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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
Farmers Insurance
Dow
McKinsey
US Army
Accenture
Johnson and Johnson
Argus Health

Generated: August 19, 2018

DrugPatentWatch Database Preview

Cetirizine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details

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What are the generic sources for cetirizine hydrochloride; pseudoephedrine hydrochloride and what is the scope of cetirizine hydrochloride; pseudoephedrine hydrochloride patent protection?

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

Cetirizine hydrochloride; pseudoephedrine hydrochloride has fifty-eight patent family members in forty countries.

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

Summary for cetirizine hydrochloride; pseudoephedrine hydrochloride
International Patents:58
US Patents:3
Tradenames:2
Applicants:4
NDAs:4
Drug Master File Entries: 39
Suppliers / Packagers: 33
Clinical Trials: 4
DailyMed Link:cetirizine hydrochloride; pseudoephedrine hydrochloride at DailyMed
Pharmacology for cetirizine hydrochloride; pseudoephedrine hydrochloride

US Patents and Regulatory Information for cetirizine hydrochloride; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pld Acquisitions CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077991-001 Mar 5, 2008 OTC No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharm Inds Ltd CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 090922-001 Sep 28, 2012 OTC No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for 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;ORAL 021150-002 Nov 9, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for cetirizine hydrochloride; pseudoephedrine hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00085 Netherlands ➤ Try a Free Trial 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 ➤ Try a Free Trial PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Citi
UBS
Covington
Accenture
Medtronic
Baxter
Teva
Fuji

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.