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Last Updated: March 28, 2024

RALTEGRAVIR POTASSIUM - Generic Drug Details


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What are the generic sources for raltegravir potassium and what is the scope of patent protection?

Raltegravir potassium is the generic ingredient in two branded drugs marketed by Msd Sub Merck and is included in three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Raltegravir potassium has one hundred and fifty-eight patent family members in forty-six countries.

There are five drug master file entries for raltegravir potassium. Nine suppliers are listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RALTEGRAVIR POTASSIUM
Generic Entry Dates for RALTEGRAVIR POTASSIUM*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;ORAL
Generic Entry Dates for RALTEGRAVIR POTASSIUM*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, CHEWABLE;ORAL
Generic Entry Dates for RALTEGRAVIR POTASSIUM*:
Constraining patent/regulatory exclusivity:
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 RALTEGRAVIR POTASSIUM

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

SponsorPhase
St. James's Hospital, IrelandPhase 4
Merck Sharp & Dohme Corp.Phase 1/Phase 2
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 1/Phase 2

See all RALTEGRAVIR POTASSIUM clinical trials

Pharmacology for RALTEGRAVIR POTASSIUM
Medical Subject Heading (MeSH) Categories for RALTEGRAVIR POTASSIUM
Paragraph IV (Patent) Challenges for RALTEGRAVIR POTASSIUM
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 RALTEGRAVIR POTASSIUM

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 raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-001 Dec 21, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 RALTEGRAVIR POTASSIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Sub Merck ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-001 Dec 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for RALTEGRAVIR POTASSIUM

Country Patent Number Title Estimated Expiration
Portugal 1441735 ⤷  Try a Trial
New Zealand 720331 Solid pharmaceutical compositions containing an integrase inhibitor ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006060711 ⤷  Try a Trial
Lithuania PA2008007 ⤷  Try a Trial
Canada 2588445 PREPARATION PHARMACEUTIQUE CONTENANT UNE COMPOSITION DE CONTROLE DU TAUX DE LIBERATION (PHARMACEUTICAL FORMULATION OF CARBOXAMIDE HIV INTEGRASE INHIBITORS CONTAINING A RELEASE RATE CONTROLLING COMPOSITION) ⤷  Try a Trial
Lithuania 2493312 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RALTEGRAVIR POTASSIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 C200800017 Spain ⤷  Try a Trial 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 0890018-5 Sweden ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR
1441735 PA2008007,C1441735 Lithuania ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
1441735 2008/010 Ireland ⤷  Try a 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 C20080001 00016 Estonia ⤷  Try a Trial PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
1441735 91428 Luxembourg ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR (ISENTRESS ); AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 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.