Generic Tikosyn Availability

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

TIKOSYN (dofetilide - capsule;oral)

  • Manufacturer: PFIZER
    Approval date: October 1, 1999
    Strength(s): 0.125MG, 0.25MG, 0.5MG [RLD]

Has a generic version of Tikosyn been approved?

No. There is currently no therapeutically equivalent version of Tikosyn available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tikosyn. 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.

  • Dofetilide polymorphs
    Patent 6,124,363
    Issued: September 26, 2000
    Inventor(s): Appleby; Ian Colin & Newbury; Trevor Jack & Nichols; Gary
    Assignee(s): Pfizer Inc.
    The invention relates to the substantially pure dofetilide polymorphs P162, P162a and P143, and to processes for the preparation of, compositions containing and to the uses of, such polymorphs.
    Patent expiration dates:
    • October 9, 2018

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.

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