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Generated: October 21, 2018

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Cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate - Generic Drug Details

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

Cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate. One supplier is listed for this compound.

US Patents and Regulatory Information for cobicistat; darunavir ethanolate; 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
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y 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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Supplementary Protection Certificates for cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0148 Netherlands ➤ Sign Up 300148, 20110131, EXPIRES: 20160130
16/063 Ireland ➤ Sign Up PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REGISTRATION NO/DATE: EU/1/14/967 20141119
073 Luxembourg ➤ Sign Up 91073, EXPIRES: 20160131
2015000092 Germany ➤ Sign Up PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
/2015 Austria ➤ Sign Up PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527
0170001 00217 Estonia ➤ Sign Up PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Harvard Business School
Medtronic
Baxter
Moodys
Farmers Insurance
Queensland Health
Mallinckrodt

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