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. 8 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 US5753675 Quinoline analogs of mevalonolactone and derivatives thereof May 19, 2015

(Expired)

Kowa Co
Livalo US5854259 Quinoline type mevalonolactones Dec 29, 2015

(Expired)

Kowa Co
Livalo US5856336 Quinoline type mevalonolactones Jan 01, 2021

(Expired)

Kowa Co
Livalo US5856336

(Pediatric)

Quinoline type mevalonolactones Jun 25, 2021

(Expired)

Kowa Co
Livalo US6465477 Stable pharmaceutical composition Dec 20, 2016

(Expired)

Kowa Co
Livalo US7022713 Hyperlipemia therapeutic agent Feb 19, 2024

(Expired)

Kowa Co
Livalo US7022713

(Pediatric)

Hyperlipemia therapeutic agent Aug 19, 2024 Kowa Co
Livalo US8557993 Crystalline forms of pitavastatin calcium Feb 02, 2024

(Expired)

Kowa Co
Livalo US8557993

(Pediatric)

Crystalline forms of pitavastatin calcium Aug 02, 2024 Kowa Co


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Pitavastatin Calcium Generics

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 Hetero Labs Ltd Unit V and was approved on Apr 30, 2024.

Given below is the list of companies who have filed for Pitavastatin Calcium generic.


1. 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


2. 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 1MG BASE tablet Prescription ORAL AB Apr 4, 2019
EQ 2MG BASE tablet Prescription ORAL AB Apr 4, 2019
EQ 4MG BASE tablet Prescription ORAL AB Apr 4, 2019


3. 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


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


5. 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 2MG BASE tablet Prescription ORAL AB Apr 30, 2024
EQ 4MG BASE tablet Prescription ORAL AB Apr 30, 2024
EQ 1MG BASE tablet Prescription ORAL AB Apr 30, 2024


6. 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 2MG BASE tablet Prescription ORAL AB Feb 22, 2023
EQ 4MG BASE tablet Prescription ORAL AB Feb 22, 2023


7. 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 2MG BASE tablet Prescription ORAL AB Dec 20, 2016
EQ 4MG BASE tablet Prescription ORAL AB Dec 20, 2016