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Crofelemer - Generic Drug Details

What are the generic drug sources for crofelemer and what is the scope of crofelemer freedom to operate?

Crofelemer is the generic ingredient in one branded drug marketed by Napo Pharms Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Crofelemer has forty patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for crofelemer

International Patents:	40
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	9
Clinical Trials:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for crofelemer
DailyMed Link:	crofelemer at DailyMed

Pharmacology for crofelemer

Drug Class	Antidiarrheal

Synonyms for crofelemer

148465-45-6
923916-82-9
AKOS016487279
D09VXM
Fulyzaq (TN)
MCULE-1910267022
MolPort-004-235-885
N-[(2-methoxyphenyl)methyl]-5-phenyl-1,2-oxazole-3-carboxamide
T5710449
Z164754034
ZINC9497828

US Patents and Regulatory Information for crofelemer

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Glossary

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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	➤ Sign Up	➤ Sign Up				➤ Sign Up
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up		Y		➤ Sign Up
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
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 crofelemer

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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

International Patents for crofelemer

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Country	Document Number	Estimated Expiration
Germany	69739394	➤ Sign Up
Russian Federation	2013123794	➤ Sign Up
Spain	2635435	➤ Sign Up
World Intellectual Property Organization (WIPO)	9816111	➤ Sign Up
South Africa	201303136	➤ Sign Up
Country	Document Number	Estimated Expiration