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Cetirizine Hydrochloride Patent Expiration

Cetirizine Hydrochloride is Used for the treatment of acute urticaria and angioedema by increasing peak plasma concentration through intravenous injection. It was first introduced by Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Div in its drug Zyrtec on Sep 27, 1996. Other drugs containing Cetirizine Hydrochloride are Quzyttir, Children'S Zyrtec Hives, Children'S Zyrtec Hives Relief, Children'S Zyrtec Allergy, Zyrtec Hives, Cetirizine Hydrochloride Hives Relief, Zerviate, Cetirizine Hydrochloride Allergy, Zyrtec Allergy. 51 different companies have introduced drugs containing Cetirizine Hydrochloride.


Cetirizine Hydrochloride Patents

Given below is the list of patents protecting Cetirizine 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
Zerviate US9254286

(Pediatric)

 Ophthalmic formulations of cetirizine and methods of use Jan 09, 2033 Harrow Eye
Zerviate US9254286 Ophthalmic formulations of cetirizine and methods of use Jul 09, 2032 Harrow Eye
Zerviate US8829005

(Pediatric)

 Ophthalmic formulations of cetirizine and methods of use Sep 15, 2030 Harrow Eye
Zerviate US8829005 Ophthalmic formulations of cetirizine and methods of use Mar 15, 2030 Harrow Eye
Zerviate US9750684 Ophthalmic formulations of cetirizine and methods of use Mar 15, 2030 Harrow Eye
Zerviate US9993471 Ophthalmic formulations of cetirizine and methods of use Mar 15, 2030 Harrow Eye
Quzyttir US8263581 Non-sedating antihistamine injection formulations and methods of use thereof Feb 28, 2030 Jdp
Quzyttir US8314083 Non-sedating antihistamine injection formulations and methods of use thereof Feb 28, 2030 Jdp
Quzyttir US8513259 Non-sedating antihistamine injection formulations and methods of use thereof Feb 11, 2030 Jdp
Quzyttir US9119771 Non-sedating antihistamine injection formulations and methods of use thereof Feb 11, 2030 Jdp
Quzyttir US9180090 Non-sedating antihistamine injection formulations and methods of use thereof Feb 11, 2030 Jdp
Children's Zyrtec Allergy US6455533 Pharmaceutical compositions for oral administration, comprising an active substance and a cyclodextrin Jul 02, 2018

(Expired)

 Kenvue Brands
Children's Zyrtec Hives Relief US6455533 Pharmaceutical compositions for oral administration, comprising an active substance and a cyclodextrin Jul 02, 2018

(Expired)

 Kenvue Brands



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 Cetirizine Hydrochloride's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 08 May, 2024 US8314083
Payment of Maintenance Fee, 12th Year, Large Entity 28 Feb, 2024 US8263581
Payment of Maintenance Fee, 8th Yr, Small Entity 09 Aug, 2023 US9254286
Payment of Maintenance Fee, 8th Year, Large Entity 15 Feb, 2023 US9119771
Payment of Maintenance Fee, 8th Yr, Small Entity 02 Mar, 2022 US8829005
Payment of Maintenance Fee, 4th Yr, Small Entity 11 Nov, 2021 US9993471
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 23 Apr, 2021 US8513259
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 23 Apr, 2021 US8314083
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 23 Apr, 2021 US9119771
Payment of Maintenance Fee, 4th Yr, Small Entity 23 Feb, 2021 US9750684


Cetirizine Hydrochloride's Family Patents

Family Patents

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Cetirizine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Cetirizine Hydrochloride. The first generic version for Cetirizine Hydrochloride was by Pld Acquisitions Llc Dba Avema Pharma Solutions and was approved on Dec 27, 2007. And the latest generic version is by Indoco Remedies Ltd and was approved on Oct 3, 2024.

