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.
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 |
Anatomical Therapeutic Chemical (ATC) Classes for XYZAL
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 | TABLET;ORAL | 022064-001 | May 25, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
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 |
>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 |
---|---|---|---|
Australia | 5934398 | ⤷ Try a Trial | |
Canada | 2145410 | ⤷ 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 |
Spain | 2122042 | ⤷ Try a Trial | |
Georgia, Republic of | P20001996 | Novel 2-(4-diphenylmethyl)-1-Piperazinyl)-Acetic Acids and their Amides, Process for Their Preparation and Pharmaceutical Compositions | ⤷ Try a Trial |
Germany | 10199021 | ⤷ Try a Trial | |
Denmark | 44082 | ⤷ 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 | CA 2002 00006 | Denmark | ⤷ Try a Trial | |
0663828 | SPC007/2002 | Ireland | ⤷ Try a Trial | SPC007/2002: 20040517, EXPIRES: 20160102 |
0058146 | SPC/GB01/052 | United Kingdom | ⤷ Try a Trial | SPC/GB01/052:, EXPIRES: 20070205 |
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 | 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 |
0663828 | 2002C/005 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LEVOCETIRIZIN. DIHYDROCHLORID; NAT. REGISTRATION: 194 IS 90 F 3 20011022; FIRST REGISTRATION: DE 49904.00.00 20010103 |
0663828 | C00663828/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LEVOCETIRIZIN; REGISTRATION NO/DATE: OICM 55754 20010926 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |