XYZAL Drug Patent Profile
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When do Xyzal patents expire, and what generic alternatives are available?
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. Fifty suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Xyzal
A generic version of XYZAL was approved as levocetirizine dihydrochloride by SYNTHON PHARMS on November 26th, 2010.
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Questions you can ask:
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Summary for XYZAL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 66 |
Patent Applications: | 150 |
Drug Prices: | Drug price information for XYZAL |
Drug Sales Revenues: | Drug sales revenues for XYZAL |
What excipients (inactive ingredients) are in XYZAL? | XYZAL excipients list |
DailyMed Link: | XYZAL at DailyMed |
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 | ⤷ 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 | ||||
Chattem Sanofi | XYZAL ALLERGY 24HR | levocetirizine dihydrochloride | SOLUTION;ORAL | 209090-001 | Jan 31, 2017 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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 | ⤷ 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 XYZAL
See the table below for patents covering XYZAL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Yugoslavia | 43511 | ⤷ Sign Up | |
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) | ⤷ Sign Up |
Poland | 239687 | ⤷ Sign Up | |
Yugoslavia | 42911 | ⤷ Sign Up | |
Finland | 820318 | ⤷ Sign Up | |
Germany | 10199021 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XYZAL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0663828 | C00663828/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: LEVOCETIRIZIN; REGISTRATION NO/DATE: OICM 55754 20010926 |
0663828 | 10/2002 | Austria | ⤷ Sign Up | PRODUCT NAME: LEVOCETIRIZIN; NAT. REGISTRATION NO/DATE: 1-24226 20011005; FIRST REGISTRATION: DE 49903.00.00; 49904.00.00 20010103 |
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 | SPC/GB01/052 | United Kingdom | ⤷ Sign Up | SPC/GB01/052:, EXPIRES: 20070205 |
0663828 | 0490019-7 | Sweden | ⤷ Sign Up | PRODICT NAME: LEVO-CETIRIZIN OCH SALTER DAERAV; NAT REGISTRATION NO/DATE: 20039 20040423; FIRST REGISTRATION: DE 49903.00.00 20010103 |
0663828 | CA 2002 00006 | Denmark | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |