FDA Orange Book · active-ingredient family
Elbasvir; grazoprevir
Elbasvir; grazoprevir is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ZEPATIER · NDA 208261
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZEPATIERRLD | MSD SUB MERCK | NDA 208261 | — | Jan 28, 2016 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7973040 | Jul 24, 2029 | in 3 yr 2 mo | SubstanceProductU-1813 |
| 8871759 | May 04, 2031 | in 4 yr 11 mo | SubstanceProductU-1813 |
Elbasvir; grazoprevir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