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


1. ACTAVIS MID ATLANTIC

Actavis Mid Atlantic Llc has filed for 1 generic for Cetirizine Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Mid Atlantic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Discontinued ORAL N/A Feb 2, 2010





2. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 1 generic for Cetirizine Hydrochloride. This 5mg/5ml version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Over the counter ORAL N/A Oct 7, 2009





3. AMNEAL PHARMS NY

Amneal Pharmaceuticals Ny Llc has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. Out of these 10mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY, 5mg version comes by the name CETIRIZINE HYDROCHLORIDE HIVES RELIEF. 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
10MG

tablet Over the counter ORAL N/A Jan 21, 2010
5MG

tablet Over the counter ORAL N/A Jan 21, 2010





4. APOTEX

Apotex Inc has filed for 1 generic for Cetirizine Hydrochloride. This 10mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

capsule Discontinued ORAL N/A Aug 12, 2016


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





5. APOTEX INC

Apotex Inc has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Over the counter ORAL N/A Dec 27, 2007
5MG

tablet Over the counter ORAL N/A Dec 27, 2007


Manufacturing Plant Locations
New

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

Country City Firm Name
Canada
Toronto Apotex Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.





6. APOZEAL PHARMS

Apozeal Pharmaceuticals Inc has filed for 1 generic for Cetirizine Hydrochloride. Given below are the details of the strengths of this generic introduced by Apozeal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Prescription ORAL AA Apr 27, 2009





7. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Cetirizine Hydrochloride. This 5mg/5ml version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Over the counter ORAL N/A Feb 2, 2010


Manufacturing Plant Locations
New

Aurobindo Pharma'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 Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





8. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Cetirizine Hydrochloride. Out of these 5mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY. 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
5MG/5ML

solution Discontinued ORAL N/A Dec 16, 2009
10MG

tablet, orally disintegrating Over the counter ORAL N/A Sep 11, 2020
5MG

tablet Over the counter ORAL N/A Aug 5, 2015


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





9. BAJAJ

Bajaj Medical Llc has filed for 1 generic for Cetirizine Hydrochloride. This 5mg/5ml version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Bajaj.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Over the counter ORAL N/A Oct 17, 2011


Manufacturing Plant Locations
New

Bajaj'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 Bajaj as present at those locations.

Country City Firm Name
United States
Chicago Bajaj Medical, LLC





10. BIONPHARMA

Bionpharma Inc has filed for 1 generic for Cetirizine Hydrochloride. Given below are the details of the strengths of this generic introduced by Bionpharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Prescription ORAL AA Oct 6, 2008


Manufacturing Plant Locations
New

Bionpharma'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 Bionpharma as present at those locations.

Country City Firm Name
United States
Princeton Bionpharma Inc.





11. CATALENT

Catalent Pharma Solutions Llc has filed for 1 generic for Cetirizine Hydrochloride. This 10mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Catalent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

capsule Over the counter ORAL N/A Sep 21, 2020


Manufacturing Plant Locations
New

Catalent's manufacturing plants are situated in 8 countries - Italy, Argentina, Australia, Belgium, United States, France, Germany, United Kingdom. Given below are the details of these plant locations as well as the firm names of Catalent as present at those locations.

Country City Firm Name
Italy
Aprilia Catalent Italy S.p.A.
Anagni Catalent Anagni SRL
Argentina
Buenos Aires Catalent Argentina S.A.I.C.
Australia
Braeside Catalent Australia Pty Ltd
Belgium
Brussels Catalent Belgium SA
United States
Kansas City Catalent CTS, LLC
Baltimore Catalent Maryland, Inc.
Malvern Catalent Micron Technologies, Inc.
Chelsea Catalent Massachusetts, LLC
Bloomington Catalent Indiana, LLC
Harmans Catalent Maryland Inc
Greenville Catalent Greenville Inc
France
Beinheim Catalent France Beinheim SA
Germany
Schorndorf Catalent Germany Schorndorf GmbH
Eberbach Catalent Germany Eberbach GmbH
United Kingdom
Dartford Catalent Micron Technologies, Limited





12. CHARTWELL MOLECULAR

Chartwell Molecular Holdings Llc has filed for 1 generic for Cetirizine Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Molecular.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Prescription ORAL AA May 11, 2012





13. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Cetirizine Hydrochloride. This 5mg/5ml version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY. 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
5MG/5ML

solution Discontinued ORAL N/A May 9, 2008





14. CIPLA LTD

Cipla Ltd has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Cipla Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Discontinued ORAL N/A Jul 25, 2013
10MG

tablet Discontinued ORAL N/A Jul 25, 2013


Manufacturing Plant Locations
New

Cipla 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 Cipla Ltd as present at those locations.

Country City Firm Name
India
Bangalore Cipla Ltd.





