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Crofelemer - Generic Drug Details
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-three patent family members in twenty-three countries.
One supplier is listed for this compound.
Summary for crofelemer
| International Patents: | 43 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 9 |
| Clinical Trials: | 10 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for crofelemer |
| DailyMed Link: | crofelemer at DailyMed |
Recent Clinical Trials for crofelemer
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The University of Texas Health Science Center, Houston | Phase 4 |
| Napo Pharmaceuticals, Inc. | Phase 4 |
| Prometheus Therapeutics and Diagnostics | Phase 4 |
Recent Litigation for crofelemer
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| NAPO PHARMACEUTICALS, INC. v. DUDAS | 2008-09-05 |
Pharmacology for crofelemer
| Drug Class | Antidiarrheal |
Synonyms for crofelemer
| 923916-82-9 |
| AKOS016487279 |
| MCULE-1910267022 |
| MolPort-004-235-885 |
| N-[(2-methoxyphenyl)methyl]-5-phenyl-1,2-oxazole-3-carboxamide |
| Z164754034 |
| ZINC9497828 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Napo Pharms Inc | MYTESI | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Napo Pharms Inc | MYTESI | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 | Start Trial | Start Trial |
| Napo Pharms Inc | MYTESI | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for crofelemer
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2012058664 | Start Trial |
| Japan | 2017019806 | Start Trial |
| European Patent Office | 2060183 | Start Trial |
| Germany | 69739394 | Start Trial |
| Spain | 2635435 | Start Trial |
| South Africa | 201303136 | Start Trial |
| Austria | 430477 | Start Trial |
| >Country | >Patent Number | >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 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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.