MYTESI Drug Patent Profile
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When do Mytesi patents expire, and what generic alternatives are available?
Mytesi is a drug marketed by Napo Pharms Inc and is included in one NDA. There are two patents protecting this drug.
This drug has twenty-seven patent family members in twenty-one 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 October 31, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for MYTESI
| International Patents: | 27 |
| US Patents: | 2 |
| 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 Loss of Exclusivity (LOE) Date for MYTESI
*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 |
Pharmacology for MYTESI
| Drug Class | Antidiarrheal |
US Patents and Regulatory Information for MYTESI
MYTESI is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MYTESI is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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
Methods and compositions for treating HIV-associated diarrhea
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
Methods and compositions for treating HIV-associated diarrhea
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Napo Pharms Inc | MYTESI | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Napo Pharms Inc | MYTESI | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Napo Pharms Inc | MYTESI | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292-001 | Dec 31, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MYTESI
When does loss-of-exclusivity occur for MYTESI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 11320155
Patent: Methods and compositions for treating HIV-associated diarrhea
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013010774
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 16416
Patent: PROCEDES ET COMPOSITIONS POUR LE TRAITEMENT DE LA DIARRHEE ASSOCIEE AU HIV (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA)
Estimated Expiration: ⤷ Sign Up
China
Patent: 3370101
Patent: Methods and compositions for treating HIV-associated diarrhea
Estimated Expiration: ⤷ Sign Up
Patent: 7595836
Patent: 用于治疗HIV相关性腹泻的方法和组合物 (Methods and compositions for treating HIV-associated diarrhea)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 71411
Patent: Metodos y composiciones para tratar diarrea asociada al vih
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 32550
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 13012650
Patent: MÉTODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 32550
Patent: PROCÉDÉS ET COMPOSITIONS POUR LE TRAITEMENT DE LA DIARRHÉE ASSOCIÉE AU HIV (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 49036
Patent: 用於治療HIV相關性腹瀉的方法和組合物 (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 35393
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 63385
Estimated Expiration: ⤷ Sign Up
Patent: 10971
Estimated Expiration: ⤷ Sign Up
Patent: 13540826
Estimated Expiration: ⤷ Sign Up
Patent: 17019806
Patent: ＨＩＶ関連の下痢を治療するための方法および組成物 (METHOD AND COMPOSITION FOR TREATING HIV-RELATED DIARRHEA)
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4065
Patent: METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 8184
Patent: MÉTODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH. (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA.)
Estimated Expiration: ⤷ Sign Up
Patent: 13004873
Patent: METODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH. (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA.)
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 140036
Patent: METODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 32550
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 32550
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 97746
Patent: СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИЧ-АССОЦИИРОВАННОЙ ДИАРЕИ (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHOEA)
Estimated Expiration: ⤷ Sign Up
Patent: 13123794
Patent: СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИЧ-АССОЦИИРОВАННОЙ ДИАРЕИ
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1303136
Patent: METHODS AND COMPOSITION FOR TREATING HIV-ASSOCIATED DIARRHEA
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 35435
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 9159
Patent: СПОСОБИ І КОМПОЗИЦІЇ ДЛЯ ЛІКУВАННЯ ВІЛ-АСОЦІЙОВАНОЇ ДІАРЕЇ
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering MYTESI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Colombia | 6771411 | Metodos y composiciones para tratar diarrea asociada al vih | ⤷ Sign Up |
| Australia | 2011320155 | Methods and compositions for treating HIV-associated diarrhea | ⤷ Sign Up |
| Portugal | 935417 | ⤷ Sign Up | |
| Australia | 2030302 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >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 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.
ISSN: 2162-2639
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