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Last Updated: March 18, 2024

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ISENTRESS Drug Patent Profile


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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 six 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

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Summary for ISENTRESS
Drug patent expirations by year for ISENTRESS
Drug Prices for ISENTRESS

See drug prices for ISENTRESS

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ISENTRESS
Generic Entry Dates for ISENTRESS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;ORAL
Generic Entry Dates for ISENTRESS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, CHEWABLE;ORAL
Generic Entry Dates for ISENTRESS*:
Constraining patent/regulatory exclusivity:
NDA:
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

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

See all ISENTRESS clinical trials

Pharmacology for ISENTRESS

US Patents and Regulatory Information for ISENTRESS

ISENTRESS is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ISENTRESS 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 ISENTRESS

N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Potassium salt of an HIV integrase inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition containing an anti-nucleating agent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

Pharmaceutical formulation containing a release rate controlling composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-001 Dec 21, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 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 ISENTRESS

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

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

Patent: 2034
Estimated Expiration: ⤷  Try a Trial

Patent: 1429
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05311671
Estimated Expiration: ⤷  Try a Trial

Patent: 10313571
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 18844
Estimated Expiration: ⤷  Try a Trial

Patent: 34645
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0518760
Estimated Expiration: ⤷  Try a Trial

Patent: 2012009857
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 88398
Estimated Expiration: ⤷  Try a Trial

Patent: 77937
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1068793
Estimated Expiration: ⤷  Try a Trial

Patent: 2655752
Estimated Expiration: ⤷  Try a Trial

Patent: 6074411
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 31485
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 46
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0120066
Estimated Expiration: ⤷  Try a Trial

Patent: 0211826
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 12859
Estimated Expiration: ⤷  Try a Trial

Patent: 24914
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 19700
Estimated Expiration: ⤷  Try a Trial

Patent: 93312
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 2418
Estimated Expiration: ⤷  Try a Trial

Patent: 0701204
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 19683
Estimated Expiration: ⤷  Try a Trial

Patent: 19700
Estimated Expiration: ⤷  Try a Trial

Patent: 93312
Estimated Expiration: ⤷  Try a Trial

Patent: 70702
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0105086
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 15011
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 57248
Estimated Expiration: ⤷  Try a Trial

India

Patent: 77DEN2012
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3614
Estimated Expiration: ⤷  Try a Trial

Patent: 9369
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 05956
Estimated Expiration: ⤷  Try a Trial

Patent: 22639
Estimated Expiration: ⤷  Try a Trial

Patent: 08521933
Estimated Expiration: ⤷  Try a Trial

Patent: 13508395
Estimated Expiration: ⤷  Try a Trial

Patent: 16034962
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 93312
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4320
Estimated Expiration: ⤷  Try a Trial

Patent: 2494
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 5227
Estimated Expiration: ⤷  Try a Trial

Patent: 07006639
Estimated Expiration: ⤷  Try a Trial

Patent: 12004903
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 985
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 120
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 5376
Estimated Expiration: ⤷  Try a Trial

Patent: 0331
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 0700138
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 8784
Estimated Expiration: ⤷  Try a Trial

Patent: 073404
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 061148
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 19700
Estimated Expiration: ⤷  Try a Trial

Patent: 93312
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 19700
Estimated Expiration: ⤷  Try a Trial

Patent: 93312
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 02865
Estimated Expiration: ⤷  Try a Trial

Patent: 12121857
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 197
Estimated Expiration: ⤷  Try a Trial

Patent: 600
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 19700
Estimated Expiration: ⤷  Try a Trial

Patent: 93312
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0704130
Estimated Expiration: ⤷  Try a Trial

Patent: 1203012
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1350420
Estimated Expiration: ⤷  Try a Trial

Patent: 1835893
Estimated Expiration: ⤷  Try a Trial

Patent: 070089990
Estimated Expiration: ⤷  Try a Trial

Patent: 120102063
Estimated Expiration: ⤷  Try a Trial

Patent: 130122031
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 70136
Estimated Expiration: ⤷  Try a Trial

Patent: 75788
Estimated Expiration: ⤷  Try a Trial

Patent: 98348
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 44463
Estimated Expiration: ⤷  Try a Trial

Patent: 0631944
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 07215
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 884
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 ISENTRESS around the world.

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 012418 КАЛИЕВАЯ СОЛЬ ИНГИБИТОРА ВИЧ-ИНТЕГРАЗЫ (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITORS) ⤷  Try a Trial
Poland 369223 ⤷  Try a Trial
South Africa 200704130 Protassium salt of an HIV integrase inhibitor ⤷  Try a Trial
Germany 122008000016 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006060730 ⤷  Try a Trial
New Zealand 533057 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ISENTRESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 SZ 30/2008 Austria ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
1441735 C20080001 Estonia ⤷  Try a Trial PRODUCT NAME: ISENTRESS; AUTHORISATION NO.: EMA/106827/2018; AUTHORISATION DATE: 20180222
1441735 319 Finland ⤷  Try a Trial
1441735 DO 67; 3-2008 Slovakia ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: Registration in Community EU/1/07/436/001-002 20071220; FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA. IT
1441735 PA2008007 Lithuania ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
1441735 C300340 Netherlands ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.