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 Pharms Ltd, Granules, Ipca Labs Ltd, 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-eight 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. Fifty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LEVOCETIRIZINE DIHYDROCHLORIDE

International Patents:	30
US Patents:	1
Tradenames:	4
Applicants:	21
NDAs:	28
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	67
Patent Applications:	272
Drug Prices:	Drug price trends for LEVOCETIRIZINE DIHYDROCHLORIDE
Drug Sales Revenues:	Drug sales revenues for LEVOCETIRIZINE DIHYDROCHLORIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVOCETIRIZINE DIHYDROCHLORIDE
What excipients (inactive ingredients) are in LEVOCETIRIZINE DIHYDROCHLORIDE?	LEVOCETIRIZINE DIHYDROCHLORIDE excipients list
DailyMed Link:	LEVOCETIRIZINE DIHYDROCHLORIDE at DailyMed

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
Osama Mohamed Hassan Ibrahim , Prof Clinical pharmacy Department- Tanta University	Phase 2
Mostafa Bahaa	Phase 2

See all LEVOCETIRIZINE DIHYDROCHLORIDE clinical trials

Generic filers with tentative approvals for LEVOCETIRIZINE DIHYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	2.5MG/5ML	SOLUTION;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

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes 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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Synthon Pharms	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	090229-001	Nov 26, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Granules	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	090486-001	Mar 26, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	091264-001	Jun 29, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chattem Sanofi	XYZAL ALLERGY 24HR	levocetirizine dihydrochloride	SOLUTION;ORAL	209090-001	Jan 31, 2017		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Macleods Pharms Ltd	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	205564-001	Jan 11, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	202915-001	Aug 21, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

International Patents for LEVOCETIRIZINE DIHYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Malaysia	149403	PHARMACEUTICAL COMPOSITION OF PIPERAZINE DERIVATIVES	⤷ Sign Up
Eurasian Patent Organization	012463	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНЫЕ ПИПЕРАЗИНА (PHARMACEUTICAL COMPOSITION CONTAINING PIPERAZINE DERIVATIVES)	⤷ Sign Up
Eurasian Patent Organization	200700067	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНЫЕ ПИПЕРАЗИНА	⤷ Sign Up
South Africa	200700939	Pharmaceutical composition of piperazine derivatives	⤷ Sign Up
Spain	2332462		⤷ Sign Up
Argentina	049846	PREPARACIONES FARMACEUTICAS DE DERIVADOS DE LA PIPERAZINA	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LEVOCETIRIZINE DIHYDROCHLORIDE

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