Genvoya is a drug owned by Gilead Sciences Inc. It is protected by 30 US drug patents filed from 2015 to 2021. Out of these, 20 drug patents are active and 10 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 06, 2033. Details of Genvoya'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. | |||
| US5814639 | Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds |
Sep, 2015
(8 years ago) |
Expired
|
| US5914331 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Jul, 2017
(7 years ago) |
Expired
|
| US6703396 | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Mar, 2021
(3 years ago) |
Expired
|
| US7390791 | Prodrugs of phosphonate nucleotide analogues |
Apr, 2025
(8 months from now) | Active |
| US7176220 | 4-oxoquinoline compound and use thereof as pharmaceutical agent |
Aug, 2026
(2 years from now) | Active |
| US7635704 | Stable crystal of 4-oxoquinoline compound |
Oct, 2026
(2 years from now) | Active |
| US8981103 | Stable crystal of 4-oxoquinoline compound |
Oct, 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). | |||
|
US5814639 (Pediatric) | Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds |
Mar, 2016
(8 years ago) |
Expired
|
|
US5914331 (Pediatric) | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Jan, 2018
(6 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
|
|
US6642245 (Pediatric) | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
May, 2021
(3 years ago) |
Expired
|
|
US6703396 (Pediatric) | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Sep, 2021
(2 years ago) |
Expired
|
| US7800788 | Upright image processing apparatus with pivotable image reading portion |
Feb, 2022
(2 years ago) |
Expired
|
| US7803788 | Prodrugs of phosphonate nucoleotide analogues |
Feb, 2022
(2 years ago) |
Expired
|
|
US7390791 (Pediatric) | Prodrugs of phosphonate nucleotide analogues |
Oct, 2025
(1 year, 2 months from now) | Active |
|
US7176220 (Pediatric) | 4-oxoquinoline compound and use thereof as pharmaceutical agent |
Feb, 2027
(2 years from now) | Active |
|
US8981103 (Pediatric) | Stable crystal of 4-oxoquinoline compound |
Apr, 2027
(2 years from now) | Active |
|
US7635704 (Pediatric) | Stable crystal of 4-oxoquinoline compound |
Apr, 2027
(2 years from now) | Active |
| US9891239 | Modulators of pharmacokinetic properties of therapeutics |
Sep, 2029
(5 years from now) | Active |
|
US9891239 (Pediatric) | Modulators of pharmacokinetic properties of therapeutics |
Mar, 2030
(5 years from now) | Active |
|
US8148374 (Pediatric) | Modulators of pharmacokinetic properties of therapeutics |
Mar, 2030
(5 years from now) | Active |
| US8633219 | Combination therapy |
Apr, 2030
(5 years from now) | Active |
|
US8633219 (Pediatric) | Combination therapy |
Oct, 2030
(6 years from now) | Active |
| US10039718 | Use of solid carrier particles to improve the processability of a pharmaceutical agent |
Oct, 2032
(8 years from now) | Active |
|
US8754065 (Pediatric) | Tenofovir alafenamide hemifumarate |
Feb, 2033
(8 years from now) | Active |
|
US9296769 (Pediatric) | Tenofovir alafenamide hemifumarate |
Feb, 2033
(8 years from now) | Active |
|
US10039718 (Pediatric) | Use of solid carrier particles to improve the processability of a pharmaceutical agent |
Apr, 2033
(8 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 Genvoya's patents.
Latest Legal Activities on Genvoya's Patents
Given below is the list of recent legal activities going on the following patents of Genvoya.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2023 | US8148374 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Sep, 2023 | US9296769 |
| Expire Patent | 31 Oct, 2022 | US7803788 |
| Expire Patent | 24 Oct, 2022 | US7800788 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 Aug, 2022 | US8981103 |
| Maintenance Fee Reminder Mailed | 16 May, 2022 | US7803788 |
| Maintenance Fee Reminder Mailed | 10 May, 2022 | US7800788 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Jan, 2022 | US10039718 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Dec, 2021 | US8754065 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Jul, 2021 | US9891239 |
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 Genvoya and ongoing litigations to help you estimate the early arrival of Genvoya generic.
Genvoya's Litigations
Genvoya has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 15, 2011, against patent number US8633219. The petitioner , challenged the validity or infringement of this patent, with Yuji Matsuzaki et al as the respondent. Click below to track the latest information on how companies are challenging Genvoya's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9891239 | August, 2013 | Decision | Manoj C. Desai et al | |
| US8633219 | August, 2011 | Decision | Yuji Matsuzaki et al | |
FDA has granted some exclusivities to Genvoya. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Genvoya, 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 Genvoya.
Exclusivity Information
Genvoya holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Genvoya's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Sep 25, 2020 |
| New Chemical Entity Exclusivity(NCE) | Nov 05, 2020 |
| New Dosing Schedule(D-173) | Dec 10, 2021 |
Several oppositions have been filed on Genvoya'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 Genvoya's generic, the next section provides detailed information on ongoing and past EP oppositions related to Genvoya patents.
Genvoya's oppositions filed in EPO
Genvoya has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 23, 2015, by Swindell & Pearson Limited. This opposition was filed on patent number EP01961695A. 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 |
| EP13164300A | Jan, 2018 | Georg Kalhammer/Stephan Teipel | Granted and Under Opposition |
| EP13164300A | Jan, 2018 | Cooke, Richard | Granted and Under Opposition |
| EP13164300A | Jan, 2018 | Aechter, Bernd | 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 |
| EP12167591A | May, 2017 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP12167590A | 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 | Teva Pharmaceutical Industries Ltd | Patent maintained as amended |
| EP01961695A | Nov, 2015 | Swindell & Pearson Limited | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Genvoya 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 Genvoya's family patents as well as insights into ongoing legal events on those patents.
Genvoya's family patents
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Generic Launch
Generic Release Date:
Genvoya's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 06, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Genvoya Generics:
There are no approved generic versions for Genvoya as of now.
How can I launch a generic of Genvoya before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Genvoya's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Genvoya'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 Genvoya -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg/150 mg/ 200 mg/10 mg | 12 Apr, 2023 | 1 | 06 Oct, 2032 |
About Genvoya
Genvoya is a drug owned by Gilead Sciences Inc. It is used for treating HIV infection with a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monoxygenase. Genvoya uses Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate as an active ingredient. Genvoya was launched by Gilead Sciences Inc in 2015.
Market Authorisation Date:
Genvoya was approved by FDA for market use on 05 November, 2015.
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 Genvoya is 05 November, 2015, its NCE-1 date is estimated to be 06 November, 2019
Active Ingredient:
Genvoya uses Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate as the active ingredient. Check out other Drugs and Companies using Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate ingredient
Treatment:
Genvoya is used for treating HIV infection with a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monoxygenase.
Dosage:
Genvoya is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG;150MG;200MG;EQ 10MG BASE | TABLET | Prescription | ORAL |