Pharsight

1. List of Akynzeo drug patents

Application	Filing Date	Opposition Party	Legal Status
EP14151676A	2016-07-20	Teva Pharmaceutical Industries Ltd	Opposition rejected

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9403772	HELSINN HLTHCARE	4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a neurokinin receptor modulator	May, 2032 (9 years from now)
US9908907	HELSINN HLTHCARE	Substituted piperaziniums for the treatment of emesis	May, 2032 (9 years from now)
US10717721	HELSINN HLTHCARE	Substituted piperaziniums for the treatment of emesis	May, 2032 (9 years from now)
US11312698	HELSINN HLTHCARE	Fosnetupitant chloride hydrochloride having improved stability	May, 2032 (9 years from now)
US8426450	HELSINN HLTHCARE	Substituted 4-phenyl pyridines having anti-emetic effect	May, 2032 (9 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9186357	HELSINN HLTHCARE	Compositions and methods for treating centrally mediated nausea and vomiting	Nov, 2030 (7 years from now)
US10828297	HELSINN HLTHCARE	Compositions and methods for treating centrally mediated nausea and vomiting	Dec, 2030 (7 years from now)
US10208073	HELSINN HLTHCARE	Solution comprising the chloride hydrochloride salt of 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-IUM-(fosnetupitant) and palonosetron hydrochloride in combination with dexamethasone as a neurokinin receptor modulator	May, 2032 (9 years from now)
US8895586	HELSINN HLTHCARE	Methods of treating emesis	May, 2032 (9 years from now)
US10624911	HELSINN HLTHCARE	Physiologically balanced injectable formulations of fosnetupitant	Jun, 2037 (14 years from now)
US11529362	HELSINN HLTHCARE	Physiologically balanced injectable formulations of fosnetupitant	Jun, 2037 (14 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Apr 19, 2023

NCE-1 date: 2022-04-19

Market Authorisation Date: 19 April, 2018

Treatment: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy

Dosage: POWDER;INTRAVENOUS; SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
235 mg/0.25 mg per 20 mL	19 Apr, 2022	1		02 Jun, 2037

Strength	Dosage	Availability
EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription
EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription