Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Boehringer Ingelheim
McKesson
Merck
Colorcon

Last Updated: October 17, 2019

DrugPatentWatch Database Preview

SYMTUZA Drug Profile

See Plans and Pricing

« Back to Dashboard

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 thirty-seven patent family members in fifty-nine 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
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 ethanolate; 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 ethanolate; 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 ethanolate; 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 ethanolate; 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 ethanolate; 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
2487163 17C1000 France   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE SULFATE D'ATAZANAVIR; REGISTRATION NO/DATE: EU/1/15/1025 20150715
1301519 300803 Netherlands   Start Trial PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
0513200 300148 Netherlands   Start Trial 300148, 20110131, EXPIRES: 20160130
2487166 17C1001 France   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET TENOFOVIR ALAFENAMIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2487162 300861 Netherlands   Start Trial PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN EN DARUNAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN. IN HET BIJZONDER DARUNAVIRETHANOLAAT; REGISTRATION NO/DATE: EU/1/14/967 20141121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Merck
Moodys
Boehringer Ingelheim
McKinsey
Mallinckrodt

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.