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Last Updated: March 18, 2024

Raltegravir potassium - Generic Drug Details


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What are the generic sources for raltegravir potassium and what is the scope of freedom to operate?

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;ORAL 022145-001 Oct 12, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 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 Y ⤷  Try a Trial
Msd Sub Merck ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial 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
>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 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;ORAL 022145-001 Oct 12, 2007 ⤷  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;ORAL 022145-001 Oct 12, 2007 ⤷  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
Germany 122009000048 ⤷  Try a Trial
Poland 1819700 ⤷  Try a Trial
Croatia P20211826 ⤷  Try a Trial
Nicaragua 200700138 SAL POTASICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH ⤷  Try a Trial
Colombia 5580777 INHIBIDORES DE HIDROXIPIRIMIDINONA CARBOXAMIDA N-SUSTITUIDOS DE VIH INTEGRASA ⤷  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 SZ 30/2008 Austria ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
1441735 C20080001 Estonia ⤷  Try a Trial PRODUCT NAME: ISENTRESS; AUTHORISATION NO.: EMA/106827/2018; AUTHORISATION DATE: 20180222
1441735 319 Finland ⤷  Try a Trial
1441735 DO 67; 3-2008 Slovakia ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: Registration in Community EU/1/07/436/001-002 20071220; FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA. IT
1441735 PA2008007 Lithuania ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
>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.