glycopyrrolate · Sumitomo Pharma Am · NDA 208437

Lonhala Magnair Kit

Earliest generic entry, as listed
7 Dec 2036

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

Blocked by patent: US 10744277.

Listed patents · 8 unexpired

PatentClaimsExpires
US 10744277drug product, use U-2941 · sets the listed date7 Dec 2036
US 10688518drug product12 Nov 2036
US 10376661drug product14 Sep 2035
US 9604018drug product16 May 2033
US 9168556drug product1 Sep 2032
US 9789270drug product30 Oct 2030
US 10940110drug product, use U-177326 Feb 2029
US 9265900drug product7 Dec 2028

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
208437 · 001 · RLD · discontinuedsolution, inhalation25MCG/ML7 Dec 2036
Expired or delisted (1)
  • US 11278683 · product · 16 Aug 2026