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Emtricitabine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for emtricitabine?

Emtricitabine is the generic ingredient in five branded drugs marketed by Gilead and Gilead Sciences Inc, and is included in six NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are fifteen drug master file entries for emtricitabine. Five suppliers are listed for this compound. There are ten tentative approvals for this compound.

Summary for Generic Name: emtricitabine

Tradenames:5
Patents:22
Applicants:2
NDAs:6
Drug Master File Entries: see list15
Suppliers / Packagers: see list5
Bulk Api Vendors: see list68
Clinical Trials: see list173
Patent Applications: see list5,211
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:emtricitabine at DailyMed

Tentative approvals for EMTRICITABINE

Applicant Application No. Form Dosage
► Subscribe► SubscribeCAPSULE; ORAL200MG
► Subscribe► SubscribeTABLET; ORAL200MG; 300MG
► Subscribe► SubscribeCAPSULE; ORAL200MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes5,922,695*PED► SubscribeY► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes8,101,629► SubscribeY ► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004RXYesYes6,043,230*PED► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-002Mar 10, 2016RXYesNo5,914,331*PED► SubscribeY► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes7,067,522► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: emtricitabine

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 Generic Ingredient: emtricitabine

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 Ingredient: emtricitabine

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: EMTRICITABINE

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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