CROFELEMER - Generic Drug Details

What are the generic drug sources for crofelemer and what is the scope of patent protection?

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

Crofelemer has twenty-seven patent family members in twenty-one countries.

One supplier is listed for this compound.

Summary for CROFELEMER

International Patents:	27
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	13
What excipients (inactive ingredients) are in CROFELEMER?	CROFELEMER excipients list
DailyMed Link:	CROFELEMER at DailyMed

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

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 CROFELEMER

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

Sponsor	Phase
Napo Pharmaceuticals, Inc.	Phase 3
Beth Israel Deaconess Medical Center	Phase 4
The University of Texas Health Science Center, Houston	Phase 4

See all CROFELEMER clinical trials

Pharmacology for CROFELEMER

Drug Class

Antidiarrheal

US Patents and Regulatory Information for CROFELEMER

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

Expired US Patents for CROFELEMER

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
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012

International Patents for CROFELEMER

Country	Patent Number	Title	Estimated Expiration
Mexico	348184	MÉTODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH. (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA.)
Japan	2017019806	ＨＩＶ関連の下痢を治療するための方法および組成物 (METHOD AND COMPOSITION FOR TREATING HIV-RELATED DIARRHEA)
Canada	2816416	PROCEDES ET COMPOSITIONS POUR LE TRAITEMENT DE LA DIARRHEE ASSOCIEE AU HIV (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA)
Russian Federation	2597746	СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИЧ-АССОЦИИРОВАННОЙ ДИАРЕИ (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHOEA)
Ecuador	SP13012650	MÉTODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH
China	103370101	Methods and compositions for treating HIV-associated diarrhea
World Intellectual Property Organization (WIPO)	2012058664