peramivir · Biocryst · NDA 206426

Rapivab

Earliest generic entry, as listed
7 May 2027

Blocked by patent: US 8778997. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 2 unexpired

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

PatentClaimsExpires
US 8778997use U-1627, U-2622, U-30697 May 2027
US 8778997 listing rowuse U-1627 · sets the listed date7 May 2027
US 8778997 listing rowuse U-2622 · sets the listed date7 May 2027
US 8778997 listing rowuse U-3069 · sets the listed date7 May 2027
US 10391075use U-2622, U-306912 Feb 2027
US 10391075 listing rowuse U-262212 Feb 2027
US 10391075 listing rowuse U-306912 Feb 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

  • Enters 12-month window basis: patent, carve-out possible · 206426-001Listed date 7 May 2027Detected 24 Oct 2026

Products covered · 1

NDA · productFormStrengthListed expiry
206426 · 001 · RLDsolution, intravenous200MG/20ML (10MG/ML)7 May 2027