You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

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

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate has four hundred and eighty-five patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
International Patents:485
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 3
DailyMed Link:COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Generic Entry Date for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE*:
Constraining patent/regulatory exclusivity:
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 COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

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

SponsorPhase
Janssen Sciences Ireland UCPhase 3
Janssen R&D IrelandPhase 3
Gilead SciencesPhase 2

See all COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE clinical trials

Paragraph IV (Patent) Challenges for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYMTUZA Tablets cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate 800 mg/150 mg/ 200 mg/10 mg 210455 1 2021-08-16

US Patents and Regulatory Information for COBICISTAT; DARUNAVIR; 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; 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; 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; 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; 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

Expired US Patents for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Supplementary Protection Certificates for COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487166 PA2016038,C2487166 Lithuania ⤷  Sign Up PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA IR TENOFOVIRO ALAFENAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487162 2016C/068 Belgium ⤷  Sign Up PRODUCT NAME: COBICISTAT ET DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967 20141121
2049506 SPC/GB15/067 United Kingdom ⤷  Sign Up PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527
2049506 61/2015 Austria ⤷  Sign Up PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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 verification 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.