Flexible Subscriptions to Match your Budget and Timeline See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Merck
Johnson and Johnson
AstraZeneca
Moodys

Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Levocetirizine dihydrochloride - Generic Drug Details

➤ Subscribe for complete access

« Back to Dashboard

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, Lannett Co Inc, Padagis Us, Taro Pharm Inds Ltd, Hetero Labs Ltd Iii, Sanofi, 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-one patent family members in twenty-five countries.

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

Drug Prices for levocetirizine dihydrochloride

See drug prices for levocetirizine dihydrochloride

Drug Sales Revenue Trends for levocetirizine dihydrochloride

See drug sales revenues for levocetirizine dihydrochloride

Recent Clinical Trials for levocetirizine dihydrochloride

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

SponsorPhase
Children's Mercy Hospital Kansas CityPhase 3
Bridgette JonesPhase 3
University Hospital, GrenoblePhase 4

See all levocetirizine dihydrochloride clinical trials

Generic filers with tentative approvals for LEVOCETIRIZINE DIHYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever 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
Hetero Labs Ltd Iii LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 091264-001 Jun 29, 2012 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Macleods Pharms Ltd LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 205564-001 Jan 11, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi XYZAL levocetirizine dihydrochloride SOLUTION;ORAL 022157-001 Jan 28, 2008 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lannett Co Inc LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride SOLUTION;ORAL 204599-001 May 15, 2017 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hetero Labs Ltd Iii LEVOCETIRIZINE HYDROCHLORIDE levocetirizine dihydrochloride SOLUTION;ORAL 210914-001 Apr 1, 2019 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 XYZAL levocetirizine dihydrochloride SOLUTION;ORAL 022157-001 Jan 28, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 ⤷  Free Forever Trial ⤷  Free Forever 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 ⤷  Free Forever 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 ⤷  Free Forever 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Dow
Baxter
Johnson and Johnson
Medtronic

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.