Orange Book product · Brand (NDA)
VIEKIRA XR
DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
At a glance
Jul 22, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
18
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 22, 2016
10 yr 1 mo ago
Today
Patent 8501238 expires
Listed drug substance patent expiration.
Sep 17, 2028
in 2 yr 3 mo
Patent 9139536 expires
Listed method-of-use patent (U-1753) expiration.
Nov 09, 2028
in 2 yr 5 mo
Patent 8188104 expires
Listed drug substance patent expiration.
May 17, 2029
in 2 yr 11 mo
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 8691938 expires
Listed drug substance patent expiration.
Apr 13, 2032
in 5 yr 11 mo
Patent 10201541 expires
Listed drug product patent expiration.
May 17, 2032
in 6 yr
Patent 10201584 expires
Listed method-of-use patent (U-1889) expiration.
May 17, 2032
in 6 yr
Patent 8466159 expires
Listed method-of-use patent (U-1637) expiration.
Sep 04, 2032
in 6 yr 4 mo
Patent 8492386 expires
Listed method-of-use patent (U-1840) expiration.
Sep 04, 2032
in 6 yr 4 mo
Patent 8680106 expires
Listed method-of-use patent (U-1637) expiration.
Sep 04, 2032
in 6 yr 4 mo
Patent 8685984 expires
Listed method-of-use patent (U-1840) expiration.
Sep 04, 2032
in 6 yr 4 mo
Patent 10105365 expires
Listed drug product patent expiration.
Jan 02, 2035
in 8 yr 8 mo
Patent 9333204 expires
Listed drug product patent expiration.
Jan 02, 2035
in 8 yr 8 mo
Patent 9744170 expires
Listed drug product patent expiration.
Jan 02, 2035
in 8 yr 8 mo
Pharmaceutical detail
Active ingredient
DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
Strength
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 208624
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 (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8501238 | Sep 17, 2028 | in 2 yr 3 mo | SubstanceProductU-1636 |
| 9139536 | Nov 09, 2028 | in 2 yr 5 mo | U-1753 |
| 8188104 | May 17, 2029 | in 2 yr 11 mo | SubstanceProductU-1636 |
| 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 |
| 8691938 | Apr 13, 2032 | in 5 yr 11 mo | SubstanceProduct |
| 10201541 | May 17, 2032 | in 6 yr | Product |
| 10201584 | May 17, 2032 | in 6 yr | U-1889 |
| 8466159 | Sep 04, 2032 | in 6 yr 4 mo | U-1637 |
| 8492386 | Sep 04, 2032 | in 6 yr 4 mo | U-1840 |
| 8680106 | Sep 04, 2032 | in 6 yr 4 mo | U-1637 |
| 8685984 | Sep 04, 2032 | in 6 yr 4 mo | U-1840 |
| 10105365 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-1889 |
| 9333204 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-1889 |
| 9744170 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-1889 |
