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Last Updated: November 27, 2022

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 twenty-seven patent family members in forty-five countries.

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

Recent Clinical Trials for raltegravir potassium

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

SponsorPhase
St. James's Hospital, IrelandPhase 4
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 1/Phase 2
ANRS, Emerging Infectious DiseasesPhase 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 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 203045-001 Dec 21, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Sub Merck ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Sub Merck 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
Msd Sub Merck ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-001 Dec 21, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Sub Merck ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 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 raltegravir potassium

Country Patent Number Title Estimated Expiration
Argentina 101429 SAL POTÁSICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH See Plans and Pricing
South Korea 20070089990 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
Hong Kong 1085665 See Plans and Pricing
Mexico 345227 COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN UN INHIBIDOR DE LA INTEGRASA. (SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING AN INTEGRASE INHIBITOR.) See Plans and Pricing
China 106074411 包含整合酶抑制剂的固体药物组合物 (SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING AN INTEGRASE INHIBITOR) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for raltegravir potassium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 C01441735/01 Switzerland See Plans and Pricing FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT
1441735 08C0026 France See Plans and Pricing PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
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 C 2008 008 Romania See Plans and Pricing PRODUCT NAME: N-(2-(4-(4-FLUOROBENZILCARBAMOIL)-5-HIDROXI-1-METIL-6-OXO-1,6-DIHIDROPIRIMIDIN-2-IL)PROPAN-2+IL)-5-METIL-1,3,4-OXADIAZOL-2-CARBOXAMIDA - RALTEGRAVIR SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA, INSPECIAL SAREA DE POTASIU; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF NATIONAL AUTHORISATION: 20071220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF FIRST AUTHORISATION IN EEA: 20071220
1441735 20221021 Netherlands See Plans and Pricing 20221021, EXPIRES: 20221219
1441735 PA2008007 Lithuania See Plans and Pricing 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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