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Last Updated: January 23, 2020

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MYTESI Drug Profile

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Which patents cover Mytesi, and when can generic versions of Mytesi launch?

Mytesi is a drug marketed by Napo Pharms Inc and is included in one NDA. There are three patents protecting this drug.

This drug has forty-four patent family members in twenty-four countries.

The generic ingredient in MYTESI is crofelemer. Additional details are available on the crofelemer profile page.

US ANDA Litigation and Generic Entry Outlook for Mytesi

Mytesi was eligible for patent challenges on December 31, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 2, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MYTESI
International Patents:44
US Patents:3
Applicants:1
NDAs:1
Clinical Trials: 1
Drug Prices: Drug price information for MYTESI
DailyMed Link:MYTESI at DailyMed
Drug patent expirations by year for MYTESI
Drug Prices for MYTESI

See drug prices for MYTESI

Generic Entry Opportunity Date for MYTESI
Generic Entry Date for MYTESI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, 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 MYTESI

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

SponsorPhase
Napo Pharmaceuticals, Inc.Phase 4

See all MYTESI clinical trials

US Patents and Regulatory Information for MYTESI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Napo Pharms Inc MYTESI crofelemer TABLET, DELAYED RELEASE;ORAL 202292-001 Dec 31, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Napo Pharms Inc MYTESI crofelemer TABLET, DELAYED RELEASE;ORAL 202292-001 Dec 31, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Napo Pharms Inc MYTESI crofelemer TABLET, DELAYED RELEASE;ORAL 202292-001 Dec 31, 2012 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

Expired US Patents for MYTESI

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Napo Pharms Inc MYTESI crofelemer TABLET, DELAYED RELEASE;ORAL 202292-001 Dec 31, 2012   Start Trial   Start Trial
Napo Pharms Inc MYTESI crofelemer TABLET, DELAYED RELEASE;ORAL 202292-001 Dec 31, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Mallinckrodt
McKesson
Colorcon
Merck

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 verifification 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.