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Last Updated: January 27, 2023

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 nineteen 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:19
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 90
Clinical Trials: 10
Patent Applications: 5,158
What excipients (inactive ingredients) are in monomethyl fumarate?monomethyl fumarate excipients list
DailyMed Link:monomethyl fumarate at DailyMed
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
European Patent Office 3110408 CAPSULES MOLLES ENTÉRIQUES À LIBÉRATION CONTRÔLÉE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS) See Plans and Pricing
Spain 2817584 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2016057133 See Plans and Pricing
Spain 2713157 See Plans and Pricing
European Patent Office 3501510 CAPSULES ENTÉRIQUES MOLLES À LIBÉRATION CONTRÔLÉE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS) See Plans and Pricing
Denmark 3110408 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.