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Duloxetine Hydrochloride Patent Expiration

Duloxetine Hydrochloride was first introduced by Eli Lilly And Co in its drug Cymbalta on Aug 3, 2004. Another drug containing Duloxetine Hydrochloride is Drizalma Sprinkle. 24 different companies have introduced drugs containing Duloxetine Hydrochloride.


Duloxetine Hydrochloride Patents

Given below is the list of patents protecting Duloxetine Hydrochloride, 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
Drizalma Sprinkle US10413525 Duloxetine sprinkles Apr 13, 2037 Sun Pharm
Drizalma Sprinkle US10959982 Duloxetine sprinkles Apr 13, 2037 Sun Pharm
Drizalma Sprinkle US11202772 Duloxetine sprinkles Apr 13, 2037 Sun Pharm
Drizalma Sprinkle US9839626 Duloxetine sprinkles Apr 13, 2037 Sun Pharm
Cymbalta US6596756

(Pediatric)

 Treatment of fibromyalgia Mar 10, 2020

(Expired)

 Lilly
Cymbalta US6596756 Treatment of fibromyalgia Sep 10, 2019

(Expired)

 Lilly
Cymbalta US5508276

(Pediatric)

 Duloxetine enteric pellets Jan 18, 2015

(Expired)

 Lilly
Cymbalta US5508276 Duloxetine enteric pellets Jul 18, 2014

(Expired)

 Lilly
Cymbalta US5023269

(Pediatric)

 3-aryloxy-3-substituted propanamines Dec 11, 2013

(Expired)

 Lilly
Cymbalta US5023269 3-aryloxy-3-substituted propanamines Jun 11, 2013

(Expired)

 Lilly



Duloxetine Hydrochloride's Family Patents

Family Patents

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Duloxetine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Duloxetine Hydrochloride. The first generic version for Duloxetine Hydrochloride was by Teva Pharmaceuticals Usa and was approved on Dec 11, 2013. And the latest generic version is by Zydus Healthcare Usa Llc and was approved on Apr 18, 2023.

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


1. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. 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
EQ 20MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 17, 2013
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 17, 2013
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 17, 2013


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





2. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 4 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Ajanta Pharma Ltd.

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

capsule, delayed rel pellets Prescription ORAL AB Jan 6, 2017
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jan 6, 2017
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jan 6, 2017
EQ 40MG BASE

capsule, delayed rel pellets Prescription ORAL AB Mar 11, 2019


Manufacturing Plant Locations
New

Ajanta 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 Ajanta Pharma Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Ajanta Pharma Ltd.





3. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jun 9, 2014
EQ 20MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jun 9, 2014
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jun 9, 2014


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited





4. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

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

capsule, delayed rel pellets Prescription ORAL AB Aug 26, 2015
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Aug 26, 2015
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Aug 26, 2015





5. APOTEX

Apotex Inc has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.

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

capsule, delayed rel pellets Discontinued ORAL N/A Jun 11, 2014
EQ 30MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Jun 11, 2014
EQ 60MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Jun 11, 2014


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. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. 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
EQ 20MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013


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





7. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 4 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Breckenridge.

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

capsule, delayed rel pellets Prescription ORAL AB Jun 11, 2014
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jun 11, 2014
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jun 11, 2014
EQ 40MG BASE

capsule, delayed rel pellets Prescription ORAL AB May 18, 2018


Manufacturing Plant Locations
New

Breckenridge'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 Breckenridge as present at those locations.

Country City Firm Name
United States
Berlin Breckenridge Pharmaceutical, Inc
Boca Raton Breckenridge Pharmaceutical, Inc.





8. CSPC OUYI

Cspc Ouyi Pharmaceutical Co Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Cspc Ouyi.

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

capsule, delayed rel pellets Prescription ORAL AB Oct 16, 2018
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Oct 16, 2018
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Oct 16, 2018


Manufacturing Plant Locations
New

Cspc Ouyi'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 Cspc Ouyi as present at those locations.

Country City Firm Name
China
Shijiazhuang CSPC Ouyi Pharmaceutical Co., Ltd.





9. ENDO OPERATIONS

Endo Operations Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Endo Operations.

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

capsule, delayed rel pellets Discontinued ORAL N/A Oct 28, 2015
EQ 30MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Oct 28, 2015
EQ 60MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Oct 28, 2015





10. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. 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
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Aug 3, 2016
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Aug 3, 2016
EQ 20MG BASE

capsule, delayed rel pellets Prescription ORAL AB Aug 3, 2016





11. INVENTIA

Inventia Healthcare Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Inventia.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Oct 28, 2015
EQ 20MG BASE

capsule, delayed rel pellets Prescription ORAL AB Oct 28, 2015
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Oct 28, 2015


Manufacturing Plant Locations
New

Inventia'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 Inventia as present at those locations.

