XERMELO Drug Patent Profile

Which patents cover Xermelo, and when can generic versions of Xermelo launch?

Xermelo is a drug marketed by Tersera and is included in one NDA. There are five patents protecting this drug.

This drug has seventy patent family members in twenty-nine countries.

The generic ingredient in XERMELO is telotristat etiprate. Two suppliers are listed for this compound. Additional details are available on the telotristat etiprate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xermelo

Xermelo was eligible for patent challenges on February 28, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 27, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XERMELO

International Patents:	70
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	5
Patent Applications:	65
Drug Prices:	Drug price information for XERMELO
What excipients (inactive ingredients) are in XERMELO?	XERMELO excipients list
DailyMed Link:	XERMELO at DailyMed

See drug prices for XERMELO

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for XERMELO

NDA:

208794

Dosage:

TABLET;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 XERMELO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Aman Chauhan	Phase 2
University of Chicago	Phase 2
Ipsen	Phase 3

See all XERMELO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for XERMELO

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for XERMELO

XERMELO is protected by five US patents and two FDA Regulatory Exclusivities.

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 XERMELO

FDA Regulatory Exclusivity protecting XERMELO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes				Y
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes				Y
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes

International Patents for XERMELO

When does loss-of-exclusivity occur for XERMELO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Peru

Poland

Portugal

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 XERMELO around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2856871
Hong Kong	1145023
Spain	2625083
Brazil	PI0720270	COMPOSTOS BASEDOS EM 4-FENIL-6-(2,2,2-TRIFLÚOR-1-FENIL ETOXI) PIRIMIDINA E PROCESSOS DE USOS DOS MESMOS

Supplementary Protection Certificates for XERMELO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2091940	2018C/009	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2091940	132018000000181	Italy		PRODUCT NAME: TELOTRISTAT O UN SUO ESTERE FARMACEUTICAMENTE ACCETTABILE, O UN SUO SALE, IN PARTICOLARE TELOTRISTAT ETILE, PIU IN PARTICOLARE SALE IPPURATO DI TELOTRISAT ETILE(XERMELO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1224, 20170920
2091940	1890014-2	Sweden		PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEREOF, IN PARTICULARLY TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL; REG. NO/DATE: EU/1/17/1224 20170920
2091940	C02091940/01	Switzerland		PRODUCT NAME: TELOTRISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66374 28.03.2018