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Simvastatin Patent Expiration

Simvastatin was first introduced by Organon Llc A Sub Of Organon And Co in its drug Zocor on Dec 23, 1991. Other drugs containing Simvastatin are Flolipid, Simvastatin. 18 different companies have introduced drugs containing Simvastatin.


Simvastatin Patents

Given below is the list of patents protecting Simvastatin, 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
Flolipid US9597289 Liquid oral simvastatin compositions Feb 23, 2030 Salerno Pharms
Flolipid US10300041 Liquid oral simvastatin compositions Apr 26, 2027 Salerno Pharms



Simvastatin's Family Patents

Family Patents

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Simvastatin Generic API Manufacturers

Several generic applications have been filed for Simvastatin. The first generic version for Simvastatin was by Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa and was approved on Jun 23, 2006. And the latest generic version is by Invagen Pharmaceuticals Inc and was approved on Nov 13, 2017.

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


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 5 different strengths of generic version for Simvastatin. 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
10MG

tablet Prescription ORAL AB Feb 26, 2008
40MG

tablet Prescription ORAL AB Feb 26, 2008
20MG

tablet Prescription ORAL AB Feb 26, 2008
80MG

tablet Prescription ORAL AB Feb 26, 2008
5MG

tablet Prescription ORAL AB Apr 5, 2013





2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 5 different strengths of generic version for Simvastatin. 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
5MG

tablet Prescription ORAL AB Dec 20, 2006
10MG

tablet Prescription ORAL AB Dec 20, 2006
20MG

tablet Prescription ORAL AB Dec 20, 2006
40MG

tablet Prescription ORAL AB Dec 20, 2006
80MG

tablet Prescription ORAL AB Dec 20, 2006


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. BIOCON PHARMA

Biocon Pharma Ltd has filed for 5 different strengths of generic version for Simvastatin. 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
5MG

tablet Prescription ORAL AB Dec 20, 2006
10MG

tablet Prescription ORAL AB Dec 20, 2006
20MG

tablet Prescription ORAL AB Dec 20, 2006
40MG

tablet Prescription ORAL AB Dec 20, 2006
80MG

tablet Prescription ORAL AB Dec 20, 2006


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





4. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 5 different strengths of generic version for Simvastatin. 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
5MG

tablet Discontinued ORAL N/A Dec 20, 2006
10MG

tablet Discontinued ORAL N/A Dec 20, 2006
20MG

tablet Discontinued ORAL N/A Dec 20, 2006
40MG

tablet Discontinued ORAL N/A Dec 20, 2006
80MG

tablet Discontinued ORAL N/A Dec 20, 2006





5. DR REDDYS LABS INC

Dr Reddys Laboratories Inc has filed for 5 different strengths of generic version for Simvastatin. 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
80MG

tablet Prescription ORAL AB Dec 20, 2006
10MG

tablet Prescription ORAL AB Dec 20, 2006
20MG

tablet Prescription ORAL AB Dec 20, 2006
40MG

tablet Prescription ORAL AB Dec 20, 2006
5MG

tablet Prescription ORAL AB Jan 23, 2008





6. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 5 different strengths of generic version for Simvastatin. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

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

tablet Prescription ORAL AB Nov 25, 2014
10MG

tablet Prescription ORAL AB Nov 25, 2014
80MG

tablet Prescription ORAL AB Nov 25, 2014
40MG

tablet Prescription ORAL AB Nov 25, 2014
5MG

tablet Prescription ORAL AB Nov 25, 2014





7. INVAGEN PHARMS

Invagen Pharmaceuticals Inc has filed for 4 different strengths of generic version for Simvastatin. Given below are the details of the strengths of this generic introduced by Invagen Pharms.

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

tablet Prescription ORAL AB Nov 13, 2017
80MG

tablet Prescription ORAL AB Nov 13, 2017
20MG

tablet Prescription ORAL AB Nov 13, 2017
10MG

tablet Prescription ORAL AB Nov 13, 2017





8. IVAX SUB TEVA PHARMS

Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 5 different strengths of generic version for Simvastatin. Given below are the details of the strengths of this generic introduced by Ivax Sub Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

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

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

tablet Discontinued ORAL N/A Jun 23, 2006
10MG

tablet Discontinued ORAL N/A Jun 23, 2006
80MG

tablet Discontinued ORAL N/A Dec 20, 2006





9. LUPIN

Lupin Ltd has filed for 5 different strengths of generic version for Simvastatin. Given below are the details of the strengths of this generic introduced by Lupin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG

(reference standard)

tablet Prescription ORAL AB May 11, 2007
10MG

tablet Prescription ORAL AB May 11, 2007
20MG

tablet Prescription ORAL AB May 11, 2007
40MG

tablet Prescription ORAL AB May 11, 2007
5MG

tablet Prescription ORAL AB Apr 14, 2009


Manufacturing Plant Locations
New

Lupin'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 Lupin as present at those locations.

