Drug Patent List
Litigation OpportunitiesNew
Newsletter
Weekly Digest

Pharsight

Guanfacine Hydrochloride Patent Expiration

Guanfacine Hydrochloride is Used for treating attention-deficit hyperactivity disorder. It was first introduced by Promius Pharma Llc in its drug Tenex on Oct 27, 1986. Another drug containing Guanfacine Hydrochloride is Intuniv. 22 different companies have introduced drugs containing Guanfacine Hydrochloride.


Guanfacine Hydrochloride Patents

Given below is the list of patents protecting Guanfacine 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
Intuniv US6811794

(Pediatric)

 Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles Jan 04, 2023

(Expired)

 Takeda Pharms Usa
Intuniv US6811794 Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles Jul 04, 2022

(Expired)

 Takeda Pharms Usa
Intuniv US6287599

(Pediatric)

 Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles Jun 20, 2021

(Expired)

 Takeda Pharms Usa
Intuniv US6287599 Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles Dec 20, 2020

(Expired)

 Takeda Pharms Usa
Intuniv US5854290

(Pediatric)

 Use of guanfacine in the treatment of behavioral disorders Mar 21, 2016

(Expired)

 Takeda Pharms Usa
Intuniv US5854290 Use of guanfacine in the treatment of behavioral disorders Sep 21, 2015

(Expired)

 Takeda Pharms Usa



Guanfacine Hydrochloride's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List

Guanfacine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Guanfacine Hydrochloride. The first generic version for Guanfacine Hydrochloride was by Watson Laboratories Inc and was approved on Oct 17, 1995. And the latest generic version is by Unichem Laboratories Ltd and was approved on Nov 19, 2024.

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


1. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 4 different strengths of generic version for Guanfacine 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 1MG BASE

tablet, extended release Prescription ORAL AB Oct 5, 2012
EQ 2MG BASE

tablet, extended release Prescription ORAL AB Oct 5, 2012
EQ 3MG BASE

tablet, extended release Prescription ORAL AB Oct 5, 2012
EQ 4MG BASE

tablet, extended release Prescription ORAL AB Oct 5, 2012


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 2 different strengths of generic version for Guanfacine 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 2MG BASE

tablet Prescription ORAL AB Apr 27, 2023
EQ 1MG BASE

tablet Prescription ORAL AB Apr 27, 2023


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 4 different strengths of generic version for Guanfacine 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 2MG BASE

tablet, extended release Prescription ORAL AB Aug 7, 2023
EQ 4MG BASE

tablet, extended release Prescription ORAL AB Aug 7, 2023
EQ 1MG BASE

tablet, extended release Prescription ORAL AB Aug 7, 2023
EQ 3MG BASE

tablet, extended release Prescription ORAL AB Aug 7, 2023


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





4. AMNEAL PHARM

Amneal Pharmaceutical has filed for 2 different strengths of generic version for Guanfacine Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

(reference standard)

tablet Prescription ORAL AB Nov 25, 1998
EQ 1MG BASE

tablet Prescription ORAL AB Nov 25, 1998


Manufacturing Plant Locations
New

Amneal 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 Amneal Pharm as present at those locations.

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





5. APOTEX

Apotex Inc has filed for 4 different strengths of generic version for Guanfacine 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 2MG BASE

tablet, extended release Prescription ORAL AB Jul 25, 2018
EQ 1MG BASE

tablet, extended release Prescription ORAL AB Jul 25, 2018
EQ 3MG BASE

tablet, extended release Prescription ORAL AB Jul 25, 2018
EQ 4MG BASE

tablet, extended release Prescription ORAL AB Jul 25, 2018


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





6. AUROBINDO PHARMA USA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE

tablet Prescription ORAL AB Jan 27, 1997
EQ 2MG BASE

tablet Prescription ORAL AB Jan 27, 1997


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
East Windsor Aurobindo Pharma USA Inc





7. EPIC PHARMA LLC

Epic Pharma Llc has filed for 2 different strengths of generic version for Guanfacine 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 2MG BASE

tablet Prescription ORAL AB Feb 28, 1997
EQ 1MG BASE

tablet Prescription ORAL AB Feb 28, 1997





8. FOSUN WANBANG

Fosun Wanbang (jiangsu) Pharmaceutical Group Co Ltd has filed for 4 different strengths of generic version for Guanfacine Hydrochloride. Given below are the details of the strengths of this generic introduced by Fosun Wanbang.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 3MG BASE

tablet, extended release Prescription ORAL AB Jun 12, 2024
EQ 4MG BASE

tablet, extended release Prescription ORAL AB Jun 12, 2024
EQ 1MG BASE

tablet, extended release Prescription ORAL AB Jun 12, 2024
EQ 2MG BASE

tablet, extended release Prescription ORAL AB Jun 12, 2024





9. I 3 PHARMS

I 3 Pharmaceuticals Llc has filed for 2 different strengths of generic version for Guanfacine Hydrochloride. Given below are the details of the strengths of this generic introduced by I 3 Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE

tablet Prescription ORAL AB Oct 5, 2023
EQ 2MG BASE

tablet Prescription ORAL AB Oct 5, 2023





10. IMPAX LABS INC

Impax Laboratories Inc has filed for 4 different strengths of generic version for Guanfacine Hydrochloride. Given below are the details of the strengths of this generic introduced by Impax Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE

tablet, extended release Discontinued ORAL N/A Oct 20, 2015
EQ 2MG BASE

tablet, extended release Discontinued ORAL N/A Oct 20, 2015
EQ 3MG BASE

tablet, extended release Discontinued ORAL N/A Oct 20, 2015
EQ 4MG BASE

tablet, extended release Discontinued ORAL N/A Oct 20, 2015





11. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 4 different strengths of generic version for Guanfacine Hydrochloride. 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
EQ 1MG BASE

