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

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What are the generic drug sources, and freedom to operate, for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate?

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

This ingredient has four hundred and fifty-eight patent family members in fifty-nine countries.

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

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

Tradenames:1
Patents:13
Applicants:1
NDAs:1
Drug Master File Entries: see list15
Suppliers / Packagers: see list2
Clinical Trials: see list1,378
Drug Prices:see low prices
DailyMed Link:emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide 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
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016RXYesYes7,390,791► SubscribeYY ► Subscribe
Gilead Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016RXYesYes7,125,879► SubscribeYY ► Subscribe
Gilead Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016RXYesYes5,914,331*PED► SubscribeY► Subscribe
Gilead Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016RXYesYes8,080,551► SubscribeYY ► Subscribe
Gilead Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 20165,814,639*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide 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
6,931,679 Foldable stand for a hammock► Subscribe
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
8,841,310Combinations of a pyrimidine containing NNRTI with RT inhibitors► Subscribe
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
5,728,575 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► 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 alafenamide fumarate

Country Document Number Estimated Expiration
European Patent Office1419152► Subscribe
Japan2011225589► Subscribe
Hungary9302377► Subscribe
HungaryE025576► Subscribe
CroatiaP20150798► 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 ALAFENAMIDE FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
853Luxembourg► SubscribePRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE ET L'EMTRICITABINE
0850Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: -RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; EN -TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
2012 00021Denmark► SubscribePRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER HYDROCHLORID ADDITIONSSALTET AF RILPIVIRIN, OG TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
2016 00063Denmark► SubscribePRODUCT NAME: RILPIVIRINHYDROCHLORID OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
2016045Lithuania► SubscribePRODUCT NAME: RILPIVIRINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
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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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