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Last Updated: January 25, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202292

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NDA 202292 describes MYTESI, which is a drug marketed by Napo Pharms Inc and is included in one NDA. There are three patents protecting this drug. Additional details are available on the MYTESI profile page.

The generic ingredient in MYTESI is crofelemer. Additional details are available on the crofelemer profile page.
Summary for 202292
Tradename:MYTESI
Applicant:Napo Pharms Inc
Ingredient:crofelemer
Patents:3
Generic Entry Opportunity Date for 202292
Generic Entry Date for 202292*:
Constraining patent/regulatory exclusivity:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength125MG
Approval Date:Dec 31, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 2, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
Patent:  Start TrialPatent Expiration:Oct 31, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
Patent:  Start TrialPatent Expiration:Oct 31, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA

Expired US Patents for NDA 202292

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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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.