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Clonidine Hydrochloride Patent Expiration

Clonidine Hydrochloride was first introduced by Boehringer Ingelheim in its drug Catapres on Approved Prior to Jan 1, 1982. Other drugs containing Clonidine Hydrochloride are Kapvay, Onyda Xr, Duraclon, Jenloga. 39 different companies have introduced drugs containing Clonidine Hydrochloride.


Clonidine Hydrochloride Patents

Given below is the list of patents protecting Clonidine 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
Onyda Xr US11918689 Liquid clonidine extended release composition Jul 28, 2041 Tris Pharma Inc
Onyda Xr US8062667 Modified release formulations containing drug-ion exchange resin complexes Mar 29, 2029 Tris Pharma Inc
Jenloga US5869100 Extended release clonidine formulation (tablet) Oct 13, 2013

(Expired)

 Concordia Pharms Inc
Kapvay US5869100 Extended release clonidine formulation (tablet) Oct 13, 2013

(Expired)

 Concordia Pharms Inc



Clonidine Hydrochloride's Family Patents

Family Patents

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Clonidine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Clonidine Hydrochloride. The first generic version for Clonidine Hydrochloride was by Watson Laboratories Inc and was approved on Jul 8, 1986. And the latest generic version is by Novast Laboratories Ltd and was approved on Mar 5, 2019.

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


1. ACTAVIS ELIZABETH

Actavis Elizabeth Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Clonidine 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
0.2MG

tablet, extended release Discontinued ORAL N/A May 15, 2015
0.3MG

tablet Prescription ORAL AB Dec 16, 1986
0.1MG

tablet, extended release Prescription ORAL AB1 May 15, 2015


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 1 generic for Clonidine 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
0.1MG

(reference standard)

tablet, extended release Prescription ORAL AB1 Nov 20, 2017


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 PHARMS LTD

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG

tablet Prescription ORAL AB Dec 6, 2011
0.1MG

tablet Prescription ORAL AB Dec 6, 2011
0.3MG

tablet Prescription ORAL AB Dec 6, 2011





4. AM REGENT

American Regent Inc has filed for 2 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Am Regent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/10ML (0.1MG/ML)

injectable Discontinued INJECTION N/A Oct 8, 2009
5MG/10ML (0.5MG/ML)

injectable Discontinued INJECTION N/A Oct 8, 2009





5. AM THERAP

American Therapeutics Inc has filed for 3 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Am Therap.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1MG

tablet Discontinued ORAL N/A Jul 8, 1986
0.2MG

tablet Discontinued ORAL N/A Jul 8, 1986
0.3MG

tablet Discontinued ORAL N/A Jul 8, 1986





6. AMNEAL PHARMS NY

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1MG

tablet, extended release Discontinued ORAL N/A Nov 20, 2017





7. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Clonidine 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
0.2MG

tablet Prescription ORAL AB Aug 31, 1988
0.1MG

tablet Prescription ORAL AB Aug 31, 1988
0.3MG

tablet Prescription ORAL AB Aug 31, 1988


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. CHARTWELL MOLECULES

Chartwell Molecules Llc has filed for 3 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Molecules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1MG

tablet Prescription ORAL AB Apr 5, 1988
0.3MG

tablet Prescription ORAL AB Apr 5, 1988
0.2MG

tablet Prescription ORAL AB Apr 5, 1988





9. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Clonidine 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
0.1MG

tablet, extended release Prescription ORAL AB1 Oct 23, 2017





10. DAVA PHARMS INC

Dava Pharmaceuticals Inc has filed for 2 different strengths of generic version for Clonidine 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
0.1MG

tablet Prescription ORAL AB Apr 5, 1988
0.2MG

tablet Prescription ORAL AB Apr 5, 1988





11. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 1 generic for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1MG

tablet, extended release Discontinued ORAL N/A Apr 30, 2018





12. DURAMED PHARMS BARR

Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc has filed for 3 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Duramed Pharms Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.3MG

