Skip to main content

Generic Lupkynis Availability

Last updated on Jun 8, 2022.

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

LUPKYNIS (voclosporin - capsule;oral)

  • Manufacturer: AURINIA
    Approval date: January 22, 2021
    Strength(s): 7.9MG [RLD]

Has a generic version of Lupkynis been approved?

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

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

  • Protocol for treatment of lupus nephritis
    Patent 10,286,036
    Issued: May 14, 2019
    Assignee(s): AURINIA PHARMACEUTICALS INC.

    By employing a pharmacodynamic dosing regimen, the effectiveness of a protocol for treatment of lupus nephritis with voclosporin can be maximized while minimizing undesirable side effects.

    Patent expiration dates:

    • December 7, 2037
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS
  • Cyclosporine analogue mixtures and their use as immunomodulating agents
    Patent 7,332,472
    Issued: February 19, 2008
    Inventor(s): Naicker; Selvaraj & Yatscoff; Randall W. & Foster; Robert T.
    Assignee(s): Isotechnika Inc.

    The invention is directed to isomeric mixtures of cyclosporine analogues that are structurally similar to cyclosporine A. The mixtures possess enhanced efficacy and reduced toxicity over the individual isomers and over naturally occurring and other presently known cyclosporines and cyclosporine derivatives. Embodiments of the present invention are directed toward cis and trans-isomers of cyclosporin A analogs referred to as ISATX247, and derivatives thereof. Mixtures of ISATX247 isomers exhibit a combination of enhanced potency and reduced toxicity over the naturally occurring and presently known cyclosporins. ISATX247 isomers and alkylated, arylated, and deuterated derivatives are synthesized by stereoselective pathways where the particular conditions of a reaction determine the degree of stereoselectivity. The ratio of isomers in a mixture may range from about 10 to 90 percent by weight of the (E)-isomer to about 90 to 10 percent by weight of the (Z)-isomer, based on the total weight of the mixture.

    Patent expiration dates:

    • October 17, 2022
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS
      ✓ 
      Drug substance
      ✓ 
      Drug product

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:

    • January 22, 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.