Orange Book product · Brand (NDA)
GEMTESA
VIBEGRON
At a glance
Dec 23, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 2020
5 yr 7 mo ago
Today
Exclusivity ends · I-955
New indication exclusivity (3 years)
Dec 18, 2027
in 1 yr 6 mo
Patent 8653260 expires
Listed drug substance patent expiration.
Apr 02, 2029
in 2 yr 10 mo
Patent 12180219 expires
Listed drug substance patent expiration.
Mar 12, 2034
in 7 yr 10 mo
Patent 8247415 expires
Listed drug substance patent expiration.
Dec 23, 2034
in 8 yr 8 mo
Patent 8247415 expires
Listed drug substance patent expiration.
Dec 23, 2034
in 8 yr 8 mo
Patent 12102638 expires
Listed method-of-use patent (U-3045) expiration.
Mar 22, 2040
in 14 yr
Patent 12357636 expires
Listed method-of-use patent (U-4219) expiration.
Jul 06, 2042
in 16 yr 3 mo
Pharmaceutical detail
Active ingredient
VIBEGRON
Strength
75MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213006
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 (1)
- I-955New indication exclusivity (3 years)
Dec 18, 2027
in 1 yr 6 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8653260 | Apr 02, 2029 | in 2 yr 10 mo | Substance |
| 12180219 | Mar 12, 2034 | in 7 yr 10 mo | SubstanceProduct |
| 8247415 | Dec 23, 2034 | in 8 yr 8 mo | SubstanceProductU-4219 |
| 8247415 | Dec 23, 2034 | in 8 yr 8 mo | SubstanceProductU-3045 |
| 12102638 | Mar 22, 2040 | in 14 yr | U-3045 |
| 12357636 | Jul 06, 2042 | in 16 yr 3 mo | U-4219 |
