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Last Updated: March 19, 2024

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, Chartwell Molecular, Padagis Us, Taro, Hetero Labs Ltd Iii, Chattem Sanofi, Dr Reddys, Dr Reddys Labs Ltd, Glenmark Generics, Granules, Macleods Pharms Ltd, Micro Labs, Micro Labs Ltd India, Perrigo R And D, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, and Us Antibiotics, and is included in twenty-seven 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 patent family members in twenty-four countries.

There are eleven drug master file entries for levocetirizine dihydrochloride. Forty-eight 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
Eurofarma Laboratorios S.A.Phase 3
Osama Mohamed Hassan Ibrahim , Prof Clinical pharmacy Department- Tanta UniversityPhase 2
Mostafa BahaaPhase 2

See all LEVOCETIRIZINE DIHYDROCHLORIDE clinical trials

Generic filers with tentative approvals for LEVOCETIRIZINE DIHYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
XYZAL Oral Solution levocetirizine dihydrochloride 0.5 mg/mL 022157 1 2009-01-14
XYZAL Tablets levocetirizine dihydrochloride 5 mg 022064 1 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
Dr Reddys LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 210375-001 Jan 19, 2018 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 211443-001 Apr 21, 2021 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090362-001 Jan 31, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Chattem Sanofi XYZAL levocetirizine dihydrochloride SOLUTION;ORAL 022157-001 Jan 28, 2008 ⤷  Try a Trial ⤷  Try a Trial
Chattem Sanofi XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 ⤷  Try a Trial ⤷  Try a Trial
Chattem Sanofi XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a 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 ⤷  Try a 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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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 verification 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.