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Last Updated: October 1, 2020

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BAFIERTAM Drug 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 fifteen patents protecting this drug.

This drug has seventeen 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.

US ANDA Litigation and Generic Entry Outlook for Bafiertam

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 27, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for BAFIERTAM
International Patents:17
US Patents:15
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 1
Drug Prices: Drug price information for BAFIERTAM
DailyMed Link:BAFIERTAM at DailyMed
Drug patent expirations by year for BAFIERTAM
Drug Prices for BAFIERTAM

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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

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

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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.