Doxepin Hydrochloride Patent Expiration

Doxepin Hydrochloride is Used for treating insomnia. It was first introduced by Pfizer Laboratories Div Pfizer Inc in its drug Sinequan on Approved Prior to Jan 1, 1982. Other drugs containing Doxepin Hydrochloride are Zonalon, Silenor, Doxepin Hydrochloride. 40 different companies have introduced drugs containing Doxepin Hydrochloride.

Doxepin Hydrochloride Patents

Given below is the list of patents protecting Doxepin 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
Silenor	US8513299	Methods of using low-dose doxepin for the improvement of sleep	Sep 07, 2030	Currax
Silenor	US9532971	Low-dose doxepin formulations and methods of making and using the same	Jun 01, 2029	Currax
Silenor	US9107898	Methods of using low-dose doxepin for the improvement of sleep	May 01, 2028	Currax
Silenor	US10548871	Low-dose doxepin formulations and methods of making and using the same	Apr 11, 2028	Currax
Silenor	US11096920	Low-dose doxepin formulations and methods of making and using the same	Apr 11, 2028	Currax
Silenor	US9907780	Low-dose doxepin formulations and methods of making and using the same	Apr 11, 2028	Currax
Silenor	US11234954	Low-dose doxepin for treatment of sleep disorders in elderly patients	Jan 18, 2028	Currax
Silenor	US7915307	Methods of improving the pharmacokinetics of doxepin	Aug 24, 2027	Currax
Silenor	US10653660	Methods of improving the pharmacokinetics of doxepin	Jul 20, 2027	Currax
Silenor	US11110074	Methods of improving the pharmacokinetics of doxepin	Jul 20, 2027	Currax
Silenor	US9572814	Methods of improving the pharmacokinetics of doxepin	Jul 20, 2027	Currax
Silenor	US10238620	Methods of using low-dose doxepin for the improvement of sleep	May 18, 2027	Currax
Silenor	US10653662	Methods of using low-dose doxepin for the improvement of sleep	May 18, 2027	Currax
Silenor	US12083090	Methods of using low-dose doxepin for the improvement of sleep	May 18, 2027	Currax
Silenor	US9486437	Methods of using low-dose doxepin for the improvement of sleep	May 18, 2027	Currax
Silenor	US9861607	Methods of using low-dose doxepin for the improvement of sleep	May 18, 2027	Currax
Silenor	US6211229	Treatment of transient and short term insomnia	Feb 17, 2020 (Expired)	Currax
Silenor	US5585115	Pharmaceutical excipient having improved compressability	Jan 09, 2015 (Expired)	Currax
Silenor	US5725884	Pharmaceutical excipient having improved compressibility	Jan 09, 2015 (Expired)	Currax
Silenor	US5866166	Pharmaceutical excipient having improved compressibility	Jan 09, 2015 (Expired)	Currax
Silenor	US5948438	Pharmaceutical formulations having improved disintegration and/or absorptivity	Jan 09, 2015 (Expired)	Currax
Silenor	US6103219	Pharmaceutical excipient having improved compressibility	Jan 09, 2015 (Expired)	Currax
Silenor	US6217909	Pharmaceutical excipient having improved compressibility	Jan 09, 2015 (Expired)	Currax
Silenor	US5502047	Treatment for insomnia	Mar 26, 2013 (Expired)	Currax

A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Doxepin Hydrochloride's patents.

Latest Legal Activities on Doxepin Hydrochloride's Patents

Given below is the list recent legal activities going on the following patents of Doxepin Hydrochloride.

