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 is approved as 4 brand and 24 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:XYZAL ALLERGY 24HR · NDA 209090

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution, tablet

Product	Applicant	Application	TE	Approved
XYZAL ALLERGY 24HRRLD	CHATTEM SANOFI	NDA 209090	—	Jan 31, 2017
XYZAL ALLERGY 24HRRLD	CHATTEM SANOFI	NDA 209089	—	Jan 31, 2017
XYZALRLD	CHATTEM SANOFI	NDA 022157	—	Jan 28, 2008
XYZALRLD	CHATTEM SANOFI	NDA 022064	—	May 25, 2007

Generic (ANDA) products (24)

Product	Applicant	Application	TE	Approved
LEVOCETIRIZINE DIHYDROCHLORIDE	IPCA LABS LTD	ANDA 204626	—	May 06, 2024
LEVOCETIRIZINE DIHYDROCHLORIDE	APOTEX	ANDA 211443	—	Apr 21, 2021
LEVOCETIRIZINE DIHYDROCHLORIDE	HETERO LABS LTD III	ANDA 213513	—	Apr 29, 2020
LEVOCETIRIZINE HYDROCHLORIDE	HETERO LABS LTD III	ANDA 210914	AA	Apr 01, 2019
LEVOCETIRIZINE DIHYDROCHLORIDE	PERRIGO R AND D	ANDA 211983	—	Mar 28, 2019
LEVOCETIRIZINE DIHYDROCHLORIDE	SANKALP LIFECARE	ANDA 211551	—	Nov 20, 2018
LEVOCETIRIZINE DIHYDROCHLORIDE	DR REDDYS	ANDA 210375	—	Jan 19, 2018
LEVOCETIRIZINE DIHYDROCHLORIDE	CHARTWELL MOLECULAR	ANDA 204599	AA	May 15, 2017
LEVOCETIRIZINE DIHYDROCHLORIDE	US ANTIBIOTICS	ANDA 204323	—	Dec 20, 2016
LEVOCETIRIZINE DIHYDROCHLORIDE	MACLEODS PHARMS LTD	ANDA 205564	AB	Jan 11, 2016
LEVOCETIRIZINE DIHYDROCHLORIDE	SUN PHARM INDS LTD	ANDA 201653	—	Jun 26, 2015
LEVOCETIRIZINE DIHYDROCHLORIDE	APOTEX	ANDA 203027	—	Feb 13, 2015
LEVOCETIRIZINE DIHYDROCHLORIDE	SCIEGEN PHARMS	ANDA 203646	AB	Sep 09, 2014
LEVOCETIRIZINE DIHYDROCHLORIDE	APOTEX	ANDA 202915	—	Aug 21, 2014
LEVOCETIRIZINE DIHYDROCHLORIDE	MICRO LABS LTD INDIA	ANDA 202046	AB	Sep 17, 2013
LEVOCETIRIZINE DIHYDROCHLORIDE	TARO	ANDA 202673	—	Jul 26, 2013
LEVOCETIRIZINE DIHYDROCHLORIDE	GRANULES	ANDA 090486	—	Mar 26, 2013
LEVOCETIRIZINE DIHYDROCHLORIDE	SUN PHARM	ANDA 090362	AB	Jan 31, 2013
LEVOCETIRIZINE DIHYDROCHLORIDE	HETERO LABS LTD III	ANDA 091264	AB	Jun 29, 2012
LEVOCETIRIZINE DIHYDROCHLORIDE	PADAGIS US	ANDA 091263	AA	Nov 07, 2011
LEVOCETIRIZINE DIHYDROCHLORIDE	TEVA PHARMS	ANDA 090199	AB	Aug 22, 2011
LEVOCETIRIZINE DIHYDROCHLORIDE	DR REDDYS LABS LTD	ANDA 090392	AB	Feb 24, 2011
LEVOCETIRIZINE DIHYDROCHLORIDE	GLENMARK PHARMS LTD	ANDA 090385	AB	Feb 24, 2011
LEVOCETIRIZINE DIHYDROCHLORIDE	SYNTHON BV	ANDA 090229	AB	Nov 26, 2010

Listed patents (1)

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 4 mo	Product

Levocetirizine dihydrochloride — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo