amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate · Takeda Pharms Usa · NDA 022063
Mydayis
Earliest generic entry, as listed · earliest of 4 marketed strengths
24 Aug 2029
Blocked by patent: US 8846100.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8846100 | drug product · sets the listed date | 24 Aug 2029 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022063 · 001 · RLD | capsule, extended release, oral | 3.125MG;3.125MG;3.125MG;3.125MG | 24 Aug 2029 |
| 022063 · 002 · RLD | capsule, extended release, oral | 6.25MG;6.25MG;6.25MG;6.25MG | 24 Aug 2029 |
| 022063 · 003 · RLD | capsule, extended release, oral | 9.375MG;9.375MG;9.375MG;9.375MG | 24 Aug 2029 |
| 022063 · 004 · RLD | capsule, extended release, oral | 12.5MG;12.5MG;12.5MG;12.5MG | 24 Aug 2029 |
Expired or delisted (1)
- US 9173857 · use U-2025 · 12 May 2026