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Generic Cytalux Availability

Last updated on Sep 6, 2023.

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

CYTALUX (pafolacianine sodium - solution;intravenous)

  • Manufacturer: ON TARGET LABS
    Approval date: November 29, 2021
    Strength(s): EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) [RLD]

Has a generic version of Cytalux been approved?

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

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

  • Patent 10,881,747

    Patent expiration dates:

    • August 26, 2033
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      Patent use: CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS
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      Drug substance
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      Drug product
  • Patent 9,061,057

    Patent expiration dates:

    • August 26, 2033
      ✓ 
      Patent use: CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS
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      Drug substance
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      Drug product
  • Patent 9,254,341

    Patent expiration dates:

    • October 4, 2033
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      Drug substance
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      Drug product
  • Patent 9,333,270

    Patent expiration dates:

    • August 26, 2033
      ✓ 
      Patent use: CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS
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      Drug substance
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      Drug product
  • Patent 9,341,629

    Patent expiration dates:

    • August 26, 2033
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      Drug substance
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      Drug product
  • Patent 9,789,208

    Patent expiration dates:

    • August 26, 2033
      ✓ 
      Patent use: CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS
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      Drug substance
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      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:

    • December 16, 2025 - ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT AND NONMALIGNANTPULMONARY LESIONS IN ADULT PATIENTS WITH KNOWN OR SUSPECTED CANCER IN THE LUNG
    • November 29, 2026 - NEW CHEMICAL ENTITY
    • November 29, 2028 - AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS IN ADULT PATIENTS WITH OVARIAN CANCER

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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