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Last Updated: November 13, 2019

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. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the MYTESI profile page.

The generic ingredient in MYTESI is crofelemer. One supplier is listed for this compound. 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.

Pharmacology for NDA: 202292
Suppliers and Packaging for NDA: 202292
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYTESI crofelemer TABLET, DELAYED RELEASE;ORAL 202292 NDA Napo Pharmaceuticals, Inc. 70564-802 70564-802-60 60 TABLET, COATED in 1 BOTTLE (70564-802-60)

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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