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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. 26 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



Spironolactone's Family Patents

Family Patents

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Spironolactone Generic API Manufacturers

Several generic applications have been filed for Spironolactone. The first generic version for Spironolactone was by Mutual Pharmaceutical Co Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Hetero Labs Ltd Unit Iii and was approved on Feb 21, 2025.

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


1. 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
50MG

tablet Prescription ORAL AB Sep 19, 2016
100MG

tablet Prescription ORAL AB Sep 19, 2016





2. 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


Manufacturing Plant Locations
New

Actavis Elizabeth's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Elizabeth as present at those locations.

Country City Firm Name
United States
Elizabeth Actavis Elizabeth LLC, A Company of Teva





3. 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


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Brookhaven Amneal Pharmaceuticals of New York, LLC
East Hanover Amneal Pharmaceuticals LLC
Branchburg Amneal Pharmaceuticals, LLC
Glasgow Amneal Pharmaceuticals LLC
Piscataway Amneal Pharmaceuticals, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Bridgewater Amneal Complex Products Research LLC
Paterson Amneal Pharmaceuticals, Llc
India
Hyderabad Amneal Oncology Private Limited
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.





4. 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





5. 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


Manufacturing Plant Locations
New

Ascot's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Ascot as present at those locations.

Country City Firm Name
United States
Cuyahoga Falls Ascot Brands Ltd.
Cary Ascot Technologies Inc





6. 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
100MG

tablet Prescription ORAL AB Mar 6, 2014
25MG

tablet Prescription ORAL AB Mar 6, 2014
50MG

tablet Prescription ORAL AB Mar 6, 2014


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
Bachupally Aurobindo Pharma Limited
Sangareddy Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
United States
East Windsor Aurobindo Pharma USA Inc





7. 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





8. GRAVITI PHARMS

Graviti Pharmaceuticals Private 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 Graviti Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

tablet Prescription ORAL AB Jan 23, 2025
50MG

tablet Prescription ORAL AB Jan 23, 2025
100MG

tablet Prescription ORAL AB Jan 23, 2025





9. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 1 generic for Spironolactone. 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
25MG/5ML

suspension Prescription ORAL AB Feb 21, 2025





10. 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





11. 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
25MG

tablet Prescription ORAL AB Apr 23, 2014
100MG

tablet Prescription ORAL AB Apr 23, 2014
50MG

tablet Prescription ORAL AB Apr 23, 2014


Manufacturing Plant Locations
New

Jubilant Generics'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 Jubilant Generics as present at those locations.

Country City Firm Name
India
Roorkee Jubilant Generics Limited





12. 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





13. 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





14. 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
100MG

tablet Prescription ORAL AB Aug 20, 2001
50MG

tablet Prescription ORAL AB Aug 20, 2001
25MG

tablet Prescription ORAL AB Aug 20, 2001


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Saint Albans Mylan Technologies, Inc.
Greensboro Mylan Pharmaceuticals Inc
Morgantown Mylan Specialty, L.P.
India
Hyderabad Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Bangalore Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





15. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 1 generic for Spironolactone. 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
25MG

tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982





16. 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
25MG

tablet Prescription ORAL AB Aug 29, 2006
100MG

tablet Prescription ORAL AB Aug 29, 2006





17. 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





18. 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





19. 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





20. 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


Manufacturing Plant Locations
New

Upsher Smith's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Upsher Smith as present at those locations.

Country City Firm Name
United States
Maple Grove Upsher Smith Laboratories, LLC





21. 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


Manufacturing Plant Locations
New

Vangard's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Vangard as present at those locations.

Country City Firm Name
United States
Berwyn Vangard Distribution





22. 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


Manufacturing Plant Locations
New

Warner Chilcott's manufacturing plants are situated in 2 countries - United States, Germany. Given below are the details of these plant locations as well as the firm names of Warner Chilcott as present at those locations.

Country City Firm Name
United States
Rockaway Warner Chilcott US LLC
Norwich Warner Chilcott Pharmaceuticals, Inc.
Manati Warner Chilcott Company LLC
Germany
Weiterstadt Warner Chilcott Deutschland GmbH





23. 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





24. 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