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 two 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:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 202292

Generic Entry Date for 202292^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	125MG
Approval Date:	Dec 31, 2012	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 31, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
Patent:	⤷ Sign Up	Patent Expiration:	Oct 31, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA

Expired US Patents for NDA 202292

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

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