Diroximel fumarate - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for diroximel fumarate and what is the scope of freedom to operate?
Diroximel fumarate
is the generic ingredient in two branded drugs marketed by Zydus and Biogen, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for diroximel fumarate
| International Patents: | 61 |
| US Patents: | 3 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 8 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for diroximel fumarate |
| What excipients (inactive ingredients) are in diroximel fumarate? | diroximel fumarate excipients list |
| DailyMed Link: | diroximel fumarate at DailyMed |
Recent Clinical Trials for diroximel fumarate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Lille | PHASE2 |
| Ministre de la Sant | PHASE2 |
| Rosetrees Trust | NA |
Anatomical Therapeutic Chemical (ATC) Classes for diroximel fumarate
Paragraph IV (Patent) Challenges for DIROXIMEL FUMARATE
| 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 diroximel fumarate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biogen | VUMERITY | diroximel fumarate | CAPSULE, DELAYED RELEASE;ORAL | 211855-001 | Oct 29, 2019 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Biogen | VUMERITY | diroximel fumarate | CAPSULE, DELAYED RELEASE;ORAL | 211855-001 | Oct 29, 2019 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | |
| Biogen | VUMERITY | diroximel fumarate | CAPSULE, DELAYED RELEASE;ORAL | 211855-001 | Oct 29, 2019 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | |
| Zydus | DIROXIMEL FUMARATE | diroximel fumarate | CAPSULE, DELAYED RELEASE;ORAL | 218596-001 | Nov 12, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 diroximel fumarate
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Biogen Netherlands B.V. | Vumerity | diroximel fumarate | EMEA/H/C/005437Vumerity 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 diroximel fumarate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2014239641 | ⤷ Start Trial | |
| Australia | 2016222363 | ⤷ Start Trial | |
| Australia | 2018200497 | ⤷ Start Trial | |
| Brazil | 112015022854 | ⤷ Start Trial | |
| Canada | 2906580 | ⤷ Start Trial | |
| Canada | 2992211 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for diroximel fumarate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2970101 | 2022/012 | Ireland | ⤷ Start Trial | PRODUCT NAME: DIROXIMEL FUMARATE; REGISTRATION NO/DATE: EU/1/21/1585/001 EU/1/21/1585/002 20211115 |
| 2970101 | PA2022003,C2970101 | Lithuania | ⤷ Start Trial | PRODUCT NAME: DIROKSIMELIO FUMARATAS ; REGISTRATION NO/DATE: EU/1/21/1585 20211115 |
| 2970101 | 8/2022 | Austria | ⤷ Start Trial | PRODUCT NAME: DIROXIMELFUMARAT; NAT. REGISTRATION NO/DATE: EU/1/21/1585 (MITTEILUNG) 20211116; FIRST REGISTRATION: LI 68066 (CH) 20210920 |
| 2970101 | PA2022003 | Lithuania | ⤷ Start Trial | PRODUCT NAME: DIROKSIMELIO FUMARATAS ; REGISTRATION NO/DATE: EU/1/21/1585 20211115 |
| 2970101 | 202240007 | Slovenia | ⤷ Start Trial | PRODUCT NAME: DIROXIMEL FUMARATE; NATIONAL AUTHORISATION NUMBER: EU/1/21/1585; DATE OF NATIONAL AUTHORISATION: 20211115; AUTHORITY FOR NATIONAL AUTHORISATION: EU; FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 68066; DATE OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 20210920; AUTHORITY OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: CH |
| 2970101 | C202230010 | Spain | ⤷ Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
