Truvada is a drug owned by Gilead Sciences Inc. It is protected by 21 US drug patents filed from 2013 to 2017 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 13, 2024. Details of Truvada'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. | |||
| US6703396 | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Mar, 2021
(3 years ago) |
Expired
|
| US5977089 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jul, 2017
(7 years ago) |
Expired
|
| US5935946 | Nucleotide analog composition and synthesis method |
Jul, 2017
(7 years ago) |
Expired
|
| US5922695 | Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability |
Jul, 2017
(7 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). | |||
|
US8716264 (Pediatric) | Compositions and methods for combination antiviral therapy |
Jul, 2024
(4 months ago) |
Expired
|
| US9744181 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(10 months ago) |
Expired
|
| US8592397 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(10 months ago) |
Expired
|
| US8716264 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(10 months ago) |
Expired
|
| US9457036 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(10 months 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
|
| US6703396 | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Mar, 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
|
|
US6043230 (Pediatric) | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jan, 2018
(6 years ago) |
Expired
|
|
US5922695 (Pediatric) | Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability |
Jan, 2018
(6 years ago) |
Expired
|
|
US5935946 (Pediatric) | Nucleotide analog composition and synthesis method |
Jan, 2018
(6 years ago) |
Expired
|
|
US5977089 (Pediatric) | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jan, 2018
(6 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
|
| US5935946 | Nucleotide analog composition and synthesis method |
Jul, 2017
(7 years ago) |
Expired
|
| US6043230 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jul, 2017
(7 years ago) |
Expired
|
| US5922695 | Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability |
Jul, 2017
(7 years ago) |
Expired
|
| US5977089 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jul, 2017
(7 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 (Pediatric) | Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds |
Mar, 2016
(8 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
|
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 Truvada and ongoing litigations to help you estimate the early arrival of Truvada generic.
Truvada's Litigations
Truvada 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 Truvada's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US5935946 | June, 2014 |
Terminated-Denied
(17 Dec, 2014) | Gilead Sciences, Inc. | MYLAN PHARMACEUTICALS INC. |
| US5922695 | June, 2014 |
Terminated-Denied
(09 Dec, 2014) | Gilead Sciences, Inc. | Mylan Pharmaceuticals Inc. |
| US5977089 | June, 2014 |
Terminated-Denied
(09 Dec, 2014) | Gilead Sciences, Inc. | Mylan Pharmaceuticals Inc. |
| US6043230 | June, 2014 |
Terminated-Denied
(09 Dec, 2014) | Gilead Sciences, Inc. | Mylan Pharmaceuticals Inc. |
| US6703396 | April, 2002 |
Decision
(04 Apr, 2002) | DIONNE | |
| US6642245 | July, 2001 |
Decision
(05 Jul, 2001) | DIONNE | |
Several oppositions have been filed on Truvada'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 Truvada's generic, the next section provides detailed information on ongoing and past EP oppositions related to Truvada patents.
Truvada's Oppositions Filed in EPO
Truvada has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 13, 2009, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP04701819A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP04701819A | Mar, 2009 | Generics [UK] Limited | Revoked |
| EP04701819A | Mar, 2009 | Teva Pharmaceutical Industries LTD. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Truvada 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 Truvada's family patents as well as insights into ongoing legal events on those patents.
Truvada's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Truvada's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 13, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Truvada Generic API suppliers:
Emtricitabine; Tenofovir Disoproxil Fumarate is the generic name for the brand Truvada. 13 different companies have already filed for the generic of Truvada, with Amneal Pharms Co having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Truvada's generic
How can I launch a generic of Truvada before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Truvada's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Truvada'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 Truvada -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg/300 mg | 26 Sep, 2008 | 1 | 08 Jun, 2017 | 09 Mar, 2021 | Extinguished |
| 100 mg/150 mg 133 mg/200 mg 167 mg/250 mg | 19 May, 2017 | 1 | 22 Aug, 2018 | 09 Mar, 2021 | Eligible |
Alternative Brands for Truvada
Truvada which is used for treating HIV-1 infection in adults and pediatric patients., has several other brand drugs in the same treatment category and using the same active ingredient (Emtricitabine; Tenofovir Disoproxil 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 |
| |||||||||||||||||
| Msd Sub Merck |
| |||||||||||||||||
| Roche |
| |||||||||||||||||
| Viiv Hlthcare |
| |||||||||||||||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Emtricitabine; Tenofovir Disoproxil Fumarate, Truvada's active ingredient. Check the complete list of approved generic manufacturers for Truvada
About Truvada
Truvada is a drug owned by Gilead Sciences Inc. It is used for treating HIV-1 infection in adults and pediatric patients. Truvada uses Emtricitabine; Tenofovir Disoproxil Fumarate as an active ingredient. Truvada was launched by Gilead in 2016.
Approval Date:
Truvada was approved by FDA for market use on 10 March, 2016.
Active Ingredient:
Truvada uses Emtricitabine; Tenofovir Disoproxil Fumarate as the active ingredient. Check out other Drugs and Companies using Emtricitabine; Tenofovir Disoproxil Fumarate ingredient
Treatment:
Truvada is used for treating HIV-1 infection in adults and pediatric patients.
Dosage:
Truvada is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG;300MG | TABLET | Prescription | ORAL |
| 100MG;150MG | TABLET | Prescription | ORAL |
| 133MG;200MG | TABLET | Prescription | ORAL |
| 167MG;250MG | TABLET | Prescription | ORAL |