Xyzal

Xyzal is a brand name of levocetirizine, approved by the FDA in the following formulation(s):

XYZAL (levocetirizine dihydrochloride - solution; oral)

• 
  Manufacturer: UCB INC
  
  Approval date: January 28, 2008
  
  Strength(s): 2.5MG/5ML ^[RLD][AA]

XYZAL (levocetirizine dihydrochloride - tablet; oral)

• 
  Manufacturer: UCB INC
  
  Approval date: May 25, 2007
  
  Strength(s): 5MG ^[RLD][AB]

Has a generic version of Xyzal been approved?

A generic version of Xyzal has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Xyzal and have been approved by the FDA:

levocetirizine dihydrochloride solution; oral

• 
  Manufacturer: SYNTHON PHARMS
  
  Approval date: November 7, 2011
  
  Strength(s): 2.5MG/5ML ^[AA]

levocetirizine dihydrochloride tablet; oral

• 
  Manufacturer: DR REDDYS LABS LTD
  
  Approval date: February 24, 2011
  
  Strength(s): 5MG ^[AB]


• 
  Manufacturer: GLENMARK GENERICS
  
  Approval date: February 24, 2011
  
  Strength(s): 5MG ^[AB]


• 
  Manufacturer: SYNTHON PHARMS
  
  Approval date: November 26, 2010
  
  Strength(s): 5MG ^[AB]


• 
  Manufacturer: TEVA PHARMS
  
  Approval date: August 22, 2011
  
  Strength(s): 5MG ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xyzal. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Methods for treating allergic disorders using optically pure (-) cetirizine
  Patent 5,698,558
  Issued: December 16, 1997
  Inventor(s): Gray; Nancy M.
  Assignee(s): Sepracor, Inc.
  Methods are disclosed utilizing optically pure (-) cetirizine for the treatment of seasonal and perennial allergic rhinitis in humans while avoiding the concomitant liability of adverse effects associated with the racemic mixture of cetirizine. The optically pure (-) isomer is also useful for the treatment of allergic asthma.
  
  Patent expiration dates:
  
  
  • September 24, 2012
    
    ✓ 
    Patent use: RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
  
  
  
  • September 24, 2012
    
    ✓ 
    Patent use: RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
  
  
  
  • March 24, 2013
    
    ✓ 
    Pediatric exclusivity
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • November 25, 2010 - PEDIATRIC EXCLUSIVITY
  
  
  • August 21, 2012 - NEW PATIENT POPULATION
  
  
  • February 21, 2013 - PEDIATRIC EXCLUSIVITY
  
  

See also...

• Xyzal Consumer Information (Drugs.com)
• Xyzal Consumer Information (Wolters Kluwer)
• Xyzal Solution Consumer Information (Wolters Kluwer)
• Xyzal Consumer Information (Cerner Multum)
• Xyzal Advanced Consumer Information (Micromedex)
• Xyzal AHFS DI Monographs (ASHP)
• Levocetirizine Consumer Information (Wolters Kluwer)
• Levocetirizine Solution Consumer Information (Wolters Kluwer)
• Levocetirizine Consumer Information (Cerner Multum)
• Levocetirizine Advanced Consumer Information (Micromedex)
• Levocetirizine Dihydrochloride AHFS DI Monographs (ASHP)