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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
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QuintilesIMS
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Deloitte
Chubb
Julphar
Medtronic
Healthtrust

Generated: September 24, 2018

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

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

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 seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

US Patents and Regulatory Information for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil 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 COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 disoproxil fumarate

International Patents for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

Country Document Number Estimated Expiration
Cyprus 1116565 ➤ Try a Free Trial
South Korea 20000029705 ➤ Try a Free Trial
Denmark 0574487 ➤ Try a Free Trial
Japan 4838396 ➤ Try a Free Trial
Norway 327639 ➤ Try a Free Trial
Denmark 1789139 ➤ Try a Free Trial
Slovenia 1789139 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0851 Netherlands ➤ Try a Free Trial 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
6 Finland ➤ Try a Free Trial
0120012 00058 Estonia ➤ Try a Free Trial PRODUCT NAME: EVIPLERA - EMTRITSITABIIN/RILPIVIRIIN (HUEDRO-;REG NO/DATE: C(2011)8956 FINAL 28.11.2011
2 6-2015 Slovakia ➤ Try a Free Trial PRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
0150041 00168 Estonia ➤ Try a Free Trial PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
0915894/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
2015037 Lithuania ➤ Try a Free Trial PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM + 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:

Cipla
Colorcon
QuintilesIMS
Farmers Insurance
Deloitte
Chubb
Julphar
Medtronic
Healthtrust

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