Crofelemer - Generic Drug Details

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What are the generic sources for crofelemer and what is the scope of 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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for crofelemer

International Patents:	45
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	13
Patent Applications:	6,286
What excipients (inactive ingredients) are in crofelemer?	crofelemer excipients list
DailyMed Link:	crofelemer at DailyMed

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

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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	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for crofelemer

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Country	Patent Number	Title	Estimated Expiration
China	103370101	Methods and compositions for treating HIV-associated diarrhea	See Plans and Pricing
Brazil	112013010774	"usos de crofelemer no tratamento de diarreia associada ao hiv"	See Plans and Pricing
World Intellectual Property Organization (WIPO)	2012058664		See Plans and Pricing
Australia	4988197		See Plans and Pricing
Japan	2013540826		See Plans and Pricing
European Patent Office	2255661		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated 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 verification 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.