tablet Discontinued ORAL N/A Aug 14, 1986
0.2MG

tablet Discontinued ORAL N/A Aug 14, 1986
0.1MG

tablet Discontinued ORAL N/A Aug 14, 1986





13. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Clonidine 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
0.1MG

tablet, extended release Discontinued ORAL N/A Apr 2, 2014
0.2MG

tablet, extended release Discontinued ORAL N/A Apr 2, 2014





14. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 2 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/10ML (0.5MG/ML)

injectable Prescription INJECTION AP Jul 8, 2011
1MG/10ML (0.1MG/ML)

injectable Prescription INJECTION AP Jul 8, 2011


Manufacturing Plant Locations
New

Fresenius Kabi 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 Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Bensenville Fresenius Kabi USA LLC (FK USA)
Skokie Fresenius Kabi USA LLC
North Andover Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC





15. HIKMA FARMACEUTICA

Hikma Farmaceutica (portugal) Sa has filed for 2 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma Farmaceutica.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/10ML (0.5MG/ML)

(reference standard)

injectable Prescription INJECTION AP Jan 26, 2011
1MG/10ML (0.1MG/ML)

injectable Prescription INJECTION AP Jan 26, 2011


Manufacturing Plant Locations
New

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

Country City Firm Name
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.





16. IMPAX LABS

Impax Laboratories Inc has filed for 3 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Impax Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.3MG

tablet Prescription ORAL AB Aug 27, 2009
0.1MG

tablet Prescription ORAL AB Aug 27, 2009
0.2MG

tablet Prescription ORAL AB Aug 27, 2009





17. INTERPHARM

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG

tablet Discontinued ORAL N/A Oct 1, 1986
0.3MG

tablet Discontinued ORAL N/A Oct 1, 1986
0.1MG

tablet Discontinued ORAL N/A Oct 1, 1986


Manufacturing Plant Locations
New

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

Country City Firm Name
Czech Republic
Prague 12 Interpharma Praha A.S.





18. JUBILANT GENERICS

Jubilant Generics Ltd has filed for 1 generic for Clonidine Hydrochloride. 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
0.1MG

tablet, extended release Prescription ORAL AB1 Jan 29, 2018


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





19. MUTUAL PHARM

Mutual Pharmaceutical Co Inc has filed for 2 different strengths of generic version for Clonidine Hydrochloride. 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
0.2MG

tablet Prescription ORAL AB Sep 4, 1987
0.1MG

tablet Prescription ORAL AB Sep 4, 1987





20. NOVAST LABS

Novast Laboratories Ltd has filed for 1 generic for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1MG

tablet, extended release Prescription ORAL AB1 Mar 5, 2019





21. PAR PHARM

Par Pharmaceutical Inc has filed for 3 different strengths of generic version for Clonidine 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
0.3MG

tablet Discontinued ORAL N/A Jul 8, 1986
0.2MG

tablet Discontinued ORAL N/A Jul 8, 1986
0.1MG

tablet Discontinued ORAL N/A Jul 8, 1986


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. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 3 different strengths of generic version for Clonidine 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
0.2MG

tablet Prescription ORAL AB Mar 9, 2007
0.3MG

tablet Prescription ORAL AB Mar 9, 2007
0.1MG

tablet Prescription ORAL AB Mar 9, 2007





23. RISING

Rising Pharma Holding Inc has filed for 3 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.3MG

tablet Discontinued ORAL N/A Jun 9, 1987
0.2MG

tablet Discontinued ORAL N/A Jun 9, 1987
0.1MG

tablet Discontinued ORAL N/A Jul 9, 1987


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





24. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Clonidine 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
0.3MG

tablet Discontinued ORAL N/A Aug 31, 1988
0.1MG

tablet Discontinued ORAL N/A Aug 31, 1988


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





25. SOMERSET THERAPS LLC

Somerset Therapeutics Llc has filed for 1 generic for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Somerset Theraps Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1MG

