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Generic Lokelma Availability

Last updated on Sep 8, 2021.

Lokelma is a brand name of sodium zirconium cyclosilicate, approved by the FDA in the following formulation(s):

LOKELMA (sodium zirconium cyclosilicate - for suspension;oral)

  • Manufacturer: ASTRAZENECA
    Approval date: May 18, 2018
    Strength(s): 5GM/PACKET [RLD], 10GM/PACKET [RLD]

Has a generic version of Lokelma been approved?

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

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

  • Extended use zirconium silicate compositions and methods of use thereof
    Patent 10,300,087
    Issued: May 28, 2019
    Assignee(s): ZS PHARMA, INC.

    The present invention relates to zirconium silicate compositions having a lead content that is below 0.6 ppm and methods of manufacturing zirconium silicate at reactor volumes exceeding 200-L with a lead content below 1.1 ppm. The lead content of the zirconium silicate of this invention are within the levels that are considered acceptable for extended use given the dose requirements for zirconium silicate.

    Patent expiration dates:

    • October 14, 2035
      ✓ 
      Patent use: TREATMENT OF HYPERKALEMIA IN ADULTS
      ✓ 
      Drug substance
  • Microporous zirconium silicate for the treatment of hyperkalemia
    Patent 10,335,432
    Issued: July 2, 2019
    Assignee(s): ZS PHARMA, INC.

    The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of UZSi-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.

    Patent expiration dates:

    • February 10, 2032
      ✓ 
      Patent use: TREATMENT OF HYPERKALEMIA IN ADULTS
  • Patent 10,398,730

    Patent expiration dates:

    • February 10, 2032
      ✓ 
      Patent use: TREATMENT OF HYPERKALEMIA IN ADULTS
  • Patent 10,413,569

    Patent expiration dates:

    • February 10, 2032
      ✓ 
      Drug substance
  • Patent 10,695,365

    Patent expiration dates:

    • October 22, 2033
      ✓ 
      Drug substance
  • Microporous zirconium silicate for the treatment of hyperkalemia
    Patent 8,802,152
    Issued: August 12, 2014
    Assignee(s): ZS Pharma, Inc.

    The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of UZSi-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.

    Patent expiration dates:

    • April 19, 2032
      ✓ 
      Drug substance
  • Microporous zirconium silicate for the treatment of hyperkalemia
    Patent 8,808,750
    Issued: August 19, 2014
    Assignee(s): ZS Pharma, Inc.

    The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of UZSi-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.

    Patent expiration dates:

    • February 10, 2032
      ✓ 
      Patent use: TREATMENT OF HYPERKALEMIA IN ADULTS
  • Microporous zirconium silicate for the treatment of hyperkalemia
    Patent 8,877,255
    Issued: November 4, 2014
    Assignee(s): ZS Pharma, Inc.

    The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of ZS-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.

    Patent expiration dates:

    • October 22, 2033
      ✓ 
      Drug substance
  • Extended use zirconium silicate compositions and methods of use thereof
    Patent 9,592,253
    Issued: March 14, 2017
    Assignee(s): ZS PHARMA, INC.

    The present invention relates to zirconium silicate compositions having a lead content that is below 0.6 ppm and methods of manufacturing zirconium silicate at reactor volumes exceeding 200-L with a lead content below 1.1 ppm. The lead content of the zirconium silicate of this invention are within the levels that are considered acceptable for extended use given the dose requirements for zirconium silicate.

    Patent expiration dates:

    • October 14, 2035
      ✓ 
      Patent use: TREATMENT OF HYPERKALEMIA IN ADULTS
      ✓ 
      Drug substance
  • Microporous zirconium silicate for the treatment of hyperkalemia
    Patent 9,844,567
    Issued: December 19, 2017
    Assignee(s): ZS PHARMA, INC.

    The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of UZSi-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.

    Patent expiration dates:

    • February 10, 2032
      ✓ 
      Patent use: TREATMENT OF HYPERKALEMIA IN ADULTS
  • Microporous zirconium silicate for the treatment of hyperkalemia
    Patent 9,861,658
    Issued: January 9, 2018
    Assignee(s): ZS PHARMA, INC.

    The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of UZSi-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.

    Patent expiration dates:

    • February 10, 2032
      ✓ 
      Patent use: TREATMENT OF HYPERKALEMIA IN ADULTS
  • Microporous zirconium silicate for the treatment of hyperkalemia
    Patent 9,913,860
    Issued: March 13, 2018
    Assignee(s): ZS PHARMA, INC.

    The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of ZS-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.

    Patent expiration dates:

    • October 22, 2033
      ✓ 
      Patent use: TREATMENT OF HYPERKALEMIA IN ADULTS
      ✓ 
      Drug substance

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:

    • April 24, 2023 - ADDITIONAL INFORMATION ADDED TO THE LABELING REGARDING THE USE IN PATIENTS ON CHRONIC HEMODIALYSIS
    • May 18, 2023 - NEW CHEMICAL ENTITY

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.