Generic Xyzal Availability

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: L PERRIGO CO
    Approval date: November 7, 2011
    Strength(s): 2.5MG/5ML [AA]
  • Manufacturer: TARO PHARM INDS
    Approval date: July 26, 2013
    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: HETERO LABS LTD III
    Approval date: June 29, 2012
    Strength(s): 5MG [AB]
  • Manufacturer: MICRO LABS LTD INDIA
    Approval date: September 17, 2013
    Strength(s): 5MG [AB]
  • Manufacturer: SANDOZ
    Approval date: March 26, 2013
    Strength(s): 5MG [AB]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: January 31, 2013
    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:
    • July 26, 2013
      ✓ 
      Patent use: RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
    • July 26, 2013
      ✓ 
      Patent use: RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
    • January 26, 2014
      ✓ 
      Pediatric exclusivity

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Watch this video series to learn about managing severe allergies (anaphylaxis).

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