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Last Updated: March 29, 2024

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CYTALUX Drug Patent Profile


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When do Cytalux patents expire, and what generic alternatives are available?

Cytalux is a drug marketed by On Target Labs and is included in one NDA. There are six patents protecting this drug.

This drug has thirty-five patent family members in twelve countries.

The generic ingredient in CYTALUX is pafolacianine sodium. One supplier is listed for this compound. Additional details are available on the pafolacianine sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Cytalux

Cytalux will be eligible for patent challenges on November 29, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 26, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for CYTALUX
International Patents:35
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in CYTALUX?CYTALUX excipients list
DailyMed Link:CYTALUX at DailyMed
Drug patent expirations by year for CYTALUX
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CYTALUX
Generic Entry Date for CYTALUX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CYTALUX
Anatomical Therapeutic Chemical (ATC) Classes for CYTALUX

US Patents and Regulatory Information for CYTALUX

CYTALUX is protected by six US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CYTALUX is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CYTALUX

Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS

Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS

Methods of manufacture of pteroyl-amino acid-fluorescent dyes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS

Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS

FDA Regulatory Exclusivity protecting CYTALUX

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT AND NONMALIGNANT PULMONARY LESIONS IN ADULT PATIENTS WITH KNOWN OR SUSPECTED CANCER IN THE LUNG
Exclusivity Expiration: ⤷  Try a Trial

AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS IN ADULT PATIENTS WITH OVARIAN CANCER
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
On Target Labs CYTALUX pafolacianine sodium SOLUTION;INTRAVENOUS 214907-001 Nov 29, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
On Target Labs CYTALUX pafolacianine sodium SOLUTION;INTRAVENOUS 214907-001 Nov 29, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
On Target Labs CYTALUX pafolacianine sodium SOLUTION;INTRAVENOUS 214907-001 Nov 29, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
On Target Labs CYTALUX pafolacianine sodium SOLUTION;INTRAVENOUS 214907-001 Nov 29, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
On Target Labs CYTALUX pafolacianine sodium SOLUTION;INTRAVENOUS 214907-001 Nov 29, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
On Target Labs CYTALUX pafolacianine sodium SOLUTION;INTRAVENOUS 214907-001 Nov 29, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for CYTALUX

When does loss-of-exclusivity occur for CYTALUX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 13381391
Estimated Expiration: ⤷  Try a Trial

Patent: 13383382
Estimated Expiration: ⤷  Try a Trial

Patent: 13383386
Estimated Expiration: ⤷  Try a Trial

Patent: 17203340
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015022810
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 02205
Estimated Expiration: ⤷  Try a Trial

Patent: 03727
Estimated Expiration: ⤷  Try a Trial

Patent: 03994
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5120903
Estimated Expiration: ⤷  Try a Trial

Patent: 5228628
Estimated Expiration: ⤷  Try a Trial

Patent: 5492905
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 9738
Estimated Expiration: ⤷  Try a Trial

Patent: 1591802
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 68335
Estimated Expiration: ⤷  Try a Trial

Patent: 68614
Estimated Expiration: ⤷  Try a Trial

Patent: 72320
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 18257
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0509
Estimated Expiration: ⤷  Try a Trial

Patent: 0673
Estimated Expiration: ⤷  Try a Trial

Patent: 0828
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 92799
Estimated Expiration: ⤷  Try a Trial

Patent: 70981
Estimated Expiration: ⤷  Try a Trial

Patent: 16512240
Estimated Expiration: ⤷  Try a Trial

Patent: 16512813
Estimated Expiration: ⤷  Try a Trial

Patent: 16512814
Estimated Expiration: ⤷  Try a Trial

Patent: 17149776
Estimated Expiration: ⤷  Try a Trial

Patent: 17214425
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 8184
Estimated Expiration: ⤷  Try a Trial

Patent: 15011830
Estimated Expiration: ⤷  Try a Trial

Patent: 15013219
Estimated Expiration: ⤷  Try a Trial

Patent: 15013223
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 65896
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CYTALUX around the world.

Country Patent Number Title Estimated Expiration
China 105228628 Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors ⤷  Try a Trial
Israel 240828 שיטות לייצור וסינתזה של קבוצות קושרות חומצת אמינו מצומדות לתרכובות המשמשות להדמיה ממוקדת של גידולים (Methods of manufacture and synthesis of amino acid linking groups conjugated to compounds used for targeted imaging of tumors) ⤷  Try a Trial
Eurasian Patent Organization 201591802 СИНТЕЗ И КОМПОЗИЦИЯ АМИНОКИСЛОТНЫХ ЛИНКЕРНЫХ ГРУПП, КОНЪЮГИРОВАННЫХ С СОЕДИНЕНИЯМИ, ПРИМЕНЯЕМЫМИ ДЛЯ НАПРАВЛЕННОЙ ВИЗУАЛИЗАЦИИ ОПУХОЛЕЙ ⤷  Try a Trial
Canada 2903994 SYNTHESE ET COMPOSITION DE GROUPES DE LIAISON D'ACIDES AMINES CONJUGUES A DES COMPOSES UTILISES POUR L'IMAGERIE CIBLEE DE TUMEURS (SYNTHESIS AND COMPOSITION OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR THE TARGETED IMAGING OF TUMORS) ⤷  Try a Trial
Japan 6270981 ⤷  Try a Trial
Canada 2903727 PROCEDES DE FABRICATION ET DE SYNTHESE DE GROUPES DE LIAISON D'ACIDE AMINE CONJUGUES A DES COMPOSES UTILISES POUR L'IMAGERIE CIBLEE DE TUMEURS (METHODS OF MANUFACTURE AND SYNTHESIS OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR TARGETED IMAGING OF TUMORS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.