CETIRIZINE HYDROCHLORIDE Drug Patent Profile
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When do Cetirizine Hydrochloride patents expire, and what generic alternatives are available?
Cetirizine Hydrochloride is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Bajaj, Bionpharma, Chartwell Molecular, Lannett Co Inc, Padagis Us, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Wockhardt, Apotex, Catalent, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Granules, Heritage Pharma, Ipca Labs Ltd, Marksans Pharma, Mylan, Orbion Pharms, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique, and Ivax Sub Teva Pharms. and is included in forty-eight NDAs.
The generic ingredient in CETIRIZINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cetirizine Hydrochloride
A generic version of CETIRIZINE HYDROCHLORIDE was approved as cetirizine hydrochloride; pseudoephedrine hydrochloride by IVAX SUB TEVA PHARMS on February 25th, 2008.
Summary for CETIRIZINE HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 37 |
NDAs: | 48 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 274 |
Clinical Trials: | 88 |
Patent Applications: | 3,188 |
Formulation / Manufacturing: | see details |
DailyMed Link: | CETIRIZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for CETIRIZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
State University of New York - Upstate Medical University | Phase 3 |
Ultragenyx Pharmaceutical Inc | Phase 1/Phase 2 |
Emory University | Phase 4 |
Pharmacology for CETIRIZINE HYDROCHLORIDE
Drug Class | Histamine-1 Receptor Antagonist |
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for CETIRIZINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for CETIRIZINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZYRTEC | Syrup | cetirizine hydrochloride | 5 mg/5 mL | 020346 | 1 | 2007-03-19 |
CHILDREN'S ZYRTEC HIVES RELIEF | Chewable Tablets | cetirizine hydrochloride | 5 mg and 10 mg | 021621 | 2005-03-25 |