Orange Book product · Brand (NDA)
PREZCOBIX
COBICISTAT; DARUNAVIR ETHANOLATE
At a glance
Mar 21, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 21, 2025
1 yr 3 mo ago
Today
Patent 7700645 expires
Listed drug substance patent expiration.
Dec 26, 2026
in 6 mo
Patent 7700645*PED expires
Listed listed patent expiration.
Jun 26, 2027
in 1 yr
Patent 8148374 expires
Listed drug substance patent expiration.
Sep 03, 2029
in 3 yr 3 mo
Patent 10039718 expires
Listed drug product patent expiration.
Oct 06, 2032
in 6 yr 5 mo
Pharmaceutical detail
Active ingredient
COBICISTAT; DARUNAVIR ETHANOLATE
Strength
150MG;EQ 675MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 205395
Product number
002
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.
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7700645 | Dec 26, 2026 | in 6 mo | SubstanceProduct |
| 7700645*PED | Jun 26, 2027 | in 1 yr | |
| 8148374 | Sep 03, 2029 | in 3 yr 3 mo | SubstanceProductU-4162 |
| 10039718 | Oct 06, 2032 | in 6 yr 5 mo | Product |
