Orange Book product · Brand (NDA)
WELIREG
BELZUTIFAN
At a glance
Aug 13, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 13, 2021
4 yr 11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 13, 2026
in 2 mo
Exclusivity ends · I-931
New indication exclusivity (3 years)
Dec 14, 2026
in 6 mo
Exclusivity ends · I-968
New indication exclusivity (3 years)
May 14, 2028
in 1 yr 11 mo
Exclusivity ends · ODE-364
Orphan-drug exclusivity (7 years)
Aug 13, 2028
in 2 yr 2 mo
Patent 9908845 expires
Listed drug substance patent expiration.
Sep 05, 2034
in 8 yr 4 mo
Patent 9908845 expires
Listed drug substance patent expiration.
Sep 05, 2034
in 8 yr 4 mo
Patent 9908845 expires
Listed drug substance patent expiration.
Sep 05, 2034
in 8 yr 4 mo
Patent RE49948 expires
Listed drug substance patent expiration.
Sep 05, 2034
in 8 yr 4 mo
Patent RE49948 expires
Listed drug substance patent expiration.
Sep 05, 2034
in 8 yr 4 mo
Patent RE49948 expires
Listed drug substance patent expiration.
Sep 05, 2034
in 8 yr 4 mo
Patent 12358870 expires
Listed drug product patent expiration.
Jun 30, 2042
in 16 yr 3 mo
Pharmaceutical detail
Active ingredient
BELZUTIFAN
Strength
40MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215383
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (4)
- NCENew chemical entity exclusivity (5 years)
Aug 13, 2026
in 2 mo
- I-931New indication exclusivity (3 years)
Dec 14, 2026
in 6 mo
- I-968New indication exclusivity (3 years)
May 14, 2028
in 1 yr 11 mo
- ODE-364Orphan-drug exclusivity (7 years)
Aug 13, 2028
in 2 yr 2 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9908845 | Sep 05, 2034 | in 8 yr 4 mo | SubstanceProductU-4195 |
| 9908845 | Sep 05, 2034 | in 8 yr 4 mo | SubstanceProductU-3201 |
| 9908845 | Sep 05, 2034 | in 8 yr 4 mo | SubstanceProductU-4176 |
| RE49948 | Sep 05, 2034 | in 8 yr 4 mo | SubstanceProductU-4195 |
| RE49948 | Sep 05, 2034 | in 8 yr 4 mo | SubstanceProductU-4176 |
| RE49948 | Sep 05, 2034 | in 8 yr 4 mo | SubstanceProductU-3201 |
| 12358870 | Jun 30, 2042 | in 16 yr 3 mo | Product |