Activity	Date	Patent Number

Payment of Maintenance Fee, 8th Yr, Small Entity	19 Jun, 2024	US9532971
Payment of Maintenance Fee, 8th Yr, Small Entity	24 Apr, 2024	US9486437
Payment of Maintenance Fee, 4th Yr, Small Entity	01 Nov, 2023	US10653660
Payment of Maintenance Fee, 4th Yr, Small Entity	01 Nov, 2023	US10653662
Payment of Maintenance Fee, 4th Yr, Small Entity	19 Jul, 2023	US10548871
Payment of Maintenance Fee, 8th Yr, Small Entity	01 Feb, 2023	US9107898
Payment of Maintenance Fee, 4th Yr, Small Entity	14 Sep, 2022	US10238620
Payment of Maintenance Fee, 12th Yr, Small Entity	14 Sep, 2022	US7915307(Litigated)
Patent Issue Date Used in PTA Calculation Critical	01 Feb, 2022	US11234954
Recordation of Patent Grant Mailed Critical	01 Feb, 2022	US11234954

Doxepin Hydrochloride's Family Patents

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Doxepin Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Doxepin Hydrochloride. The first generic version for Doxepin Hydrochloride was by Mylan Pharmaceuticals Inc and was approved on May 13, 1986. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Jul 25, 2024.

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

1. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 2 different strengths of generic version for Doxepin 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 3MG BASE	tablet	Prescription	ORAL	AB	Jul 26, 2013
EQ 6MG BASE	tablet	Prescription	ORAL	AB	Jul 26, 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. ADAPTIS

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

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 150MG BASE	capsule	Discontinued	ORAL	N/A	Apr 19, 2022

3. AIPING PHARM INC

Aiping Pharmaceutical Inc has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Aiping Pharm Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Jul 28, 2020
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Jul 28, 2020
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Jul 28, 2020
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Jul 28, 2020
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Jul 28, 2020

4. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 7 different strengths of generic version for Doxepin 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 10MG BASE	capsule	Prescription	ORAL	AB	Sep 13, 2019
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Sep 13, 2019
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Sep 13, 2019
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Sep 13, 2019
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Sep 13, 2019
EQ 6MG BASE	tablet	Discontinued	ORAL	N/A	Jul 1, 2024
EQ 3MG BASE	tablet	Discontinued	ORAL	N/A	Jul 1, 2024

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.

5. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 5 different strengths of generic version for Doxepin 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 100MG BASE	capsule	Prescription	ORAL	AB	Apr 21, 2021
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Apr 21, 2021
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Apr 21, 2021
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Apr 21, 2021
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Apr 21, 2021

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
Vadodara	Alembic Pharmaceuticals Ltd
Panchmahal	Alembic Pharmaceuticals Limited
Vadodara	Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal	Alembic Pharmaceuticals Limited (Units I and II)
Vadodara	Alembic Pharmaceuticals Limited
Vadodara	Alembic Pharmaceuticals, Ltd

6. AMNEAL

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

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
5%	cream	Prescription	TOPICAL	AB	Aug 16, 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

Hauppauge	Amneal Pharmaceuticals of New York, LLC
East Hanover	Amneal Pharmaceuticals LLC
Glasgow	Amneal Pharmaceuticals LLC
Brookhaven	Amneal Pharmaceuticals of New York, LLC
Branchburg	Amneal Pharmaceuticals, LLC
Paterson	Amneal Pharmaceuticals, Llc
Bridgewater	Amneal Complex Products Research LLC
Piscataway	Amneal Pharmaceuticals, LLC

India

Ahmedabad	Amneal Pharmaceuticals Private Ltd.
Matoda	Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad	Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad	Amneal Oncology Private Limited

7. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Jun 28, 2017
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Jun 28, 2017
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Jun 28, 2017
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Jun 28, 2017
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Jun 28, 2017

8. APPCO

Appco Pharma Llc has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Appco.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Apr 1, 2021
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Apr 1, 2021
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Apr 1, 2021
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Apr 1, 2021
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Apr 1, 2021

Manufacturing Plant Locations
^New

Appco'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 Appco as present at those locations.

