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Last Updated: December 7, 2021

Volunteer for clinical trials for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at ClinicalTrialExchange

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EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details

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What are the generic drug sources for emtricitabine; tenofovir alafenamide fumarate and what is the scope of freedom to operate?

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

Emtricitabine; tenofovir alafenamide fumarate has three hundred and eight patent family members in fifty-nine countries.

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

Recent Clinical Trials for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sebastien GALLIEN/Henri Mondor University Hospital- Infectiology DepartmentPhase 4
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaPhase 4
LAMBERT ASSOUMOU/ UNITE 1136 INSERMPhase 4

See all EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Paragraph IV (Patent) Challenges for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Tradename Dosage Ingredient NDA Submissiondate
DESCOVY TABLET;ORAL emtricitabine; tenofovir alafenamide fumarate 208215 2019-11-05

US Patents and Regulatory Information for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Supplementary Protection Certificates for EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513200 122004000015 Germany ⤷  Try it Free PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
1663240 300851 Netherlands ⤷  Try it Free PRODUCT 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; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
0513200 7/2004 Austria ⤷  Try it Free PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
0915894 08C0020 France ⤷  Try it Free PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
1663240 15C0071 France ⤷  Try it Free PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Boehringer Ingelheim
McKesson
Baxter
Dow

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