Pharsight

1. Tecfidera patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP13169139A	2023-04-20	BIOGARAN	Granted and Under Opposition
EP13169139A	2023-04-20	Dr. Schön, Neymeyr & Partner Patentanwälte mbB	Granted and Under Opposition
EP13169139A	2023-04-19	Glenmark Pharmaceuticals Europe Ltd	Granted and Under Opposition
EP13169139A	2023-04-19	Kraus & Weisert Patentanwälte PartGmbB	Granted and Under Opposition
EP13169139A	2023-04-18	Accord Healthcare Ltd	Granted and Under Opposition
EP13169139A	2023-04-14	Adalvo Ltd.	Granted and Under Opposition
EP13169139A	2023-03-06	TEVA PHARMACEUTICAL INDUSTRIES, LTD.	Granted and Under Opposition
EP13169139A	2023-02-24	Stada-Arzneimittel Aktiengesellschaft	Granted and Under Opposition
EP13169139A	2022-10-10	G. L. Pharma GmbH	Granted and Under Opposition
EP13169139A	2022-09-23	Zentiva k.s.	Granted and Under Opposition
EP13169139A	2022-07-21	Polpharma S.A.	Granted and Under Opposition
EP13169139A	2022-07-21	Hexal AG	Granted and Under Opposition
EP13169139A	2022-07-20	neuraxpharm Arzneimittel GmbH	Granted and Under Opposition
EP13169139A	2022-07-20	Generics [UK] Limited (trading as Mylan)	Granted and Under Opposition
EP08725256A	2014-02-28	Actavis Group PTC ehf	Revoked
EP08725256A	2014-02-28	Synthon B.V.	Revoked
EP08725256A	2014-02-28	Forward Pharma A/S	Revoked
EP08725256A	2014-02-27	Generics [UK] Limited	Revoked
EP08725256A	2014-02-27	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Revoked
EP08725256A	2014-02-27	Gallafent, Antony Xavier	Revoked
EP08725256A	2014-02-26	European Opposition Limited	Revoked
EP08725256A	2014-02-21	G. L. Pharma GmbH	Revoked
EP08725256A	2014-02-13	Hexal AG	Revoked
EP08725256A	2014-02-05	Zentiva k.s.	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8399514	March, 2019	Terminated-Other	Biogen MA Inc.	Sawai USA, Inc.
US8399514	July, 2018	Final Written Decision on Remand	Biogen MA Inc.	Mylan Pharmaceuticals Inc. et al.
US8399514	September, 2015	FWD Entered	Biogen Idec MA Inc	Coalition For Affordable Drugs V LLC
US8399514	May, 2015	Terminated-Denied	Biogen MA Inc.	Coalition for Affordable Drugs V LLC

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).
US8399514	BIOGEN INC	Treatment for multiple sclerosis	Feb, 2028 (4 years from now)
US10994003	BIOGEN INC	Dimethyl fumarate and vaccination regimens	Mar, 2035 (11 years from now)
US10391160	BIOGEN INC	Dimethyl fumarate and vaccination regimens	Mar, 2035 (11 years from now)
US10555993	BIOGEN INC	Dimethyl fumarate and vaccination regimens	Mar, 2035 (11 years from now)
US11007167	BIOGEN INC	Methods of treating multiple sclerosis	Nov, 2035 (12 years from now)
US11246850	BIOGEN INC	Methods of treating multiple sclerosis	Nov, 2035 (12 years from now)
US10959972	BIOGEN INC	Methods of treating multiple sclerosis	Nov, 2035 (12 years from now)
US11129806	BIOGEN INC	Methods of treating multiple sclerosis	Nov, 2035 (12 years from now)
US11007166	BIOGEN INC	Methods of treating multiple sclerosis	Nov, 2035 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M (M)	Feb 5, 2023

Drugs and Companies using DIMETHYL FUMARATE ingredient

Market Authorisation Date: 27 March, 2013

Treatment: Method of treating multiple sclerosis; Method of treating relapsing forms of multiple sclerosis before and after administering an inactive vaccine

Dosage: CAPSULE, DELAYED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
120 mg and 240 mg	27 Mar, 2017	29	17 Aug, 2020	07 Feb, 2028	Deferred

Strength	Dosage	Availability
120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription
240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription

TECFIDERA family patents

2. Vumerity patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP14767892A	2019-03-06	Hexal AG	Granted and Under Opposition
EP14767892A	2019-03-06	Generics (UK) Ltd	Granted and Under Opposition
EP14767892A	2019-03-05	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition

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.
US8669281	BIOGEN INC	Prodrugs of fumarates and their use in treating various diseases	Sep, 2033 (9 years from now)
US10080733	BIOGEN INC	Prodrugs of fumarates and their use in treating various diseases	Sep, 2033 (9 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).
US9090558	BIOGEN INC	Prodrugs of fumarates and their use in treating various diseases	Sep, 2033 (9 years from now)