Country

City

Firm Name

United States

Piscataway	Appco Pharma LLC
Somerset	Appco Pharma, LLC

9. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 7 different strengths of generic version for Doxepin 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 75MG BASE	capsule	Prescription	ORAL	AB	Mar 27, 2019
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Mar 27, 2019
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Mar 27, 2019
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Mar 27, 2019
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Mar 27, 2019
EQ 6MG BASE	tablet	Discontinued	ORAL	N/A	Jul 25, 2024
EQ 3MG BASE	tablet	Discontinued	ORAL	N/A	Jul 25, 2024

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

10. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 5 different strengths of generic version for Doxepin Hydrochloride. 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
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Sep 4, 2020
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Sep 4, 2020
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Sep 4, 2020
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Sep 4, 2020
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Sep 4, 2020

11. DAVA PHARMS INC

Dava Pharmaceuticals Inc has filed for 6 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Dava Pharms Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 50MG BASE	capsule	Discontinued	ORAL	N/A	Jan 5, 1988
EQ 25MG BASE	capsule	Discontinued	ORAL	N/A	Jan 5, 1988
EQ 10MG BASE	capsule	Discontinued	ORAL	N/A	Jan 5, 1988
EQ 150MG BASE	capsule	Discontinued	ORAL	N/A	Jan 5, 1988
EQ 100MG BASE	capsule	Discontinued	ORAL	N/A	Jan 5, 1988
EQ 75MG BASE	capsule	Discontinued	ORAL	N/A	Jan 5, 1988

12. ENDO OPERATIONS

Endo Operations Ltd has filed for 6 different strengths of generic version for Doxepin 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 25MG BASE	capsule	Discontinued	ORAL	N/A	Nov 9, 1987
EQ 100MG BASE	capsule	Discontinued	ORAL	N/A	Nov 9, 1987
EQ 10MG BASE	capsule	Discontinued	ORAL	N/A	Nov 9, 1987
EQ 50MG BASE	capsule	Discontinued	ORAL	N/A	Nov 9, 1987
EQ 75MG BASE	capsule	Discontinued	ORAL	N/A	Nov 9, 1987
EQ 150MG BASE (reference standard)	capsule	Prescription	ORAL	AB	Nov 9, 1987

13. EPIC PHARMA LLC

Epic Pharma Llc has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Oct 16, 2020
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Oct 16, 2020
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Oct 16, 2020
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Mar 3, 2022
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Mar 3, 2022

14. JUBILANT CADISTA

Jubilant Cadista Pharmaceuticals Inc has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Jubilant Cadista.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Mar 14, 2022
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Mar 14, 2022
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Mar 14, 2022
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Mar 14, 2022
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Mar 14, 2022

Manufacturing Plant Locations
^New

Jubilant Cadista'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 Jubilant Cadista as present at those locations.

Country

City

Firm Name

United States

Salisbury

Jubilant Cadista Pharmaceuticals, Inc.

15. LANNETT CO INC

Lannett Co Inc has filed for 6 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 10MG BASE/ML (reference standard)	concentrate	Prescription	ORAL	N/A	Dec 29, 1998
EQ 10MG BASE	capsule	Discontinued	ORAL	N/A	Jul 24, 2020
EQ 75MG BASE	capsule	Discontinued	ORAL	N/A	Jul 24, 2020
EQ 50MG BASE	capsule	Discontinued	ORAL	N/A	Jul 24, 2020
EQ 25MG BASE	capsule	Discontinued	ORAL	N/A	Jul 24, 2020
EQ 100MG BASE	capsule	Discontinued	ORAL	N/A	Jul 24, 2020

16. LEADING

Leading Pharma Llc has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Leading.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Mar 9, 2021
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Mar 9, 2021
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Mar 9, 2021
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Mar 9, 2021
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Mar 9, 2021

Manufacturing Plant Locations
^New

Leading'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 Leading as present at those locations.

Country

City

Firm Name

United States

Seattle	Leading Edge Jet Center
Fairfield	Leading Pharma, LLC

17. MANKIND PHARMA

Mankind Pharma Ltd has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Mankind Pharma.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Feb 9, 2022
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Feb 9, 2022
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Feb 9, 2022
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Feb 9, 2022
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Feb 9, 2022

Manufacturing Plant Locations
^New

Mankind 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 Mankind Pharma as present at those locations.

