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
Sponsor | Phase |
---|---|
Napo Pharmaceuticals, Inc. | Phase 3 |
Beth Israel Deaconess Medical Center | Phase 4 |
Napo Pharmaceuticals, Inc. | 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 |
---|---|---|---|
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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