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Last Updated: August 11, 2022

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 ninety-five patent family members in forty-three countries.

The generic ingredient in ISENTRESS is raltegravir potassium. There are five drug master file entries for this compound. Six 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 Generic Entry Opportunity 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
Unity Health TorontoPhase 2
St. Michael's Hospital, TorontoPhase 2
Canadian Institutes of Health Research (CIHR)Phase 2

See all ISENTRESS clinical trials

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Potassium salt of an HIV integrase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-001 Dec 21, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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: See Plans and Pricing

Patent: 1429
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05311671
Estimated Expiration: See Plans and Pricing

Patent: 10313571
Estimated Expiration: See Plans and Pricing

Austria

Patent: 8844
Estimated Expiration: See Plans and Pricing

Patent: 4645
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0518760
Estimated Expiration: See Plans and Pricing

Patent: 2012009857
Estimated Expiration: See Plans and Pricing

Canada

Patent: 88398
Estimated Expiration: See Plans and Pricing

Patent: 77937
Estimated Expiration: See Plans and Pricing

China

Patent: 1068793
Estimated Expiration: See Plans and Pricing

Patent: 2655752
Estimated Expiration: See Plans and Pricing

Patent: 6074411
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 31485
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 46
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120066
Estimated Expiration: See Plans and Pricing

Patent: 0211826
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12859
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 19700
Estimated Expiration: See Plans and Pricing

Patent: 93312
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2418
Estimated Expiration: See Plans and Pricing

Patent: 0701204
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 19683
Estimated Expiration: See Plans and Pricing

Patent: 19700
Estimated Expiration: See Plans and Pricing

Patent: 93312
Estimated Expiration: See Plans and Pricing

Patent: 70702
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0105086
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 15011
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 57248
Estimated Expiration: See Plans and Pricing

India

Patent: 77DEN2012
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3614
Estimated Expiration: See Plans and Pricing

Patent: 9369
Estimated Expiration: See Plans and Pricing

Japan

Patent: 05956
Estimated Expiration: See Plans and Pricing

Patent: 22639
Estimated Expiration: See Plans and Pricing

Patent: 08521933
Estimated Expiration: See Plans and Pricing

Patent: 13508395
Estimated Expiration: See Plans and Pricing

Patent: 16034962
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 93312
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 4320
Estimated Expiration: See Plans and Pricing

Patent: 2494
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 5227
Estimated Expiration: See Plans and Pricing

Patent: 07006639
Estimated Expiration: See Plans and Pricing

Patent: 12004903
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 985
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 120
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5376
Estimated Expiration: See Plans and Pricing

Patent: 0331
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 0700138
Estimated Expiration: See Plans and Pricing

Norway

Patent: 8784
Estimated Expiration: See Plans and Pricing

Patent: 073404
Estimated Expiration: See Plans and Pricing

Peru

Patent: 061148
Estimated Expiration: See Plans and Pricing

Poland

Patent: 19700
Estimated Expiration: See Plans and Pricing

Patent: 93312
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 19700
Estimated Expiration: See Plans and Pricing

Patent: 93312
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 02865
Estimated Expiration: See Plans and Pricing

Patent: 12121857
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 197
Estimated Expiration: See Plans and Pricing

Patent: 600
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 19700
Estimated Expiration: See Plans and Pricing

Patent: 93312
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0704130
Estimated Expiration: See Plans and Pricing

Patent: 1203012
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1350420
Estimated Expiration: See Plans and Pricing

Patent: 1835893
Estimated Expiration: See Plans and Pricing

Patent: 070089990
Estimated Expiration: See Plans and Pricing

Patent: 120102063
Estimated Expiration: See Plans and Pricing

Patent: 130122031
Estimated Expiration: See Plans and Pricing

Spain

Patent: 70136
Estimated Expiration: See Plans and Pricing

Patent: 75788
Estimated Expiration: See Plans and Pricing

Patent: 98348
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 44463
Estimated Expiration: See Plans and Pricing

Patent: 0631944
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 07215
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 884
Estimated Expiration: See Plans and Pricing

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
Japan 2013508395 See Plans and Pricing
Argentina 101429 SAL POTÁSICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH See Plans and Pricing
Yugoslavia 35604 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ISENTRESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 20221021 Netherlands See Plans and Pricing 20221021, EXPIRES: 20221219
1441735 DO 67; 3-2008 Slovakia See Plans and Pricing 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 C01441735/01 Switzerland See Plans and Pricing FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT
>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.