Pravastatin Sodium Patent Expiration

Pravastatin Sodium is used for secondary prevention of coronary events in patients with a history of myocardial infarction and normal cholesterol levels. It was first introduced by Bristol Myers Squibb in its drug Pravachol on Oct 31, 1991. 19 different companies have introduced drugs containing Pravastatin Sodium.


Pravastatin Sodium Patents

Given below is the list of patents protecting Pravastatin Sodium, 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
Pravachol US5622985

(Pediatric)

Method for preventing a second heart attack employing an HMG CoA reductase inhibitor Oct 22, 2014

(Expired)

Bristol Myers Squibb
Pravachol US5622985 Method for preventing a second heart attack employing an HMG CoA reductase inhibitor Apr 22, 2014

(Expired)

Bristol Myers Squibb



Pravastatin Sodium's Family Patents

Family Patents

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Pravastatin Sodium Generic API Manufacturers

Several generic applications have been filed for Pravastatin Sodium. The first generic version for Pravastatin Sodium was by Teva Pharmaceuticals Usa Inc and was approved on Apr 24, 2006. And the latest generic version is by Hisun Pharmaceutical Hangzhou Co Ltd and was approved on Nov 23, 2018.

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


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG

tablet Prescription ORAL AB Nov 17, 2016
10MG

tablet Prescription ORAL AB Nov 17, 2016
80MG

tablet Prescription ORAL AB Nov 17, 2016
20MG

tablet Prescription ORAL AB Nov 17, 2016





2. APNAR PHARMA LP

Apnar Pharma Lp has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Apnar Pharma Lp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG

tablet Prescription ORAL AB Oct 23, 2006
20MG

tablet Prescription ORAL AB Oct 23, 2006
10MG

tablet Prescription ORAL AB Oct 23, 2006
80MG

tablet Prescription ORAL AB Feb 11, 2008





3. APOTEX

Apotex Inc has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 23, 2006
20MG

tablet Prescription ORAL AB Oct 23, 2006
40MG

tablet Prescription ORAL AB Oct 23, 2006
80MG

tablet Prescription ORAL AB Dec 28, 2007


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





4. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Pravastatin Sodium. 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
40MG

tablet Prescription ORAL AB Feb 2, 2017
10MG

tablet Prescription ORAL AB Feb 2, 2017
20MG

tablet Prescription ORAL AB Feb 2, 2017
80MG

tablet Prescription ORAL AB Feb 2, 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
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





5. BIOCON PHARMA

Biocon Pharma Inc has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Biocon Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Apr 13, 2018
80MG

tablet Prescription ORAL AB Apr 13, 2018
20MG

tablet Prescription ORAL AB Apr 13, 2018
40MG

tablet Prescription ORAL AB Apr 13, 2018


Manufacturing Plant Locations
New

Biocon Pharma'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 Biocon Pharma as present at those locations.

Country City Firm Name
India
Bengaluru Biocon Pharma Limited





6. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Prescription ORAL AB Jan 8, 2008
10MG

tablet Prescription ORAL AB Jan 8, 2008
40MG

tablet Prescription ORAL AB Jan 8, 2008
80MG

tablet Prescription ORAL AB Jan 8, 2008





7. CIPLA

Cipla Ltd has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Prescription ORAL AB Oct 23, 2006
10MG

tablet Prescription ORAL AB Oct 23, 2006
40MG

tablet Prescription ORAL AB Oct 23, 2006
80MG

tablet Prescription ORAL AB Mar 22, 2016


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





8. DR REDDYS LABS INC

Dr Reddys Laboratories Inc has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 23, 2006
20MG

tablet Prescription ORAL AB Oct 23, 2006
40MG

tablet Prescription ORAL AB Oct 23, 2006
80MG

tablet Prescription ORAL AB Dec 28, 2007





9. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG

tablet Prescription ORAL AB May 11, 2007
20MG

tablet Prescription ORAL AB May 11, 2007
10MG

tablet Prescription ORAL AB May 11, 2007
80MG

tablet Prescription ORAL AB Dec 28, 2007





10. HISUN PHARM HANGZHOU

Hisun Pharmaceutical Hangzhou Co Ltd has filed for 3 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Hisun Pharm Hangzhou.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG

tablet Discontinued ORAL N/A Nov 23, 2018
20MG

tablet Discontinued ORAL N/A Nov 23, 2018
80MG

tablet Discontinued ORAL N/A Nov 23, 2018





11. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A May 27, 2010
40MG

tablet Discontinued ORAL N/A May 27, 2010
20MG

tablet Discontinued ORAL N/A May 27, 2010
80MG

tablet Discontinued ORAL N/A May 27, 2010





12. PLIVA HRVATSKA DOO

Pliva Hrvatska Doo has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Pliva Hrvatska Doo.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG

tablet Discontinued ORAL N/A Nov 21, 2006
10MG

tablet Discontinued ORAL N/A Nov 21, 2006
20MG

tablet Discontinued ORAL N/A Nov 21, 2006
30MG

tablet Discontinued ORAL N/A Nov 21, 2006





13. RANBAXY LABS LTD

Ranbaxy Laboratories Ltd has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Ranbaxy Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Apr 23, 2007
80MG

tablet Discontinued ORAL N/A Apr 23, 2007
40MG

tablet Discontinued ORAL N/A Apr 23, 2007
20MG

tablet Discontinued ORAL N/A Apr 23, 2007





14. SANDOZ

Sandoz Inc has filed for 3 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Oct 23, 2006
40MG

tablet Discontinued ORAL N/A Oct 23, 2006
20MG

tablet Discontinued ORAL N/A Oct 23, 2006


Manufacturing Plant Locations
New

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

Country City Firm Name
Austria
Langkampfen Sandoz GmbH
Kundl Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





15. TEVA

Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Apr 24, 2006
20MG

tablet Prescription ORAL AB Apr 24, 2006
40MG

tablet Prescription ORAL AB Apr 24, 2006


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Miami Teva Branded Pharmaceutical Products R & D, Inc.
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Horsham Teva Branded Pharmaceutical Products R&D
Fort Dodge TEVA Animal Health Inc
India
Bhind Teva API India Ltd- Malanpur
Gajraula, Amroha Teva API India Private Ltd.
Canada
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Markham Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





16. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 1 generic for Pravastatin Sodium. 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
80MG

(reference standard)

tablet Prescription ORAL AB Jan 15, 2008





17. WATSON LABS

Watson Laboratories Inc has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG

tablet Prescription ORAL AB Oct 23, 2006
20MG

tablet Prescription ORAL AB Oct 23, 2006
10MG

tablet Prescription ORAL AB Oct 23, 2006
80MG

tablet Prescription ORAL AB Dec 28, 2007





18. ZYDUS PHARMS USA

Zydus Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Pravastatin Sodium. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG

tablet Prescription ORAL AB Apr 30, 2008
80MG

tablet Prescription ORAL AB Apr 30, 2008
20MG

tablet Prescription ORAL AB Apr 30, 2008
10MG

tablet Discontinued ORAL N/A Apr 30, 2008