MYTESI Drug Patent 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-five patent family members in twenty-five countries.
The generic ingredient in MYTESI is crofelemer. One supplier is listed for this compound. Additional details are available on the crofelemer profile page.
DrugPatentWatch® 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: | 45 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for MYTESI |
| What excipients (inactive ingredients) are in MYTESI? | MYTESI excipients list |
| DailyMed Link: | MYTESI at DailyMed |
DrugPatentWatch® Estimated 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 |
|---|---|
| Beth Israel Deaconess Medical Center | Phase 4 |
| Napo Pharmaceuticals, Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for MYTESI
US Patents and Regulatory Information for MYTESI
MYTESI is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MYTESI is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting MYTESI
Method of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
Methods and compositions for treating HIV-associated diarrhea
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
Methods and compositions for treating HIV-associated diarrhea
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
| 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 | 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 | ||||
| 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 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 | 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 MYTESI
See the table below for patents covering MYTESI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | 537898 | See Plans and Pricing | |
| Peru | 20140036 | METODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH | See Plans and Pricing |
| World Intellectual Property Organization (WIPO) | 9816111 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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 verification 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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