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Last Updated: September 30, 2022

BAFIERTAM Drug Patent Profile


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When do Bafiertam patents expire, and when can generic versions of Bafiertam launch?

Bafiertam is a drug marketed by Banner Life Sciences and is included in one NDA. There are nineteen patents protecting this drug.

This drug has twenty patent family members in seven countries.

The generic ingredient in BAFIERTAM is monomethyl fumarate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the monomethyl fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Bafiertam

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 10, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for BAFIERTAM
International Patents:20
US Patents:19
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 85
Clinical Trials: 3
Patent Applications: 1,782
Drug Prices: Drug price information for BAFIERTAM
What excipients (inactive ingredients) are in BAFIERTAM?BAFIERTAM excipients list
DailyMed Link:BAFIERTAM at DailyMed
Drug patent expirations by year for BAFIERTAM
Drug Prices for BAFIERTAM

See drug prices for BAFIERTAM

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BAFIERTAM
Generic Entry Date for BAFIERTAM*:
Constraining patent/regulatory exclusivity:
NDA:
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 BAFIERTAM

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

SponsorPhase
Banner Life Sciences LLCPhase 1

See all BAFIERTAM clinical trials

US Patents and Regulatory Information for BAFIERTAM

BAFIERTAM is protected by nineteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BAFIERTAM is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BAFIERTAM

Fumarate esters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Fumarate ester dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Fumarate ester pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Fumarate ester pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Fumarate ester pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Fumarate ester pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Controlled release fumarate esters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Controlled release fumarate esters
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Fumarate ester pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Fumarate ester pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Fumarate ester dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Fumarate ester dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Fumarate ester dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Fumarate ester pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

Fumarate ester dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Fumarate ester dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING MULTIPLE SCLEROSIS

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 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
>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 BAFIERTAM

When does loss-of-exclusivity occur for BAFIERTAM?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15222880
Estimated Expiration: See Plans and Pricing

Patent: 15328676
Estimated Expiration: See Plans and Pricing

Patent: 16253548
Estimated Expiration: See Plans and Pricing

Patent: 17204505
Estimated Expiration: See Plans and Pricing

Canada

Patent: 39990
Estimated Expiration: See Plans and Pricing

Patent: 62916
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 10408
Estimated Expiration: See Plans and Pricing

Patent: 01510
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 10408
Estimated Expiration: See Plans and Pricing

Patent: 01510
Estimated Expiration: See Plans and Pricing

Patent: 66487
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7326
Estimated Expiration: See Plans and Pricing

Patent: 1402
Estimated Expiration: See Plans and Pricing

Patent: 5752
Estimated Expiration: See Plans and Pricing

Spain

Patent: 13157
Estimated Expiration: See Plans and Pricing

Patent: 17584
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BAFIERTAM around the world.

Country Patent Number Title Estimated Expiration
Israel 275752 קפסולות רכות למעיים של פומאראט אסטרים עם שחרור מבוקר (Controlled release enteric soft capsules of fumarate esters) See Plans and Pricing
Canada 2962916 CAPSULES MOLLES ENTERIQUES A LIBERATION CONTROLEE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS) See Plans and Pricing
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
Canada 2939990 CAPSULES MOLLES ENTERIQUES A LIBERATION CONTROLEE D'ESTERS DE FUMARATE (CONTROLLED RELEASE ENTERIC SOFT CAPSULES OF FUMARATE ESTERS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2017151184 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Baxter
Express Scripts
Colorcon
Dow

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.