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Last Updated: April 7, 2020

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ISENTRESS HD Drug 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 five patents protecting this drug.

This drug has one hundred and fifteen patent family members in forty-four countries.

The generic ingredient in ISENTRESS HD 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 Hd

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

Indicators of Generic Entry

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

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Recent Clinical Trials for ISENTRESS HD

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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 HD clinical trials

Pharmacology for ISENTRESS HD
Paragraph IV (Patent) Challenges for ISENTRESS HD
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 HD

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 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 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 Y   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 HD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 08C0026 France   Start Trial PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
1441735 122008000016 Germany   Start Trial PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 PA2008 007, C1441735 Lithuania   Start Trial PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 PA2008007 Lithuania   Start Trial PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
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
1441735 CA 2008 00021 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Harvard Business School
Boehringer Ingelheim
Baxter
Medtronic

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.