You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 13, 2024

~ Buy the VUMERITY (diroximel fumarate) Drug Profile, 2024 PDF Report in the Report Store ~

VUMERITY Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

< Available with Subscription >

  Try a Trial

Drug patent expirations by year for VUMERITY
Drug Prices for VUMERITY

See drug prices for VUMERITY

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VUMERITY
Generic Entry Date for VUMERITY*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
BiogenPhase 1
BiogenPhase 3
Banner Life Sciences LLCPhase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VUMERITY is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Prodrugs of fumarates and their use in treating various diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Prodrugs of fumarates and their use in treating various diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Prodrugs of fumarates and their use in treating various diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 14239641
Estimated Expiration: ⤷  Try a Trial

Patent: 16222363
Estimated Expiration: ⤷  Try a Trial

Patent: 18200497
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015022854
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 06580
Estimated Expiration: ⤷  Try a Trial

Patent: 92211
Estimated Expiration: ⤷  Try a Trial

Patent: 81513
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5452213
Estimated Expiration: ⤷  Try a Trial

Patent: 7501110
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0181169
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20529
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 70101
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 9873
Estimated Expiration: ⤷  Try a Trial

Patent: 1500926
Estimated Expiration: ⤷  Try a Trial

Patent: 1890239
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 70101
Estimated Expiration: ⤷  Try a Trial

Patent: 66668
Estimated Expiration: ⤷  Try a Trial

Patent: 30264
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1011
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 12966
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 40044
Estimated Expiration: ⤷  Try a Trial

Patent: 200009
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 1440
Estimated Expiration: ⤷  Try a Trial

Patent: 0511
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 73353
Estimated Expiration: ⤷  Try a Trial

Patent: 87648
Estimated Expiration: ⤷  Try a Trial

Patent: 16520524
Estimated Expiration: ⤷  Try a Trial

Patent: 17149735
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 2022003
Estimated Expiration: ⤷  Try a Trial

Patent: 70101
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 6368
Estimated Expiration: ⤷  Try a Trial

Patent: 15011897
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1337
Estimated Expiration: ⤷  Try a Trial

Patent: 3459
Estimated Expiration: ⤷  Try a Trial

Patent: 7435
Estimated Expiration: ⤷  Try a Trial

Patent: 1985
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 70101
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 70101
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 497
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201707543P
Estimated Expiration: ⤷  Try a Trial

Patent: 201707547T
Estimated Expiration: ⤷  Try a Trial

Patent: 201710567S
Estimated Expiration: ⤷  Try a Trial

Patent: 201507371R
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 70101
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1814474
Estimated Expiration: ⤷  Try a Trial

Patent: 2085557
Estimated Expiration: ⤷  Try a Trial

Patent: 150131284
Estimated Expiration: ⤷  Try a Trial

Patent: 180003640
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 83355
Estimated Expiration: ⤷  Try a Trial

Patent: 55137
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 6648
Estimated Expiration: ⤷  Try a Trial

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
Lithuania PA2022003 ⤷  Try a Trial
Eurasian Patent Organization 201890239 ФУМАРАТЫ КАК ПРОЛЕКАРСТВА И ИХ ПРИМЕНЕНИЕ ПРИ ЛЕЧЕНИИ РАЗЛИЧНЫХ ЗАБОЛЕВАНИЙ ⤷  Try a Trial
China 107501110 富马酸酯前体药物及其在治疗多种疾病中的应用 (Prodrugs of fumarates and their use in treating various diseases) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VUMERITY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2970101 122022000014 Germany ⤷  Try a Trial PRODUCT NAME: DIROXIMELFUMARAT; NAT. REGISTRATION NO/DATE: EU/1/21/1585 20211115; FIRST REGISTRATION: SCHWEIZ 68066 20210920
2970101 22C1011 France ⤷  Try a Trial PRODUCT NAME: DIROXIMEL FUMARATE; NAT. REGISTRATION NO/DATE: EU/1/21/1585 20211116; FIRST REGISTRATION: CH - 68066 20210920
2970101 CA 2022 00010 Denmark ⤷  Try a Trial PRODUCT NAME: DIROXIMELFUMARAT; NAT. REG. NO/DATE: EU/1/21/1585 20211116; FIRST REG. NO/DATE: CH 68066 20210920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.