15. CONTRACT PHARMACAL

Contract Pharmacal Corp has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Contract Pharmacal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Over the counter ORAL N/A Dec 27, 2007
10MG

tablet Over the counter ORAL N/A Dec 27, 2007


Manufacturing Plant Locations
New

Contract Pharmacal'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 Contract Pharmacal as present at those locations.

Country City Firm Name
United States
Hauppauge Contract Pharmacal Corporation





16. CYPRESS PHARM

Cypress Pharmaceutical Inc has filed for 1 generic for Cetirizine Hydrochloride. This 5mg/5ml version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Cypress Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Discontinued ORAL N/A Oct 10, 2008


Manufacturing Plant Locations
New

Cypress 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 Cypress Pharm as present at those locations.

Country City Firm Name
United States
Madison Cypress Pharmaceutical, Inc





17. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. Out of these 10mg version comes by the name CETIRIZINE HYDROCHLORIDE HIVES, 5mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Over the counter ORAL N/A Jan 15, 2008
5MG

tablet Over the counter ORAL N/A Jan 15, 2008





18. GLENMARK PHARMS INC

Glenmark Pharmaceuticals Inc Usa has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Over the counter ORAL N/A Dec 28, 2007
5MG

tablet Over the counter ORAL N/A Dec 28, 2007





19. GRANULES

Granules India Ltd has filed for 1 generic for Cetirizine Hydrochloride. This 10mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Granules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Over the counter ORAL N/A Dec 22, 2017


Manufacturing Plant Locations
New

Granules'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 Granules as present at those locations.

Country City Firm Name
United States
Chantilly Granules Pharmaceuticals Inc.
Manassas Granules Consumer Health Inc.
India
Secunderabad Granules India Limited
Visakhapatnam Granules India Limited
Sangareddy District Granules India Limited
Parawada Mandal Granules India Limited
Medchal-Malkhajgiri District Granules India Limited





20. HERITAGE PHARMA

Heritage Pharma Labs Inc has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Heritage Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Dec 28, 2007
5MG

tablet Discontinued ORAL N/A Dec 28, 2007


Manufacturing Plant Locations
New

Heritage 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 Heritage Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Heritage Pharmaceuticals Inc
East Brunswick Heritage Pharmaceuticals, Inc. DBA AVET Pharmaceutical LABS





21. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 1 generic for Cetirizine Hydrochloride. This 5mg/5ml version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY. 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
5MG/5ML

solution Over the counter ORAL N/A Mar 13, 2019





22. INDOCO

Indoco Remedies Ltd has filed for 1 generic for Cetirizine Hydrochloride. Given below are the details of the strengths of this generic introduced by Indoco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Over the counter ORAL N/A Oct 3, 2024


Manufacturing Plant Locations
New

Indoco'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 Indoco as present at those locations.

Country City Firm Name
India
Taluka Khalapur, District Raigad Indoco Remedies Limited
Verna Indoco Remedies Limited (Plant I)
Navi Mumbai Indoco Remedies Limited
Verna Indoco Remedies Limited





23. IPCA LABS LTD

Ipca Laboratories Ltd has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE HIVES. Given below are the details of the strengths of this generic introduced by Ipca Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Mar 11, 2014
5MG

tablet Discontinued ORAL N/A Mar 11, 2014





24. JUBILANT GENERICS

Jubilant Generics Ltd has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. Out of these 5mg version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, 10mg version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF. 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
5MG

tablet, chewable Over the counter ORAL N/A Feb 19, 2015
10MG

tablet, chewable Over the counter ORAL N/A Feb 19, 2015


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





25. LANNETT CO INC

Lannett Co Inc has filed for 1 generic for Cetirizine 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
5MG/5ML

solution Discontinued ORAL N/A Sep 25, 2009





26. MARKSANS PHARMA

Marksans Pharma Ltd has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. Out of these 5mg version comes by the name CETIRIZINE HYDROCHLORIDE HIVES, 10mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY. 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
5MG

tablet Over the counter ORAL N/A Jun 15, 2010
10MG

tablet Over the counter ORAL N/A Jun 15, 2010


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





27. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE HIVES. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Over the counter ORAL N/A Dec 27, 2007
10MG

tablet Over the counter ORAL N/A Dec 27, 2007


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Saint Albans Mylan Technologies, Inc.
Rockford Mylan Institutional, Inc.
Morgantown Mylan Specialty, L.P.
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Greensboro Mylan Pharmaceuticals Inc
India
Sinnar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Bangalore Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





