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Last Updated: June 23, 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-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Monomethyl fumarate has twenty 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:20
US Patents:21
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Australia 2017204505 Controlled release enteric soft capsules of fumarate esters ⤷  Sign Up
Canada 2962916 CAPSULES MOLLES ENTERIQUES A LIBERATION CONTROLEE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS) ⤷  Sign Up
Australia 2015328676 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2021142062 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2017040272 ⤷  Sign Up
Denmark 3110408 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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