aclidinium bromide; formoterol fumarate · Azurity · NDA 210595

Duaklir Pressair

Earliest generic entry, as listed
13 Mar 2029

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

Blocked by patent: US 10085974, US 11000517.

Listed patents · 2 unexpired

PatentClaimsExpires
US 10085974drug product, use U-2513 · sets the listed date13 Mar 2029
US 11000517drug product, use U-2513 · sets the listed date13 Mar 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 · 1

NDA · productFormStrengthListed expiry
210595 · 001 · RLD · discontinuedpowder, metered, inhalation0.4MG/INH;0.012MG/INH13 Mar 2029