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Last Updated: October 23, 2021

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Raltegravir potassium - Generic Drug Details

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

Raltegravir potassium is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme 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 seventeen patent family members in forty-five countries.

There are five drug master file entries for raltegravir potassium. Seven 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
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
Anatomical Therapeutic Chemical (ATC) Classes for raltegravir potassium
Paragraph IV (Patent) Challenges for RALTEGRAVIR POTASSIUM
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 raltegravir potassium

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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-001 Dec 21, 2011 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Merck Sharp Dohme ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-001 Dec 21, 2011 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 raltegravir potassium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 C20080001 Estonia ⤷  Try it Free PRODUCT NAME: ISENTRESS; AUTHORISATION NO.: EMA/106827/2018; AUTHORISATION DATE: 20180222
1441735 C01441735/01 Switzerland ⤷  Try it Free FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT
1441735 C20080001 00016 Estonia ⤷  Try it Free PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
1441735 2008/010 Ireland ⤷  Try it Free 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 319 Finland ⤷  Try it Free
1441735 SPC010/2008 Ireland ⤷  Try it Free SPC010/2008: 20091119, EXPIRES: 20221219
1441735 C300340 Netherlands ⤷  Try it Free PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Merck
Dow
Colorcon
Johnson and Johnson

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