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Generated: December 17, 2017

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Cetirizine hydrochloride - Generic Drug Details

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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 Apotex Inc, Bionpharma Inc, Strides Pharma, Eyevance Pharms, Actavis Mid Atlantic, Allied Pharma Inc, Amneal Pharms, Aurobindo Pharma Ltd, Bio Pharm Inc, Breckenridge Pharm, Perrigo R And D, Ranbaxy Labs Ltd, Silarx, Taro, Teva Pharms, Vintage, Wockhardt, Aurobindo Pharma, Cypress Pharm, Tris Pharma Inc, J And J Consumer Inc, Sun Pharm Inds Inc, Jubilant Generics, Novel Labs Inc, Sandoz, Sun Pharma Global, Actavis Elizabeth, Amneal Pharms Ny, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Ipca Labs Ltd, Jubilant Cadista, Mylan, Orchid Hlthcare, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique Pharm Labs, 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.

Cetirizine hydrochloride has thirty-eight patent family members in twenty-one countries and two supplementary protection certificates in two countries.

There are thirty-nine drug master file entries for cetirizine hydrochloride. One hundred and fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for cetirizine hydrochloride

Medical Subject Heading (MeSH) Categories for cetirizine hydrochloride

Tentative approvals for CETIRIZINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe5MG/5MLSYRUP;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds LtdCETIRIZINE HYDROCHLORIDE ALLERGYcetirizine hydrochlorideTABLET;ORAL077498-002Dec 27, 2007OTCNoNo► Subscribe► Subscribe► Subscribe
TaroCHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFcetirizine hydrochlorideSYRUP;ORAL201546-002May 20, 2011OTCNoNo► Subscribe► Subscribe► Subscribe
J And J Consumer IncZYRTECcetirizine hydrochlorideSYRUP;ORAL020346-001Sep 27, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Contract PharmacalCETIRIZINE HYDROCHLORIDE ALLERGYcetirizine hydrochlorideTABLET;ORAL076047-001Dec 27, 2007OTCNoNo► Subscribe► Subscribe► Subscribe
J And J Consumer IncZYRTEC-D 12 HOURcetirizine hydrochloride; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021150-002Nov 9, 2007OTCYesYes► Subscribe► SubscribeY► Subscribe
Orchid HlthcareCETIRIZINE HYDROCHLORIDE ALLERGYcetirizine hydrochlorideTABLET;ORAL078862-002Feb 19, 2009OTCNoNo► Subscribe► Subscribe► Subscribe
Ranbaxy Labs LtdCHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFcetirizine hydrochlorideSYRUP;ORAL090183-001Apr 24, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdCETIRIZINE HYDROCHLORIDE ALLERGYcetirizine hydrochlorideTABLET;ORAL078343-004Jan 15, 2008OTCNoNo► Subscribe► Subscribe► Subscribe
Apotex IncCETIRIZINE HYDROCHLORIDE ALLERGYcetirizine hydrochlorideTABLET;ORAL078317-002Dec 27, 2007OTCNoNo► Subscribe► Subscribe► Subscribe
Cipla LtdCETIRIZINE HYDROCHLORIDE ALLERGYcetirizine hydrochlorideTABLET;ORAL077318-001Jul 25, 2013OTCNoNo► Subscribe► 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 IncZYRTECcetirizine hydrochlorideSYRUP;ORAL020346-001Sep 27, 1996► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cetirizine hydrochloride

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
8,569,273Ophthalmic 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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International Patent Family for Ingredient: cetirizine hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2010107689► Subscribe
World Intellectual Property Organization (WIPO)9901133► Subscribe
Portugal994710► Subscribe
Japan2016190879► Subscribe
Japan2002508773► Subscribe
Indonesia23806► Subscribe
Japan2012520882► Subscribe
Japan2007091760► Subscribe
China1261799► Subscribe
Canada2294783► 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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
UBS
Accenture
US Army
Boehringer Ingelheim
Novartis
Baxter
Moodys
Medtronic

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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