Amlodipine Besylate; Hydrochlorothiazide; Valsartan Patent Expiration

Amlodipine Besylate; Hydrochlorothiazide; Valsartan is Used for treating high blood pressure. It was first introduced by Novartis Pharmaceuticals Corp in its drug Exforge Hct on Apr 30, 2009. 7 different companies have introduced drugs containing Amlodipine Besylate; Hydrochlorothiazide; Valsartan.


Amlodipine Besylate; Hydrochlorothiazide; Valsartan Patents

Given below is the list of patents protecting Amlodipine Besylate; Hydrochlorothiazide; Valsartan, 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
Exforge Hct US8475839

(Pediatric)

Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same Nov 16, 2023

(Expired)

Novartis
Exforge Hct US8101599 Pharmaceutical composition containing anti-hypertensive agents May 16, 2023

(Expired)

Novartis
Exforge Hct US8475839 Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same May 16, 2023

(Expired)

Novartis
Exforge Hct US6294197

(Pediatric)

Solid oral dosage forms of valsartan Dec 18, 2017

(Expired)

Novartis
Exforge Hct US6294197 Solid oral dosage forms of valsartan Jun 18, 2017

(Expired)

Novartis
Exforge Hct US5399578

(Pediatric)

Acyl compounds Sep 21, 2012

(Expired)

Novartis



Amlodipine Besylate; Hydrochlorothiazide; Valsartan's Family Patents

Family Patents

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Amlodipine Besylate; Hydrochlorothiazide; Valsartan Generic API Manufacturers

Several generic applications have been filed for Amlodipine Besylate; Hydrochlorothiazide; Valsartan. The first generic version for Amlodipine Besylate; Hydrochlorothiazide; Valsartan was by Teva Pharmaceuticals Usa and was approved on Sep 25, 2012. And the latest generic version is by Macleods Pharmaceuticals Ltd and was approved on Jan 7, 2025.

Given below is the list of companies who have filed for Amlodipine Besylate; Hydrochlorothiazide; Valsartan generic, along with the locations of their manufacturing plants worldwide.


1. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 5 different strengths of generic version for Amlodipine Besylate; Hydrochlorothiazide; Valsartan. All of these versions come by the name AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE. 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
EQ 5MG BASE; 12.5MG; 160MG

tablet Prescription ORAL AB Dec 19, 2017
EQ 5MG BASE; 25MG; 160MG

tablet Prescription ORAL AB Dec 19, 2017
EQ 10MG BASE; 12.5MG; 160MG

tablet Prescription ORAL AB Dec 19, 2017
EQ 10MG BASE; 25MG; 160MG

tablet Prescription ORAL AB Dec 19, 2017
EQ 10MG BASE; 25MG; 320MG

tablet Prescription ORAL AB Dec 19, 2017


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
Medchal Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





2. LUPIN LTD

Lupin Ltd has filed for 5 different strengths of generic version for Amlodipine Besylate; Hydrochlorothiazide; Valsartan. All of these versions come by the name AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE. 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
EQ 5MG BASE; 25MG; 160MG

tablet Prescription ORAL AB Jun 3, 2015
EQ 10MG BASE; 25MG; 320MG

tablet Prescription ORAL AB Jun 3, 2015
EQ 5MG BASE; 12.5MG; 160MG

tablet Prescription ORAL AB Jun 3, 2015
EQ 10MG BASE; 25MG; 160MG

tablet Prescription ORAL AB Jun 3, 2015
EQ 10MG BASE; 12.5MG; 160MG

tablet Prescription ORAL AB Jun 3, 2015


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.





3. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 5 different strengths of generic version for Amlodipine Besylate; Hydrochlorothiazide; Valsartan. All of these versions come by the name AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE. 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
EQ 5MG BASE; 12.5MG; 160MG

tablet Prescription ORAL AB Jan 7, 2025
EQ 5MG BASE; 25MG; 160MG

tablet Prescription ORAL AB Jan 7, 2025
EQ 10MG BASE; 25MG; 320MG

tablet Prescription ORAL AB Jan 7, 2025
EQ 10MG BASE; 25MG; 160MG

tablet Prescription ORAL AB Jan 7, 2025
EQ 10MG BASE; 12.5MG; 160MG

tablet Prescription ORAL AB Jan 7, 2025





4. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 5 different strengths of generic version for Amlodipine Besylate; Hydrochlorothiazide; Valsartan. All of these versions come by the name AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE. 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
EQ 10MG BASE; 12.5MG; 160MG

tablet Prescription ORAL AB Jun 1, 2015
EQ 5MG BASE; 12.5MG; 160MG

tablet Prescription ORAL AB Jun 1, 2015
EQ 5MG BASE; 25MG; 160MG

tablet Prescription ORAL AB Jun 1, 2015
EQ 10MG BASE; 25MG; 160MG

tablet Prescription ORAL AB Jun 1, 2015
EQ 10MG BASE; 25MG; 320MG

tablet Prescription ORAL AB Jun 1, 2015


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
Bangalore Strides Pharma Science Limited
Puducherry Strides Pharma Science Limited





5. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 5 different strengths of generic version for Amlodipine Besylate; Hydrochlorothiazide; Valsartan. All of these versions come by the name AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE; 12.5MG; 160MG

tablet Discontinued ORAL N/A Sep 25, 2012
EQ 5MG BASE; 25MG; 160MG

tablet Discontinued ORAL N/A Sep 25, 2012
EQ 10MG BASE; 25MG; 160MG

tablet Discontinued ORAL N/A Sep 25, 2012
EQ 10MG BASE; 25MG; 320MG

tablet Discontinued ORAL N/A Sep 25, 2012
EQ 10MG BASE; 12.5MG; 160MG

tablet Discontinued ORAL N/A Sep 25, 2012





6. TORRENT

Torrent Pharmaceuticals Ltd has filed for 5 different strengths of generic version for Amlodipine Besylate; Hydrochlorothiazide; Valsartan. All of these versions come by the name AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE; 12.5MG; 160MG

tablet Discontinued ORAL N/A Jun 3, 2015
EQ 5MG BASE; 25MG; 160MG

tablet Discontinued ORAL N/A Jun 3, 2015
EQ 10MG BASE; 12.5MG; 160MG

tablet Discontinued ORAL N/A Jun 3, 2015
EQ 10MG BASE; 25MG; 160MG

tablet Discontinued ORAL N/A Jun 3, 2015
EQ 10MG BASE; 25MG; 320MG

tablet Discontinued ORAL N/A Jun 3, 2015


Manufacturing Plant Locations
New

Torrent'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 Torrent as present at those locations.

Country City Firm Name
India
Bharuch Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Gandhi Nagar Torrent Pharmaceuticals Limited
United States
Basking Ridge Torrent Pharma Inc.
Kalamazoo Torrent Pharma Inc.