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Dutasteride Patent Expiration

Dutasteride is used for treating benign prostatic hyperplasia and other androgen-responsive conditions by inhibiting the 5 alpha testosterone reductase enzyme with dutasteride or its derivatives. It was first introduced by Waylis Therapeutics Llc in its drug Avodart on Nov 20, 2001. 19 different companies have introduced drugs containing Dutasteride.


Dutasteride Patents

Given below is the list of patents protecting Dutasteride, 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
Avodart US5565467 Androstenone derivative Nov 20, 2015

(Expired)

 Waylis Therap
Avodart US5846976 Androstenone derivative Sep 17, 2013

(Expired)

 Waylis Therap
Avodart US5998427 Androstenones Sep 17, 2013

(Expired)

 Waylis Therap



Dutasteride's Family Patents

Family Patents

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Dutasteride Generic API Manufacturers

Several generic applications have been filed for Dutasteride. The first generic version for Dutasteride was by Barr Laboratories Inc and was approved on Dec 21, 2010. And the latest generic version is by Strides Pharma Global Pte Ltd and was approved on Jun 22, 2018.

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


1. ACELLA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Mar 17, 2016


Manufacturing Plant Locations
New

Acella'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 Acella as present at those locations.

Country City Firm Name
United States
Alpharetta Acella Pharmaceuticals, LLC





2. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Discontinued ORAL N/A Nov 20, 2015





3. ADAPTIS

Adaptis Pharma Private Ltd has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Adaptis.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Apr 7, 2017





4. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 1 generic for Dutasteride. 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
0.5MG

capsule Prescription ORAL AB Nov 20, 2015





5. APOTEX

Apotex Inc has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Discontinued ORAL N/A Nov 24, 2015


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





6. ASCENT PHARMS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Oct 21, 2016





7. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Nov 20, 2015


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd'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 Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





8. BARR

Barr Laboratories Inc has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Dec 21, 2010


Manufacturing Plant Locations
New

Barr's manufacturing plants are situated in 4 countries - Mexico, Singapore, United States, Philippines. Given below are the details of these plant locations as well as the firm names of Barr as present at those locations.

Country City Firm Name
Mexico
Aldama Barra La Coma, S. De R.L
Singapore
Singapore Barramundi Asia Pte Ltd
United States
Englewood Barrett E. Cowan, MD
Montezuma Barrington Dairies
Forest Barr Laboratories Inc.
Live Oak Barrington Dairy Farm
Newton Barrett Technology, LLC
Harrison Barrington Chemical Corporation
Davie Barrier Technologies LLC
Lee Barrington Coffee Roasting Company, Inc.
Belvidere Barred Woods, LLC
Greenwood Barr Enterprises, Inc.
Buffalo Barrel and Brine Inc
Dillon Barretts Minerals Inc
Hereford Barrett and Crofoot Feedyard, West
Commerce Barreras Meat Co
Lake Barrington Barrington Ventures, Ltd
Franklin Barrett Distribution Centers, Inc.
Hereford Barrett and Crofoot, LLP
Somerset Barrett Distribution Centers Inc
Barrett Barrett Farm Supply, Inc.
Memphis Barrett Distribution Centers
Curtis Bay Barrett Distribution Center
Madison Barriques Holding Company, LLC
Machipongo Barrier Island Seafood
Brainerd Barrett Ag Service, Inc.
Swartz Creek Barrett Donut Mixes, Inc..
Paso Robles Barreto Cellars
Arecibo Barreto Dairy, Inc.
Randolph Barrett Farm
Philippines
Bulacan Barrio Fiesta Manufacturing Corporation





9. CHARTWELL

Chartwell Life Molecules Llc has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Chartwell.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Nov 20, 2015


Manufacturing Plant Locations
New

Chartwell'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 Chartwell as present at those locations.

Country City Firm Name
United States
Congers Chartwell Life Sciences LLC
Congers Chartwell Pharmaceuticals LLC
Richboro Chartwells Division of Compass Group / Commodities Locker
West Caldwell Chartwell Pharmaceuticals West Caldwell LLC
Carmel Chartwell Pharmaceuticals Carmel LLC





10. HERITAGE PHARMS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Discontinued ORAL N/A Oct 13, 2017





11. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Discontinued ORAL N/A Nov 23, 2015


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





12. HUMANWELL PURACAP

Humanwell Puracap Pharmaceutical Wuhan Co Ltd has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Humanwell Puracap.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Nov 21, 2017


Manufacturing Plant Locations
New

Humanwell Puracap'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 Humanwell Puracap as present at those locations.

Country City Firm Name
China
Wuhan Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.





13. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 1 generic for Dutasteride. 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
0.5MG

capsule Discontinued ORAL N/A Jun 14, 2016





14. NOSTRUM LABS INC

Nostrum Laboratories Inc has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Nostrum Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Discontinued ORAL N/A Nov 20, 2015





15. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Discontinued ORAL N/A Nov 20, 2015


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Phoenix Rising Sun Farms Inc
East Brunswick Rising Pharma Holding, Inc.
Livingston Risingsun Iodine Products Corp.
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





16. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Discontinued ORAL N/A Jun 22, 2018


Manufacturing Plant Locations
New

Strides Pharma'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 Strides Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Strides Pharma Inc.
Chestnut Ridge Strides Pharma, Inc.
India
Puducherry Strides Pharma Science Limited
Bangalore Strides Pharma Science Limited





17. VINTAGE

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Discontinued ORAL N/A Nov 20, 2015


Manufacturing Plant Locations
New

Vintage'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 Vintage as present at those locations.

Country City Firm Name
United States
Traver Vintage Cheese Company
Kearny Vintage Food Corp.
Calistoga Vintage Wine Estates, Inc
Wapato Vintage Wine Estates Inc
Bristol Vintage Imports, Inc.
Pownal Vintage Maine Kitchen LLC
Huntsville Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Fort Wayne Vintage Chemical, Inc.
North Garden Vintage Virginia Apples LLC dba Albermarle Ciderworks
Durham Vintage Bee, Inc.
Walla Walla Vintage Wine Estates, Inc.





18. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 1 generic for Dutasteride. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Oct 4, 2017


Manufacturing Plant Locations
New

Zydus Lifesciences'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 Zydus Lifesciences as present at those locations.

Country City Firm Name
India
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Ankleshwar Zydus Lifesciences Limited
Ahmedabad Zydus Lifesciences Limited
Jarod Zydus Lifesciences Limited
District Solan Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited
Matoda Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited