Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Dow
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Express Scripts
Colorcon

Last Updated: November 20, 2019

DrugPatentWatch Database Preview

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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for CROFELEMER
Recent Clinical Trials for CROFELEMER

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SponsorPhase
Prometheus Therapeutics and DiagnosticsPhase 4
The University of Texas Health Science Center, HoustonPhase 4
Napo Pharmaceuticals, Inc.Phase 4

See all CROFELEMER clinical trials

Recent Litigation for CROFELEMER

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District Court Litigation
Case NameDate
NAPO PHARMACEUTICALS, INC. v. DUDAS2008-09-05

See all CROFELEMER litigation

Pharmacology for CROFELEMER
Drug ClassAntidiarrheal
Synonyms for CROFELEMER
923916-82-9
AKOS016487279
MCULE-1910267022
MolPort-004-235-885
N-[(2-methoxyphenyl)methyl]-5-phenyl-1,2-oxazole-3-carboxamide
Z164754034
ZINC9497828

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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Express Scripts
Dow
Moodys
McKinsey

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