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Generated: December 12, 2018

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Emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

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

Emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Amneal Pharms Co, Aurobindo Pharma Ltd, Mylan Pharms Inc, Teva Pharms Usa, and Gilead, and is included in five NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Emtricitabine; tenofovir disoproxil fumarate has three hundred and twenty-three patent family members in forty-five countries.

There are seventeen drug master file entries for emtricitabine; tenofovir disoproxil fumarate. Twelve suppliers are listed for this compound. There are six tentative approvals for this compound.

Tentative approvals for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up200MG; 300MGTABLET; ORAL
➤ Sign Up➤ Sign Up200MG; 300MGTABLET; ORAL
➤ Sign Up➤ Sign Up200MG; 300MGTABLET; ORAL

US Patents and Regulatory Information for emtricitabine; 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
Mylan Pharms Inc EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 206436-001 Apr 9, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 2016 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Amneal Pharms Co EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 209721-002 Aug 22, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-002 Mar 10, 2016 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 2016 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-003 Mar 10, 2016 ➤ Sign Up ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 ➤ Sign Up ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-002 Mar 10, 2016 ➤ Sign Up ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 2016 ➤ Sign Up ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-003 Mar 10, 2016 ➤ Sign Up ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-003 Mar 10, 2016 ➤ Sign Up ➤ Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 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; tenofovir disoproxil fumarate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021 France ➤ Sign Up PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
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
0148 Netherlands ➤ Sign Up 300148, 20110131, EXPIRES: 20160130
15/052 Ireland ➤ Sign Up PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
C0032 France ➤ Sign Up PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
15/053 Ireland ➤ Sign Up PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
C/GB04/016 United Kingdom ➤ Sign Up PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
AstraZeneca
Moodys
Cantor Fitzgerald
Teva
McKesson
Queensland Health
Farmers Insurance
Boehringer Ingelheim

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