Pharsight

1. Entresto patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP13750725A	2022-01-28	STADA Arzneimittel AG	Revoked
EP13750725A	2022-01-28	Generics [UK] Limited	Revoked
EP13750725A	2022-01-28	Algemeen Octrooi- en Merkenbureau B.V.	Revoked
EP13750725A	2022-01-27	Teva Pharmaceutical Industries Ltd	Revoked
EP13750725A	2022-01-27	Wuesthoff & Wuesthoff Patentanwälte PartG mbB	Revoked
EP13750725A	2022-01-26	Alfred E. Tiefenbacher (GmbH & Co. KG)	Revoked
EP10176094A	2021-04-15	Krka, d.d., Novo mesto	Granted and Under Opposition
EP10176094A	2021-04-15	betapharm Arzneimittel GmbH	Granted and Under Opposition
EP10176094A	2021-04-15	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Granted and Under Opposition
EP10176094A	2021-04-15	Alfred E. Tiefenbacher (GmbH & Co. KG)	Granted and Under Opposition
EP10176094A	2021-04-14	D Young & Co LLP	Granted and Under Opposition
EP10176094A	2021-04-14	STADA Arzneimittel AG	Granted and Under Opposition
EP10176094A	2021-04-07	Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi	Granted and Under Opposition
EP10176094A	2021-01-19	Generics [UK] Limited	Granted and Under Opposition
EP06827689A	2014-10-29	Maiwald Patentanwalts GmbH	Revoked
EP03704413A	2008-05-21	Mundipharma GmbH	Opposition procedure closed

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8101659	August, 2020	Terminated-Denied	Novartis Pharmaceuticals Corporation	Biocon Pharma Limited

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.
US8877938	NOVARTIS PHARMS CORP	Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations	May, 2027 (3 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).
US8796331	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jan, 2023 (8 months ago)
US8404744	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jan, 2023 (8 months ago)
US8404744 (Pediatric)	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jul, 2023 (2 months ago)
US8796331 (Pediatric)	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jul, 2023 (2 months ago)
US7468390	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Nov, 2023 (a month from now)
US7468390 (Pediatric)	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	May, 2024 (7 months from now)
US8101659	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jan, 2025 (1 year, 3 months from now)
US8101659 (Pediatric)	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jul, 2025 (1 year, 9 months from now)
US9388134	NOVARTIS PHARMS CORP	Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations	Nov, 2026 (3 years from now)
US9388134 (Pediatric)	NOVARTIS PHARMS CORP	Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations	May, 2027 (3 years from now)
US8877938 (Pediatric)	NOVARTIS PHARMS CORP	Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations	Nov, 2027 (4 years from now)
US9937143	NOVARTIS PHARMS CORP	Inhibitors for treating diseases characterized by atrial enlargement or remodeling	Aug, 2033 (9 years from now)
US9517226	NOVARTIS PHARMS CORP	Inhibitors for treating diseases characterized by atrial enlargement or remodeling	Aug, 2033 (9 years from now)
US11135192	NOVARTIS PHARMS CORP	Inhibitors for treating diseases characterized by atrial enlargement or remodeling	Aug, 2033 (9 years from now)
US11058667	NOVARTIS PHARMS CORP	Sacubitril-valsartan dosage regimen for treating heart failure	May, 2036 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M (M)	Feb 16, 2024
Pediatric Exclusivity (PED)	Apr 1, 2023

Drugs and Companies using SACUBITRIL; VALSARTAN ingredient

Market Authorisation Date: 07 July, 2015

Treatment: Treatment of heart failure; Treatment of heart failure with preserved ejection fraction; Treating chronic heart failure with reduced ejection fraction in patients not taking an ace inhibitor or an arb...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
24 mg/26 mg, 49 mg/51 mg 97 mg/103 mg	08 Jul, 2019	18		27 May, 2027

Strength	Dosage	Availability
24MG;26MG	TABLET;ORAL	Prescription
49MG;51MG	TABLET;ORAL	Prescription
97MG;103MG	TABLET;ORAL	Prescription

ENTRESTO family patents

2. Jadenu patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP14710654A	2019-07-31	INVOKAT Intellectual Property Services	Patent maintained as amended
EP14710654A	2019-07-30	HGF Limited	Patent maintained as amended
EP14710654A	2019-07-23	Teva Pharmaceutical Industries Ltd	Patent maintained as amended
EP16188627A	2018-09-20	HGF Limited	Granted and Under Opposition
EP16188627A	2018-09-20	Teva Pharmaceutical Industries Ltd.	Granted and Under Opposition

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9283209	NOVARTIS PHARMS CORP	Oral formulations of deferasirox	Nov, 2034 (11 years from now)