Country

City

Firm Name

India

Imt Manesar	Mankind Pharma Limited
Paonta Sahib	Mankind Pharma Limited

18. MICRO LABS

Micro Labs Ltd has filed for 5 different strengths of generic version for Doxepin Hydrochloride. 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
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Jun 27, 2023
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Jun 27, 2023
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Jun 27, 2023
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Jun 27, 2023
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Jun 27, 2023

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

Bengaluru	Micro Labs Limited, Central Analytical Laboratory
Bengaluru	Micro Labs Limited
Verna	Micro Labs Limited
Bangalore	Micro Labs Limited

19. MSN

Msn Laboratories Private Ltd has filed for 7 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Msn.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Jun 24, 2022
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Jun 24, 2022
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Jun 24, 2022
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Jun 24, 2022
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Jun 24, 2022
EQ 3MG BASE	tablet	Prescription	ORAL	AB	Apr 3, 2023
EQ 6MG BASE	tablet	Prescription	ORAL	AB	Apr 3, 2023

Manufacturing Plant Locations
^New

Msn'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 Msn as present at those locations.

Country

City

Firm Name

India

Jinnaram, Sangareddy	MSN Laboratories Private Limited - Formulations Division
Yadadri Bhuvanagiri District	MSN Organics Private Limited
Rangareddy District	MSN Laboratories Private Limited (Formulations Division, Unit-II)
Medak	MSN LIFE SCIENCES PRIVATE LIMITED
Rangareddy District	MSN Laboratories Private Limited
Isnapur	MSN Laboratories Private Limited, Unit-II
Sangareddy	MSN Laboratories Private Ltd.
Kamareddy	MSN Life Sciences Private Limited
Sangareddy	MSN Pharmachem Private Limited
Sangareddy	MSN Laboratories Private Limited, R&D Center

United States

Piscataway

MSN PHARMACEUTICALS INC

20. MYLAN PHARMS INC

Mylan Pharmaceuticals Inc has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Pharms Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 25MG BASE (reference standard)	capsule	Prescription	ORAL	AB	May 13, 1986
EQ 50MG BASE	capsule	Prescription	ORAL	AB	May 13, 1986
EQ 10MG BASE	capsule	Prescription	ORAL	AB	May 13, 1986
EQ 75MG BASE	capsule	Prescription	ORAL	AB	May 13, 1986
EQ 100MG BASE (reference standard)	capsule	Prescription	ORAL	AB	May 13, 1986

21. PAR PHARM

Par Pharmaceutical Inc has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Par Pharm.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 25MG BASE	capsule	Discontinued	ORAL	N/A	Nov 9, 1987
EQ 50MG BASE	capsule	Discontinued	ORAL	N/A	Nov 9, 1987
EQ 75MG BASE	capsule	Discontinued	ORAL	N/A	Nov 9, 1987
EQ 150MG BASE	capsule	Prescription	ORAL	N/A	Nov 9, 1987
EQ 10MG BASE	capsule	Discontinued	ORAL	N/A	Nov 9, 1987

Manufacturing Plant Locations
^New

Par Pharm'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 Par Pharm as present at those locations.

Country

City

Firm Name

United States

Stratford	Par Pharmaceutical Inc.
Hauppauge	Par Pharmaceuticals

22. PHARM ASSOC

Pharmaceutical Assoc Inc has filed for 1 generic for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Pharm Assoc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 10MG BASE/ML	concentrate	Discontinued	ORAL	N/A	Jan 15, 2004

23. PHARMOBEDIENT CNSLTG

Pharmobedient Consulting has filed for 1 generic for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Pharmobedient Cnsltg.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 10MG BASE/ML	concentrate	Discontinued	ORAL	N/A	Jul 20, 1988

24. PUREPAC PHARM

Purepac Pharmaceutical Co has filed for 6 different strengths of generic version for Doxepin Hydrochloride. 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
EQ 75MG BASE	capsule	Discontinued	ORAL	N/A	Sep 8, 1988
EQ 100MG BASE	capsule	Discontinued	ORAL	N/A	Sep 8, 1988
EQ 150MG BASE	capsule	Discontinued	ORAL	N/A	Sep 8, 1988
EQ 25MG BASE	capsule	Discontinued	ORAL	N/A	Dec 28, 1990
EQ 50MG BASE	capsule	Discontinued	ORAL	N/A	Dec 28, 1990
EQ 10MG BASE	capsule	Discontinued	ORAL	N/A	Dec 28, 1990

