cliffwatch

rezafungin acetate · Mundipharma · NDA 217417

Rezzayo

Earliest generic entry, as listed
14 Jul 2038

Blocked by patent: US 11197909.

Listed patents · 7 unexpired

PatentClaimsExpires
US 11197909substance, product, use U-356614 Jul 2038
US 11819533substance, product, use U-356611 Jul 2038
US 11712459product, use U-356615 Mar 2037
US 8722619substance, product, use U-35669 May 2036
US 10702573substance, product, use U-356614 Mar 2033
US 9526835substance, product, use U-356614 Mar 2033
US 11654196substance, product, use U-35662 Mar 2032

Exclusivities · 4 unexpired

GAINqualified infectious disease product22 Mar 2035
GAINqualified infectious disease product22 Mar 2033
ODE-426orphan drug (7 years)22 Mar 2030
NCEnew chemical entity (5 years)22 Mar 2028

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
217417 · 001 · RLDpowder, intravenousEQ 200MG BASE/VIAL14 Jul 2038