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Generic Sotylize Availability

Last updated on Jan 11, 2023.

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

SOTYLIZE (sotalol hydrochloride - solution;oral)

  • Manufacturer: AZURITY
    Approval date: October 22, 2014
    Strength(s): 5MG/ML (5MG/ML) [RLD]

Has a generic version of Sotylize been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Sotylize. 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: Generic Drug FAQ.

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.

  • Sotalol compositions and uses of the same
    Patent 10,206,895
    Issued: February 19, 2019
    Assignee(s): ARBOR PHARMACEUTICALS, INC.

    The present invention provides oral solutions containing sotalol hydrochloride which advantageously avoid swallowing while providing with improved stability. The present invention also relates to methods of using the oral solutions for treatment of diseases and disorders, such as delay in reoccurrence of atrial fibrillation/atrial flutter and/or ventricular arrhythmias.

    Patent expiration dates:

    • April 1, 2034
      ✓ 
      Patent use: SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
      ✓ 
      Drug product
    • April 1, 2034
      ✓ 
      Patent use: INDICATED FOR THE TREATMENT OF VENTRICULAR ARRHYTHMIAS, SUCH AS SUSTAINED VENTRICULAR TACHYCARDIA, THAT IN THE JUDGEMENT OF THE PHYSICIAN ARE LIFE-THREATENING
      ✓ 
      Drug product
  • Patent 11,013,703

    Patent expiration dates:

    • April 1, 2034
      ✓ 
      Drug product
  • Sotalol compositions and uses of the same
    Patent 9,724,297
    Issued: August 8, 2017
    Assignee(s): ARBOR PHARMACEUTICALS, INC.

    The present invention provides oral solutions containing sotalol hydrochloride which advantageously avoid swallowing while providing with improved stability. The present invention also relates to methods of using the oral solutions for treatment of diseases and disorders, such as delay in reoccurrence of atrial fibrillation/atrial flutter and/or ventricular arrhythmias.

    Patent expiration dates:

    • August 31, 2035
      ✓ 
      Patent use: SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
      ✓ 
      Drug product

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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