Emtricitabine; Tenofovir Alafenamide Fumarate Patent Expiration

Emtricitabine; Tenofovir Alafenamide Fumarate is Used for managing and treating HIV infection. It was first introduced by Gilead Sciences Inc in its drug Descovy on Apr 4, 2016. 3 different companies have introduced drugs containing Emtricitabine; Tenofovir Alafenamide Fumarate.


Emtricitabine; Tenofovir Alafenamide Fumarate Patents

Given below is the list of patents protecting Emtricitabine; Tenofovir Alafenamide Fumarate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Descovy US8754065

(Pediatric)

Tenofovir alafenamide hemifumarate Feb 15, 2033 Gilead Sciences Inc
Descovy US9296769

(Pediatric)

Tenofovir alafenamide hemifumarate Feb 15, 2033 Gilead Sciences Inc
Descovy US8754065 Tenofovir alafenamide hemifumarate Aug 15, 2032 Gilead Sciences Inc
Descovy US9296769 Tenofovir alafenamide hemifumarate Aug 15, 2032 Gilead Sciences Inc
Descovy US7390791

(Pediatric)

Prodrugs of phosphonate nucleotide analogues Jul 07, 2025 Gilead Sciences Inc
Descovy US7390791 Prodrugs of phosphonate nucleotide analogues Jan 07, 2025

(Expired)

Gilead Sciences Inc
Descovy US7803788 Prodrugs of phosphonate nucoleotide analogues Feb 02, 2022

(Expired)

Gilead Sciences Inc
Descovy US6703396

(Pediatric)

Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Sep 09, 2021

(Expired)

Gilead Sciences Inc
Descovy US6642245

(Pediatric)

Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane May 04, 2021

(Expired)

Gilead Sciences Inc
Descovy US6703396 Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Mar 09, 2021

(Expired)

Gilead Sciences Inc
Descovy US6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Nov 04, 2020

(Expired)

Gilead Sciences Inc
Descovy US5914331

(Pediatric)

Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Jan 02, 2018

(Expired)

Gilead Sciences Inc
Descovy US5914331 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Jul 02, 2017

(Expired)

Gilead Sciences Inc
Descovy US5814639

(Pediatric)

Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds Mar 29, 2016

(Expired)

Gilead Sciences Inc
Descovy US5814639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds Sep 29, 2015

(Expired)

Gilead Sciences Inc



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Emtricitabine; Tenofovir Alafenamide Fumarate Generic API Manufacturers

Several generic applications have been filed for Emtricitabine; Tenofovir Alafenamide Fumarate. The first generic version for Emtricitabine; Tenofovir Alafenamide Fumarate was by Apotex Inc and was approved on May 17, 2024. And the latest generic version is by Lupin Ltd and was approved on Dec 13, 2024.

Given below is the list of companies who have filed for Emtricitabine; Tenofovir Alafenamide Fumarate generic, along with the locations of their manufacturing plants worldwide.


1. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Emtricitabine; Tenofovir Alafenamide Fumarate. All of these versions come by the name EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
120MG; EQ 15MG BASE

tablet Discontinued ORAL N/A May 17, 2024
200MG; EQ 25MG BASE

tablet Discontinued ORAL N/A May 17, 2024


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Toronto Apotex Inc.
Brantford Apotex Pharmachem Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Etobicoke Apotex, Inc.
Winnipeg Apotex Fermentation Inc.
India
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre





2. LUPIN LTD

Lupin Ltd has filed for 1 generic for Emtricitabine; Tenofovir Alafenamide Fumarate. This 200mg;eq 25mg base version comes by the name EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; EQ 25MG BASE

tablet Prescription ORAL AB Dec 13, 2024


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.