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Cetirizine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details

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Cetirizine hydrochloride; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Sun Pharm Inds Ltd, J And J Consumer Inc, Ivax Sub Teva Pharms, and Sandoz, and is included in four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-five patent family members in forty countries.

There are thirty-nine drug master file entries for cetirizine hydrochloride; pseudoephedrine hydrochloride. Thirty-four suppliers are listed for this compound.

Summary for Generic Name: cetirizine hydrochloride; pseudoephedrine hydrochloride

Tradenames:2
Patents:3
Applicants:4
NDAs:4
Drug Master File Entries: see list39
Suppliers / Packagers: see list34
Clinical Trials: see list1,019
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:cetirizine hydrochloride; pseudoephedrine hydrochloride at DailyMed

Pharmacology for Ingredient: cetirizine hydrochloride; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
J And J Consumer Inc
ZYRTEC-D 12 HOUR
cetirizine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021150-002Nov 9, 2007OTCYesYes7,014,867► subscribeY ► subscribe
Sun Pharm Inds Ltd
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
cetirizine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL090922-001Sep 28, 2012OTCNoNo► subscribe► subscribe
Sandoz
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
cetirizine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL077991-001Mar 5, 2008OTCNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: cetirizine hydrochloride; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
ZYRTEC-D 12 HOUR
cetirizine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021150-002Nov 9, 20076,489,329► subscribe
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Non-Orange Book Patents for Generic Ingredient: cetirizine hydrochloride; pseudoephedrine 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
6,489,329 Pharmaceutical compositions for the treatment of rhinitis► 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; pseudoephedrine hydrochloride

Country Document Number Estimated Expiration
Hungary229803► subscribe
Japan4041460► subscribe
Colombia4820432► 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; PSEUDOEPHEDRINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01C/045Belgium► subscribePRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
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
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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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