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Last Updated: October 4, 2024

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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 Msd Sub Merck and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-nine patent family members in forty-six countries.

The generic ingredient in ISENTRESS HD 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 Hd

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

There are two Paragraph IV patent challenges 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

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Recent Clinical Trials for ISENTRESS HD

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 HD clinical trials

Pharmacology for ISENTRESS HD
Paragraph IV (Patent) Challenges for ISENTRESS HD
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ISENTRESS HD Tablets raltegravir potassium 600 mg 022145 1 2022-10-21
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 five US patents.

Patents protecting ISENTRESS HD

Solid pharmaceutical compositions containing an integrase inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION

N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Potassium salt of an HIV integrase inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition containing an anti-nucleating agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV INFECTION

Solid pharmaceutical compositions containing an integrase inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 HD

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ISENTRESS HD

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

Country Patent Number Title Estimated Expiration
Cyprus 1112859 ⤷  Sign Up
South Africa 200704130 Protassium salt of an HIV integrase inhibitor ⤷  Sign Up
Luxembourg 91428 ⤷  Sign Up
Australia 2005311671 Potassium salt of an HIV integrase inhibitor ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ISENTRESS HD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 C20080001 00016 Estonia ⤷  Sign Up PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
1441735 67 3-2008 Slovakia ⤷  Sign Up PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: EU/1/07/436/001 - EU/1/07/436/002 20080102
1441735 91428 Luxembourg ⤷  Sign Up PRODUCT NAME: RALTEGRAVIR (ISENTRESS ); AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 20080102
1441735 08C0026 France ⤷  Sign Up PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
>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.