Symtuza Patent Expiration

Symtuza is a drug owned by Janssen Products Lp. It is protected by 14 US drug patents filed from 2018 to 2021. Out of these, 7 drug patents are active and 7 have expired. Symtuza's patents have been open to challenges since 06 November, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 19, 2038. Details of Symtuza's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US9296769 Tenofovir alafenamide hemifumarate
Aug, 2032

(7 years from now)

Active
US8754065 Tenofovir alafenamide hemifumarate
Aug, 2032

(7 years from now)

Active
US8148374 Modulators of pharmacokinetic properties of therapeutics
Sep, 2029

(4 years from now)

Active
US7700645 Pseudopolymorphic forms of a HIV protease inhibitor
Dec, 2026

(2 years from now)

Active
US7390791 Prodrugs of phosphonate nucleotide analogues
Apr, 2025

(4 months from now)

Active
US8518987 Pseudopolymorphic forms of a HIV protease inhibitor
Feb, 2024

(9 months ago)

Expired
US6703396 Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Mar, 2021

(3 years ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10786518 Compositions and methods of treating HIV
Jul, 2038

(13 years from now)

Active
US10039718 Use of solid carrier particles to improve the processability of a pharmaceutical agent
Oct, 2032

(7 years from now)

Active
US7803788 Prodrugs of phosphonate nucoleotide analogues
Feb, 2022

(2 years ago)

Expired
US6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Nov, 2020

(4 years ago)

Expired
US8597876 Method of treating HIV infection
Jun, 2019

(5 years ago)

Expired
US7470506 Fitness assay and associated methods
Jun, 2019

(5 years ago)

Expired
US9889115 Fitness assay and associated methods
Jun, 2019

(5 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Symtuza's patents.

Given below is the list of recent legal activities going on the following patents of Symtuza.

Activity Date Patent Number
Patent litigations
Recordation of Patent Grant Mailed 29 Sep, 2020 US10786518
Patent Issue Date Used in PTA Calculation 29 Sep, 2020 US10786518
Email Notification 15 Sep, 2020 US10786518
Issue Notification Mailed 09 Sep, 2020 US10786518
Application Is Considered Ready for Issue 24 Aug, 2020 US10786518
Dispatch to FDC 24 Aug, 2020 US10786518
Issue Fee Payment Received 20 Aug, 2020 US10786518
Issue Fee Payment Verified 20 Aug, 2020 US10786518
Mailing Corrected Notice of Allowability 16 Jul, 2020 US10786518
Printer Rush- No mailing 16 Jul, 2020 US10786518


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Symtuza and ongoing litigations to help you estimate the early arrival of Symtuza generic.

Symtuza's Litigations

Symtuza been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 05, 2001, against patent number US6642245. The petitioner , challenged the validity of this patent, with DIONNE as the respondent. Click below to track the latest information on how companies are challenging Symtuza's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8518987 April, 2015 Terminated-Denied
(16 Oct, 2015)
Janssen Sciences Ireland UC Lupin Limited
US6703396 April, 2002 Decision
(04 Apr, 2002)
DIONNE
US6642245 July, 2001 Decision
(05 Jul, 2001)
DIONNE


FDA has granted some exclusivities to Symtuza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Symtuza, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Symtuza.

Exclusivity Information

Symtuza holds 2 exclusivities. All of its exclusivities have expired in 2021. Details of Symtuza's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Nov 05, 2020
New Combination(NC) Jul 17, 2021

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Several oppositions have been filed on Symtuza's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Symtuza's generic, the next section provides detailed information on ongoing and past EP oppositions related to Symtuza patents.

