Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Accenture
QuintilesIMS
Argus Health
Julphar
Teva
McKinsey
UBS
Cantor Fitzgerald
Cipla
Fish and Richardson

Generated: December 11, 2017

DrugPatentWatch Database Preview

Cetirizine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details

« Back to Dashboard

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, Sandoz, 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 and two supplementary protection certificates in two 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

Pharmacology for cetirizine hydrochloride; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva PharmsCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEcetirizine hydrochloride; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL077170-001Feb 25, 2008OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
J And J Consumer IncZYRTEC-D 12 HOURcetirizine hydrochloride; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021150-002Nov 9, 2007OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm Inds LtdCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEcetirizine hydrochloride; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL090922-001Sep 28, 2012OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
J And J Consumer IncZYRTEC-D 12 HOURcetirizine hydrochloride; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021150-002Nov 9, 2007OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
SandozCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEcetirizine hydrochloride; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL077991-001Mar 5, 2008OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
J And J Consumer IncZYRTEC-D 12 HOURcetirizine hydrochloride; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021150-002Nov 9, 2007OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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 IncZYRTEC-D 12 HOURcetirizine hydrochloride; pseudoephedrine hydrochlorideTABLET, EXTENDED RELEASE;ORAL021150-002Nov 9, 2007► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: cetirizine hydrochloride; pseudoephedrine hydrochloride

Country Document Number Estimated Expiration
Germany60232445► Subscribe
Japan4041460► Subscribe
Hungary0400386► Subscribe
Costa Rica7198► Subscribe
Spain2324769► Subscribe
Mexico9702532► Subscribe
Brazil0210650► Subscribe
CroatiaP20031057► Subscribe
South Africa200309720► Subscribe
Australia2002345024► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cerilliant
Queensland Health
Argus Health
Johnson and Johnson
Novartis
AstraZeneca
Deloitte
Moodys
UBS
Fish and Richardson

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot