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Last Updated: September 22, 2020

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XYZAL Drug Profile

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When do Xyzal patents expire, and what generic alternatives are available?

Xyzal is a drug marketed by Sanofi Aventis Us and is included in four NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

The generic ingredient in XYZAL is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

Paragraph IV (Patent) Challenges for XYZAL
Tradename Dosage Ingredient NDA Submissiondate
XYZAL SOLUTION;ORAL levocetirizine dihydrochloride 022157 2009-01-14
XYZAL TABLET;ORAL levocetirizine dihydrochloride 022064 2007-12-17

US Patents and Regulatory Information for XYZAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride SOLUTION;ORAL 022157-001 Jan 28, 2008 AA RX Yes No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us XYZAL ALLERGY 24HR levocetirizine dihydrochloride TABLET;ORAL 209089-001 Jan 31, 2017 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us XYZAL ALLERGY 24HR levocetirizine dihydrochloride SOLUTION;ORAL 209090-001 Jan 31, 2017 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 XYZAL

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

Supplementary Protection Certificates for XYZAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0058146 SPC/GB01/052 United Kingdom   Start Trial SPC/GB01/052:, EXPIRES: 20070205
0663828 SPC007/2002 Ireland   Start Trial SPC007/2002: 20040517, EXPIRES: 20160102
0663828 C300085 Netherlands   Start Trial 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
0663828 CR 2002 00006 Denmark   Start Trial PRODUCT NAME: LEVOCETIRIZIN OG FARMACEUTISK ACCEPTABLE SALTE DERAF; NAT. REG. NO/DATE: 32719 20011008; FIRST REG. NO/DATE: EU 49903.00.00, 49904.00.00 20010103
0058146 2001C/045 Belgium   Start Trial PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
0663828 0490019-7 Sweden   Start Trial PRODICT NAME: LEVO-CETIRIZIN OCH SALTER DAERAV; NAT REGISTRATION NO/DATE: 20039 20040423; FIRST REGISTRATION: DE 49903.00.00 20010103
0663828 2002C/005 Belgium   Start Trial PRODUCT NAME: LEVOCETIRIZIN. DIHYDROCHLORID; NAT. REGISTRATION: 194 IS 90 F 3 20011022; FIRST REGISTRATION: DE 49904.00.00 20010103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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