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Cetirizine hydrochloride - Generic Drug Details
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What are the generic sources for cetirizine hydrochloride and what is the scope of patent protection?
Cetirizine hydrochloride
is the generic ingredient in fifteen branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma Inc, Catalent, Strides Pharma, Eyevance, JDP, Actavis Mid Atlantic, Amneal Pharms, Breckenridge, Lannett Co Inc, MLV, Perrigo Pharms Co, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Torrent, Wockhardt, Athem, Aurobindo Pharma, Cypress Pharm, Hetero Labs Ltd Iii, Perrigo R And D, Quagen, Tris Pharma Inc, J And J Consumer Inc, Sun Pharm Inds Inc, Jubilant Generics, Novel Labs Inc, Sandoz, Sun Pharm, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules, Heritage Pharma, Ipca Labs Ltd, Marksans Pharma, Mylan, Orchid Hlthcare, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Ivax Sub Teva Pharms, and is included in seventy-five NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Cetirizine hydrochloride has twenty-two patent family members in seven countries.
There are thirty-nine drug master file entries for cetirizine hydrochloride. One hundred and thirty-two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for cetirizine hydrochloride
International Patents: | 22 |
US Patents: | 11 |
Tradenames: | 15 |
Applicants: | 49 |
NDAs: | 75 |
Drug Master File Entries: | 39 |
Suppliers / Packagers: | 132 |
Bulk Api Vendors: | 213 |
Clinical Trials: | 78 |
Patent Applications: | 5,007 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in cetirizine hydrochloride? | cetirizine hydrochloride excipients list |
DailyMed Link: | cetirizine hydrochloride at DailyMed |
Recent Clinical Trials for cetirizine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Assiut University | Phase 4 |
Cairo University | Phase 2/Phase 3 |
Ciusss de L'Est de l'Île de Montréal | Phase 3 |
Generic filers with tentative approvals for CETIRIZINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 5MG/5ML | SYRUP;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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
Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ZYRTEC | SYRUP;ORAL | cetirizine hydrochloride | 020346 | 2007-03-19 |
CHILDREN'S ZYRTEC ALLERGY | TABLET, CHEWABLE;ORAL | cetirizine hydrochloride | 021621 | 2005-03-25 |
CHILDREN'S ZYRTEC HIVES RELIEF | TABLET, CHEWABLE;ORAL | cetirizine hydrochloride | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Torrent | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | cetirizine hydrochloride | SYRUP;ORAL | 090474-001 | Mar 30, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Perrigo R And D | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SYRUP;ORAL | 204226-001 | Sep 9, 2013 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
Sandoz | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 078692-002 | Feb 14, 2008 | OTC | No | Yes | Start Trial | Start Trial | Start Trial | ||||
Ipca Labs Ltd | CETIRIZINE HYDROCHLORIDE HIVES | cetirizine hydrochloride | TABLET;ORAL | 202277-001 | Mar 11, 2014 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for cetirizine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | ZYRTEC | cetirizine hydrochloride | SYRUP;ORAL | 020346-001 | Sep 27, 1996 | Start Trial | Start Trial |
J And J Consumer Inc | CHILDREN'S ZYRTEC HIVES RELIEF | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-005 | Nov 16, 2007 | Start Trial | Start Trial |
J And J Consumer Inc | CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-003 | Nov 16, 2007 | Start Trial | Start Trial |
J And J Consumer Inc | CHILDREN'S ZYRTEC ALLERGY | cetirizine hydrochloride | TABLET, CHEWABLE;ORAL | 021621-004 | Nov 16, 2007 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for cetirizine hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 6144393 | Start Trial |
Japan | 6449202 | Start Trial |
Japan | 2016190878 | Start Trial |
World Intellectual Property Organization (WIPO) | 2011116020 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for cetirizine hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0058146 | 2001C/045 | Belgium | Start Trial | PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103 |
0663828 | C300085 | Netherlands | Start Trial | PRODUCT NAME: LEVOCETIRIZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LEVOCETIRINE DIHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 26770 20011009; FIRST REGISTRATION: DE 49903.00.00 AND 49904.00.00 20010103 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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