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Serving leading biopharmaceutical companies globally:

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US Army
McKesson
Teva
Citi
Chinese Patent Office
Covington
Queensland Health
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Generated: October 19, 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 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.

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

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

Summary for Generic Name: cetirizine hydrochloride

US Patents:7
Tradenames:14
Applicants:40
NDAs:67
Drug Master File Entries: see list39
Suppliers / Packagers: see list162
Bulk Api Vendors: see list147
Clinical Trials: see list2,335
Patent Applications: see list4,553
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

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
Perrigo R And D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
SYRUP;ORAL204226-001Sep 9, 2013OTCNoNo► Subscribe► Subscribe► Subscribe
Unique Pharm Labs
CETIRIZINE HYDROCHLORIDE HIVES
cetirizine hydrochloride
TABLET;ORAL077829-003Aug 26, 2009OTCNoNo► Subscribe► Subscribe► Subscribe
J And J Consumer Inc
CHILDREN'S ZYRTEC HIVES RELIEF
cetirizine hydrochloride
TABLET, CHEWABLE;ORAL021621-005Nov 16, 2007DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Bionpharma Inc
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
CAPSULE;ORAL022429-004Jul 23, 2009OTCYesYes► Subscribe► Subscribe► Subscribe
Taro
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride
SYRUP;ORAL076601-001Jun 20, 2008AARXNoNo► Subscribe► Subscribe► Subscribe
Perrigo R And D
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET;ORAL078336-001Dec 27, 2007OTCNoNo► Subscribe► Subscribe► Subscribe
Bio Pharm Inc
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
SYRUP;ORAL090474-002Mar 30, 2009OTCNoNo► Subscribe► Subscribe► Subscribe
Jubilant Generics
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
cetirizine hydrochloride
TABLET, CHEWABLE;ORAL091116-003Feb 19, 2015OTCNoNo► Subscribe► Subscribe► Subscribe
Jubilant Cadista
CETIRIZINE HYDROCHLORIDE ALLERGY
cetirizine hydrochloride
TABLET;ORAL078933-001Jun 15, 2010OTCNoNo► Subscribe► Subscribe► Subscribe
Tris Pharma Inc
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
cetirizine hydrochloride
SYRUP;ORAL090572-002Nov 16, 2012OTCNoNo► 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 Inc
ZYRTEC
cetirizine hydrochloride
SYRUP;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
Hong Kong1029060► Subscribe
World Intellectual Property Organization (WIPO)9901133► Subscribe
Spain2184293► Subscribe
New Zealand501820► Subscribe
Australia8201598► Subscribe
China1261799► Subscribe
Japan2013522312► Subscribe
Russian Federation2192863► Subscribe
World Intellectual Property Organization (WIPO)2011116020► Subscribe
Japan2016190879► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Mallinckrodt
Johnson and Johnson
Novartis
Teva
Fish and Richardson
Fuji
QuintilesIMS
Cerilliant

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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