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Elvitegravir - Generic Drug Details

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Elvitegravir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-four patent family members in thirty-two countries.

There are four drug master file entries for elvitegravir. One supplier is listed for this compound.

Summary for Generic Name: elvitegravir

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list4
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc
VITEKTA
elvitegravir
TABLET;ORAL203093-001Sep 24, 2014RXNo7,635,704► subscribeYY ► subscribe
Gilead Sciences Inc
VITEKTA
elvitegravir
TABLET;ORAL203093-002Sep 24, 2014RXYes8,981,103► subscribeYY ► subscribe
Gilead Sciences Inc
VITEKTA
elvitegravir
TABLET;ORAL203093-002Sep 24, 2014RXYes7,635,704► subscribeYY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: elvitegravir

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
8,232,4014-oxoquinoline compound and use thereof as HIV integrase inhibitor► 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: elvitegravir

Country Document Number Estimated Expiration
Malaysia136173► subscribe
Israel179250► subscribe
Japan3567162► 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: ELVITEGRAVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013018Lithuania► subscribePRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013 05 24 EU/1/13/830/002 20130524
13/052Ireland► subscribePRODUCT NAME: ELVITEGRAVIR OR A HYDRATE, SOLVATE, TAUTOMER OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
C0061France► subscribePRODUCT NAME: ELVITEGRAVIR OU UN HYDRATE, SOLVATE, TAUTOMERE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CEUX-CI; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
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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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