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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 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

Drug patent expirations by year for MYTESI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MYTESI

Generic Entry Date for MYTESI^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 202292 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

See all MYTESI clinical trials

Pharmacology for MYTESI

Drug Class	Antidiarrheal

Anatomical Therapeutic Chemical (ATC) Classes for MYTESI

A07XA	Other antidiarrheals
A07X	OTHER ANTIDIARRHEALS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

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 ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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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	⤷ Try a Trial	⤷ Try a Trial
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012	⤷ Try a Trial	⤷ Try a Trial
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012	⤷ Try a Trial	⤷ Try a Trial
>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
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2013010774
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 16416
Estimated Expiration: ⤷ Try a Trial

China

Patent: 3370101
Estimated Expiration: ⤷ Try a Trial

Patent: 7595836
Estimated Expiration: ⤷ Try a Trial

Colombia

Patent: 71411
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 32550
Estimated Expiration: ⤷ Try a Trial

Ecuador

Patent: 13012650
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 32550
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 49036
Estimated Expiration: ⤷ Try a Trial

Hungary

Patent: 35393
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 63385
Estimated Expiration: ⤷ Try a Trial

Patent: 10971
Estimated Expiration: ⤷ Try a Trial

Patent: 13540826
Estimated Expiration: ⤷ Try a Trial

Patent: 17019806
Estimated Expiration: ⤷ Try a Trial

Malaysia

Patent: 4065
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 8184
Estimated Expiration: ⤷ Try a Trial

Patent: 13004873
Estimated Expiration: ⤷ Try a Trial

Peru

Patent: 140036
Estimated Expiration: ⤷ Try a Trial

Poland

Patent: 32550
Estimated Expiration: ⤷ Try a Trial

Portugal

Patent: 32550
Estimated Expiration: ⤷ Try a Trial

Russian Federation

Patent: 97746
Estimated Expiration: ⤷ Try a Trial

Patent: 13123794
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 1303136
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 35435
Estimated Expiration: ⤷ Try a Trial

Ukraine

Patent: 9159
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
Australia	4988197		⤷ Try a Trial
Canada	2269078	FORMULATIONS ENTERALES DE COMPOSITIONS POLYMERES PRO-ANTHOCYANIDIQUES A PROPRIETES ANTI-DIARRHEIQUES (ENTERIC FORMULATIONS OF PROANTHOCYANIDIN POLYMER ANTIDIARRHEAL COMPOSITIONS)	⤷ Try a Trial
Japan	6310971		⤷ Try a Trial
Denmark	2632550		⤷ Try a Trial
Colombia	6771411	Metodos y composiciones para tratar diarrea asociada al vih	⤷ Try a Trial
Russian Federation	2597746	СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИЧ-АССОЦИИРОВАННОЙ ДИАРЕИ (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHOEA)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

Summary for MYTESI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MYTESI

Recent Clinical Trials for MYTESI

Pharmacology for MYTESI

Anatomical Therapeutic Chemical (ATC) Classes for MYTESI

Patents protecting MYTESI

When does loss-of-exclusivity occur for MYTESI?

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MYTESI