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Last Updated: August 14, 2020

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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 five 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. Six suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

US ANDA Litigation and Generic Entry Outlook for Isentress

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

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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Drug patent expirations by year for ISENTRESS
Drug Prices for ISENTRESS

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Recent Clinical Trials for ISENTRESS

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SponsorPhase
Canadian Institutes of Health Research (CIHR)Phase 2
CIHR Canadian HIV Trials NetworkPhase 2
St. Michael's Hospital, TorontoPhase 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 HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 C20080001 Estonia   Start Trial PRODUCT NAME: ISENTRESS; AUTHORISATION NO.: EMA/106827/2018; AUTHORISATION DATE: 20180222
1441735 C300340 Netherlands   Start Trial PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 20221021 Netherlands   Start Trial 20221021, EXPIRES: 20221219
1441735 2008/010 Ireland   Start Trial 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 91428 Luxembourg   Start Trial PRODUCT NAME: ISENTRESS- RALTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 20080201
1441735 SZ 30/2008 Austria   Start Trial PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
1441735 SPC/GB08/020 United Kingdom   Start Trial PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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