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 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
Sponsor | Phase |
---|---|
Napo Pharmaceuticals, Inc. | Phase 3 |
Beth Israel Deaconess Medical Center | Phase 4 |
The University of Texas Health Science Center, Houston | Phase 4 |
Pharmacology for crofelemer
Drug Class | Antidiarrheal |
Anatomical Therapeutic Chemical (ATC) Classes for crofelemer
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 |
---|---|---|---|
Russian Federation | 2013123794 | СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИЧ-АССОЦИИРОВАННОЙ ДИАРЕИ | ⤷ Sign Up |
Brazil | 112013010774 | "usos de crofelemer no tratamento de diarreia associada ao hiv" | ⤷ Sign Up |
Spain | 2635435 | ⤷ Sign Up | |
Hungary | E035393 | ⤷ 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.