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Last Updated: June 19, 2021

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ISENTRESS Drug Profile


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

Isentress is a drug marketed by Merck Sharp Dohme and is included in three NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

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. Seven 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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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

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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
St. Michael's Hospital, TorontoPhase 2
Canadian Institutes of Health Research (CIHR)Phase 2
CIHR Canadian HIV Trials NetworkPhase 2

See all ISENTRESS clinical trials

Paragraph IV (Patent) Challenges for ISENTRESS
Tradename Dosage Ingredient NDA Submissiondate
ISENTRESS TABLET;ORAL raltegravir potassium 022145 2011-10-12
ISENTRESS HD TABLET;ORAL raltegravir potassium 022145 2011-10-12

US Patents and Regulatory Information for ISENTRESS

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

Supplementary Protection Certificates for ISENTRESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 C300340 Netherlands   Get Started Free PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 122008000016 Germany   Get Started Free PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 67 3-2008 Slovakia   Get Started Free PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: EU/1/07/436/001 - EU/1/07/436/002 20080102
1441735 C200800017 Spain   Get Started Free 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 2008/010 Ireland   Get Started Free PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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