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Last Updated: January 18, 2020

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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 forty patent family members in fifty-nine countries.

The generic ingredient in SYMTUZA is cobicistat; darunavir; 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; emtricitabine; tenofovir alafenamide fumarate profile page.

US ANDA Litigation and Generic Entry Outlook for Symtuza

  Start Trial

Symtuza was eligible for patent challenges on November 5th, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 4th, 2032. This may change due to patent challenges or generic licensing.

There have been twenty-three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Drug patent expirations by year for SYMTUZA
Drug Prices for SYMTUZA

See drug prices 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.

Recent Clinical Trials for SYMTUZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Janssen PharmaceuticalsPhase 3
NEAT ID FoundationPhase 3
Gilead SciencesPhase 3

See all SYMTUZA clinical trials

Recent Litigation for SYMTUZA

Identify potential future generic entrants

District Court Litigation
Case NameDate
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2019-01-15
JANSSEN PRODUCTS, L.P. v. AMNEAL PHARMACEUTICALS, LLC2018-12-26
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.2018-06-27

See all SYMTUZA litigation

PTAB Litigation
PetitionerDate
Lupin Limited2015-04-09

See all SYMTUZA litigation

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; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SYMTUZA

Supplementary Protection Certificates for SYMTUZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487166 59/2016 Austria   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND TENOFOVIR ALAFENAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE TENOFOVIR ALAFENAMID FUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 (MITTEILUNG) 20151123
2049506 262 5024-2015 Slovakia   Start Trial PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZA-; REGISTRATION NO/DATE: EU/1/13/830 20130527
2049506 1590060-8 Sweden   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
2487162 C20170003 00221 Estonia   Start Trial PRODUCT NAME: DARUNAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/14/967 21.11.2014
1301519 11/2016 Austria   Start Trial PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061/001-002 (MITTEILUNG) 20151123
2487163 1790002-8 Sweden   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REG. NO/DATE: EU/1/15/1025 20150715
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
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Boehringer Ingelheim
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Harvard Business School

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