cliffwatch

netupitant; palonosetron hydrochloride · Helsinn Hlthcare · NDA 205718, 210493

Akynzeo

Earliest generic entry, as listed · earliest of 2 marketed strengths
25 Sep 2035

Other strengths are listed to 2 Jun 2037.

Blocked by patent: US 10233154, US 10676440, US 10961195, US 9951016.

Listed patents · 24 unexpired

PatentClaimsExpires
US 10624911product2 Jun 2037
US 11529362product2 Jun 2037
US 12208109product2 Jun 2037
US 10233154substance25 Sep 2035
US 10676440substance, product25 Sep 2035
US 10961195substance, product25 Sep 2035
US 9951016substance, product25 Sep 2035
US 10208073use U-230123 May 2032
US 10717721substance23 May 2032
US 11312698substance, product23 May 2032
US 8426450substance, product23 May 2032
US 8895586use U-230123 May 2032
US 9403772substance, use U-230123 May 2032
US 9908907substance, product23 May 2032
US 9271975use U-22939 Sep 2031
US 10828297use U-229317 Dec 2030
US 10828297use U-230117 Dec 2030
US 11559523product, use U-352218 Nov 2030
US 12042494product, use U-352218 Nov 2030
US 8623826use U-229318 Nov 2030
US 8951969product18 Nov 2030
US 9186357use U-230118 Nov 2030
US 9186357use U-229318 Nov 2030
US 9943515use U-229318 Nov 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

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 3

NDA · productFormStrengthListed expiry
205718 · 001 · RLDcapsule, oral300MG;EQ 0.5MG BASE25 Sep 2035
210493 · 001 · RLD · discontinuedpowder, intravenousEQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL2 Jun 2037
210493 · 002 · RLDsolution, intravenousEQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)2 Jun 2037