Country City Firm Name
India
Thane Inventia Healthcare Pvt Ltd.
Thane Inventia Healthcare Limited





12. LUPIN LTD

Lupin Ltd has filed for 4 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013
EQ 20MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013
EQ 40MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013


Manufacturing Plant Locations
New

Lupin 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 Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





13. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Mar 23, 2017
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Mar 23, 2017
EQ 20MG BASE

capsule, delayed rel pellets Prescription ORAL AB Mar 23, 2017





14. MARKSANS PHARMA

Marksans Pharma Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Marksans Pharma.

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

capsule, delayed rel pellets Discontinued ORAL N/A Dec 11, 2013
EQ 30MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Dec 11, 2013
EQ 60MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Dec 11, 2013


Manufacturing Plant Locations
New

Marksans 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 Marksans Pharma as present at those locations.

Country City Firm Name
United States
Commack Marksans Pharmaceuticals Ltd
India
Verna Marksans Pharma Limited





15. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Prinston Inc.

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

capsule, delayed rel pellets Prescription ORAL AB May 18, 2017
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB May 18, 2017
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB May 18, 2017





16. QINGDAO BAHEAL PHARM

Qingdao Baheal Pharmaceutical Co Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Qingdao Baheal Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Apr 17, 2019
EQ 20MG BASE

capsule, delayed rel pellets Prescription ORAL AB Apr 17, 2019
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Apr 17, 2019


Manufacturing Plant Locations
New

Qingdao Baheal Pharm'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 Qingdao Baheal Pharm as present at those locations.

Country City Firm Name
China
Qingdao Qingdao BAHEAL Pharmaceutical Co.,Ltd.





17. SUN PHARM

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

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

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
India
Dadra Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
New Delhi Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd.
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Halol Sun Pharmaceutical Industries Ltd.
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd





18. SUNSHINE

Sunshine Lake Pharma Co Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Sunshine.

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

capsule, delayed rel pellets Prescription ORAL AB Feb 11, 2021
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Feb 11, 2021
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Feb 11, 2021


Manufacturing Plant Locations
New

Sunshine's manufacturing plants are situated in 6 countries - United States, Peru, India, Thailand, China, Mozambique. Given below are the details of these plant locations as well as the firm names of Sunshine as present at those locations.

Country City Firm Name
United States
Andrews Sunshine Dairy, LLC
Jacksonville Sunshine Peanut Company
Glenwood Springs Sunshine & Moons, LLC
Rochester Sunshine Fund Raising Co.
Evergreen Sunshine Honey Bees LLC
Portland Sunshine Dairy Foods Management LLC
Augusta Sunshine Honey Inc.
Bridgeville Sunshine Burger & Specialty Food Company, LLC
Doral Sunshine Bottling Co, Inc.
North Las Vegas Sunshine Fresh Nevada LLC
Artesia Sunshine Evergreen Inc.
Dublin Sunshine Mills, Inc
Halifax Sunshine Mills, Inc.
Tupelo Sunshine Mills, Inc.
Methuen Sunshine International Foods, Inc.
Alhambra Sunshine Bakery
Columbus Sunshine Apiaries
Red Bay Sunshine Mills aka World Pet Care
Maumee Sunshine Inc Of Nw Ohio
Indianapolis SUNSHINE INTERNATIONAL LLC
Peru
Tambogrande Sunshine Export S.A.C
India
Surat Sunshine Global Hospital
Thailand
Tha Mai Sunshine International
China
Dongguan Sunshine Lake Pharma Co., Ltd
Mozambique
Boane Sunshine Nut Limitada





19. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 60MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Dec 11, 2013
EQ 30MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Dec 11, 2013
EQ 20MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Dec 11, 2013





20. TORRENT

Torrent Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Torrent.

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

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Dec 11, 2013


Manufacturing Plant Locations
New

Torrent'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 Torrent as present at those locations.

Country City Firm Name
India
Gandhi Nagar Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Bharuch Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
United States
Basking Ridge Torrent Pharma Inc.
Kalamazoo Torrent Pharma Inc.





21. YAOPHARMA CO LTD

Yaopharma Co Ltd has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Yaopharma Co Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 60MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Aug 16, 2019
EQ 20MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Aug 16, 2019
EQ 30MG BASE

capsule, delayed rel pellets Discontinued ORAL N/A Aug 16, 2019


Manufacturing Plant Locations
New

Yaopharma Co Ltd'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 Yaopharma Co Ltd as present at those locations.

Country City Firm Name
China
Yubei Yaopharma Co Ltd





22. ZYDUS HLTHCARE

Zydus Healthcare Usa Llc has filed for 4 different strengths of generic version for Duloxetine Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jan 8, 2014
EQ 20MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jan 8, 2014
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jan 8, 2014
EQ 40MG BASE

capsule, delayed rel pellets Prescription ORAL AB Apr 18, 2023





23. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Duloxetine Hydrochloride. 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
EQ 60MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jan 8, 2014
EQ 30MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jan 8, 2014
EQ 20MG BASE

capsule, delayed rel pellets Prescription ORAL AB Jan 8, 2014