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MYTESI Drug Profile
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Which patents cover Mytesi, and when can generic versions of Mytesi launch?
Mytesi is a drug marketed by Napo Pharms Inc and is included in one NDA. There are three patents protecting this drug.
This drug has forty-four patent family members in twenty-four countries.
The generic ingredient in MYTESI is crofelemer. Additional details are available on the crofelemer profile page.
US ANDA Litigation and Generic Entry Outlook for Mytesi
Mytesi was eligible for patent challenges on December 31, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 2, 2022. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for MYTESI
| International Patents: | 44 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for MYTESI |
| DailyMed Link: | MYTESI at DailyMed |
Generic Entry Opportunity Date for MYTESI
Generic Entry Date for MYTESI*:
Constraining patent/regulatory exclusivity:
NDA:
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 MYTESI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Napo Pharmaceuticals, Inc. | Phase 4 |
US Patents and Regulatory Information for MYTESI
| 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 | Y | 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 | ||||
| >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 MYTESI
| 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 MYTESI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 2632550 | Start Trial |
| Peru | 20140036 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2012058664 | Start Trial |
| Mexico | 348184 | Start Trial |
| Portugal | 935417 | Start Trial |
| Australia | 775330 | Start Trial |
| Ecuador | SP13012650 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
