cliffwatch

budesonide; formoterol fumarate; glycopyrrolate · Astrazeneca Ab · NDA 212122

Breztri Aerosphere

Earliest generic entry, as listed · earliest of 2 marketed strengths
5 Oct 2038

Blocked by patent: US 11331442, US 11833292.

Listed patents · 16 unexpired

PatentClaimsExpires
US 11331442product5 Oct 2038
US 11833292product5 Oct 2038
US 8815258use U-288917 Mar 2031
US 8815258use U-450317 Mar 2031
US 10716753product, use U-450328 May 2030
US 10716753product, use U-288928 May 2030
US 8324266use U-450328 May 2030
US 8324266use U-288928 May 2030
US 8703806use U-450328 May 2030
US 8703806use U-288928 May 2030
US 8808713product, use U-288928 May 2030
US 8808713product, use U-450328 May 2030
US 9415009use U-288928 May 2030
US 9415009use U-450328 May 2030
US 9463161product, use U-450328 May 2030
US 9463161product, use U-288928 May 2030

Exclusivities · 1 unexpired

NSnew strength27 Apr 2029

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 · 2

NDA · productFormStrengthListed expiry
212122 · 001 · RLDaerosol, metered, inhalation0.16MG/INH;0.0048MG/INH;0.009MG/INH5 Oct 2038
212122 · 002 · RLDaerosol, metered, inhalation0.16MG/INH;0.0048MG/INH;0.018MG/INH5 Oct 2038