Amlodipine Besylate; Atorvastatin Calcium Patent Expiration

Amlodipine Besylate; Atorvastatin Calcium is used for treating hypercholesterolemia, hyperlipidemia, and hypertension. It was first introduced by Pharmacia And Upjohn Co Llc in its drug Caduet on Jan 30, 2004. 5 different companies have introduced drugs containing Amlodipine Besylate; Atorvastatin Calcium.


Amlodipine Besylate; Atorvastatin Calcium Patents

Given below is the list of patents protecting Amlodipine Besylate; Atorvastatin Calcium, 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
Caduet US6455574 Therapeutic combination Aug 11, 2018

(Expired)

Pharmacia
Caduet US5969156

(Pediatric)

Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin) Jan 08, 2017

(Expired)

Pharmacia
Caduet US5969156 Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin) Jul 08, 2016

(Expired)

Pharmacia
Caduet US5686104

(Pediatric)

Stable oral CI-981 formulation and process of preparing same May 11, 2015

(Expired)

Pharmacia
Caduet US5686104 Stable oral CI-981 formulation and process of preparing same Nov 11, 2014

(Expired)

Pharmacia
Caduet US6126971

(Pediatric)

Stable oral CI-981 formulation and process for preparing same Jul 19, 2013

(Expired)

Pharmacia
Caduet US6126971 Stable oral CI-981 formulation and process for preparing same Jan 19, 2013

(Expired)

Pharmacia



Amlodipine Besylate; Atorvastatin Calcium's Family Patents

Family Patents

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Amlodipine Besylate; Atorvastatin Calcium Generic API Manufacturers

Several generic applications have been filed for Amlodipine Besylate; Atorvastatin Calcium. The first generic version for Amlodipine Besylate; Atorvastatin Calcium was by Mylan Pharmaceuticals Inc and was approved on Nov 29, 2013. And the latest generic version is by Apotex Inc and was approved on Nov 18, 2019.

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


1. APOTEX

Apotex Inc has filed for 8 different strengths of generic version for Amlodipine Besylate; Atorvastatin Calcium. All of these versions come by the name AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE; EQ 20MG BASE

tablet Prescription ORAL AB Nov 18, 2019
EQ 5MG BASE; EQ 40MG BASE

tablet Prescription ORAL AB Nov 18, 2019
EQ 5MG BASE; EQ 80MG BASE

tablet Prescription ORAL AB Nov 18, 2019
EQ 10MG BASE; EQ 10MG BASE

tablet Prescription ORAL AB Nov 18, 2019
EQ 10MG BASE; EQ 20MG BASE

tablet Prescription ORAL AB Nov 18, 2019
EQ 10MG BASE; EQ 40MG BASE

tablet Prescription ORAL AB Nov 18, 2019
EQ 10MG BASE; EQ 80MG BASE

tablet Prescription ORAL AB Nov 18, 2019
EQ 5MG BASE; EQ 10MG BASE

tablet Prescription ORAL AB Nov 18, 2019


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





2. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 11 different strengths of generic version for Amlodipine Besylate; Atorvastatin Calcium. All of these versions come by the name AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 10MG BASE; EQ 80MG BASE

tablet Prescription ORAL AB Mar 7, 2014
EQ 2.5MG BASE; EQ 10MG BASE

tablet Prescription ORAL AB Mar 7, 2014
EQ 2.5MG BASE; EQ 20MG BASE

tablet Prescription ORAL AB Mar 7, 2014
EQ 2.5MG BASE; EQ 40MG BASE

tablet Prescription ORAL AB Mar 7, 2014
EQ 5MG BASE; EQ 10MG BASE

tablet Prescription ORAL AB Mar 7, 2014
EQ 5MG BASE; EQ 20MG BASE

tablet Prescription ORAL AB Mar 7, 2014
EQ 5MG BASE; EQ 40MG BASE

tablet Prescription ORAL AB Mar 7, 2014
EQ 5MG BASE; EQ 80MG BASE

tablet Prescription ORAL AB Mar 7, 2014
EQ 10MG BASE; EQ 10MG BASE

tablet Prescription ORAL AB Mar 7, 2014
EQ 10MG BASE; EQ 20MG BASE

tablet Prescription ORAL AB Mar 7, 2014
EQ 10MG BASE; EQ 40MG BASE

tablet Prescription ORAL AB Mar 7, 2014





3. MYLAN

Mylan Pharmaceuticals Inc has filed for 11 different strengths of generic version for Amlodipine Besylate; Atorvastatin Calcium. All of these versions come by the name AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 10MG BASE; EQ 80MG BASE

tablet Prescription ORAL AB Nov 29, 2013
EQ 2.5MG BASE; EQ 10MG BASE

tablet Discontinued ORAL N/A Nov 29, 2013
EQ 2.5MG BASE; EQ 20MG BASE

tablet Discontinued ORAL N/A Nov 29, 2013
EQ 2.5MG BASE; EQ 40MG BASE

tablet Discontinued ORAL N/A Nov 29, 2013
EQ 5MG BASE; EQ 10MG BASE

tablet Prescription ORAL AB Nov 29, 2013
EQ 5MG BASE; EQ 20MG BASE

tablet Prescription ORAL AB Nov 29, 2013
EQ 5MG BASE; EQ 40MG BASE

tablet Prescription ORAL AB Nov 29, 2013
EQ 5MG BASE; EQ 80MG BASE

tablet Prescription ORAL AB Nov 29, 2013
EQ 10MG BASE; EQ 10MG BASE

tablet Prescription ORAL AB Nov 29, 2013
EQ 10MG BASE; EQ 20MG BASE

tablet Prescription ORAL AB Nov 29, 2013
EQ 10MG BASE; EQ 40MG BASE

tablet Prescription ORAL AB Nov 29, 2013


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





4. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 11 different strengths of generic version for Amlodipine Besylate; Atorvastatin Calcium. All of these versions come by the name AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM. 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
EQ 10MG BASE; EQ 80MG BASE

tablet Prescription ORAL AB Jan 11, 2019
EQ 2.5MG BASE; EQ 40MG BASE

tablet Prescription ORAL AB Jan 11, 2019
EQ 5MG BASE; EQ 10MG BASE

tablet Prescription ORAL AB Jan 11, 2019
EQ 5MG BASE; EQ 20MG BASE

tablet Prescription ORAL AB Jan 11, 2019
EQ 5MG BASE; EQ 40MG BASE

tablet Prescription ORAL AB Jan 11, 2019
EQ 5MG BASE; EQ 80MG BASE

tablet Prescription ORAL AB Jan 11, 2019
EQ 10MG BASE; EQ 10MG BASE

tablet Prescription ORAL AB Jan 11, 2019
EQ 10MG BASE; EQ 20MG BASE

tablet Prescription ORAL AB Jan 11, 2019
EQ 10MG BASE; EQ 40MG BASE

tablet Prescription ORAL AB Jan 11, 2019
EQ 2.5MG BASE; EQ 10MG BASE

tablet Prescription ORAL AB Jan 11, 2019
EQ 2.5MG BASE; EQ 20MG BASE

tablet Prescription ORAL AB Jan 11, 2019