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Raltegravir potassium - Generic Drug Details

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

This ingredient has seventy-eight patent family members in forty-one countries.

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

Summary for Generic Name: raltegravir potassium

Tradenames:1
Patents:4
Applicants:1
NDAs:3
Drug Master File Entries: see list5
Suppliers / Packaging: see list6
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: raltegravir potassium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
POWDER;ORAL205786-001Dec 20, 2013RXYes7,169,780► subscribeYY ► subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET, CHEWABLE;ORAL203045-001Dec 21, 2011RXNo7,217,713► subscribe ► subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET;ORAL022145-001Oct 12, 2007RXYes7,435,734► subscribe ► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,357,798Process for preparing N-alkylated hydroxypyrimidinone compounds► subscribe
7,820,660N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: raltegravir potassium

Country Document Number Estimated Expiration
Iceland2436► subscribe
Eurasian Patent Organization012418► subscribe
Portugal1819700► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RALTEGRAVIR POTASSIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008 00021Denmark► subscribe
C/GB08/020United Kingdom► subscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
67; 3-2008Slovakia► subscribePRODUCT 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
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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 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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