Pharsight

1. Cialis patent expiration

Treatment: erectile dysfunction; Treatment of erectile dysfunction; Treatment of sexual dys...

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US6943166	June, 2018	Institution Denied	ICOS Corporation et al.	Aquestive Therapeutics, Inc.
US6943166	June, 2018	Terminated-Denied	ICOS Corporation	Aquestive Therapeutics, Inc.
US6943166	July, 2017	Terminated-Settled	ICOS Corporation	Dr. Reddy's Laboratories, Inc.
US6943166	July, 2017	Terminated-Settled	ICOS Corporation	Argentum Pharmaceuticals LLC
US6943166	November, 2016	Terminated-Settled	ICOS Corporation	Mylan Pharmaceuticals Inc.
US6943166	December, 2016	Institution Denied	ICOS Corporation et al.	MonoSol Rx, LLC
US6943166	December, 2016	Terminated-Denied	ICOS Corporation	MonoSol Rx, LLC
US6943166	February, 2016	Institution Denied	ICOS Corporation et al.	IntelGenx Corp.
US6943166	February, 2016	Terminated-Denied	ICOS Corporation	IntelGenx Corp.
US6821975	January, 2015	Final Written Decision	ICOS Corporation et al.	Actelion Pharmaceuticals Ltd
US6821975	January, 2015	FWD Entered	ICOS Corporation	Actelion Pharmaceuticals Ltd
US7182958	January, 2015	Final Written Decision	ICOS Corporation et al.	Actelion Pharmaceuticals Ltd
US7182958	January, 2015	FWD Entered	ICOS Corporation	Actelion Pharmaceuticals Ltd

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).
US6943166 (Pediatric)	LILLY	Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction	Oct, 2020 (5 years ago)
US6821975	LILLY	Beta-carboline drug products	Nov, 2020 (5 years ago)
US6140329	LILLY	Use of cGMP-phosphodiesterase inhibitors in methods and compositions to treat impotence	Jul, 2016 (9 years ago)
US7182958	LILLY	β-carboline pharmaceutical compositions	Apr, 2020 (5 years ago)
US5859006 (Pediatric)	LILLY	Tetracyclic derivatives; process of preparation and use	May, 2018 (7 years ago)
US6821975 (Pediatric)	LILLY	Beta-carboline drug products	May, 2021 (4 years ago)
US5859006	LILLY	Tetracyclic derivatives; process of preparation and use	Nov, 2017 (8 years ago)
US7182958 (Pediatric)	LILLY	β-carboline pharmaceutical compositions	Oct, 2020 (5 years ago)
US6943166	LILLY	Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction	Apr, 2020 (5 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-641)	Oct 06, 2014
New Indication(I-642)	Oct 06, 2014
M(M-219)	Feb 15, 2021
Pediatric Exclusivity(PED)	Aug 15, 2021

Market Authorisation Date: 07 January, 2008

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
2.5 mg	14 Oct, 2008	1	22 May, 2018	19 Nov, 2020	Eligible
5 mg, 10 mg and 20 mg	21 Nov, 2007	1	22 May, 2018	19 Nov, 2020	Eligible

Treatment: Treatment of erectile dysfunction

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.
US6656935	VIVUS LLC	Aromatic nitrogen-containing 6-membered cyclic compounds	Apr, 2025 (8 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7501409	VIVUS LLC	Preparations for oral administration	May, 2023 (2 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 27, 2017
New Dosing Schedule(D-140)	Sep 17, 2017
M(M-282)	Oct 18, 2025

NCE-1 date: 27 April, 2016

Market Authorisation Date: 27 April, 2012

Dosage: TABLET