cefiderocol sulfate tosylate · Shionogi · NDA 209445

Fetroja

Earliest generic entry, as listed
3 Sep 2035

Blocked by patent: US 10004750, US 9949982.

Listed patents · 5 unexpired

PatentClaimsExpires
US 10004750substance, product3 Sep 2035
US 9949982product3 Sep 2035
US 9238657substance, product, use U-28214 Nov 2033
US 9238657substance, product, use U-347014 Nov 2033
US 9238657substance, product, use U-347114 Nov 2033

Exclusivities · 1 unexpired

GAINqualified infectious disease product14 Nov 2029

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
209445 · 001 · RLDpowder, intravenousEQ 1GM BASE/VIAL3 Sep 2035
Expired or delisted (1)
  • NCE · 14 Nov 2024