CETIRIZINE HYDROCHLORIDE Drug Patent Profile
✉ Email this page to a colleague
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, Indoco, 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, Ivax Sub Teva Pharms, and Ppi-dac. and is included in fifty 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for CETIRIZINE HYDROCHLORIDE?
- What are the global sales for CETIRIZINE HYDROCHLORIDE?
- What is Average Wholesale Price for CETIRIZINE HYDROCHLORIDE?
Summary for CETIRIZINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 39 |
| NDAs: | 50 |
| Finished Product Suppliers / Packagers: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 274 |
| Clinical Trials: | 91 |
| Patent Applications: | 3,075 |
| DailyMed Link: | CETIRIZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for CETIRIZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Emory University | Phase 3 |
| CURE Drug Repurposing Collaboratory (CDRC) | Phase 3 |
| Ruijin Hospital | Phase 1/Phase 2 |
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 |
US Patents and Regulatory Information for CETIRIZINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Unichem | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | cetirizine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210507-001 | Sep 10, 2024 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma Ltd | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | cetirizine hydrochloride | TABLET;ORAL | 090760-004 | Aug 5, 2015 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Heritage Pharma | CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 078615-003 | Dec 28, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
