Is there a generic for Levocetirizine dihydrochloride?

Yes. The FDA Orange Book lists 24 approved generic (ANDA) applications for Levocetirizine dihydrochloride, referencing the brand XYZAL ALLERGY 24HR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Levocetirizine dihydrochloride?

XYZAL ALLERGY 24HR (NDA 209090, CHATTEM SANOFI) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Levocetirizine dihydrochloride?

The Orange Book lists 1 patent against Levocetirizine dihydrochloride products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Levocetirizine dihydrochloride are approved?

Levocetirizine dihydrochloride is approved in the following dosage forms: solution, tablet.

FDA Orange Book · active-ingredient family

Levocetirizine dihydrochloride

Levocetirizine dihydrochloride: 4 brands, 24 generics; first approved May 25, 2007; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 24 ANDA applications approved.

Earliest patent expiry Oct 16, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 16, 2027

in 1 yr

Brand (NDA) products

Originator applications

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XYZAL ALLERGY 24HRRLDRS
CHATTEM SANOFINDA 2090902017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/5ML SOLUTION ORAL OTC -
XYZAL ALLERGY 24HRRLDRS
CHATTEM SANOFINDA 2090892017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL OTC -
XYZALRLD
CHATTEM SANOFINDA 0221572008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/5ML SOLUTION ORAL Discontinued -
XYZALRLD
CHATTEM SANOFINDA 0220642007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/5ML	SOLUTION	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/5ML	SOLUTION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

Generic (ANDA) products (24)

Abbreviated applications

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LEVOCETIRIZINE DIHYDROCHLORIDE
IPCA LABS LTDANDA 2046262024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
LEVOCETIRIZINE DIHYDROCHLORIDE
APOTEXANDA 2114432021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
LEVOCETIRIZINE DIHYDROCHLORIDE
HETERO LABS LTD IIIANDA 2135132020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL OTC -
LEVOCETIRIZINE HYDROCHLORIDE
HETERO LABS LTD IIIANDA 2109142019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/5ML SOLUTION ORAL Rx AA
LEVOCETIRIZINE DIHYDROCHLORIDE
PERRIGO R AND DANDA 2119832019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL OTC -
LEVOCETIRIZINE DIHYDROCHLORIDE
SANKALP LIFECAREANDA 2115512018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL OTC -
LEVOCETIRIZINE DIHYDROCHLORIDE
DR REDDYSANDA 2103752018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL OTC -
LEVOCETIRIZINE DIHYDROCHLORIDE
CHARTWELL MOLECULARANDA 2045992017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/5ML SOLUTION ORAL Rx AA
LEVOCETIRIZINE DIHYDROCHLORIDE
US ANTIBIOTICSANDA 2043232016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
LEVOCETIRIZINE DIHYDROCHLORIDE
MACLEODS PHARMSANDA 2055642016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
LEVOCETIRIZINE DIHYDROCHLORIDE
SUN PHARM INDS LTDANDA 2016532015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
LEVOCETIRIZINE DIHYDROCHLORIDE
APOTEXANDA 2030272015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
LEVOCETIRIZINE DIHYDROCHLORIDE
SCIEGEN PHARMSANDA 2036462014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
LEVOCETIRIZINE DIHYDROCHLORIDE
APOTEXANDA 2029152014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/5ML SOLUTION ORAL Discontinued -
LEVOCETIRIZINE DIHYDROCHLORIDE
MICRO LABS LTD INDIAANDA 2020462013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
LEVOCETIRIZINE DIHYDROCHLORIDE
TAROANDA 2026732013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/5ML SOLUTION ORAL Discontinued -
LEVOCETIRIZINE DIHYDROCHLORIDE
GRANULESANDA 0904862013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
LEVOCETIRIZINE DIHYDROCHLORIDE
SUN PHARMANDA 0903622013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
LEVOCETIRIZINE DIHYDROCHLORIDE
HETERO LABS LTD IIIANDA 0912642012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
LEVOCETIRIZINE DIHYDROCHLORIDERS
PADAGIS USANDA 0912632011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/5ML SOLUTION ORAL Rx AA
LEVOCETIRIZINE DIHYDROCHLORIDE
TEVA PHARMSANDA 0901992011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
LEVOCETIRIZINE DIHYDROCHLORIDE
DR REDDYS LABS LTDANDA 0903922011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
LEVOCETIRIZINE DIHYDROCHLORIDERS
GLENMARK PHARMS LTDANDA 0903852011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
LEVOCETIRIZINE DIHYDROCHLORIDE
SYNTHON BVANDA 0902292010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/5ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/5ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/5ML	SOLUTION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/5ML	SOLUTION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/5ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8633194	Oct 16, 2027	in 1 yr	Product

Approval history

FDA approval span

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First approval

May 25, 2007

19 yr 8 mo ago

Most recent approval

May 06, 2024

2 yr 6 mo ago

Approvals span 2007–2024 across 28 FDA applications.

Brand (NDA) 414%

Generic (ANDA) 2486%

Levocetirizine dihydrochloride: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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