amphetamine · Neos Theraps Inc · NDA 204325

Adzenys Er

Earliest generic entry, as listed
28 Jun 2032

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 8709491, US 9017731, US 9265737.

Listed patents · 3 unexpired

PatentClaimsExpires
US 8709491drug product · sets the listed date28 Jun 2032
US 9017731drug product · sets the listed date28 Jun 2032
US 9265737drug product · sets the listed date28 Jun 2032

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 · 1

NDA · productFormStrengthListed expiry
204325 · 001 · RLD · discontinuedsuspension, extended release, oralEQ 1.25MG BASE/ML28 Jun 2032