Orange Book product · Brand (NDA)
IDVYNSO
DORAVIRINE; ISLATRAVIR
At a glance
Apr 20, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 20, 2026
2 mo ago
Today
Patent 7339053 expires
Listed drug substance patent expiration.
May 31, 2027
in 1 yr
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 20, 2031
in 4 yr 11 mo
Patent 8486975 expires
Listed drug substance patent expiration.
Aug 30, 2032
in 6 yr 3 mo
Pharmaceutical detail
Active ingredient
DORAVIRINE; ISLATRAVIR
Strength
100MG;0.25MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 216964
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Apr 20, 2031
in 4 yr 11 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7339053 | May 31, 2027 | in 1 yr | Substance |
| 8486975 | Aug 30, 2032 | in 6 yr 3 mo | SubstanceProductU-4527 |
