lisdexamfetamine dimesylate · Azurity · NDA 219847

Arynta

Earliest generic entry, as listed
30 Aug 2040

Blocked by patent: US 11576878.

Listed patents · 3 unexpired

PatentClaimsExpires
US 11576878drug product · sets the listed date30 Aug 2040
US 12433859drug product, use U-84216 Apr 2040
US 12582620drug product16 Apr 2040

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
219847 · 001 · RLDsolution, oral10MG/ML30 Aug 2040