Generic Xyzal Availability
Xyzal is a brand name of levocetirizine, approved by the FDA in the following formulation(s):
XYZAL (levocetirizine dihydrochloride - solution; oral)
XYZAL (levocetirizine dihydrochloride - tablet; oral)
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
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Manufacturer: SYNTHON PHARMS
Approval date: November 7, 2011
Strength(s): 2.5MG/5ML [AA]
levocetirizine dihydrochloride tablet; oral
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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: 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.
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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✓
- July 26, 2013✓
- January 26, 2014✓
- July 26, 2013
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:
- 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)
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A 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 Exclusivity | Exclusivity 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. |
| RLD | A 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. |
| AA | Products 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. |
| AB | Products 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. |
