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Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate - Generic Drug Details

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Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and eighty-seven patent family members in fifty countries.

There are fifteen drug master file entries for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. Three suppliers are listed for this compound.

Summary for Generic Name: emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

Tradenames:1
Patents:16
Applicants:1
NDAs:1
Drug Master File Entries: see list15
Suppliers / Packagers: see list3
Clinical Trials: see list1,378
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate at DailyMed
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, 2011RXYesYes7,125,879► subscribeYY ► subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes6,703,396*PED► subscribeY► subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 20115,814,639*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

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
6,069,249 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability► subscribe
5,827,727 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► subscribe
RE38333 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability► 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; rilpivirine hydrochloride; tenofovir disoproxil fumarate

Country Document Number Estimated Expiration
Canada2104399► subscribe
China104586850► subscribe
United Kingdom0004887► 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; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/041United Kingdom► subscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
0768Netherlands► subscribePRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2012 00021Denmark► subscribe
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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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