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Generated: July 26, 2017
What are the generic drug sources for crofelemer and what is the scope of crofelemer 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Clinical Trials: see list | 8 |
| Drug Prices: | see low prices |
| DailyMed Link: | crofelemer at DailyMed |
| Drug Class | Antidiarrheal |
| 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 | FULYZAQ | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Napo Pharms Inc | FULYZAQ | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Napo Pharms Inc | FULYZAQ | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Napo Pharms Inc | FULYZAQ | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Napo Pharms Inc | FULYZAQ | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,585,868 | Methods and compositions for treating HIV-associated diarrhea | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 69739394 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20000049206 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2269078 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 935417 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2011320155 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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