DIROXIMEL FUMARATE - Generic Drug Details
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What are the generic sources for diroximel fumarate and what is the scope of freedom to operate?
Diroximel fumarate
is the generic ingredient in one branded drug marketed by Biogen Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Diroximel fumarate has fifty-two patent family members in twenty-six countries.
There is one drug master file entry for diroximel fumarate. One supplier is listed for this compound.
Summary for DIROXIMEL FUMARATE
| International Patents: | 52 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 5 |
| Patent Applications: | 155 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DIROXIMEL FUMARATE
Generic Entry Date for DIROXIMEL FUMARATE*:
Constraining patent/regulatory exclusivity:
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 DIROXIMEL FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Biogen | Phase 2 |
| Biogen | Phase 1 |
| Biogen | Phase 3 |
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 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 | ⤷ 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 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/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 DIROXIMEL FUMARATE
| 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 |
| Spain | 2683355 | ⤷ Try a Trial | |
| Brazil | 112015022854 | pró-farmacos de fumaratos e uso do mesmo no tratamento de várias doenças | ⤷ Try a Trial |
| Japan | 2017149735 | フマル酸エステルのプロドラッグおよび種々の疾患の治療におけるその使用 (PRODRUGS OF FUMARATES AND THEIR USE IN TREATING VARIOUS DISEASES) | ⤷ Try a 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 | 8/2022 | Austria | ⤷ Try a Trial | PRODUCT NAME: DIROXIMELFUMARAT; NAT. REGISTRATION NO/DATE: EU/1/21/1585 (MITTEILUNG) 20211116; FIRST REGISTRATION: LI 68066 (CH) 20210920 |
| 2970101 | PA2022003 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DIROKSIMELIO FUMARATAS ; REGISTRATION NO/DATE: EU/1/21/1585 20211115 |
| 2970101 | LUC00251 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DIROXIMEL FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/21/1585 20211116 |
| 2970101 | PA2022003,C2970101 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DIROKSIMELIO FUMARATAS ; REGISTRATION NO/DATE: EU/1/21/1585 20211115 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
