glucagon · Xeris · NDA 212097

Gvoke Pfs

Earliest generic entry, as listed
22 Apr 2036

Blocked by patent: US 11590205, US 9649364.

Listed patents · 2 unexpired

PatentClaimsExpires
US 11590205drug product, use U-2742 · sets the listed date22 Apr 2036
US 9649364drug product, use U-2742 · sets the listed date22 Apr 2036

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 · 2

NDA · productFormStrengthListed expiry
212097 · 001 · RLD · discontinuedsolution, subcutaneous0.5MG/0.1ML (0.5MG/0.1ML)22 Apr 2036
212097 · 002 · RLDsolution, subcutaneous1MG/0.2ML (1MG/0.2ML)22 Apr 2036