Crofelemer - Generic Drug Details
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What are the generic 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
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 |
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 | Y | 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 | ||||
>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 |
---|---|---|---|
China | 103370101 | Methods and compositions for treating HIV-associated diarrhea | See Plans and Pricing |
Brazil | 112013010774 | "usos de crofelemer no tratamento de diarreia associada ao hiv" | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2012058664 | See Plans and Pricing | |
Australia | 4988197 | See Plans and Pricing | |
Japan | 2013540826 | See Plans and Pricing | |
European Patent Office | 2255661 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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