28. NOVEL LABS INC

Novel Laboratories Inc has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Novel Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet, chewable Over the counter ORAL N/A Mar 8, 2016
10MG

tablet, chewable Over the counter ORAL N/A Mar 8, 2016





29. ORBION PHARMS

Orbion Pharmaceuticals Private Ltd has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Orbion Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Over the counter ORAL N/A Feb 19, 2009
10MG

tablet Over the counter ORAL N/A Feb 19, 2009





30. PADAGIS US

Padagis Us Llc has filed for 1 generic for Cetirizine Hydrochloride. Given below are the details of the strengths of this generic introduced by Padagis Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

(reference standard)

solution Prescription ORAL AA Jun 17, 2008


Manufacturing Plant Locations
New

Padagis Us'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 Padagis Us as present at those locations.

Country City Firm Name
United States
Minneapolis Padagis US LLC





31. PERRIGO R AND D

Perrigo R And D Co has filed for 3 different strengths of generic version for Cetirizine Hydrochloride. Out of these 10mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY, 5mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY, 5mg/5ml version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Perrigo R And D.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet, orally disintegrating Over the counter ORAL N/A Sep 2, 2015
5MG

tablet Over the counter ORAL N/A Dec 27, 2007
5MG/5ML

solution Over the counter ORAL N/A Sep 9, 2013





32. PHARM ASSOC

Pharmaceutical Associates Inc has filed for 1 generic for Cetirizine 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
5MG/5ML

solution Prescription ORAL AA Jun 18, 2008





33. PLD ACQUISITIONS

Pld Acquisitions Llc Dba Avema Pharma Solutions has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Pld Acquisitions.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Over the counter ORAL N/A Dec 27, 2007
5MG

tablet Over the counter ORAL N/A Dec 27, 2007


Manufacturing Plant Locations
New

Pld Acquisitions'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 Pld Acquisitions as present at those locations.

Country City Firm Name
United States
Doral PLD Acquisitions LLC





34. QUAGEN

Quagen Pharmaceuticals Llc has filed for 1 generic for Cetirizine Hydrochloride. This 5mg/5ml version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Quagen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Over the counter ORAL N/A May 16, 2019


Manufacturing Plant Locations
New

Quagen'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 Quagen as present at those locations.

Country City Firm Name
United States
West Caldwell Quagen Pharma, LLC
West Caldwell Quagen Pharmacuticals, LLC





35. RANBAXY LABS LTD

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Discontinued ORAL N/A Jun 18, 2008





36. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

(reference standard)

tablet, chewable Over the counter ORAL N/A Feb 14, 2008
5MG

tablet, chewable Over the counter ORAL N/A Feb 14, 2008


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
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





37. STRIDES SOFTGELS

Strides Softgels Pte Ltd has filed for 1 generic for Cetirizine Hydrochloride. This 10mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Strides Softgels.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

capsule Over the counter ORAL N/A Jul 21, 2017





38. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY. 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
5MG

tablet, chewable Discontinued ORAL N/A Aug 30, 2011
10MG

tablet, chewable Discontinued ORAL N/A Aug 30, 2011


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
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Baruch Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Ltd.
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Dadra Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Mohali Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Halol Sun Pharmaceutical Industries Ltd.
Ahmednagar Sun Pharmaceutical Industries Limited
New Delhi Sun Pharmaceutical Industries Limited





39. SUN PHARM INDS INC

Sun Pharmaceutical Industries Inc has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE ALLERGY. 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
5MG

tablet, chewable Discontinued ORAL N/A Jan 11, 2008
10MG

tablet, chewable Discontinued ORAL N/A Jan 11, 2008





40. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. Out of these 10mg version comes by the name CETIRIZINE HYDROCHLORIDE HIVES, 5mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Over the counter ORAL N/A Dec 27, 2007
5MG

tablet Over the counter ORAL N/A Dec 27, 2007





41. TARO

Taro Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Cetirizine Hydrochloride. Out of these 5mg/5ml version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, 10mg version comes by the name CETIRIZINE HYDROCHLORIDE HIVES RELIEF, 5mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Taro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Over the counter ORAL N/A May 20, 2011
10MG

tablet Over the counter ORAL N/A Jul 22, 2009
5MG

tablet Over the counter ORAL N/A Jul 22, 2009


Manufacturing Plant Locations
New

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.





42. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 1 generic for Cetirizine 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
5MG/5ML

solution Discontinued ORAL N/A May 27, 2008





43. TORRENT PHARMS LLC

Torrent Pharmaceuticals Llc has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Torrent Pharms Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Apr 15, 2010
5MG

tablet Discontinued ORAL N/A Apr 15, 2010





44. TRIS PHARMA INC

Tris Pharma Inc has filed for 1 generic for Cetirizine Hydrochloride. This 5mg/5ml version comes by the name CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF. Given below are the details of the strengths of this generic introduced by Tris Pharma Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Discontinued ORAL N/A Nov 16, 2012


Manufacturing Plant Locations
New

Tris Pharma Inc'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 Tris Pharma Inc as present at those locations.

Country City Firm Name
United States
Monmouth Junction Tris Pharma Inc.





45. UNICHEM

Unichem Laboratories Ltd has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. All of these versions come by the name CETIRIZINE HYDROCHLORIDE ALLERGY. Given below are the details of the strengths of this generic introduced by Unichem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Jun 26, 2009
5MG

tablet Discontinued ORAL N/A Jun 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
District Raigad Unichem Laboratories Ltd
Pilerne Bardez Unichem Laboratories Limited
Mumbai Unichem Laboratories Limited
Kolhapur Unichem Laboratories Limited
Pithampur Unichem Laboratories Limited
Ghaziabad Unichem Laboratories Ltd.
United States
East Brunswick Unichem Pharmaceuticals USA Inc.
Hasbrouck Heights Unichem Pharmaceuticals Usa Inc





46. UNIQUE

Unique Pharmaceutical Laboratories A Div Of Jb Chemicals And Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Cetirizine Hydrochloride. Out of these 10mg version comes by the name CETIRIZINE HYDROCHLORIDE ALLERGY, 5mg version comes by the name CETIRIZINE HYDROCHLORIDE HIVES. Given below are the details of the strengths of this generic introduced by Unique.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Over the counter ORAL N/A Aug 26, 2009
5MG

tablet Over the counter ORAL N/A Aug 26, 2009


Manufacturing Plant Locations
New

Unique's manufacturing plants are situated in 5 countries - United States, India, Canada, Portugal, Taiwan. Given below are the details of these plant locations as well as the firm names of Unique as present at those locations.

Country City Firm Name
United States
Cypress Unique Distributors, Inc. dba Florentino Ice Cream
Chatsworth Unique Laboratories, Inc.
Landing Unique Encapsulation Technology, LLC
Ottawa Uniquely Emu Products, Inc.
Norman Unique Confections LLC
Garner Unique Food Company
Bridgeport Unique Instruments, Inc.
Nashville Unique Surgical Inc
Everett Unique sushi
Concord Unique Molded Foam Technologies, Inc.
Gold Canyon Unique Ingredients LLC.
Cumberland Unique Soy Products International, LLC
Richmond Hill Unique Importer & Distributor Inc.
Brownsville Unique Candies Llc
Bisbee Unique Coffee, LLC
India
New Delhi Unique Fragrances
Surat Unique Hospital- Multispecialty & Research Institute
Ankleshwar Unique Chemicals
Navi Mumbai Unique Chemicals
Sonepat Unique Fragrances
Bharuch Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd)
Canada
Cambridge Unique Global Product and Distribution Inc.
Portugal
Velas Uniqueijo - Uniao de Cooperativas Agricolas de Lacticinios de Sao Jorge, UCRL
Taiwan
Toucheng Township Unique Safety Equipment Co., Ltd





47. WOCKHARDT

Wockhardt Ltd has filed for 1 generic for Cetirizine Hydrochloride. Given below are the details of the strengths of this generic introduced by Wockhardt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML

solution Discontinued ORAL N/A Aug 28, 2009


Manufacturing Plant Locations
New

Wockhardt'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 Wockhardt as present at those locations.

Country City Firm Name
India
Solan, Nalagarh Wockhardt Limited - Baddi
Ankleshwar Wockhardt, Ltd.
Aurangabad Wockhardt Limited