Generic Cytalux Availability
Last updated on Apr 10, 2025.
Cytalux is a brand name of pafolacianine, approved by the FDA in the following formulation(s):
CYTALUX (pafolacianine sodium - solution;intravenous)
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Manufacturer: ON TARGET LABS
Approval date: November 29, 2021
Strength(s): EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) [RLD]
Is there a generic version of Cytalux available?
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.
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Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent 10,881,747
Issued: January 5, 2021
Inventor(s): Kularatne Sumith A.
Assignee(s): Purdue Research FoundationThe present disclosure relates to compounds that are useful as near-infrared fluorescence probes, wherein the compounds include i) a pteroyl ligand that binds to a target receptor protein, ii) a dye molecule, and iii) a linker molecule that comprises an amino acid or derivative thereof. The disclosure further describes methods and compositions for incorporating the compounds as used for the targeted imaging of tumors. Conjugation of the amino acid linking groups increase specificity and detection of the compound. Methods and compositions for use thereof in diagnostic imaging are contemplated.
Patent expiration dates:
- August 26, 2033✓✓✓
- August 26, 2033
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Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent 9,061,057
Issued: June 23, 2015
Inventor(s): Kularatne Sumith A. & Mahalingam Sakkarapalayam M. & Low Philip S.
Assignee(s): Purdue Research FoundationThe present disclosure relates to compounds that are useful as near-infrared fluorescence probes, wherein the compounds include i) a pteroyl ligand that binds to a target receptor protein, ii) a dye molecule, and iii) a linker molecule that comprises an amino acid or derivative thereof. The disclosure further describes methods and compositions for making and using the compounds, methods incorporating the compounds, and kits incorporating the compounds.
Patent expiration dates:
- August 26, 2033✓✓✓
- August 26, 2033
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Methods of manufacture of pteroyl-amino acid-fluorescent dyes
Patent 9,254,341
Issued: February 9, 2016
Inventor(s): Kularatne; Sumith A. et al.The present invention discloses a process for preparing a compound having the formula ##STR00001##
Including Reacting a compound of the formula 1: ##STR00002##
with a compound of the formula: ##STR00003##
in the presence of a polar solvent and trifluoroacetic acid to provide a compound of the formula: ##STR00004##
or a racemic mixture thereof; and further reacting the compound of the formula: ##STR00005##
or a racemic mixture thereof; with sodium hydroxide and a compound of the formula: ##STR00006##
wherein
R.sup.1 and R.sup.2 are as defined above.Patent expiration dates:
- October 4, 2033✓✓
- October 4, 2033
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Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent 9,333,270
Issued: May 10, 2016
Inventor(s): Low Philip S. & Kularatne Sumith A. & Mahalingam Sakkarapalayam M.
Assignee(s): Purdue Research FoundationThe present disclosure relates to compounds that are useful as near-infrared fluorescence probes, wherein the compounds include i) a pteroyl ligand that binds to a target receptor protein, ii) a dye molecule, and iii) a linker molecule that comprises an amino acid or derivative thereof. The disclosure further describes methods and compositions for making and using the compounds, methods incorporating the compounds, and kits incorporating the compounds.
Patent expiration dates:
- August 26, 2033✓✓✓
- August 26, 2033
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Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent 9,341,629
Issued: May 17, 2016
Inventor(s): Kularatne Sumith A. & Mahalingam Sakkarapalayam M. & Low Philip S.
Assignee(s): Purdue Research FoundationThe present disclosure relates to compounds that are useful as near-infrared fluorescence probes, wherein the compounds include i) a pteroyl ligand that binds to a target receptor protein, ii) a dye molecule, and iii) a linker molecule that comprises an amino acid or derivative thereof. The disclosure further describes methods and compositions for making and using the compounds, methods incorporating the compounds, and kits incorporating the compounds.
Patent expiration dates:
- August 26, 2033✓✓
- August 26, 2033
-
Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent 9,789,208
Issued: October 17, 2017
Inventor(s): Kularatne Sumith A.
Assignee(s): Purdue Research FoundationThe present disclosure relates to compounds that are useful as near-infrared fluorescence probes, wherein the compounds include i) a pteroyl ligand that binds to a target receptor protein, ii) a dye molecule, and iii) a linker molecule that comprises an amino acid or derivative thereof. The disclosure further describes methods and compositions for incorporating the compounds as used for the targeted imaging of tumors. Conjugation of the amino acid linking groups increase specificity and detection of the compound. Methods and compositions for use thereof in diagnostic imaging are contemplated.
Patent expiration dates:
- August 26, 2033✓✓✓
- August 26, 2033
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 NONMALIGNANT PULMONARY 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
More about Cytalux (pafolacianine)
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- During pregnancy
- FDA approval history
- Drug class: malignancy photosensitizers
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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.
