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Cetirizine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for cetirizine hydrochloride?

Cetirizine hydrochloride is the generic ingredient in thirteen 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, Nostrum Labs Inc, Wockhardt, Bionpharma Inc, Unique Pharm Labs, Silarx, Sun Pharm Inds Inc, Cadista Pharms, 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, Par Pharm Inc, Torrent Pharms Llc, Novel Labs Inc, Vintage, Sun Pharm Inds Ltd, and Ivax Sub Teva Pharms, and is included in sixty-five NDAs. There are five 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 nineteen countries.

There are thirty-nine drug master file entries for cetirizine hydrochloride. One hundred and sixty-four suppliers are listed for this compound.

Summary for Generic Name: cetirizine hydrochloride

Tradenames:13
Patents:5
Applicants:39
NDAs:65
Drug Master File Entries: see list39
Suppliers / Packagers: see list164
Bulk Api Vendors: see list147
Clinical Trials: see list1,004
Patent Applications: see list4,810
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:cetirizine hydrochloride at DailyMed

Pharmacology for Ingredient: cetirizine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bio Pharm Inc
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
cetirizine hydrochloride
SYRUP;ORAL090474-001Mar 30, 2009OTCNoNo► Subscribe► Subscribe
Unique Pharm Labs
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET;ORAL077829-004Aug 26, 2009OTCNoNo► Subscribe► Subscribe
Orchid Hlthcare
CETIRIZINE HYDROCHLORIDE HIVES
cetirizine hydrochloride
TABLET;ORAL078862-004Feb 19, 2009OTCNoNo► Subscribe► Subscribe
Bionpharma Inc
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
CAPSULE;ORAL022429-004Jul 23, 2009OTCYesYes► Subscribe► Subscribe
Bio Pharm Inc
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
SYRUP;ORAL090474-002Mar 30, 2009OTCNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: cetirizine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
ZYRTEC
cetirizine hydrochloride
SYRUP;ORAL020346-001Sep 27, 19964,525,358*PED► Subscribe
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International Patent Family for Ingredient: cetirizine hydrochloride

Country Document Number Estimated Expiration
Russian Federation2192863► Subscribe
New Zealand501820► Subscribe
Poland192348► Subscribe
Indonesia23806► Subscribe
Japan2002508773► 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 Certificates for Tradename: CETIRIZINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00085Netherlands► SubscribePRODUCT 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/045Belgium► SubscribePRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
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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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