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Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Patent Expiration

Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate is Used for managing HIV-1 infection in adults and pediatric patients aged 12 years and older. It was first introduced by Gilead Sciences Llc in its drug Atripla on Jul 12, 2006. 9 different companies have introduced drugs containing Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate.


Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Patents

Given below is the list of patents protecting Efavirenz; 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
Atripla US8598185 Unitary pharmaceutical dosage form Apr 28, 2029 Gilead Sciences
Atripla US9018192 Unitary pharmaceutical dosage form Jun 13, 2026 Gilead Sciences
Atripla US9545414 Unitary pharmaceutical dosage form Jun 13, 2026 Gilead Sciences
Atripla US8716264

(Pediatric)

 Compositions and methods for combination antiviral therapy Jul 03, 2024

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

 Gilead Sciences
Atripla US6703396

(Pediatric)

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

(Expired)

 Gilead Sciences
Atripla US6642245

(Pediatric)

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

(Expired)

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

(Expired)

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

(Expired)

 Gilead Sciences
Atripla US6639071

(Pediatric)

 Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Aug 14, 2018

(Expired)

 Gilead Sciences
Atripla US6939964

(Pediatric)

 Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Jul 20, 2018

(Expired)

 Gilead Sciences
Atripla US6639071 Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Feb 14, 2018

(Expired)

 Gilead Sciences
Atripla US5922695

(Pediatric)

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

(Expired)

 Gilead Sciences
Atripla US5935946

(Pediatric)

 Nucleotide analog composition and synthesis method Jan 25, 2018

(Expired)

 Gilead Sciences
Atripla US5977089

(Pediatric)

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

(Expired)

 Gilead Sciences
Atripla US6043230

(Pediatric)

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

(Expired)

 Gilead Sciences
Atripla US6939964 Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Jan 20, 2018

(Expired)

 Gilead Sciences
Atripla US5914331

(Pediatric)

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

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

 Gilead Sciences
Atripla US5663169

(Pediatric)

 Benzoxazinones as inhibitors of HIV reverse transcriptase Mar 02, 2015

(Expired)

 Gilead Sciences
Atripla US5663169 Benzoxazinones as inhibitors of HIV reverse transcriptase Sep 02, 2014

(Expired)

 Gilead Sciences
Atripla US5519021

(Pediatric)

 Benzoxazinones as inhibitors of HIV reverse transcriptase Nov 21, 2013

(Expired)

 Gilead Sciences
Atripla US5519021 Benzoxazinones as inhibitors of HIV reverse transcriptase May 21, 2013

(Expired)

 Gilead Sciences
Atripla US5811423 Benzoxazinones as inhibitors of HIV reverse transcriptase Aug 07, 2012

(Expired)

 Gilead Sciences



Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate's Family Patents

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Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Generic API Manufacturers

Several generic applications have been filed for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate. The first generic version for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate was by Aurobindo Pharma Ltd and was approved on Sep 4, 2018. And the latest generic version is by Mylan Pharmaceuticals Inc and was approved on Sep 5, 2024.

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


1. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate. This 600mg;200mg;300mg version comes by the name EFAVIRENZ, 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
600MG; 200MG; 300MG

(reference standard)

tablet Prescription ORAL AB Sep 4, 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
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





2. CIPLA

Cipla Ltd has filed for 1 generic for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate. This 600mg;200mg;300mg version comes by the name EFAVIRENZ, 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
600MG; 200MG; 300MG

tablet Prescription ORAL AB Jun 3, 2019


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
Vasco Da Gama Cipla Limited
Raigad Cipla Limited
Mumbai Cipla Limited
Bengaluru Cipla Limited
Pithampur, District Dhar Cipla Limited
Bangalore Cipla Ltd.
Kurkumbh Village, Dist. Pune Cipla, Ltd.





3. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 1 generic for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate. This 600mg;200mg;300mg version comes by the name EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG; 200MG; 300MG

tablet Prescription ORAL AB Jan 24, 2022





4. LAURUS

Laurus Labs Ltd has filed for 1 generic for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate. This 600mg;200mg;300mg version comes by the name EFAVIRENZ, 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
600MG; 200MG; 300MG

tablet Prescription ORAL AB Dec 22, 2021


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)
Anakapalli Laurus Labs Limited
Hyderabad Laurus Labs Limited
Anikapalli District Laurus Labs Limited
Visakhapatnam Laurus Labs Limited





5. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 1 generic for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate. This 600mg;200mg;300mg version comes by the name EFAVIRENZ, 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
600MG; 200MG; 300MG

tablet Prescription ORAL AB Sep 13, 2021





6. MYLAN

Mylan Pharmaceuticals Inc has filed for 1 generic for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG; 200MG; 300MG

tablet Discontinued ORAL N/A Sep 5, 2024


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Morgantown Mylan Specialty, L.P.
Saint Albans Mylan Technologies, Inc.
Greensboro Mylan Pharmaceuticals Inc
India
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





7. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate. This 600mg;200mg;300mg version comes by the name EFAVIRENZ; 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
600MG; 200MG; 300MG

tablet Discontinued ORAL N/A Oct 3, 2023


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
East Brunswick Strides Pharma Inc.
Chestnut Ridge Strides Pharma, Inc.
India
Puducherry Strides Pharma Science Limited
Bangalore Strides Pharma Science Limited





8. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 1 generic for Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate. This 600mg;200mg;300mg version comes by the name EFAVIRENZ, 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
600MG; 200MG; 300MG

tablet Prescription ORAL AB Nov 9, 2018