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. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US6703396 | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Mar, 2021
(3 years ago) |
Expired
|
| US8518987 | Pseudopolymorphic forms of a HIV protease inhibitor |
Feb, 2024
(5 months ago) |
Expired
|
| US7390791 | Prodrugs of phosphonate nucleotide analogues |
Apr, 2025
(8 months from now) | Active |
| US7700645 | Pseudopolymorphic forms of a HIV protease inhibitor |
Dec, 2026
(2 years from now) | Active |
| US8148374 | Modulators of pharmacokinetic properties of therapeutics |
Sep, 2029
(5 years from now) | Active |
| US9296769 | Tenofovir alafenamide hemifumarate |
Aug, 2032
(8 years from now) | Active |
| US8754065 | Tenofovir alafenamide hemifumarate |
Aug, 2032
(8 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9889115 | Fitness assay and associated methods |
Jun, 2019
(5 years ago) |
Expired
|
| US7470506 | Fitness assay and associated methods |
Jun, 2019
(5 years ago) |
Expired
|
| US8597876 | Method of treating HIV infection |
Jun, 2019
(5 years ago) |
Expired
|
| US6642245 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Nov, 2020
(3 years ago) |
Expired
|
| US7803788 | Prodrugs of phosphonate nucoleotide analogues |
Feb, 2022
(2 years ago) |
Expired
|
| US10039718 | Use of solid carrier particles to improve the processability of a pharmaceutical agent |
Oct, 2032
(8 years from now) | Active |
| US10786518 | Compositions and methods of treating HIV |
Jul, 2038
(13 years from now) | Active |
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.
Latest Legal Activities on Symtuza's Patents
Given below is the list of recent legal activities going on the following patents of Symtuza.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 09, 2015, against patent number US8518987. The petitioner Lupin Limited, challenged the validity or infringement of this patent, with Janssen Sciences Ireland UC as the respondent. Click below to track the latest information on how companies are challenging Symtuza's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8518987 | April, 2015 | Terminated-Denied | Janssen Sciences Ireland UC | Lupin Limited |
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 |
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 |
|---|---|---|---|
| | |||
| 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
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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.
Market Authorisation Date:
Symtuza was approved by FDA for market use on 17 July, 2018.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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 |