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Levocetirizine dihydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for levocetirizine dihydrochloride?

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

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

Summary for Generic Name: levocetirizine dihydrochloride

Tradenames:3
Patents:1
Applicants:17
NDAs:20
Drug Master File Entries: see list13
Suppliers / Packagers: see list30
Bulk Api Vendors: see list25
Clinical Trials: see list41
Patent Applications: see list187
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 2007RXYesYes► Subscribe► Subscribe
Macleods Pharms Ltd
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL205564-001Jan 11, 2016RXNoNo► Subscribe► Subscribe
Nostrum Labs Inc
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL204323-001Dec 20, 2016RXNoNo► Subscribe► Subscribe
Micro Labs Ltd India
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL202046-001Sep 17, 2013RXNoNo► Subscribe► Subscribe
Sanofi-aventis Us
XYZAL ALLERGY 24HR
levocetirizine dihydrochloride
SOLUTION;ORAL209090-001Jan 31, 2017OTCYesNo► 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
Ucb Inc
XYZAL
levocetirizine dihydrochloride
SOLUTION;ORAL022157-001Jan 28, 20085,698,558*PED► Subscribe
Ucb Inc
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 20074,525,358► Subscribe
Ucb Inc
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 20075,698,558*PED► Subscribe
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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 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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