FDA Orange Book · active-ingredient family
Daclatasvir dihydrochloride
Daclatasvir dihydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DAKLINZA · NDA 206843
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAKLINZARLD×3 | BRISTOL-MYERS SQUIBB | NDA 206843 | — | Jul 24, 2015 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8900566 | Aug 08, 2027 | in 1 yr 2 mo | U-1725 |
| 9421192 | Aug 08, 2027 | in 1 yr 2 mo | SubstanceU-1725 |
| 8642025 | Aug 11, 2027 | in 1 yr 2 mo | SubstanceProductU-1724 |
| 8329159 | Jul 24, 2029 | in 3 yr 2 mo | Substance |
| 8629171 | Jun 13, 2031 | in 5 yr 1 mo | SubstanceProductU-1724 |
Daclatasvir dihydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
