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Generic Korsuva Availability

Last updated on Nov 8, 2022.

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

KORSUVA (difelikefalin acetate - solution;intravenous)

  • Manufacturer: CARA THERAP
    Approval date: August 23, 2021
    Strength(s): EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) [RLD]

Has a generic version of Korsuva been approved?

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

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

  • Synthetic peptide amides and dimers thereof
    Patent 10,017,536
    Issued: July 10, 2018
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic peptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure: The compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
      ✓ 
      Drug substance
  • Synthetic peptide amides
    Patent 10,138,270
    Issued: November 27, 2018
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic peptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure of formula I: Pharmaceutical compositions containing these compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions. Such treatable pain includes visceral pain, neuropathic pain and hyperalgesia. Inflammation associated with conditions such as IBD and IBS, ocular and otic inflammation, other disorders and conditions such as pruritis, edema, hyponatremia, hypokalemia, ileus, tussis and glaucoma are treatable or preventable with the pharmaceutical compositions of the invention.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
  • Patent 10,793,596

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Synthetic peptide amides
    Patent 7,402,564
    Issued: July 22, 2008
    Inventor(s): Schteingart; Claudio D. & Menzaghi; Frédérique & Jiang; Guangcheng & Alexander; Roberta Vezza & Sueiras-Diaz; Javier & Spencer; Robert H. & Chalmers; Derek T. & Luo; Zhiyong
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic peptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure of formula I: Pharmaceutical compositions containing these compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions. Such treatable pain includes visceral pain, neuropathic pain and hyperalgesia. Inflammation associated with conditions such as IBD and IBS, ocular and otic inflammation, other disorders and conditions such as pruritis, edema, hyponatremia, hypokalemia, ileus, tussis and glaucoma are treatable or preventable with the pharmaceutical compositions of the invention.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Synthetic peptide amides and dimeric forms thereof
    Patent 7,713,937
    Issued: May 11, 2010
    Inventor(s): Schteingart; Claudio D. & Menzaghi; Frédérique & Jiang; Guangcheng & Alexander; Roberta Vezza & Sueiras-Diaz; Javier & Spencer; Robert H. & Chalmers; Derek T. & Luo; Zhiyong
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic peptide amides that are ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure: wherein Xaa is a D-amino acid and G is selected from the following three groups: The compounds are useful in the prophylaxis and treatment of pain, pruritis and inflammation associated with a variety of diseases and conditions.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Synthetic peptide amides
    Patent 7,727,963
    Issued: June 1, 2010
    Inventor(s): Schteingart; Claudio D. & Jiang; Guangcheng & Alexander; Roberta Vezza & Sueiras-Diaz; Javier & Luo; Zhiyong
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic tetrapeptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. An exemplary synthetic tetrapeptide amide of the invention is D-Phe-D-Phe-D-Leu-(ε-Me) D-Lys-[4-Amidinohomopiperazine amide]: Pharmaceutical compositions containing these compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions. Such treatable pain includes visceral pain, neuropathic pain and hyperalgesia. Inflammation associated with conditions such as IBD and IBS, ocular and otic inflammation, other disorders and conditions such as pruritis, edema, hyponatremia, hypokalemia, ileus, tussis and glaucoma are treatable or preventable with the pharmaceutical compositions of the invention.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Synthetic peptide amides
    Patent 8,217,007
    Issued: July 10, 2012
    Inventor(s): Schteingart; Claudio D. & Menzaghi; Frédérique & Jiang; Guangcheng & Alexander; Roberta Vezza & Sueiras-Diaz; Javier & Spencer; Robert H. & Chalmers; Derek T. & Luo; Robert Zhiyong
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic peptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure of formula I: Pharmaceutical compositions containing these compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions. Such treatable pain includes visceral pain, neuropathic pain and hyperalgesia. Inflammation associated with conditions such as IBD and IBS, ocular and otic inflammation, other disorders and conditions such as pruritis, edema, hyponatremia, hypokalemia, ileus, tussis and glaucoma are treatable or preventable with the pharmaceutical compositions of the invention.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
  • Uses of synthetic peptide amides
    Patent 8,236,766
    Issued: August 7, 2012
    Inventor(s): Schteingart; Claudio D. & Menzaghi; Frederique & Jiang; Guangcheng & Alexander; Roberta Vezza & Sueiras-Diaz; Javier & Spencer; Robert H. & Chalmers; Derek T. & Luo; Zhiyong
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic peptide amides that are ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure: wherein Xaa is a D-amino acid and G is selected from the following three groups: The compounds are useful in the prophylaxis and treatment of pain, pruritus and inflammation associated with a variety of diseases and conditions.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
  • Synthetic peptide amides and dimeric forms thereof
    Patent 8,486,894
    Issued: July 16, 2013
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic peptide amides that are ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure: wherein Xaa is a D-amino acid and G is selected from the following three groups: The compounds are useful in the prophylaxis and treatment of pain, pruritis and inflammation associated with a variety of diseases and conditions.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
  • Synthetic peptide amides and dimers thereof
    Patent 8,536,131
    Issued: September 17, 2013
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic peptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure: The compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Synthetic peptide amides and dimers thereof
    Patent 9,334,305
    Issued: May 10, 2016
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic peptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure: The compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)
  • Synthetic peptide amides
    Patent 9,359,399
    Issued: June 7, 2016
    Assignee(s): Cara Therapeutics, Inc.

    The invention relates to synthetic peptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure of formula I: Pharmaceutical compositions containing these compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions. Such treatable pain includes visceral pain, neuropathic pain and hyperalgesia. Inflammation associated with conditions such as IBD and IBS, ocular and otic inflammation, other disorders and conditions such as pruritis, edema, hyponatremia, hypokalemia, ileus, tussis and glaucoma are treatable or preventable with the pharmaceutical compositions of the invention.

    Patent expiration dates:

    • November 12, 2027
      ✓ 
      Patent use: TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)

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 23, 2026 - 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.