dexmethylphenidate hydrochloride; serdexmethylphenidate chloride · Commave Sub · NDA 212994
Azstarys
Earliest generic entry, as listed · earliest of 3 marketed strengths
9 Dec 2037
Blocked by patent: US 10584112, US 10584113, US 10759778, US 10858341, US 10954213.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10584112 | substance, product | 9 Dec 2037 |
| US 10584113 | product | 9 Dec 2037 |
| US 10759778 | product | 9 Dec 2037 |
| US 10858341 | use U-3094 | 9 Dec 2037 |
| US 10954213 | use U-3094 | 9 Dec 2037 |
| US 9079928 | product | 7 May 2035 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212994 · 001 · RLD | capsule, oral | EQ 5.2MG BASE;EQ 26.1MG BASE | 9 Dec 2037 |
| 212994 · 002 · RLD | capsule, oral | EQ 7.8MG BASE;EQ 39.2MG BASE | 9 Dec 2037 |
| 212994 · 003 · RLD | capsule, oral | EQ 10.4MG BASE;EQ 52.3MG BASE | 9 Dec 2037 |
Expired or delisted (1)
- NCE · 7 May 2026