tablet, extended release Discontinued ORAL N/A Jun 2, 2015
EQ 2MG BASE

tablet, extended release Discontinued ORAL N/A Jun 2, 2015
EQ 3MG BASE

tablet, extended release Discontinued ORAL N/A Jun 2, 2015
EQ 4MG BASE

tablet, extended release Discontinued ORAL N/A Jun 2, 2015





12. RUBICON

Rubicon Research Private Ltd has filed for 2 different strengths of generic version for Guanfacine Hydrochloride. Given below are the details of the strengths of this generic introduced by Rubicon.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet Prescription ORAL BX Oct 17, 2023
EQ 1MG BASE

tablet Prescription ORAL BX Oct 17, 2023


Manufacturing Plant Locations
New

Rubicon'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 Rubicon as present at those locations.

Country City Firm Name
United States
Geismar Rubicon, LLC
Indianapolis Rubicon Foods LLC
Canada
Concord Rubicon Research Canada Limited
India
Ambarnath Rubicon Research Private Limited





13. SANDOZ

Sandoz Inc has filed for 4 different strengths of generic version for Guanfacine 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 1MG BASE

tablet, extended release Prescription ORAL AB Jun 3, 2015
EQ 2MG BASE

tablet, extended release Prescription ORAL AB Jun 3, 2015
EQ 3MG BASE

tablet, extended release Prescription ORAL AB Jun 3, 2015
EQ 4MG BASE

tablet, extended release Prescription ORAL AB Jun 3, 2015


Manufacturing Plant Locations
New

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
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





14. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 4 different strengths of generic version for Guanfacine 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 4MG BASE

tablet, extended release Prescription ORAL AB Nov 16, 2017
EQ 1MG BASE

tablet, extended release Prescription ORAL AB Nov 16, 2017
EQ 2MG BASE

tablet, extended release Prescription ORAL AB Nov 16, 2017
EQ 3MG BASE

tablet, extended release Prescription ORAL AB Nov 16, 2017


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





15. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 4 different strengths of generic version for Guanfacine 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 1MG BASE

tablet, extended release Prescription ORAL AB Jun 2, 2015
EQ 2MG BASE

tablet, extended release Prescription ORAL AB Jun 2, 2015
EQ 3MG BASE

tablet, extended release Prescription ORAL AB Jun 2, 2015
EQ 4MG BASE

tablet, extended release Prescription ORAL AB Jun 2, 2015





16. TWI PHARMS

Twi Pharmaceuticals Inc has filed for 4 different strengths of generic version for Guanfacine Hydrochloride. Given below are the details of the strengths of this generic introduced by Twi Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE

tablet Prescription ORAL AB Jun 8, 2022
EQ 2MG BASE

tablet Prescription ORAL AB Jun 8, 2022
EQ 3MG BASE

tablet, extended release Prescription ORAL AB Jun 2, 2015
EQ 4MG BASE

tablet, extended release Prescription ORAL AB Jun 2, 2015





17. UNICHEM

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE

tablet, extended release Prescription ORAL AB Nov 19, 2024
EQ 2MG BASE

tablet, extended release Prescription ORAL AB Nov 19, 2024
EQ 3MG BASE

tablet, extended release Prescription ORAL AB Nov 19, 2024
EQ 4MG BASE

tablet, extended release Prescription ORAL AB Nov 19, 2024


Manufacturing Plant Locations
New

Unichem'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 Unichem as present at those locations.

Country City Firm Name
India
Kolhapur Unichem Laboratories Limited
District Raigad Unichem Laboratories Ltd
Pithampur Unichem Laboratories Limited
Mumbai Unichem Laboratories Limited
Ghaziabad Unichem Laboratories Ltd.
Pilerne Bardez Unichem Laboratories Limited
United States
Hasbrouck Heights Unichem Pharmaceuticals Usa Inc
East Brunswick Unichem Pharmaceuticals USA Inc.





18. WATSON LABS

Watson Laboratories Inc has filed for 2 different strengths of generic version for Guanfacine 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 2MG BASE

tablet Discontinued ORAL N/A Jun 25, 1997
EQ 1MG BASE

tablet Discontinued ORAL N/A Jun 25, 1997





19. XIROMED

Xiromed Pharma Espana Sl has filed for 2 different strengths of generic version for Guanfacine Hydrochloride. Given below are the details of the strengths of this generic introduced by Xiromed.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE

tablet Prescription ORAL AB Feb 23, 2024
EQ 2MG BASE

tablet Prescription ORAL AB Feb 23, 2024


Manufacturing Plant Locations
New

Xiromed'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 Xiromed as present at those locations.

Country City Firm Name
United States
Florham Park XIROMED LLC





20. YICHANG HUMANWELL

Yichang Humanwell Pharmaceutical Co Ltd has filed for 4 different strengths of generic version for Guanfacine Hydrochloride. Given below are the details of the strengths of this generic introduced by Yichang Humanwell.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2MG BASE

tablet, extended release Prescription ORAL AB Nov 25, 2020
EQ 1MG BASE

tablet, extended release Prescription ORAL AB Nov 25, 2020
EQ 3MG BASE

tablet, extended release Prescription ORAL AB Nov 25, 2020
EQ 4MG BASE

tablet, extended release Prescription ORAL AB Nov 25, 2020


Manufacturing Plant Locations
New

Yichang Humanwell'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 Yichang Humanwell as present at those locations.

Country City Firm Name
China
Yichang Yichang Humanwell Oral Solid Dosage Plant