Spironolactone Patent Expiration

Spironolactone is Used for managing edema in cirrhotic patients and treating heart failure with reduced ejection fraction to increase survival and reduce hospitalizations. It was first introduced by Pfizer Inc in its drug Aldactone on Dec 30, 1982. Another drug containing Spironolactone is Carospir. 23 different companies have introduced drugs containing Spironolactone.


Spironolactone Patents

Given below is the list of patents protecting Spironolactone, 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
Carospir US10493083 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US10624906 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US10660907 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US10888570 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US11389461 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US11395828 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US11491166 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US9757394 Spironolactone aqueous formulations Oct 28, 2036 Cmp Dev Llc


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Spironolactone Generics

Several generic applications have been filed for Spironolactone. The first generic version for Spironolactone was by Chartwell Rx Sciences Llc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Amneal Pharmaceuticals Llc and was approved on Sep 5, 2023.

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


1. SUPERPHARM

Superpharm Corp has filed for 1 generic for Spironolactone. Given below are the details of the strengths of this generic introduced by Superpharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Nov 7, 1986


2. LEDERLE

Lederle Laboratories Div American Cyanamid Co has filed for 1 generic for Spironolactone. Given below are the details of the strengths of this generic introduced by Lederle.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


3. MYLAN

Mylan Pharmaceuticals Inc has filed for 3 different strengths of generic version for Spironolactone. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Prescription ORAL AB Aug 20, 2001
50MG tablet Prescription ORAL AB Aug 20, 2001
100MG tablet Prescription ORAL AB Aug 20, 2001


4. VANGARD

Vangard Laboratories Inc Div Midway Medical Co has filed for 1 generic for Spironolactone. Given below are the details of the strengths of this generic introduced by Vangard.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Feb 1, 1982


5. UPSHER SMITH

Upsher Smith Laboratories Inc has filed for 1 generic for Spironolactone. Given below are the details of the strengths of this generic introduced by Upsher Smith.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


6. JUBILANT GENERICS

Jubilant Generics Ltd has filed for 3 different strengths of generic version for Spironolactone. Given below are the details of the strengths of this generic introduced by Jubilant Generics.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Apr 23, 2014
25MG tablet Prescription ORAL AB Apr 23, 2014
100MG tablet Prescription ORAL AB Apr 23, 2014


7. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 3 different strengths of generic version for Spironolactone. 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
25MG tablet Prescription ORAL AB Sep 19, 2016
100MG tablet Prescription ORAL AB Sep 19, 2016
50MG tablet Prescription ORAL AB Sep 19, 2016


8. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 3 different strengths of generic version for Spironolactone. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Prescription ORAL AB Jul 2, 2010
50MG tablet Prescription ORAL AB Jul 2, 2010
100MG tablet Prescription ORAL AB Jul 2, 2010


9. MUTUAL PHARM

Mutual Pharmaceutical Co Inc has filed for 1 generic for Spironolactone. Given below are the details of the strengths of this generic introduced by Mutual Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


10. OXFORD PHARMS

Oxford Pharmaceuticals Llc has filed for 3 different strengths of generic version for Spironolactone. 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
50MG tablet Prescription ORAL AB Aug 29, 2006
100MG tablet Prescription ORAL AB Aug 29, 2006
25MG tablet Prescription ORAL AB Aug 29, 2006


11. WATSON LABS

Watson Laboratories Inc has filed for 1 generic for Spironolactone. 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
25MG tablet Discontinued ORAL N/A Mar 2, 1982


12. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Spironolactone. 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
50MG tablet Prescription ORAL AB Jul 18, 2018
25MG tablet Prescription ORAL AB Jul 18, 2018
100MG tablet Prescription ORAL AB Jul 18, 2018


13. AMNEAL

Amneal Pharmaceuticals Llc has filed for 1 generic for Spironolactone. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/5ML suspension Prescription ORAL AB Sep 5, 2023


14. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Spironolactone. 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
25MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982


15. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 3 different strengths of generic version for Spironolactone. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Prescription ORAL AB Jul 23, 1986
100MG tablet Prescription ORAL AB Aug 11, 1999
50MG tablet Prescription ORAL AB Aug 11, 1999


16. WARNER CHILCOTT

Warner Chilcott Div Warner Lambert Co has filed for 1 generic for Spironolactone. Given below are the details of the strengths of this generic introduced by Warner Chilcott.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Nov 18, 1982


17. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 3 different strengths of generic version for Spironolactone. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jul 29, 1999
100MG tablet Discontinued ORAL N/A Jul 29, 1999
25MG tablet Discontinued ORAL N/A Mar 15, 2006


18. ASCOT

Ascot Hosp Pharmaceuticals Inc Div Travenol Laboratories Inc has filed for 1 generic for Spironolactone. Given below are the details of the strengths of this generic introduced by Ascot.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Oct 20, 1982


19. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Spironolactone. 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
25MG tablet Prescription ORAL AB Mar 6, 2014
50MG tablet Prescription ORAL AB Mar 6, 2014
100MG tablet Prescription ORAL AB Mar 6, 2014


20. PUREPAC PHARM

Purepac Pharmaceutical Co has filed for 1 generic for Spironolactone. Given below are the details of the strengths of this generic introduced by Purepac Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Oct 14, 1983


21. IVAX PHARMS

Ivax Pharmaceuticals Inc has filed for 1 generic for Spironolactone. Given below are the details of the strengths of this generic introduced by Ivax Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982