Orange Book product · Brand (NDA)
DAKLINZA
DACLATASVIR DIHYDROCHLORIDE
At a glance
Jul 24, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2015
11 yr 1 mo ago
Today
Patent 8900566 expires
Listed method-of-use patent (U-1725) expiration.
Aug 08, 2027
in 1 yr 2 mo
Patent 8900566 expires
Listed method-of-use patent (U-1724) expiration.
Aug 08, 2027
in 1 yr 2 mo
Patent 9421192 expires
Listed drug substance patent expiration.
Aug 08, 2027
in 1 yr 2 mo
Patent 9421192 expires
Listed drug substance patent expiration.
Aug 08, 2027
in 1 yr 2 mo
Patent 8642025 expires
Listed drug substance patent expiration.
Aug 11, 2027
in 1 yr 2 mo
Patent 8642025 expires
Listed drug substance patent expiration.
Aug 11, 2027
in 1 yr 2 mo
Patent 8329159 expires
Listed drug substance patent expiration.
Jul 24, 2029
in 3 yr 2 mo
Patent 8629171 expires
Listed drug substance patent expiration.
Jun 13, 2031
in 5 yr 1 mo
Pharmaceutical detail
Active ingredient
DACLATASVIR DIHYDROCHLORIDE
Strength
EQ 30MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 206843
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 (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8900566 | Aug 08, 2027 | in 1 yr 2 mo | U-1725 |
| 8900566 | Aug 08, 2027 | in 1 yr 2 mo | U-1724 |
| 9421192 | Aug 08, 2027 | in 1 yr 2 mo | SubstanceU-1725 |
| 9421192 | Aug 08, 2027 | in 1 yr 2 mo | SubstanceU-1724 |
| 8642025 | Aug 11, 2027 | in 1 yr 2 mo | SubstanceProductU-1724 |
| 8642025 | Aug 11, 2027 | in 1 yr 2 mo | SubstanceProductU-1725 |
| 8329159 | Jul 24, 2029 | in 3 yr 2 mo | Substance |
| 8629171 | Jun 13, 2031 | in 5 yr 1 mo | SubstanceProductU-1724 |
