cliffwatch

isavuconazonium sulfate · Astellas · NDA 207500, 207501

Cresemba

Earliest generic entry, as listed · earliest of 3 marketed strengths
8 Jun 2031

Blocked by exclusivity: PED.

Listed patents · 2 unexpired

4 Orange Book listing rows for 2 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 10206879drug product14 Mar 2028
US 10206879 listing rowdrug product14 Sep 2027
US 10206879 listing rowpediatric extension14 Mar 2028
US 10603280drug product14 Mar 2028
US 10603280 listing rowdrug product14 Sep 2027
US 10603280 listing rowpediatric extension14 Mar 2028

Exclusivities · 7 unexpired

PEDpediatric (6 months added)8 Jun 2031
ODE-454orphan drug (7 years)8 Dec 2030
ODE-458orphan drug (7 years)8 Dec 2030
ODE-453orphan drug (7 years)8 Dec 2030
ODE-459orphan drug (7 years)8 Dec 2030
GAINqualified infectious disease product6 Sep 2027
PEDpediatric (6 months added)8 Jun 2027
NPPnew patient population8 Dec 2026

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

  • 24 Oct 2026Exclusivity expires within 90 days NPP · 207501-001
  • 24 Oct 2026Exclusivity expires within 90 days NPP · 207500-001
  • 24 Oct 2026Exclusivity expires within 90 days NPP · 207500-002

Products covered · 3

NDA · productFormStrengthListed expiry
207500 · 001 · RLDcapsule, oral186MG8 Jun 2031
207500 · 002 · RLDcapsule, oral74.5MG8 Jun 2031
207501 · 001 · RLDpowder, intravenous372MG8 Jun 2031
Expired or delisted (6)
  • US 6812238 · — · 30 Apr 2026
  • US 6812238 · substance · 31 Oct 2025
  • PED · 6 Sep 2022
  • ODE* · 6 Mar 2022
  • ODE-90 · 6 Mar 2022
  • ODE-305 · 6 Mar 2022