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Last Updated: May 10, 2021

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CETIRIZINE HYDROCHLORIDE - Generic Drug Details

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

Cetirizine hydrochloride is the generic ingredient in fifteen branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma Inc, Catalent, Strides Pharma, Eyevance, JDP, Actavis Mid Atlantic, Amneal Pharms, Breckenridge, Lannett Co Inc, MLV, Perrigo Pharms Co, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Torrent, Wockhardt, Athem, Aurobindo Pharma, Cypress Pharm, Hetero Labs Ltd Iii, Perrigo R And D, Quagen, Tris Pharma Inc, J And J Consumer Inc, Sun Pharm Inds Inc, Jubilant Generics, Novel Labs Inc, Sandoz, Sun Pharm, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules, Heritage Pharma, Ipca Labs Ltd, Marksans Pharma, Mylan, Orchid Hlthcare, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Ivax Sub Teva Pharms, and is included in seventy-five NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Cetirizine hydrochloride has twenty-two patent family members in seven countries.

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

Summary for CETIRIZINE HYDROCHLORIDE
International Patents:22
US Patents:11
Tradenames:15
Applicants:49
NDAs:75
Drug Master File Entries: 39
Finished Product Suppliers / Packagers: 133
Raw Ingredient (Bulk) Api Vendors: 222
Clinical Trials: 79
Patent Applications: 4,948
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in CETIRIZINE HYDROCHLORIDE?CETIRIZINE HYDROCHLORIDE excipients list
DailyMed Link:CETIRIZINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for CETIRIZINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Emory UniversityPhase 4
Assiut UniversityPhase 4
Cairo UniversityPhase 2/Phase 3

See all CETIRIZINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for CETIRIZINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $105MG/5MLSYRUP;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CETIRIZINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for CETIRIZINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ZYRTEC SYRUP;ORAL cetirizine hydrochloride 020346 2007-03-19
CHILDREN'S ZYRTEC ALLERGY TABLET, CHEWABLE;ORAL cetirizine hydrochloride 021621 2005-03-25
CHILDREN'S ZYRTEC HIVES RELIEF TABLET, CHEWABLE;ORAL cetirizine hydrochloride 021621 2005-03-25

US Patents and Regulatory Information for CETIRIZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quagen CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 212266-001 May 16, 2019 OTC No No   Get Started for $10   Get Started for $10   Get Started for $10
Amneal Pharms Ny CETIRIZINE HYDROCHLORIDE HIVES RELIEF cetirizine hydrochloride TABLET;ORAL 078780-002 Jan 21, 2010 OTC No No   Get Started for $10   Get Started for $10   Get Started for $10
J And J Consumer Inc ZYRTEC cetirizine hydrochloride SYRUP;ORAL 020346-001 Sep 27, 1996 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Eyevance ZERVIATE cetirizine hydrochloride SOLUTION/DROPS;OPHTHALMIC 208694-001 May 30, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CETIRIZINE HYDROCHLORIDE

Supplementary Protection Certificates for CETIRIZINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0058146 2001C/045 Belgium   Get Started for $10 PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
0663828 C300085 Netherlands   Get Started for $10 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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