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EMTRIVA Drug Profile

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Which patents cover Emtriva, and what substitute generic drugs are available?

Emtriva is a drug marketed by Gilead and is included in two NDAs. There are three patents protecting this drug.

This drug has one hundred and seventy patent family members in thirty-four countries.

The generic ingredient in EMTRIVA is emtricitabine. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. There are ten tentative approvals for this compound. Additional details are available on the emtricitabine profile page.

Summary for Tradename: EMTRIVA

Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list5
Bulk Api Vendors: see list67
Clinical Trials: see list3
Patent Applications: see list3,093
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EMTRIVA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003RXYesYes5,914,331*PED► SubscribeY► Subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 2005RXYesYes5,914,331*PED► SubscribeY► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003RXYesYes6,642,245*PED► SubscribeY► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003RXYesYes6,703,396*PED► SubscribeY► Subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 2005RXYesYes6,703,396*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: EMTRIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 20035,210,085*PED► Subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 20055,210,085*PED► Subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 20055,814,639*PED► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 20035,814,639*PED► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 20037,402,588*PED► Subscribe
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Non-Orange Book Patents for Tradename: EMTRIVA

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
6,812,233 Therapeutic nucleosides► Subscribe
6,069,252 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,892,025 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane► 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 Tradename: EMTRIVA

Country Document Number Estimated Expiration
European Patent Office1808434► Subscribe
Portugal100198► Subscribe
Norway932980► Subscribe
Russian Federation2235724► Subscribe
Norway312399► 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: EMTRIVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/022United Kingdom► SubscribePRODUCT NAME: A COMBINATION OF EFAVIRENZ, EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF, AND TENOFOVIR OR A PHARMACEUTICALLY ACCEPTABLE PRODRUG, SALT OR ESTER THEREOF, PARTICULARLY TENOFOVIR DISOPROXIL, ESPECIALLY TENOFOVIR DISOPROXIL FUMARATE; REGISTERED: UK EU/1/07/430/001 20071213
C/GB04/016United Kingdom► SubscribePRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
0148Netherlands► Subscribe300148, 20110131, EXPIRES: 20160130
C0021France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0852Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
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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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