VUMERITY Drug Patent Profile
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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 forty-nine patent family members in twenty-five 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 has been one patent litigation case 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: | 49 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Clinical Trials: | 3 |
Patent Applications: | 88 |
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 |


DrugPatentWatch® Estimated Generic Entry Opportunity 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
Sponsor | Phase |
---|---|
Biogen | Phase 1 |
Biogen | Phase 3 |
Banner Life Sciences LLC | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for VUMERITY
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 See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS
Prodrugs of fumarates and their use in treating various diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Prodrugs of fumarates and their use in treating various diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Biogen Inc | VUMERITY | diroximel fumarate | CAPSULE, DELAYED RELEASE;ORAL | 211855-001 | Oct 29, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Biogen Inc | VUMERITY | diroximel fumarate | CAPSULE, DELAYED RELEASE;ORAL | 211855-001 | Oct 29, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
>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: See Plans and Pricing
Patent: 16222363
Estimated Expiration: See Plans and Pricing
Patent: 18200497
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2015022854
Estimated Expiration: See Plans and Pricing
Canada
Patent: 06580
Estimated Expiration: See Plans and Pricing
Patent: 92211
Estimated Expiration: See Plans and Pricing
Patent: 81513
Estimated Expiration: See Plans and Pricing
China
Patent: 5452213
Estimated Expiration: See Plans and Pricing
Patent: 7501110
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0181169
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 20529
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 70101
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 9873
Estimated Expiration: See Plans and Pricing
Patent: 1500926
Estimated Expiration: See Plans and Pricing
Patent: 1890239
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 70101
Estimated Expiration: See Plans and Pricing
Patent: 66668
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 12966
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 40044
Estimated Expiration: See Plans and Pricing
Patent: 200009
Estimated Expiration: See Plans and Pricing
Israel
Patent: 1440
Estimated Expiration: See Plans and Pricing
Patent: 0511
Estimated Expiration: See Plans and Pricing
Japan
Patent: 73353
Estimated Expiration: See Plans and Pricing
Patent: 87648
Estimated Expiration: See Plans and Pricing
Patent: 16520524
Estimated Expiration: See Plans and Pricing
Patent: 17149735
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 2022003
Estimated Expiration: See Plans and Pricing
Patent: 70101
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 6368
Estimated Expiration: See Plans and Pricing
Patent: 15011897
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 1337
Estimated Expiration: See Plans and Pricing
Patent: 3459
Estimated Expiration: See Plans and Pricing
Patent: 7435
Estimated Expiration: See Plans and Pricing
Patent: 1985
Estimated Expiration: See Plans and Pricing
Poland
Patent: 70101
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 70101
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 497
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 201707543P
Estimated Expiration: See Plans and Pricing
Patent: 201707547T
Estimated Expiration: See Plans and Pricing
Patent: 201710567S
Estimated Expiration: See Plans and Pricing
Patent: 201507371R
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 70101
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1814474
Estimated Expiration: See Plans and Pricing
Patent: 2085557
Estimated Expiration: See Plans and Pricing
Patent: 150131284
Estimated Expiration: See Plans and Pricing
Patent: 180003640
Estimated Expiration: See Plans and Pricing
Spain
Patent: 83355
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 6648
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
Croatia | P20181169 | See Plans and Pricing | |
Portugal | 2970101 | See Plans and Pricing | |
Spain | 2683355 | See Plans and Pricing | |
Eurasian Patent Organization | 029873 | ФУМАРАТЫ КАК ПРОЛЕКАРСТВА И ИХ ПРИМЕНЕНИЕ ПРИ ЛЕЧЕНИИ РАЗЛИЧНЫХ ЗАБОЛЕВАНИЙ (PRODRUGS OF FUMARATES AND THEIR USE IN TREATING VARIOUS DISEASES) | See Plans and Pricing |
>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 | See Plans and Pricing | PRODUCT NAME: DIROXIMELFUMARAT; NAT. REGISTRATION NO/DATE: EU/1/21/1585 20211115; FIRST REGISTRATION: SCHWEIZ 68066 20210920 |
2970101 | 2022C/507 | Belgium | See Plans and Pricing | PRODUCT NAME: DIROXIMEL FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/21/1585 20211116 |
2970101 | PA2022003 | Lithuania | See Plans and Pricing | PRODUCT NAME: DIROKSIMELIO FUMARATAS ; REGISTRATION NO/DATE: EU/1/21/1585 20211115 |
2970101 | CA 2022 00010 | Denmark | See Plans and Pricing | 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 |