FDA Orange Book · active-ingredient family
Dexmethylphenidate hydrochloride; serdexmethylphenidate chloride
Dexmethylphenidate hydrochloride; serdexmethylphenidate chloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AZSTARYS · NDA 212994
1
Brand (NDA)
0
Generics (ANDA)
6
Listed patents
3
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AZSTARYSRLD×3 | COMMAVE SUB | NDA 212994 | — | May 07, 2021 |
Marketing exclusivity (3)
- NCENew chemical entity exclusivity (5 years)
May 07, 2026
1 mo ago
- NCENew chemical entity exclusivity (5 years)
May 07, 2026
1 mo ago
- 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 |
| 10858341 | Dec 09, 2037 | in 11 yr 8 mo | U-3094 |
| 10954213 | Dec 09, 2037 | in 11 yr 8 mo | U-3094 |
| 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 |
Dexmethylphenidate hydrochloride; serdexmethylphenidate chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
