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Last Updated: August 7, 2020

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Levocetirizine dihydrochloride - Generic Drug Details

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What are the generic sources for levocetirizine dihydrochloride and what is the scope of freedom to operate?

Levocetirizine dihydrochloride is the generic ingredient in four branded drugs marketed by Apotex, L Perrigo Co, Lannett Co Inc, Taro Pharm Inds Ltd, Hetero Labs Ltd Iii, Sanofi Aventis Us, Dr Reddys Labs Ltd, Fosun Pharma, Glenmark Generics, Macleods Pharms Ltd, Micro Labs, Micro Labs Ltd India, Neopharma, Perrigo R And D, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Pharms, and Teva Pharms, and is included in twenty-six NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levocetirizine dihydrochloride has thirty-one patent family members in twenty-five countries.

There are thirteen drug master file entries for levocetirizine dihydrochloride. Forty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for levocetirizine dihydrochloride

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Drug Sales Revenue Trends for levocetirizine dihydrochloride

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Recent Clinical Trials for levocetirizine dihydrochloride

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

SponsorPhase
Postgraduate Institute of Medical Education and ResearchPhase 4
University Hospital, GrenoblePhase 4
Zensei Pharmaceutical Co., Ltd.Phase 1

See all levocetirizine dihydrochloride clinical trials

Generic filers with tentative approvals for LEVOCETIRIZINE DIHYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2.5MG/5MLSOLUTION;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 levocetirizine dihydrochloride
Paragraph IV (Patent) Challenges for LEVOCETIRIZINE DIHYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
XYZAL ALLERGY 24HR SOLUTION;ORAL levocetirizine dihydrochloride 209090 2018-01-04
XYZAL SOLUTION;ORAL levocetirizine dihydrochloride 022157 2009-01-14
XYZAL TABLET;ORAL levocetirizine dihydrochloride 022064 2007-12-17

US Patents and Regulatory Information for levocetirizine dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Micro Labs LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 211551-001 Nov 20, 2018 OTC No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 203646-001 Sep 9, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii LEVOCETIRIZINE HYDROCHLORIDE levocetirizine dihydrochloride SOLUTION;ORAL 210914-001 Apr 1, 2019 AA RX No No   Start Trial   Start Trial   Start Trial
Apotex LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 203027-001 Feb 13, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us XYZAL ALLERGY 24HR levocetirizine dihydrochloride SOLUTION;ORAL 209090-001 Jan 31, 2017 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Fosun Pharma LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090486-001 Mar 26, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
>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 levocetirizine dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride SOLUTION;ORAL 022157-001 Jan 28, 2008   Start Trial   Start Trial
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007   Start Trial   Start Trial
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for levocetirizine dihydrochloride

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

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