25. QUANTUM PHARMICS

Quantum Pharmics Ltd has filed for 6 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Quantum Pharmics.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 75MG BASE	capsule	Discontinued	ORAL	N/A	Sep 29, 1987
EQ 50MG BASE	capsule	Discontinued	ORAL	N/A	Sep 29, 1987
EQ 10MG BASE	capsule	Discontinued	ORAL	N/A	Sep 29, 1987
EQ 25MG BASE	capsule	Discontinued	ORAL	N/A	Sep 29, 1987
EQ 150MG BASE	capsule	Discontinued	ORAL	N/A	Mar 15, 1989
EQ 100MG BASE	capsule	Discontinued	ORAL	N/A	Mar 15, 1989

26. RK PHARMA

Rk Pharma Inc has filed for 2 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Rk Pharma.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 3MG BASE	tablet	Prescription	ORAL	AB	Jan 20, 2016
EQ 6MG BASE	tablet	Prescription	ORAL	AB	Jan 20, 2016

Manufacturing Plant Locations
^New

Rk Pharma'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 Rk Pharma as present at those locations.

Country

City

Firm Name

United States

Pearl River

RK Pharma Inc.

27. SANDOZ

Sandoz Inc has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 75MG BASE	capsule	Discontinued	ORAL	N/A	May 15, 1986
EQ 25MG BASE	capsule	Discontinued	ORAL	N/A	May 15, 1986
EQ 50MG BASE	capsule	Discontinued	ORAL	N/A	May 15, 1986
EQ 100MG BASE	capsule	Discontinued	ORAL	N/A	Mar 2, 1987
EQ 10MG BASE	capsule	Discontinued	ORAL	N/A	Mar 2, 1987

Manufacturing Plant Locations
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Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country

City

Firm Name

Austria

Langkampfen	Sandoz GmbH
Kundl	Sandoz GmbH

United States

East Hanover	Sandoz Incorporated
Princeton	Sandoz Inc

Spain

Les Franqueses Del Valles	Sandoz Industrial Products S.A.
Palafolls	Sandoz Industrial Products, S.A.

India

Navi Mumbai

Sandoz Private Limited

28. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 2 different strengths of generic version for Doxepin Hydrochloride. 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
EQ 3MG BASE	tablet	Prescription	ORAL	AB	Jul 24, 2020
EQ 6MG BASE	tablet	Prescription	ORAL	AB	Jul 24, 2020

Manufacturing Plant Locations
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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

Chestnut Ridge	Strides Pharma, Inc.
East Brunswick	Strides Pharma Inc.

India

Puducherry	Strides Pharma Science Limited
Bangalore	Strides Pharma Science Limited

29. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 4 different strengths of generic version for Doxepin Hydrochloride. 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
EQ 75MG BASE	capsule	Discontinued	ORAL	N/A	Feb 18, 1988
EQ 50MG BASE	capsule	Discontinued	ORAL	N/A	Feb 18, 1988
EQ 25MG BASE	capsule	Discontinued	ORAL	N/A	Feb 18, 1988
EQ 100MG BASE	capsule	Discontinued	ORAL	N/A	Feb 18, 1988

30. TARO

Taro Pharmaceutical Industries Ltd has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Taro.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Jul 1, 2020
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Jul 1, 2020
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Jul 1, 2020
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Jul 1, 2020
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Jul 1, 2020

Manufacturing Plant Locations
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Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.

Country

City

Firm Name

United States

Honolulu	Taro Delight, LLC
Hawthorne	Taro Pharmaceuticals U.S.A., Inc.

Israel

Haifa

Taro Pharmaceutical Industries, Ltd.

Canada

Brampton

Taro Pharmaceuticals Inc.

31. TEVA PHARMS

Teva Pharmaceuticals Development Inc has filed for 2 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 10MG BASE/ML	concentrate	Discontinued	ORAL	N/A	Nov 9, 1987
5%	cream	Prescription	TOPICAL	AB	Feb 17, 2023

32. UNIQUE PHARM

Unique Pharmaceutical Laboratories has filed for 5 different strengths of generic version for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Unique Pharm.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Aug 21, 2023
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Aug 21, 2023
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Aug 21, 2023
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Aug 21, 2023
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Aug 21, 2023

Manufacturing Plant Locations
^New

Unique Pharm'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 Unique Pharm as present at those locations.

