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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Mallinckrodt
Argus Health
Chinese Patent Office
Boehringer Ingelheim
McKinsey
Queensland Health
Dow
Cerilliant
Moodys

Generated: July 21, 2017

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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 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 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 two patent family members in forty-three countries.

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

Summary for Generic Name: raltegravir potassium

Tradenames:2
Patents:6
Applicants:1
NDAs:3
Drug Master File Entries: see list5
Suppliers / Packagers: see list9
Bulk Api Vendors: see list44
Clinical Trials: see list828
Patent Applications: see list5
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:raltegravir potassium at DailyMed

Pharmacology for Ingredient: 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
raltegravir potassium
TABLET, CHEWABLE;ORAL203045-001Dec 21, 2011RXYesNo7,754,731► SubscribeYY ► Subscribe
Merck Sharp Dohme
ISENTRESS HD
raltegravir potassium
TABLET;ORAL022145-002May 26, 2017RXYesNo7,217,713► Subscribe ► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET, CHEWABLE;ORAL203045-002Dec 21, 2011RXYesYes7,217,713► Subscribe ► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
TABLET;ORAL022145-001Oct 12, 2007RXYesYes7,217,713► Subscribe ► Subscribe
Merck Sharp Dohme
ISENTRESS HD
raltegravir potassium
TABLET;ORAL022145-002May 26, 2017RXYesNo7,435,734► 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
7,820,660N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase► Subscribe
8,357,798Process for preparing N-alkylated hydroxypyrimidinone compounds► 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
China101068793► Subscribe
Australia2002334207► Subscribe
Israel183614► Subscribe
Russian Federation2602865► 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
428Luxembourg► Subscribe91428, EXPIRES: 20230102
2008 007, C1441735Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
C010/2008Ireland► SubscribeSPC010/2008: 20091119, EXPIRES: 20221219
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
2008007,C1441735Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
Julphar
Teva
UBS
Federal Trade Commission
Fish and Richardson
Argus Health
Merck
Boehringer Ingelheim
Moodys

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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