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Generated: October 19, 2017
What are the generic drug sources for cetirizine hydrochloride and what is the scope of cetirizine hydrochloride patent protection?
Cetirizine hydrochloride is the generic ingredient in fourteen branded drugs marketed by Cypress Pharm, Taro, Apotex Inc, Actavis Elizabeth, Jubilant Generics, Actavis Mid Atlantic, Cipla Ltd, J And J Consumer Inc, Perrigo R And D, Allied Pharma Inc, Wockhardt, Bionpharma Inc, Unique Pharm Labs, Silarx, Sun Pharm Inds Inc, Jubilant Cadista, Sun Pharma Global, Dr Reddys Labs Ltd, Sandoz, Contract Pharmacal, Aurobindo Pharma, Aurobindo Pharma Ltd, Orchid Hlthcare, Amneal Pharms, Bio Pharm Inc, Ranbaxy Labs Ltd, Tris Pharma Inc, Ipca Labs Ltd, Mylan, Teva Pharms, Amneal Pharms Ny, Unichem, Breckenridge Pharm, Strides Pharma, Torrent Pharms Llc, Novel Labs Inc, Nicox Ophthalmics, Vintage, Sun Pharm Inds Ltd, and Ivax Sub Teva Pharms, and is included in sixty-seven NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| US Patents: | 7 |
| Tradenames: | 14 |
| Applicants: | 40 |
| NDAs: | 67 |
| Drug Master File Entries: see list | 39 |
| Suppliers / Packagers: see list | 162 |
| Bulk Api Vendors: see list | 147 |
| Clinical Trials: see list | 2,335 |
| Patent Applications: see list | 4,553 |
| Therapeutic Class: | Respiratory Tract Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | cetirizine hydrochloride at DailyMed |
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
| Applicant | Application No. | Strength | Dosage Form |
| u | ► Subscribe | 5MG/5ML | SYRUP;ORAL |
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| 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 | ► Subscribe | ► Subscribe | ||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,569,273 | Ophthalmic formulations of cetirizine and methods of use | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hong Kong | 1029060 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 9901133 | ► Subscribe | |||||||||||||
| Spain | 2184293 | ► Subscribe | |||||||||||||
| New Zealand | 501820 | ► Subscribe | |||||||||||||
| Australia | 8201598 | ► Subscribe | |||||||||||||
| China | 1261799 | ► Subscribe | |||||||||||||
| Japan | 2013522312 | ► Subscribe | |||||||||||||
| Russian Federation | 2192863 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 2011116020 | ► Subscribe | |||||||||||||
| Japan | 2016190879 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00085 | Netherlands | ► Subscribe | 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 | ||||||||||||
| 01C/045 | Belgium | ► Subscribe | PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103 | ||||||||||||
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Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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