Orange Book product · Brand (NDA)
TECHNIVIE
OMBITASVIR; PARITAPREVIR; RITONAVIR
At a glance
Jul 24, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2015
11 yr 1 mo ago
Today
Patent 8642538 expires
Listed drug substance patent expiration.
Sep 10, 2029
in 3 yr 3 mo
Patent 9006387 expires
Listed method-of-use patent (U-1687) expiration.
Jun 10, 2030
in 4 yr
Patent 8420596 expires
Listed drug substance patent expiration.
Apr 10, 2031
in 4 yr 11 mo
Patent 9044480 expires
Listed method-of-use patent (U-1638) expiration.
Apr 10, 2031
in 4 yr 11 mo
Patent 8686026 expires
Listed drug product patent expiration.
Jun 09, 2031
in 5 yr 1 mo
Patent 8420596*PED expires
Listed listed patent expiration.
Oct 10, 2031
in 5 yr 5 mo
Patent 8691938 expires
Listed drug substance patent expiration.
Apr 13, 2032
in 5 yr 11 mo
Pharmaceutical detail
Active ingredient
OMBITASVIR; PARITAPREVIR; RITONAVIR
Strength
12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 207931
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8642538 | Sep 10, 2029 | in 3 yr 3 mo | SubstanceProductU-1638 |
| 9006387 | Jun 10, 2030 | in 4 yr | U-1687 |
| 8420596 | Apr 10, 2031 | in 4 yr 11 mo | SubstanceProduct |
| 9044480 | Apr 10, 2031 | in 4 yr 11 mo | U-1638 |
| 8686026 | Jun 09, 2031 | in 5 yr 1 mo | Product |
| 8420596*PED | Oct 10, 2031 | in 5 yr 5 mo | |
| 8691938 | Apr 13, 2032 | in 5 yr 11 mo | SubstanceProduct |
