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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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 |
|---|---|---|---|
| Denmark | 5388 | ⤷ Sign Up | |
| Netherlands | 300074 | ⤷ Sign Up | |
| Georgia, Republic of | P20001996 | Novel 2-(4-diphenylmethyl)-1-Piperazinyl)-Acetic Acids and their Amides, Process for Their Preparation and Pharmaceutical Compositions | ⤷ Sign Up |
| Australia | 8023182 | ⤷ Sign Up | |
| Norway | 820297 | ⤷ 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 | 2002C/005 | Belgium | ⤷ Sign Up | PRODUCT NAME: LEVOCETIRIZIN. DIHYDROCHLORID; NAT. REGISTRATION: 194 IS 90 F 3 20011022; FIRST REGISTRATION: DE 49904.00.00 20010103 |
| 0058146 | 2001C/045 | Belgium | ⤷ Sign Up | PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103 |
| 0663828 | SPC007/2002 | Ireland | ⤷ Sign Up | SPC007/2002: 20040517, EXPIRES: 20160102 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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