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Last Updated: May 28, 2022

ISENTRESS HD Drug Patent Profile


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Which patents cover Isentress Hd, and what generic alternatives are available?

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

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

The generic ingredient in ISENTRESS HD 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 Hd

Isentress Hd 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 HD
Drug Prices for ISENTRESS HD

See drug prices for ISENTRESS HD

Recent Clinical Trials for ISENTRESS HD

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

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

See all ISENTRESS HD clinical trials

Paragraph IV (Patent) Challenges for ISENTRESS HD
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ISENTRESS HD Tablets raltegravir potassium 400 mg 022145 1 2011-10-12

US Patents and Regulatory Information for ISENTRESS HD

ISENTRESS HD is protected by six US patents.

Patents protecting ISENTRESS HD

Solid pharmaceutical compositions containing an integrase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION

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

Solid pharmaceutical compositions containing an 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
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme 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
Merck Sharp Dohme 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
Merck Sharp Dohme 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
Merck Sharp Dohme 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
Merck Sharp Dohme 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
>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 HD

See the table below for patents covering ISENTRESS HD around the world.

Country Patent Number Title Estimated Expiration
Malaysia 162494 SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING AN INTEGRASE INHIBITOR See Plans and Pricing
Mexico 2007006639 SAL DE POTASIO DE UN INHIBIDOR DE LA INTEGRASA DEL VIRUS DE INMUNODEFICIENCIA HUMANA. (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR.) See Plans and Pricing
Eurasian Patent Organization 012418 КАЛИЕВАЯ СОЛЬ ИНГИБИТОРА ВИЧ-ИНТЕГРАЗЫ (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITORS) See Plans and Pricing
South Korea 20130122031 POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR See Plans and Pricing
Croatia P20211826 See Plans and Pricing
China 102229605 See Plans and Pricing
Colombia 5580777 INHIBIDORES DE HIDROXIPIRIMIDINONA CARBOXAMIDA N-SUSTITUIDOS DE VIH INTEGRASA See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ISENTRESS HD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 PA2008 007, C1441735 Lithuania See Plans and Pricing PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 122008000016 Germany See Plans and Pricing PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 PA2008007,C1441735 Lithuania See Plans and Pricing PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
1441735 C20080001 Estonia See Plans and Pricing PRODUCT NAME: ISENTRESS; AUTHORISATION NO.: EMA/106827/2018; AUTHORISATION DATE: 20180222
1441735 C300340 Netherlands See Plans and Pricing PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 08C0026 France See Plans and Pricing PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
1441735 SZ 30/2008 Austria See Plans and Pricing PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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