Orange Book product · Brand (NDA)
AZSTARYS
DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
At a glance
May 07, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 07, 2021
5 yr 2 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 07, 2026
1 mo ago
Today
Patent 9079928 expires
Listed drug product patent expiration.
May 07, 2035
in 9 yr
Patent 10584112 expires
Listed drug substance patent expiration.
Dec 09, 2037
in 11 yr 8 mo
Patent 10584113 expires
Listed drug product patent expiration.
Dec 09, 2037
in 11 yr 8 mo
Patent 10759778 expires
Listed drug product patent expiration.
Dec 09, 2037
in 11 yr 8 mo
Patent 10858341 expires
Listed method-of-use patent (U-3094) expiration.
Dec 09, 2037
in 11 yr 8 mo
Patent 10954213 expires
Listed method-of-use patent (U-3094) expiration.
Dec 09, 2037
in 11 yr 8 mo
Pharmaceutical detail
Active ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
Strength
EQ 5.2MG BASE;EQ 26.1MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 212994
Product number
001
Marketing status
RX
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.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
May 07, 2026
1 mo ago
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9079928 | May 07, 2035 | in 9 yr | Product |
| 10584112 | Dec 09, 2037 | in 11 yr 8 mo | SubstanceProduct |
| 10584113 | Dec 09, 2037 | in 11 yr 8 mo | Product |
| 10759778 | Dec 09, 2037 | in 11 yr 8 mo | Product |
| 10858341 | Dec 09, 2037 | in 11 yr 8 mo | U-3094 |
| 10954213 | Dec 09, 2037 | in 11 yr 8 mo | U-3094 |
