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
Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University	Phase 2
Osama Mohamed Hassan Ibrahim , Prof Clinical pharmacy Department- Tanta University	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
Dr Reddys Labs Ltd	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	090392-001	Feb 24, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chattem Sanofi	XYZAL ALLERGY 24HR	levocetirizine dihydrochloride	TABLET;ORAL	209089-001	Jan 31, 2017		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064-001	May 25, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
Micro Labs	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	211551-001	Nov 20, 2018		OTC	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
Cyprus	1109670		⤷ Sign Up
Poland	1768649		⤷ Sign Up
Peru	20060484	PREPARACIONES FARMACEUTICAS LIQUIDAS QUE COMPRENDEN UN COMPUESTO DE BENZHIDRIL PIPERIZINA	⤷ Sign Up
New Zealand	552182	Pharmaceutical composition of piperazine derivatives	⤷ Sign Up
Spain	2332462		⤷ 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
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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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