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Emtricitabine; Tenofovir Disoproxil Fumarate Patent Expiration

Emtricitabine; Tenofovir Disoproxil Fumarate is Used for treating HIV-1 infection in adults and pediatric patients. It was first introduced by Gilead Sciences Inc in its drug Truvada on Aug 2, 2004. 14 different companies have introduced drugs containing Emtricitabine; Tenofovir Disoproxil Fumarate.


Emtricitabine; Tenofovir Disoproxil Fumarate Patents

Given below is the list of patents protecting Emtricitabine; Tenofovir Disoproxil 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
Truvada US8716264

(Pediatric)

 Compositions and methods for combination antiviral therapy Jul 13, 2024

(Expired)

 Gilead
Truvada US8592397 Compositions and methods for combination antiviral therapy Jan 13, 2024

(Expired)

 Gilead
Truvada US8716264 Compositions and methods for combination antiviral therapy Jan 13, 2024

(Expired)

 Gilead
Truvada US9457036 Compositions and methods for combination antiviral therapy Jan 13, 2024

(Expired)

 Gilead
Truvada US9744181 Compositions and methods for combination antiviral therapy Jan 13, 2024

(Expired)

 Gilead
Truvada US6703396

(Pediatric)

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

(Expired)

 Gilead
Truvada US6642245

(Pediatric)

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

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

 Gilead
Truvada US5922695

(Pediatric)

 Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Jan 25, 2018

(Expired)

 Gilead
Truvada US5935946

(Pediatric)

 Nucleotide analog composition and synthesis method Jan 25, 2018

(Expired)

 Gilead
Truvada US5977089

(Pediatric)

 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Jan 25, 2018

(Expired)

 Gilead
Truvada US6043230

(Pediatric)

 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Jan 25, 2018

(Expired)

 Gilead
Truvada US5914331

(Pediatric)

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

(Expired)

 Gilead
Truvada US5922695 Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Jul 25, 2017

(Expired)

 Gilead
Truvada US5922695 Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Jul 25, 2017

(Expired)

 Gilead
Truvada US5935946 Nucleotide analog composition and synthesis method Jul 25, 2017

(Expired)

 Gilead
Truvada US5935946 Nucleotide analog composition and synthesis method Jul 25, 2017

(Expired)

 Gilead
Truvada US5977089 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Jul 25, 2017

(Expired)

 Gilead
Truvada US5977089 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Jul 25, 2017

(Expired)

 Gilead
Truvada US6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Jul 25, 2017

(Expired)

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

(Expired)

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

(Expired)

 Gilead
Truvada US5814639

(Pediatric)

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

(Expired)

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

(Expired)

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

(Expired)

 Gilead



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Emtricitabine; Tenofovir Disoproxil Fumarate Generic API Manufacturers

Several generic applications have been filed for Emtricitabine; Tenofovir Disoproxil Fumarate. The first generic version for Emtricitabine; Tenofovir Disoproxil Fumarate was by Teva Pharmaceuticals Usa Inc and was approved on Jun 8, 2017. And the latest generic version is by Hetero Labs Ltd Unit Iii and was approved on Mar 3, 2025.

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


1. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 4 different strengths of generic version for Emtricitabine; Tenofovir Disoproxil Fumarate. All of these versions come by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Prescription ORAL AB Aug 22, 2018
100MG; 150MG

tablet Prescription ORAL AB Aug 22, 2018
167MG; 250MG

tablet Prescription ORAL AB Aug 22, 2018
133MG; 200MG

tablet Prescription ORAL AB Aug 22, 2018





2. APOTEX

Apotex Inc has filed for 1 generic for Emtricitabine; Tenofovir Disoproxil Fumarate. This 200mg;300mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL 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
200MG; 300MG

tablet Discontinued ORAL N/A Jun 16, 2021


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
North York Apotex Inc.
Brantford Apotex Pharmachem Inc.
Richmond Hill Apotex Inc.
Etobicoke Apotex, Inc.
Toronto Apotex Inc.
Winnipeg Apotex Fermentation Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bangalore Apotex Pharmachem India Pvt Ltd.
Bengaluru Apotex Research Private Limited





3. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Emtricitabine; Tenofovir Disoproxil Fumarate. This 200mg;300mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Prescription ORAL AB Jan 26, 2018


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Sangareddy Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
United States
East Windsor Aurobindo Pharma USA Inc





4. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Emtricitabine; Tenofovir Disoproxil Fumarate. All of these versions come by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
167MG; 250MG

tablet Prescription ORAL AB Mar 9, 2023
133MG; 200MG

tablet Prescription ORAL AB Mar 9, 2023
100MG; 150MG

tablet Prescription ORAL AB Mar 9, 2023


Manufacturing Plant Locations
New

Aurobindo Pharma 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 Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





5. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Emtricitabine; Tenofovir Disoproxil Fumarate. This 200mg;300mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Prescription ORAL AB Jun 4, 2021





6. CIPLA

Cipla Ltd has filed for 1 generic for Emtricitabine; Tenofovir Disoproxil Fumarate. This 200mg;300mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Discontinued ORAL N/A Apr 2, 2021


Manufacturing Plant Locations
New

Cipla'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 Cipla as present at those locations.

Country City Firm Name
India
Mumbai Cipla Limited
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Vasco Da Gama Cipla Limited
Raigad Cipla Limited
Pithampur, District Dhar Cipla Limited
Bangalore Cipla Ltd.
Bengaluru Cipla Limited





7. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 4 different strengths of generic version for Emtricitabine; Tenofovir Disoproxil Fumarate. Out of these 200mg;300mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, 100mg;150mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, 167mg;250mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, 133mg;200mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Prescription ORAL AB Oct 7, 2021
100MG; 150MG

tablet Prescription ORAL AB Mar 3, 2025
167MG; 250MG

tablet Prescription ORAL AB Mar 3, 2025
133MG; 200MG

tablet Prescription ORAL AB Mar 3, 2025





8. LAURUS

Laurus Labs Ltd has filed for 1 generic for Emtricitabine; Tenofovir Disoproxil Fumarate. This 200mg;300mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Laurus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Prescription ORAL AB Jul 26, 2019


Manufacturing Plant Locations
New

Laurus'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 Laurus as present at those locations.

Country City Firm Name
India
Anakapalli Laurus Labs Limited (Unit-5)
Hyderabad Laurus Labs Limited
Visakhapatnam Laurus Labs Limited
Anikapalli District Laurus Labs Limited
Anakapalli Laurus Labs Limited





9. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 1 generic for Emtricitabine; Tenofovir Disoproxil Fumarate. This 200mg;300mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Prescription ORAL AB May 15, 2020





10. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 1 generic for Emtricitabine; Tenofovir Disoproxil Fumarate. This 200mg;300mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Prescription ORAL AB Apr 9, 2018





11. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Emtricitabine; Tenofovir Disoproxil Fumarate. This 200mg;300mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Prescription ORAL AB Jan 13, 2021


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
Chestnut Ridge Strides Pharma, Inc.
East Brunswick Strides Pharma Inc.
India
Puducherry Strides Pharma Science Limited
Bangalore Strides Pharma Science Limited





12. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Emtricitabine; Tenofovir Disoproxil Fumarate. This 200mg;300mg version comes by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Prescription ORAL AB Jun 8, 2017





13. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Emtricitabine; Tenofovir Disoproxil Fumarate. All of these versions come by the name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; 300MG

tablet Prescription ORAL AB Feb 28, 2020
167MG; 250MG

tablet Prescription ORAL AB Jul 1, 2021
100MG; 150MG

tablet Prescription ORAL AB Jul 1, 2021
133MG; 200MG

tablet Prescription ORAL AB Jul 1, 2021