telotristat etiprate · Tersera · NDA 208794

Xermelo

Earliest generic entry, as listed
28 Feb 2031

Blocked by patent: US 7709493.

Listed patents · 5 unexpired

PatentClaimsExpires
US 7709493drug substance, use U-1979 · sets the listed date28 Feb 2031
US 8193204drug substance27 Feb 2031
US 8653094use U-197919 Dec 2028
US 7553840drug substance11 Dec 2027
US 7968559use U-197911 Dec 2027

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
208794 · 001 · RLDtablet, oralEQ 250MG BASE28 Feb 2031