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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Chinese Patent Office
Farmers Insurance
Moodys
McKinsey
QuintilesIMS
Colorcon
Express Scripts
Julphar

Generated: January 22, 2019

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

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What are the generic drug sources for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate and what is the scope of emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate patent protection?

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.

Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate has five hundred and thirteen patent family members in sixty countries.

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

US Patents and Regulatory Information for emtricitabine; rilpivirine hydrochloride; 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 ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for 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;ORAL 208351-001 Mar 1, 2016 ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0853 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
2016000024 Germany ➤ Sign Up PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
0768 Netherlands ➤ Sign Up PRODUCT 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
0513200/01 Switzerland ➤ Sign Up PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
2015 00055 Denmark ➤ Sign Up PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
2015035 Lithuania ➤ Sign Up PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Cipla
McKinsey
Express Scripts
Argus Health
Teva
Harvard Business School
Daiichi Sankyo
Fuji

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