Country City Firm Name
India
Mumbai Lupin Limited
Pune Lupin Bioresearch Center
Vasco Da Gama Lupin Limited
Aurangabad Lupin Ltd.
Dabhasa LUPIN MANUFACTURING SOLUTIONS LIMITED
Pithampur Lupin Limited
Navi Mumbai LUPIN LIMITED
Mandideep Lupin Limited (Unit II)
Mandideep Lupin Limited
Nagpur Lupin Limited
Tarapur, Thane Lupin Limited
Pirangut Lupin Limited
Anakapalli District Lupin Manufacturing Solutions Limited
Pithampur Lupin Limited (Unit 1)
United States
Coral Springs Lupin Research Inc
Baltimore Lupin Pharmaceuticals Inc.





10. MICRO LABS

Micro Labs Ltd has filed for 5 different strengths of generic version for Simvastatin. Given below are the details of the strengths of this generic introduced by Micro Labs.

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

tablet Prescription ORAL AB Sep 16, 2011
10MG

tablet Prescription ORAL AB Sep 16, 2011
80MG

tablet Prescription ORAL AB Sep 16, 2011
5MG

tablet Prescription ORAL AB Sep 16, 2011
40MG

tablet Prescription ORAL AB Sep 16, 2011


Manufacturing Plant Locations
New

Micro Labs'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 Micro Labs as present at those locations.

Country City Firm Name
India
Bangalore Micro Labs Limited
Verna Micro Labs Limited
Bengaluru Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory





11. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 5 different strengths of generic version for Simvastatin. 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
80MG

tablet Discontinued ORAL N/A Jun 8, 2010
20MG

tablet Discontinued ORAL N/A Jun 8, 2010
10MG

tablet Discontinued ORAL N/A Jun 8, 2010
5MG

tablet Discontinued ORAL N/A Jun 8, 2010
40MG

tablet Discontinued ORAL N/A Jun 8, 2010





12. OXFORD PHARMS

Oxford Pharmaceuticals Llc has filed for 5 different strengths of generic version for Simvastatin. Given below are the details of the strengths of this generic introduced by Oxford Pharms.

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

tablet Prescription ORAL AB Aug 30, 2010
5MG

tablet Prescription ORAL AB Aug 30, 2010
10MG

tablet Prescription ORAL AB Aug 30, 2010
40MG

tablet Prescription ORAL AB Aug 30, 2010
80MG

tablet Prescription ORAL AB Aug 30, 2010





13. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 5 different strengths of generic version for Simvastatin. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG

tablet Discontinued ORAL N/A Jun 23, 2006
5MG

tablet Discontinued ORAL N/A Dec 20, 2006
10MG

tablet Discontinued ORAL N/A Dec 20, 2006
20MG

tablet Discontinued ORAL N/A Dec 20, 2006
40MG

tablet Discontinued ORAL N/A Dec 20, 2006





14. WATSON LABS TEVA

Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 5 different strengths of generic version for Simvastatin. Given below are the details of the strengths of this generic introduced by Watson Labs Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Discontinued ORAL N/A Dec 20, 2006
10MG

tablet Discontinued ORAL N/A Dec 20, 2006
20MG

tablet Discontinued ORAL N/A Dec 20, 2006
40MG

tablet Discontinued ORAL N/A Dec 20, 2006
80MG

tablet Discontinued ORAL N/A Dec 20, 2006





15. ZYDUS PHARMS USA

Zydus Pharmaceuticals Usa Inc has filed for 5 different strengths of generic version for Simvastatin. 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
5MG

tablet Prescription ORAL AB Dec 20, 2006
10MG

tablet Prescription ORAL AB Dec 20, 2006
20MG

tablet Prescription ORAL AB Dec 20, 2006
40MG

tablet Prescription ORAL AB Dec 20, 2006
80MG

tablet Prescription ORAL AB Dec 20, 2006