tablet, extended release Discontinued ORAL N/A Oct 12, 2018





26. SUN PHARM INDS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.3MG

tablet Discontinued ORAL N/A Jul 3, 2014
0.2MG

tablet Discontinued ORAL N/A Jul 3, 2014
0.1MG

tablet Discontinued ORAL N/A Jul 3, 2014





27. TEVA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.3MG

tablet Discontinued ORAL N/A Jul 8, 1986
0.2MG

tablet Discontinued ORAL N/A Jul 8, 1986
0.1MG

tablet Discontinued ORAL N/A Jul 8, 1986


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Horsham Teva Branded Pharmaceutical Products R&D
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Fort Dodge TEVA Animal Health Inc
Miami Teva Branded Pharmaceutical Products R & D, Inc.
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
Canada
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





28. TRUPHARMA

Trupharma Llc has filed for 3 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Trupharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.2MG

tablet Prescription ORAL AB Sep 4, 1987
0.3MG

tablet Prescription ORAL AB Sep 4, 1987
0.1MG

tablet Prescription ORAL AB Sep 4, 1987





29. UNICHEM

Unichem Laboratories Ltd has filed for 3 different strengths of generic version for Clonidine 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
0.3MG

(reference standard)

tablet Prescription ORAL AB Aug 26, 2009
0.1MG

tablet Prescription ORAL AB Aug 26, 2009
0.2MG

tablet Prescription ORAL AB Aug 26, 2009


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





30. WARNER CHILCOTT

Warner Chilcott Div Warner Lambert Co has filed for 3 different strengths of generic version for Clonidine Hydrochloride. 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
0.3MG

tablet Discontinued ORAL N/A Jun 13, 1988
0.1MG

tablet Discontinued ORAL N/A Jun 13, 1988
0.2MG

tablet Discontinued ORAL N/A Jun 13, 1988


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
Manati Warner Chilcott Company LLC
Norwich Warner Chilcott Pharmaceuticals, Inc.
Germany
Weiterstadt Warner Chilcott Deutschland GmbH





31. WATSON LABS

Watson Laboratories Inc has filed for 3 different strengths of generic version for Clonidine 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
0.2MG

tablet Discontinued ORAL N/A Mar 23, 1987
0.3MG

tablet Discontinued ORAL N/A Mar 23, 1987
0.1MG

tablet Discontinued ORAL N/A Mar 23, 1987





32. XGEN PHARMS

Xgen Pharmaceuticals Djb Inc has filed for 2 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Xgen Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/10ML (0.5MG/ML)

injectable Prescription INJECTION AP Oct 29, 2013
1MG/10ML (0.1MG/ML)

injectable Prescription INJECTION AP Oct 29, 2013





33. XIAMEN LP PHARM CO

Xiamen Lp Pharmacuetical Co Ltd has filed for 1 generic for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Xiamen Lp Pharm Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1MG

tablet, extended release Prescription ORAL AB1 Nov 20, 2017





34. YUNG SHIN PHARM

Yung Shin Pharmaceutical Industrial Co Ltd has filed for 3 different strengths of generic version for Clonidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Yung Shin Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.3MG

tablet Prescription ORAL AB Jun 13, 2013
0.1MG

tablet Prescription ORAL AB Jun 13, 2013
0.2MG

tablet Prescription ORAL AB Jun 13, 2013


Manufacturing Plant Locations
New

Yung Shin Pharm's manufacturing plants are situated in 2 countries - China, Taiwan. Given below are the details of these plant locations as well as the firm names of Yung Shin Pharm as present at those locations.

Country City Firm Name
China
Kunshan Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd.
Taiwan
Taichung City Yung Shin Pharmaceutical Industry Co., Ltd.





35. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Clonidine 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
5MG/10ML (0.5MG/ML)

injectable Prescription INJECTION AP Feb 20, 2014
1MG/10ML (0.1MG/ML)

injectable Prescription INJECTION AP Feb 20, 2014