Pharsight

1. Akynzeo patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP14151676A	2016-07-20	Teva Pharmaceutical Industries Ltd	Opposition rejected

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6297375	HELSINN HLTHCARE	4-phenyl-pyridine derivatives	Mar, 2023 (6 months ago)
US9951016	HELSINN HLTHCARE	Crystalline forms of an NK-1 antagonist	Sep, 2035 (12 years from now)
US10961195	HELSINN HLTHCARE	Crystalline forms of an NK-1 antagonist	Sep, 2035 (12 years from now)
US10676440	HELSINN HLTHCARE	Crystalline forms of an NK-1 antagonist	Sep, 2035 (12 years from now)
US10233154	HELSINN HLTHCARE	Crystalline forms of an NK-1 antagonist	Sep, 2035 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11559523	HELSINN HLTHCARE	Compositions and methods for treating centrally mediated nausea and vomiting	Nov, 2030 (7 years from now)
US8951969	HELSINN HLTHCARE	Compositions and methods for treating centrally mediated nausea and vomiting	Nov, 2030 (7 years from now)
US9943515	HELSINN HLTHCARE	Compositions and methods for treating centrally mediated nausea and vomiting	Nov, 2030 (7 years from now)
US8623826	HELSINN HLTHCARE	Compositions and methods for treating centrally mediated nausea and vomiting	Nov, 2030 (7 years from now)
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)
US9271975	HELSINN HLTHCARE	Compositions and methods for treating centrally mediated nausea and vomiting	Sep, 2031 (7 years from now)

Drugs and Companies using NETUPITANT; PALONOSETRON HYDROCHLORIDE ingredient

Market Authorisation Date: 10 October, 2014

Treatment: Method of treating emesis; Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy...

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
300MG;EQ 0.5MG BASE	CAPSULE;ORAL	Prescription

AKYNZEO family patents

2. Akynzeo patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP14151676A	2016-07-20	Teva Pharmaceutical Industries Ltd	Opposition rejected

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9908907	HELSINN HLTHCARE	Substituted piperaziniums for the treatment of emesis	May, 2032 (8 years from now)
US10717721	HELSINN HLTHCARE	Substituted piperaziniums for the treatment of emesis	May, 2032 (8 years from now)
US8426450	HELSINN HLTHCARE	Substituted 4-phenyl pyridines having anti-emetic effect	May, 2032 (8 years from now)
US11312698	HELSINN HLTHCARE	Fosnetupitant chloride hydrochloride having improved stability	May, 2032 (8 years from now)
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 (8 years from now)
These drug 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)
US8895586	HELSINN HLTHCARE	Methods of treating emesis	May, 2032 (8 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 (8 years from now)
US11529362	HELSINN HLTHCARE	Physiologically balanced injectable formulations of fosnetupitant	Jun, 2037 (13 years from now)
US10624911	HELSINN HLTHCARE	Physiologically balanced injectable formulations of fosnetupitant	Jun, 2037 (13 years from now)

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

Drugs and Companies using FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE ingredient

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

AKYNZEO family patents

3. Aloxi patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP04706657A	2009-07-08	DR REDDYS LABORATORIES (UK) LIMITED	Revoked
EP04706657A	2009-07-08	White, Martin Paul	Revoked
EP04706657A	2009-07-08	Tecnimede Sociedade Tecnico-Medicinal, S.A.	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9173942	February, 2016	Terminated-Denied	Helsinn Healthcare S.A.	Dr. Reddy's Laboratories, Ltd
US8729094	July, 2015	Terminated-Denied	Helsinn Healthcare S.A.	Dr. Reddy's Laboratories, Ltd
US8729094	July, 2015	Terminated-Denied	Helsinn Healthcare S.A.	Dr. Reddy's Laboratories, Ltd.
US8598219	September, 2014	Terminated-Denied	Helsinn Healthcare S.A.	Accord Healthcare, Inc.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7947724	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US9066980	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US8729094	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US9457020	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US8518981	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US9439854	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US8598219	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US8598218	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US9457021	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US9125905	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US7960424	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US9173942	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US7947725	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jan, 2024 (4 months from now)
US7947724 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US7947725 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US7960424 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US8518981 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US8598218 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US9066980 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US9457021 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US8598219 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US9125905 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US8729094 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US9457020 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US9439854 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)
US9173942 (Pediatric)	HELSINN HLTHCARE	Liquid pharmaceutical formulations of palonosetron	Jul, 2024 (10 months from now)

Drugs and Companies using PALONOSETRON HYDROCHLORIDE ingredient

Market Authorisation Date: 25 July, 2003

Treatment: Prevention of chemotherapy-induced nausea and vomiting

Dosage: INJECTABLE;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.05 mg/mL, 1.5 mL and 5 mL vials	27 May, 2011	3	13 Oct, 2015	13 Apr, 2015	Extinguished

Strength	Dosage	Availability
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE;INTRAVENOUS	Discontinued
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE;INTRAVENOUS	Discontinued

ALOXI family patents

4. Truseltiq patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9067896	HELSINN HLTHCARE	Crystalline forms of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl) -phenylamino]-pyrimidin-4-yl}-1-methyl-urea and salts thereof	Aug, 2028 (4 years from now)
US8552002	HELSINN HLTHCARE	Compounds and compositions as protein kinase inhibitors	Aug, 2029 (5 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11160804	HELSINN HLTHCARE	Pharmaceutical dosage forms	Dec, 2034 (11 years from now)
US10278969	HELSINN HLTHCARE	Pharmaceutical dosage forms	Dec, 2034 (11 years from now)