cocaine hydrochloride · Lxo Ireland · NDA 209963

Goprelto

Earliest generic entry, as listed
7 Feb 2037

Blocked by patent: US 10016407, US 10149843, US 10231961, US 10413505, US 10420760, US 10857095, US 10894012, US 10933060, US 10973811, US 10987347, US 11040032, US 9867815.

Listed patents · 12 unexpired

15 Orange Book listing rows for 12 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 10016407use U-2329 · sets the listed date7 Feb 2037
US 10149843use U-2478, U-24797 Feb 2037
US 10149843 listing rowuse U-2478 · sets the listed date7 Feb 2037
US 10149843 listing rowuse U-2479 · sets the listed date7 Feb 2037
US 10231961drug product · sets the listed date7 Feb 2037
US 10413505use U-2479 · sets the listed date7 Feb 2037
US 10420760use U-2478 · sets the listed date7 Feb 2037
US 10857095use U-3014 · sets the listed date7 Feb 2037
US 10894012use U-3014 · sets the listed date7 Feb 2037
US 10933060use U-3014 · sets the listed date7 Feb 2037
US 10973811use U-2226 · sets the listed date7 Feb 2037
US 10987347use U-2225 · sets the listed date7 Feb 2037
US 11040032drug product · sets the listed date7 Feb 2037
US 9867815use U-2225, U-2226, U-22277 Feb 2037
US 9867815 listing rowuse U-2225 · sets the listed date7 Feb 2037
US 9867815 listing rowuse U-2226 · sets the listed date7 Feb 2037
US 9867815 listing rowuse U-2227 · sets the listed date7 Feb 2037

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

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
209963 · 001 · RLDsolution, nasal4%7 Feb 2037