ISENTRESS Drug Patent Profile

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

Isentress is a drug marketed by Msd Sub Merck and is included in three NDAs. There are eight patents protecting this drug.

This drug has one hundred and twenty-five patent family members in forty-five countries.

The generic ingredient in ISENTRESS is raltegravir potassium. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

DrugPatentWatch^® Generic Entry Outlook for Isentress

Isentress was eligible for patent challenges on October 12, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 11, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ISENTRESS

International Patents:	125
US Patents:	6
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	88
Patent Applications:	4,903
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ISENTRESS
What excipients (inactive ingredients) are in ISENTRESS?	ISENTRESS excipients list
DailyMed Link:	ISENTRESS at DailyMed

See drug prices for ISENTRESS

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

NDA:

205786

Dosage:

POWDER;ORAL

NDA:

203045

Dosage:

TABLET, CHEWABLE;ORAL

NDA:

022145

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 ISENTRESS

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

Sponsor	Phase
Canadian Institutes of Health Research (CIHR)	Phase 2
Unity Health Toronto	Phase 2
St. Michael's Hospital, Toronto	Phase 2

See all ISENTRESS clinical trials

Pharmacology for ISENTRESS

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ISENTRESS

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ISENTRESS

ISENTRESS is protected by six US patents.

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 ISENTRESS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013		RX	Yes	Yes					Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007		RX	Yes	Yes
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011		RX	Yes	No
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013		RX	Yes	Yes
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011		RX	Yes	Yes

Expired US Patents for ISENTRESS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011

International Patents for ISENTRESS

When does loss-of-exclusivity occur for ISENTRESS?

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

Argentina

Australia

Austria

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Nicaragua

Norway

Peru

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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 ISENTRESS around the world.

Country	Patent Number	Title	Estimated Expiration
Nicaragua	200700138	SAL POTASICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH
Slovenia	2493312
Australia	2005311652	Pharmaceutical formulation of carboxamide HIV integrase inhibitors containing a release rate controlling composition
Costa Rica	9146	SAL POTASICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH
Austria	518844
Japan	3927175

Supplementary Protection Certificates for ISENTRESS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	PA2008 007, C1441735	Lithuania		PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735	0890018-5	Sweden		PRODUCT NAME: RALTEGRAVIR
1441735	C 2008 008	Romania		PRODUCT NAME: N-(2-(4-(4-FLUOROBENZILCARBAMOIL)-5-HIDROXI-1-METIL-6-OXO-1,6-DIHIDROPIRIMIDIN-2-IL)PROPAN-2+IL)-5-METIL-1,3,4-OXADIAZOL-2-CARBOXAMIDA - RALTEGRAVIR SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA, INSPECIAL SAREA DE POTASIU; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF NATIONAL AUTHORISATION: 20071220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF FIRST AUTHORISATION IN EEA: 20071220
1441735	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
1441735	C200800017	Spain		PRODUCT NAME: RALTEGRAVIR; NATIONAL AUTHORISATION NUMBER: UE/1/07/436/001-002; DATE OF AUTHORISATION: 20071220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UE/1/07/436/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20071220
1441735	319	Finland