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Last Updated: November 5, 2024

CROFELEMER - Generic Drug Details


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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
Generic Entry Date for CROFELEMER*:
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.

Recent Clinical Trials for CROFELEMER

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

SponsorPhase
Napo Pharmaceuticals, Inc.Phase 3
Beth Israel Deaconess Medical CenterPhase 4
Napo Pharmaceuticals, Inc.Phase 4

See all CROFELEMER clinical trials

Pharmacology for CROFELEMER
Drug ClassAntidiarrheal

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 ⤷  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
>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

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

Country Patent Number Title Estimated Expiration
Poland 2632550 ⤷  Sign Up
Mexico 348184 MÉTODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH. (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA.) ⤷  Sign Up
Brazil 112013010774 "usos de crofelemer no tratamento de diarreia associada ao hiv" ⤷  Sign Up
Spain 2635435 ⤷  Sign Up
China 103370101 Methods and compositions for treating HIV-associated diarrhea ⤷  Sign Up
Canada 2816416 PROCEDES ET COMPOSITIONS POUR LE TRAITEMENT DE LA DIARRHEE ASSOCIEE AU HIV (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA) ⤷  Sign Up
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) ⤷  Sign Up
>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.