cliffwatch

glycerol phenylbutyrate · Horizon Therap Us · NDA 203284

Ravicti

Earliest generic entry, as listed
22 Sep 2030

Blocked by patent: US 10045958, US 10045959, US 10183002, US 10183003, US 10183004, US 10183005, US 10183006, US 10668040, US 8642012, US 9254278, US 9326966, US 9561197, US 9962359, US 9999608. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 14 unexpired

PatentClaimsExpires
US 10045958use U-181622 Sep 2030
US 10045959use U-181622 Sep 2030
US 10183002use U-181622 Sep 2030
US 10183003use U-181622 Sep 2030
US 10183004use U-181622 Sep 2030
US 10183005use U-181622 Sep 2030
US 10183006use U-181622 Sep 2030
US 10668040use U-181622 Sep 2030
US 8642012use U-138322 Sep 2030
US 9254278use U-181622 Sep 2030
US 9326966use U-181622 Sep 2030
US 9561197use U-138322 Sep 2030
US 9962359use U-181622 Sep 2030
US 9999608use U-181622 Sep 2030

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

  • 25 Oct 2026Generic approved · 203284-001
  • 25 Oct 2026Generic approved · 203284-001
  • 25 Oct 2026Generic approved · 203284-001
  • 25 Oct 2026Generic approved · 203284-001
  • 25 Oct 2026Generic approved · 203284-001
  • 25 Oct 2026Generic approved · 203284-001

Products covered · 1

NDA · productFormStrengthListed expiry
203284 · 001 · RLDliquid, oral1.1GM/ML22 Sep 2030