Country

City

Firm Name

India

Bharuch

Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd)

33. VELZEN PHARMA PVT

Velzen Pharma Pvt Ltd has filed for 1 generic for Doxepin Hydrochloride. Given below are the details of the strengths of this generic introduced by Velzen Pharma Pvt.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
EQ 150MG BASE	capsule	Prescription	ORAL	AB	Mar 1, 2021

34. WATSON LABS

Watson Laboratories Inc has filed for 6 different strengths of generic version for Doxepin Hydrochloride. 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
EQ 25MG BASE	capsule	Discontinued	ORAL	N/A	Mar 29, 1991
EQ 50MG BASE	capsule	Discontinued	ORAL	N/A	Apr 30, 1987
EQ 100MG BASE	capsule	Discontinued	ORAL	N/A	Apr 30, 1987
EQ 10MG BASE	capsule	Discontinued	ORAL	N/A	Mar 29, 1991
EQ 75MG BASE	capsule	Discontinued	ORAL	N/A	Feb 9, 1988
EQ 150MG BASE	capsule	Discontinued	ORAL	N/A	Feb 9, 1988

35. WATSON LABS TEVA

Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Doxepin Hydrochloride. 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
EQ 50MG BASE	capsule	Discontinued	ORAL	N/A	Mar 29, 1991

36. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 8 different strengths of generic version for Doxepin Hydrochloride. 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
EQ 150MG BASE	capsule	Prescription	ORAL	AB	Mar 21, 2023
EQ 100MG BASE	capsule	Prescription	ORAL	AB	Mar 23, 2023
EQ 25MG BASE	capsule	Prescription	ORAL	AB	Mar 23, 2023
EQ 10MG BASE	capsule	Prescription	ORAL	AB	Mar 23, 2023
EQ 50MG BASE	capsule	Prescription	ORAL	AB	Mar 23, 2023
EQ 75MG BASE	capsule	Prescription	ORAL	AB	Mar 23, 2023
EQ 3MG BASE	tablet	Prescription	ORAL	AB	Aug 16, 2023
EQ 6MG BASE	tablet	Prescription	ORAL	AB	Aug 16, 2023

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
District Solan	Zydus Lifesciences Limited
Matoda	Zydus Lifesciences Limited
Ahmedabad	ZYDUS LIFESCIENCES LIMITED
Thane	Zydus Lifesciences Limited
Moraiya, Ahmedabad	Zydus Lifesciences Limited
Jarod	Zydus Lifesciences Limited
Dabhasa	Zydus Lifesciences Limited
Ankleshwar	Zydus Lifesciences Limited

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1. ACTAVIS ELIZABETH

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2. ADAPTIS

3. AIPING PHARM INC

4. AJANTA PHARMA LTD

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5. ALEMBIC

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6. AMNEAL

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7. AMNEAL PHARMS CO

8. APPCO

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9. AUROBINDO PHARMA LTD

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10. CHARTWELL RX

11. DAVA PHARMS INC

12. ENDO OPERATIONS

13. EPIC PHARMA LLC

14. JUBILANT CADISTA

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15. LANNETT CO INC

16. LEADING

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17. MANKIND PHARMA

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18. MICRO LABS

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19. MSN

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20. MYLAN PHARMS INC

21. PAR PHARM

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22. PHARM ASSOC

23. PHARMOBEDIENT CNSLTG

24. PUREPAC PHARM

25. QUANTUM PHARMICS

26. RK PHARMA

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27. SANDOZ

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28. STRIDES PHARMA

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29. SUN PHARM INDUSTRIES

30. TARO

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31. TEVA PHARMS

32. UNIQUE PHARM

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33. VELZEN PHARMA PVT

34. WATSON LABS

35. WATSON LABS TEVA

36. ZYDUS LIFESCIENCES

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