Symtuza's Oppositions Filed in EPO

Symtuza has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 06, 2015, by Alfred E. Tiefenbacher (Gmbh & Co. Kg). This opposition was filed on patent number EP03753571A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP16180589A Oct, 2020 Cooke, Richard Granted and Under Opposition
EP16180589A Oct, 2020 Teva Pharmaceutical Industries Ltd. Granted and Under Opposition
EP16180589A Jan, 2020 STADA Arzneimittel AG Granted and Under Opposition
EP14168686A Apr, 2018 Cooke, Richard Opposition rejected
EP13164300A Jan, 2018 Georg Kalhammer/Stephan Teipel Granted and Under Opposition
EP13164300A Jan, 2018 Aechter, Bernd Granted and Under Opposition
EP13164300A Jan, 2018 Cooke, Richard Granted and Under Opposition
EP12753867A Jul, 2017 FRKelly Granted and Under Opposition
EP12753867A Jul, 2017 Sandoz GmbH Granted and Under Opposition
EP12753867A Jul, 2017 Teva Pharmaceutical Industries Ltd Granted and Under Opposition
EP12167591A May, 2017 Cooke, Richard Revoked
EP12167590A May, 2017 Cooke, Richard Revoked
EP12167590A May, 2017 Teva Pharmaceutical Industries LTD. Revoked
EP12167591A May, 2017 Teva Pharmaceutical Industries LTD. Revoked
EP12167589A May, 2017 Cooke, Richard Granted and Under Opposition
EP12167589A May, 2017 Teva Pharmaceutical Industries Ltd. Granted and Under Opposition
EP12167596A Apr, 2017 Cooke, Richard Revoked
EP12167596A Apr, 2017 Teva Pharmaceutical Industries Ltd Revoked
EP09739981A Jun, 2016 Cooke, Richard Revoked
EP09739981A Jun, 2016 Teva Pharmaceutical Industries Ltd Revoked
EP10703766A Apr, 2016 Cooke, Richard Revoked
EP10703766A Apr, 2016 Teva Pharmaceutical Industries Ltd Revoked
EP07836007A Mar, 2016 Trösch, Dominique Granted and Under Opposition
EP07836007A Mar, 2016 Georg Kalhammer/Stephan Teipel Granted and Under Opposition
EP07836007A Mar, 2016 Teva Pharmaceutical Industries LTD. Granted and Under Opposition
EP01961695A Nov, 2015 HEXAL PHARMA AG Patent maintained as amended
EP01961695A Nov, 2015 Strawman Limited Patent maintained as amended
EP01961695A Nov, 2015 Swindell & Pearson Limited Patent maintained as amended
EP01961695A Nov, 2015 Teva Pharmaceutical Industries Ltd Patent maintained as amended
EP03753571A Mar, 2015 Wittkopp, Alexander Patent maintained as amended
EP10180831A Mar, 2015 Wittkopp, Alexander Patent maintained as amended
EP03753571A Mar, 2015 Strawman Limited Patent maintained as amended
EP10180831A Mar, 2015 Strawman Limited Patent maintained as amended
EP10180831A Mar, 2015 Alfred E. Tiefenbacher (GmbH & Co. KG) Patent maintained as amended
EP03753571A Mar, 2015 Alfred E. Tiefenbacher (GmbH & Co. KG) Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Symtuza is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Symtuza's family patents as well as insights into ongoing legal events on those patents.

Symtuza's Family Patents

Symtuza has patent protection in a total of 50 countries. It's US patent count contributes only to 14.0% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Symtuza.

Family Patents

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Generic Launch

Generic Release Date:

Symtuza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 19, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Symtuza Generics:

There are no approved generic versions for Symtuza as of now.

How can I launch a generic of Symtuza before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Symtuza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Symtuza's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Symtuza -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
800 mg/150 mg/ 200 mg/10 mg 16 Aug, 2021 1 19 Jul, 2038





About Symtuza

Symtuza is a drug owned by Janssen Products Lp. It is used for treating HIV-1 infection in various patient populations, including those with no prior treatment history or virologically suppressed individuals. Symtuza uses Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate as an active ingredient. Symtuza was launched by Janssen Prods in 2018.

Approval Date:

Symtuza was approved by FDA for market use on 17 July, 2018.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Symtuza is 17 July, 2018, its NCE-1 date is estimated to be 06 November, 2019.

Active Ingredient:

Symtuza uses Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate as the active ingredient. Check out other Drugs and Companies using Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate ingredient

Treatment:

Symtuza is used for treating HIV-1 infection in various patient populations, including those with no prior treatment history or virologically suppressed individuals.

Dosage:

Symtuza is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
150MG;800MG;200MG;EQ 10MG BASE TABLET Prescription ORAL