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 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: | 91 |
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 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
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 ⤷ 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 |
---|---|---|---|
Mexico | 2015011897 | PROFARMACOS DE FUMARATOS Y SU USO EN EL TRATAMIENTO DE DIFERENTES ENFERMEDADES. (PRODRUGS OF FUMARATES AND THEIR USE IN TREATING VARIOUS DESEASES.) | ⤷ Try a Trial |
Poland | 2970101 | ⤷ Try a Trial | |
Eurasian Patent Organization | 201890239 | ФУМАРАТЫ КАК ПРОЛЕКАРСТВА И ИХ ПРИМЕНЕНИЕ ПРИ ЛЕЧЕНИИ РАЗЛИЧНЫХ ЗАБОЛЕВАНИЙ | ⤷ 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 | C202230010 | Spain | ⤷ Try a Trial | 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 | 122022000014 | Germany | ⤷ Try a Trial | PRODUCT NAME: DIROXIMELFUMARAT; NAT. REGISTRATION NO/DATE: EU/1/21/1585 20211115; FIRST REGISTRATION: SCHWEIZ 68066 20210920 |
2970101 | LUC00251 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DIROXIMEL FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/21/1585 20211116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |