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VUMERITY Drug Patent Profile

Which patents cover Vumerity, and when can generic versions of Vumerity launch?

Vumerity is a drug marketed by Biogen Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-two patent family members in twenty-six countries.

The generic ingredient in VUMERITY is diroximel fumarate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the diroximel fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vumerity

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 20, 2033. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VUMERITY

International Patents:	52
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	3
Patent Applications:	86
Drug Prices:	Drug price information for VUMERITY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VUMERITY
What excipients (inactive ingredients) are in VUMERITY?	VUMERITY excipients list
DailyMed Link:	VUMERITY at DailyMed

See drug prices for VUMERITY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VUMERITY

NDA:

211855

Dosage:

CAPSULE, DELAYED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VUMERITY

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Biogen	Phase 1
Biogen	Phase 3
Banner Life Sciences LLC	Phase 1

See all VUMERITY clinical trials

Paragraph IV (Patent) Challenges for VUMERITY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VUMERITY	Delayed-release Capsules	diroximel fumarate	231 mg	211855	1	2020-12-23

US Patents and Regulatory Information for VUMERITY

VUMERITY is protected by three US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VUMERITY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biogen Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855-001	Oct 29, 2019		RX	Yes	Yes
Biogen Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855-001	Oct 29, 2019		RX	Yes	Yes			Y	Y
Biogen Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855-001	Oct 29, 2019		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for VUMERITY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Biogen Netherlands B.V.	Vumerity	diroximel fumarate	EMEA/H/C/005437 Vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see Section 5.1 for important information on the populations for which efficacy has been established).	Authorised	no	no	no	2021-11-15

International Patents for VUMERITY

When does loss-of-exclusivity occur for VUMERITY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VUMERITY around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018200497	PRODRUGS OF FUMARATES AND THEIR USE IN TREATING VARIOUS DISEASES
European Patent Office	2970101	PROMÉDICAMENTS DE FUMARATES ET LEUR UTILISATION POUR LE TRAITEMENT DE DIVERSES MALADIES (PRODRUGS OF FUMARATES AND THEIR USE IN TREATING VARIOUS DESEASES)
Slovenia	2970101
Singapore	10201710567S	PRODRUGS OF FUMARATES AND THEIR USE IN TREATING VARIOUS DISEASES
Hungary	E040044
Canada	2906580	PROMEDICAMENTS DE FUMARATES ET LEUR UTILISATION POUR LE TRAITEMENT DE DIVERSES MALADIES (PRODRUGS OF FUMARATES AND THEIR USE IN TREATING VARIOUS DESEASES)
Canada	2992211	PROMEDICAMENTS DE FUMARATES ET LEUR UTILISATION POUR LE TRAITEMENT DE DIVERSES MALADIES (PRODRUGS OF FUMARATES AND THEIR USE IN TREATING VARIOUS DISEASES)

Supplementary Protection Certificates for VUMERITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2970101	CA 2022 00010	Denmark		PRODUCT NAME: DIROXIMELFUMARAT; NAT. REG. NO/DATE: EU/1/21/1585 20211116; FIRST REG. NO/DATE: CH 68066 20210920
2970101	PA2022003,C2970101	Lithuania		PRODUCT NAME: DIROKSIMELIO FUMARATAS ; REGISTRATION NO/DATE: EU/1/21/1585 20211115
2970101	C202230010	Spain		PRODUCT NAME: FUMARATO DE DIROXIMEL; NATIONAL AUTHORISATION NUMBER: EU/1/21/1585; DATE OF AUTHORISATION: 20211115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 68066; DATE OF FIRST AUTHORISATION IN EEA: 20210920
2970101	2290010-4	Sweden		PRODUCT NAME: DIROXIMELFUMARAT; NAT. REG. NO/DATE: EU/1/21/1585 20211116; FIRST REG.: CH 68066 20210920
2970101	122022000014	Germany		PRODUCT NAME: DIROXIMELFUMARAT; NAT. REGISTRATION NO/DATE: EU/1/21/1585 20211115; FIRST REGISTRATION: SCHWEIZ 68066 20210920
2970101	301165	Netherlands		PRODUCT NAME: DIROXIMELFUMARAAT; REGISTRATION NO/DATE: 68066 20210920
2970101	2022C/507	Belgium		PRODUCT NAME: DIROXIMEL FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/21/1585 20211116