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Last Updated: March 29, 2024

XYZAL Drug Patent Profile


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Which patents cover Xyzal, and when can generic versions of Xyzal launch?

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

The generic ingredient in XYZAL is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Forty-eight 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 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 XYZAL

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

International Patents for XYZAL

See the table below for patents covering XYZAL around the world.

Country Patent Number Title Estimated Expiration
Netherlands 300085 ⤷  Try a Trial
Canada 1199918 ACIDES 2-[4-(DIPHENYLMETHYL)-1-PIPERAZINYL] ACETIQUES ET LEURS AMIDES (2-[4-(DIPHENYLMETHYL)-1-PIPERAZINYL]-ACETIC ACIDS AND THEIR AMIDES) ⤷  Try a Trial
European Patent Office 0663828 L'utilisation de (-) Cetirizine pour le traitement de la rhinite allergique et de l'asthme (Treating allergic rhinitis and asthma using (-) Cetirizine) ⤷  Try a Trial
Hong Kong 86485 2-(4-DIPHENYLMETHYL)-1-PIPERAZINYL)-ACETIC ACIDS AND THEIR AMIDES,PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XYZAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663828 10/2002 Austria ⤷  Try a Trial PRODUCT NAME: LEVOCETIRIZIN; NAT. REGISTRATION NO/DATE: 1-24226 20011005; FIRST REGISTRATION: DE 49903.00.00; 49904.00.00 20010103
0058146 2001C/045 Belgium ⤷  Try a Trial PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
0663828 CR 2002 00006 Denmark ⤷  Try a 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
0663828 C300085 Netherlands ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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