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Last Updated: May 27, 2022

Crofelemer - Generic Drug Details


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What are the generic drug 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

SponsorPhase
Napo Pharmaceuticals, Inc.Phase 3
Beth Israel Deaconess Medical CenterPhase 4
Prometheus Therapeutics and DiagnosticsPhase 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 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 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
>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 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

Country Patent Number Title Estimated Expiration
Taiwan 537898 See Plans and Pricing
Denmark 2632550 See Plans and Pricing
World Intellectual Property Organization (WIPO) 9816111 See Plans and Pricing
China 103370101 Methods and compositions for treating HIV-associated diarrhea See Plans and Pricing
South Korea 20000049206 See Plans and Pricing
Ukraine 109159 СПОСОБИ І КОМПОЗИЦІЇ ДЛЯ ЛІКУВАННЯ ВІЛ-АСОЦІЙОВАНОЇ ДІАРЕЇ See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Boehringer Ingelheim
Johnson and Johnson
Baxter
Medtronic

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.