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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Cipla
Farmers Insurance
Chubb
Healthtrust
Covington
QuintilesIMS
Argus Health

Generated: December 18, 2018

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SYMTUZA Drug Profile

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When do Symtuza patents expire, and when can generic versions of Symtuza launch?

Symtuza is a drug marketed by Janssen Prods and is included in one NDA. There are thirteen patents protecting this drug.

This drug has six hundred and seventeen patent family members in fifty-eight countries.

The generic ingredient in SYMTUZA is cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate profile page.

Drug patent expirations by year for SYMTUZA
Generic Entry Opportunity Date for SYMTUZA
Generic Entry Date for SYMTUZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for SYMTUZA

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 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 ➤ 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 ➤ 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 SYMTUZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90012-8 Sweden ➤ Sign Up PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061/001-002 20151123
2016 00012 Denmark ➤ Sign Up PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
2016040 Lithuania ➤ Sign Up PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
2016039 Lithuania ➤ Sign Up PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Cipla
Farmers Insurance
Chubb
Healthtrust
Covington
QuintilesIMS
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.