Pitavastatin Calcium Patent Expiration

Pitavastatin Calcium is Used for improving lipid profiles in patients with hyperlipidemia or mixed dyslipidemia. It was first introduced by Kowa Co Ltd in its drug Livalo on Aug 3, 2009. 9 different companies have introduced drugs containing Pitavastatin Calcium.


Pitavastatin Calcium Patents

Given below is the list of patents protecting Pitavastatin 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
Livalo US7022713

(Pediatric)

Hyperlipemia therapeutic agent Aug 19, 2024

(Expired)

Kowa Co
Livalo US8557993

(Pediatric)

Crystalline forms of pitavastatin calcium Aug 02, 2024

(Expired)

Kowa Co
Livalo US7022713 Hyperlipemia therapeutic agent Feb 19, 2024

(Expired)

Kowa Co
Livalo US8557993 Crystalline forms of pitavastatin calcium Feb 02, 2024

(Expired)

Kowa Co
Livalo US5856336

(Pediatric)

Quinoline type mevalonolactones Jun 25, 2021

(Expired)

Kowa Co
Livalo US5856336 Quinoline type mevalonolactones Jan 01, 2021

(Expired)

Kowa Co
Livalo US6465477 Stable pharmaceutical composition Dec 20, 2016

(Expired)

Kowa Co
Livalo US5854259 Quinoline type mevalonolactones Dec 29, 2015

(Expired)

Kowa Co
Livalo US5753675 Quinoline analogs of mevalonolactone and derivatives thereof May 19, 2015

(Expired)

Kowa Co



Pitavastatin Calcium's Family Patents

Family Patents

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Pitavastatin Calcium Generic API Manufacturers

Several generic applications have been filed for Pitavastatin Calcium. The first generic version for Pitavastatin Calcium was by Aurobindo Pharma Ltd and was approved on Dec 20, 2016. And the latest generic version is by Amneal Pharmaceuticals Of Ny Llc and was approved on Aug 20, 2024.

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


1. AMNEAL PHARMS NY

Amneal Pharmaceuticals Of Ny Llc has filed for 3 different strengths of generic version for Pitavastatin Calcium. Given below are the details of the strengths of this generic introduced by Amneal Pharms Ny.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE

tablet Prescription ORAL AB Aug 20, 2024
EQ 2MG BASE

tablet Prescription ORAL AB Aug 20, 2024
EQ 4MG BASE

tablet Prescription ORAL AB Aug 20, 2024





2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Pitavastatin Calcium. 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 1MG BASE

tablet Prescription ORAL AB Dec 20, 2016
EQ 4MG BASE

tablet Prescription ORAL AB Dec 20, 2016
EQ 2MG BASE

tablet Prescription ORAL AB Dec 20, 2016


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





3. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 3 different strengths of generic version for Pitavastatin Calcium. 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
EQ 4MG BASE

tablet Prescription ORAL AB Apr 30, 2024
EQ 2MG BASE

tablet Prescription ORAL AB Apr 30, 2024
EQ 1MG BASE

tablet Prescription ORAL AB Apr 30, 2024





4. LUPIN LTD

Lupin Ltd has filed for 3 different strengths of generic version for Pitavastatin Calcium. 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 1MG BASE

tablet Prescription ORAL AB Nov 20, 2023
EQ 2MG BASE

tablet Prescription ORAL AB Nov 20, 2023
EQ 4MG BASE

tablet Prescription ORAL AB Nov 20, 2023


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.





5. MYLAN

Mylan Pharmaceuticals Inc has filed for 3 different strengths of generic version for Pitavastatin 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 4MG BASE

tablet Prescription ORAL AB Apr 4, 2019
EQ 1MG BASE

tablet Prescription ORAL AB Apr 4, 2019
EQ 2MG BASE

tablet Prescription ORAL AB Apr 4, 2019


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





6. ORIENT PHARMA CO LTD

Orient Pharma Co Ltd has filed for 3 different strengths of generic version for Pitavastatin Calcium. Given below are the details of the strengths of this generic introduced by Orient Pharma Co Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE

tablet Prescription ORAL AB Feb 3, 2017
EQ 2MG BASE

tablet Prescription ORAL AB Feb 3, 2017
EQ 4MG BASE

tablet Prescription ORAL AB Feb 3, 2017





7. SAWAI USA

Sawai Usa Inc has filed for 3 different strengths of generic version for Pitavastatin Calcium. Given below are the details of the strengths of this generic introduced by Sawai Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE

tablet Prescription ORAL AB Feb 3, 2017
EQ 2MG BASE

tablet Prescription ORAL AB Feb 3, 2017
EQ 4MG BASE

tablet Prescription ORAL AB Feb 3, 2017





8. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Pitavastatin 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 1MG BASE

tablet Prescription ORAL AB Feb 22, 2023
EQ 4MG BASE

tablet Prescription ORAL AB Feb 22, 2023
EQ 2MG BASE

tablet Prescription ORAL AB Feb 22, 2023