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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Medtronic
Fuji
McKinsey
Cipla
Healthtrust
Federal Trade Commission
Covington
Daiichi Sankyo

Generated: February 22, 2018

DrugPatentWatch Database Preview

Raltegravir potassium - Generic Drug Details

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What are the generic drug sources for raltegravir potassium and what is the scope of raltegravir potassium 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 five 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 ten patent family members in forty-three countries.

There are five drug master file entries for raltegravir potassium. Eleven suppliers are listed for this compound.
Summary for raltegravir potassium
Pharmacology for raltegravir potassium
Medical Subject Heading (MeSH) Categories for raltegravir potassium

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 No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium POWDER;ORAL 205786-001 Dec 20, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET, CHEWABLE;ORAL 203045-002 Dec 21, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for raltegravir potassium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,357,798 Process for preparing N-alkylated hydroxypyrimidinone compounds ➤ Try a Free Trial
7,820,660 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for raltegravir potassium

Supplementary Protection Certificates for raltegravir potassium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008007 Lithuania ➤ Try a Free Trial PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
2008 00021 Denmark ➤ Try a Free Trial
00340 Netherlands ➤ Try a Free Trial PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
2008000016 Germany ➤ Try a Free Trial PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
C010/2008 Ireland ➤ Try a Free Trial SPC010/2008: 20091119, EXPIRES: 20221219
2008007,C1441735 Lithuania ➤ Try a Free Trial PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
67; 3-2008 Slovakia ➤ Try a Free 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
/2008 Austria ➤ Try a Free Trial PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436/001- EU/1/07/436/002 20071220
30/2008 Austria ➤ Try a Free Trial PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
1441735/01 Switzerland ➤ Try a Free Trial FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
McKesson
McKinsey
Daiichi Sankyo
Cipla
Chubb
Merck
Express Scripts
Harvard Business School

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 verifification 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.

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