags
- substance · product · use code U-4565
- Product numbers
- 001
US 10,335,388, use patent
patent.txt line 16,818- Expiry as listed
- 14 Apr 2036
- Rule
- R1
- Flags
- use code U-4565
- Product numbers
- 001
US 12,358,870, product patent
patent.txt line 16,819- Expiry as listed
- 30 Jun 2042
- Rule
- R1
- Flags
- product
- Product numbers
- 001
Listed exclusivities
Each exclusivity FDA lists for NDA 215383, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
NCE exclusivity
exclusivity.txt line 1,557- Date
- 13 Aug 2026
- Rule
- R3
- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
I-931 exclusivity
exclusivity.txt line 1,554- Date
- 14 Dec 2026
- Rule
- R3
- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
I-968 exclusivity
exclusivity.txt line 1,555- Date
- 14 May 2028
- Rule
- R3
- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
ODE-364 exclusivity
exclusivity.txt line 1,558- Date
- 13 Aug 2028
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
I-994 exclusivity
exclusivity.txt line 1,556- Date
- 12 Jun 2029
- Rule
- R3
- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
Paragraph IV list rows giving NDA 215383
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 215383, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 215383
Belzutifan · Tablets · 40 mg
RLD/NDA as listed: Welireg 215383- First PIV submission
- 13 Aug 2025
- ANDAs
- 3
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Jun 2042
Notes from the trace
- R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.
Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week