Descovy is a drug owned by Gilead Sciences Inc. It is protected by 15 US drug patents filed from 2016 to 2022. Out of these, 6 drug patents are active and 9 have expired. Descovy'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 Feb 15, 2033. Details of Descovy'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. | |||
| US8754065 | Tenofovir alafenamide hemifumarate |
Aug, 2032
(7 years from now) | Active |
| US9296769 | Tenofovir alafenamide hemifumarate |
Aug, 2032
(7 years from now) | Active |
| US7390791 | Prodrugs of phosphonate nucleotide analogues |
Apr, 2025
(4 months from now) | Active |
| US6703396 | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Mar, 2021
(3 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
|
| US5814639 | Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds |
Sep, 2015
(9 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9296769 (Pediatric) | Tenofovir alafenamide hemifumarate |
Feb, 2033
(8 years from now) | Active |
|
US8754065 (Pediatric) | Tenofovir alafenamide hemifumarate |
Feb, 2033
(8 years from now) | Active |
|
US7390791 (Pediatric) | Prodrugs of phosphonate nucleotide analogues |
Oct, 2025
(10 months from now) | Active |
| US7803788 | Prodrugs of phosphonate nucoleotide analogues |
Feb, 2022
(2 years ago) |
Expired
|
|
US6703396 (Pediatric) | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Sep, 2021
(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
|
| US6642245 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Nov, 2020
(4 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
|
|
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
|
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 Descovy's patents.
Latest Legal Activities on Descovy's Patents
Given below is the list of recent legal activities going on the following patents of Descovy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Sep, 2023 | US9296769 |
| Expire Patent Critical | 31 Oct, 2022 | US7803788 |
| Maintenance Fee Reminder Mailed Critical | 16 May, 2022 | US7803788 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Dec, 2021 | US8754065 |
| Patent Term Extension Certificate Critical | 19 Aug, 2020 | US7390791 |
| Election in Response to Notice of Final Determination | 18 Mar, 2020 | US7390791 |
| Election in Response to Notice of Final Determination | 18 Mar, 2020 | US7803788 |
| Notice of Final Determination -Election Required | 19 Feb, 2020 | US7390791 |
| Notice of Final Determination -Election Required | 19 Feb, 2020 | US7803788 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Dec, 2019 | US7390791 |
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 Descovy and ongoing litigations to help you estimate the early arrival of Descovy generic.
Descovy's Litigations
Descovy 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 Descovy's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6703396 | April, 2002 |
Decision
(04 Apr, 2002) | DIONNE | |
| US6642245 | July, 2001 |
Decision
(05 Jul, 2001) | DIONNE | |
FDA has granted some exclusivities to Descovy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Descovy, 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 Descovy.
Exclusivity Information
Descovy holds 6 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Descovy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Sep 28, 2020 |
| New Chemical Entity Exclusivity(NCE) | Nov 05, 2020 |
| New Indication(I-812) | Oct 03, 2022 |
| Orphan Drug Exclusivity(ODE-284) | Sep 28, 2024 |
| Orphan Drug Exclusivity(ODE-285) | Sep 28, 2024 |
| Orphan Drug Exclusivity(ODE-457) | Jan 07, 2029 |
Several oppositions have been filed on Descovy'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 Descovy's generic, the next section provides detailed information on ongoing and past EP oppositions related to Descovy patents.
Descovy's Oppositions Filed in EPO
Descovy has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 23, 2015, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP01961695A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| 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 |
| 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 |
US patents provide insights into the exclusivity only within the United States, but Descovy 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 Descovy's family patents as well as insights into ongoing legal events on those patents.
Descovy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Descovy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 15, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Descovy Generic API suppliers:
Emtricitabine; Tenofovir Alafenamide Fumarate is the generic name for the brand Descovy. 1 company has already filed for the generic of Descovy. Check out the entire list of companies who have already received approval for Descovy's generic
How can I launch a generic of Descovy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Descovy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Descovy'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 Descovy -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 120 mg/15 mg | 31 Oct, 2022 | 1 | 15 Aug, 2032 | ||
| 200 mg/25 mg | 05 Nov, 2019 | 6 | 15 Aug, 2032 |
Alternative Brands for Descovy
Descovy which is used for managing and treating HIV infection., has several other brand drugs in the same treatment category and using the same active ingredient (Emtricitabine; Tenofovir Alafenamide Fumarate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
| |||||||||||||
| Agouron Pharms |
| |||||||||||||
| Bristol Myers Squibb |
| |||||||||||||
| Gilead |
| |||||||||||||
| Gilead Sciences |
| |||||||||||||
| Gilead Sciences Inc |
| |||||||||||||
| Glaxosmithkline |
| |||||||||||||
| Merck Sharp Dohme |
| |||||||||||||
| Msd Sub Merck |
| |||||||||||||
| Viiv Hlthcare |
| |||||||||||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Emtricitabine; Tenofovir Alafenamide Fumarate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Janssen Prods |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Emtricitabine; Tenofovir Alafenamide Fumarate, Descovy's active ingredient. Check the complete list of approved generic manufacturers for Descovy
About Descovy
Descovy is a drug owned by Gilead Sciences Inc. It is used for managing and treating HIV infection. Descovy uses Emtricitabine; Tenofovir Alafenamide Fumarate as an active ingredient. Descovy was launched by Gilead Sciences Inc in 2022.
Approval Date:
Descovy was approved by FDA for market use on 07 January, 2022.
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 Descovy is 07 January, 2022, its NCE-1 date is estimated to be 06 November, 2019.
Active Ingredient:
Descovy uses Emtricitabine; Tenofovir Alafenamide Fumarate as the active ingredient. Check out other Drugs and Companies using Emtricitabine; Tenofovir Alafenamide Fumarate ingredient
Treatment:
Descovy is used for managing and treating HIV infection.
Dosage:
Descovy is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG;EQ 25MG BASE | TABLET | Prescription | ORAL |
| 120MG;EQ 15MG BASE | TABLET | Prescription | ORAL |