Simvastatin Patent Expiration
Simvastatin was first introduced by Organon Llc A Sub Of Organon And Co
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
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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 Yiling Pharmaceutical Ltd and was approved on Nov 27, 2024.
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 |
|---|---|---|---|---|---|
| 80MG | tablet | Prescription | ORAL | AB | Feb 26, 2008 |
| 10MG | tablet | Prescription | ORAL | AB | Feb 26, 2008 |
| 20MG | tablet | Prescription | ORAL | AB | Feb 26, 2008 |
| 40MG | 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 |
| |||||||||
| United States |
| |||||||||
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 |
| |||
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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Nov 25, 2014 |
| 10MG | tablet | Prescription | ORAL | AB | Nov 25, 2014 |
| 20MG | tablet | Prescription | ORAL | AB | Nov 25, 2014 |
| 40MG | tablet | Prescription | ORAL | AB | Nov 25, 2014 |
| 80MG | 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 |
| 10MG | tablet | Prescription | ORAL | AB | Nov 13, 2017 |
| 20MG | 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 |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | May 11, 2007 |
| 20MG | tablet | Prescription | ORAL | AB | May 11, 2007 |
| 40MG | tablet | Prescription | ORAL | AB | May 11, 2007 |
| 80MG
(reference standard) | 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 |
| |||||||||||||||||||||||||||||
| United States |
| |||||||||||||||||||||||||||||
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 |
|---|---|---|---|---|---|
| 80MG | tablet | Prescription | ORAL | AB | Sep 16, 2011 |
| 5MG | tablet | Prescription | ORAL | AB | Sep 16, 2011 |
| 10MG | tablet | Prescription | ORAL | AB | Sep 16, 2011 |
| 20MG | 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 |
| |||||||||
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 |
|---|---|---|---|---|---|
| 20MG | tablet | Discontinued | ORAL | N/A | Jun 8, 2010 |
| 5MG | tablet | Discontinued | ORAL | N/A | Jun 8, 2010 |
| 10MG | tablet | Discontinued | ORAL | N/A | Jun 8, 2010 |
| 40MG | tablet | Discontinued | ORAL | N/A | Jun 8, 2010 |
| 80MG | 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 |
|---|---|---|---|---|---|
| 80MG | tablet | Prescription | ORAL | AB | Aug 30, 2010 |
| 5MG | tablet | Prescription | ORAL | AB | Aug 30, 2010 |
| 10MG | tablet | Prescription | ORAL | AB | Aug 30, 2010 |
| 20MG | tablet | Prescription | ORAL | AB | Aug 30, 2010 |
| 40MG | 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. YILING
Yiling Pharmaceutical Ltd has filed for 4 different strengths of generic version for Simvastatin. Given below are the details of the strengths of this generic introduced by Yiling.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG | tablet | Prescription | ORAL | AB | Nov 27, 2024 |
| 10MG | tablet | Prescription | ORAL | AB | Nov 27, 2024 |
| 20MG | tablet | Prescription | ORAL | AB | Nov 27, 2024 |
| 80MG | tablet | Prescription | ORAL | AB | Nov 27, 2024 |
Manufacturing Plant Locations New
Yiling's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Yiling as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| China |
| |||
16. 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 |
| 20MG | tablet | Prescription | ORAL | AB | Dec 20, 2006 |
| 40MG | tablet | Prescription | ORAL | AB | Dec 20, 2006 |
| 80MG | tablet | Prescription | ORAL | AB | Dec 20, 2006 |
| 10MG | tablet | Prescription | ORAL | AB | Dec 20, 2006 |