FDA Orange Book · active-ingredient family
Dasabuvir sodium; ombitasvir; paritaprevir; ritonavir
Dasabuvir sodium; ombitasvir; paritaprevir; ritonavir is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VIEKIRA XR · NDA 208624
1
Brand (NDA)
0
Generics (ANDA)
18
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VIEKIRA XRRLD | ABBVIE | NDA 208624 | — | Jul 22, 2016 |
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 |
| 9044480 | Apr 10, 2031 | in 4 yr 11 mo | U-1638 |
| 8420596 | Apr 10, 2031 | in 4 yr 11 mo | SubstanceProduct |
| 8686026 | Jun 09, 2031 | in 5 yr 1 mo | Product |
| 8691938 | Apr 13, 2032 | in 5 yr 11 mo | SubstanceProduct |
| 10201584 | May 17, 2032 | in 6 yr | U-1889 |
| 10201541 | May 17, 2032 | in 6 yr | Product |
| 8466159 | Sep 04, 2032 | in 6 yr 4 mo | U-1637 |
| 8685984 | Sep 04, 2032 | in 6 yr 4 mo | U-1840 |
| 8680106 | Sep 04, 2032 | in 6 yr 4 mo | U-1637 |
| 8492386 | Sep 04, 2032 | in 6 yr 4 mo | U-1840 |
| 9333204 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-1889 |
| 9744170 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-1889 |
| 10105365 | Jan 02, 2035 | in 8 yr 8 mo | ProductU-1889 |
Dasabuvir sodium; ombitasvir; paritaprevir; ritonavir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
