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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Argus Health
Fish and Richardson
Cipla
Accenture
Medtronic
Mallinckrodt
US Army
AstraZeneca
Teva

Generated: September 20, 2017

DrugPatentWatch Database Preview

Levocetirizine dihydrochloride - Generic Drug Details

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

Levocetirizine dihydrochloride
is the generic ingredient in three branded drugs marketed by Apotex Inc, Allied Pharma Inc, Synthon Pharms, Micro Labs Ltd India, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sanofi-aventis Us, Sun Pharma Global, L Perrigo Co, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Taro Pharm Inds, Glenmark Generics, Sandoz, Dr Reddys Labs Ltd, Silarx Pharms Inc, and Teva Pharms, and is included in twenty-one 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 twenty-nine patent family members in twenty-four countries.

There are thirteen drug master file entries for levocetirizine dihydrochloride. Thirty-two suppliers are listed for this compound.

Summary for Generic Name: levocetirizine dihydrochloride

Tradenames:3
Patents:1
Applicants:17
NDAs:21
Drug Master File Entries: see list13
Suppliers / Packagers: see list32
Bulk Api Vendors: see list25
Clinical Trials: see list114
Patent Applications: see list195
Therapeutic Class:Respiratory Tract Agents
Drug Prices:see low prices
DailyMed Link:levocetirizine dihydrochloride at DailyMed

Pharmacology for Ingredient: levocetirizine dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL090486-001Mar 26, 2013DISCNNoNo► Subscribe► Subscribe► Subscribe
Macleods Pharms Ltd
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL205564-001Jan 11, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharma Global
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL090362-001Jan 31, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Hetero Labs Ltd Iii
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL091264-001Jun 29, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Taro Pharm Inds
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
SOLUTION;ORAL202673-001Jul 26, 2013AARXNoNo► Subscribe► Subscribe► Subscribe
Sanofi-aventis Us
XYZAL ALLERGY 24HR
levocetirizine dihydrochloride
SOLUTION;ORAL209090-001Jan 31, 2017OTCYesNo► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
XYZAL ALLERGY 24HR
levocetirizine dihydrochloride
TABLET;ORAL209089-001Jan 31, 2017OTCYesNo► Subscribe► Subscribe► Subscribe
Micro Labs Ltd India
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL202046-001Sep 17, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Allied Pharma Inc
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL204323-001Dec 20, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Glenmark Generics
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL090385-001Feb 24, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: levocetirizine dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi-aventis Us
XYZAL
levocetirizine dihydrochloride
SOLUTION;ORAL022157-001Jan 28, 2008► Subscribe► Subscribe
Sanofi-aventis Us
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 2007► Subscribe► Subscribe
Sanofi-aventis Us
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 2007► Subscribe► Subscribe
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International Patent Family for Ingredient: levocetirizine dihydrochloride

Country Document Number Estimated Expiration
Hong Kong1103958► Subscribe
Eurasian Patent Organization200700067► Subscribe
Cyprus1109670► Subscribe
South Africa200700939► Subscribe
Eurasian Patent Organization012463► Subscribe
Malaysia149403► Subscribe
Japan2008505949► Subscribe
Israel180010► Subscribe
Norway20070832► Subscribe
BrazilPI0513257► Subscribe
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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.

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Supplementary Protection Certificates for Tradename: LEVOCETIRIZINE DIHYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
01C/045Belgium► SubscribePRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKinsey
Dow
Chinese Patent Office
Citi
Johnson and Johnson
McKesson
Fuji
Covington
Moodys
Express Scripts

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.

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