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Last Updated: March 28, 2024

MONOMETHYL FUMARATE - Generic Drug Details


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What are the generic drug sources for monomethyl fumarate and what is the scope of patent protection?

Monomethyl fumarate is the generic ingredient in one branded drug marketed by Banner Life Sciences and is included in one NDA. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Monomethyl fumarate has nineteen patent family members in seven countries.

There are two drug master file entries for monomethyl fumarate. One supplier is listed for this compound.

Summary for MONOMETHYL FUMARATE
International Patents:19
US Patents:20
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 97
Clinical Trials: 10
Patent Applications: 5,215
What excipients (inactive ingredients) are in MONOMETHYL FUMARATE?MONOMETHYL FUMARATE excipients list
DailyMed Link:MONOMETHYL FUMARATE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MONOMETHYL FUMARATE
Generic Entry Date for MONOMETHYL 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 MONOMETHYL FUMARATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
BiogenPhase 3
Banner Life Sciences LLCPhase 1
Almirall, S.A.Phase 1

See all MONOMETHYL FUMARATE clinical trials

US Patents and Regulatory Information for MONOMETHYL FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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

International Patents for MONOMETHYL FUMARATE

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2015130998 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2017040272 ⤷  Try a Trial
European Patent Office 3766487 CAPSULES ENTÉRIQUES MOLLES À LIBÉRATION CONTRÔLÉE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS) ⤷  Try a Trial
Israel 247326 קפסולות רכות למעיים של פומאראט אסטרים עם שחרור מבוקר (Controlled release enteric soft capsules of fumarate esters) ⤷  Try a Trial
Spain 2713157 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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