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
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 |
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
Drug Class | Optical Imaging Agent |
Mechanism of Action | Fluorescence Contrast Activity |
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 | ||||
>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 |
---|---|---|---|
Australia | 2017203340 | Synthesis And Composition Of Amino Acid Linking Groups Conjugated To Compounds Used For The Targeted Imaging Of Tumors | ⤷ Try a Trial |
Spain | 2765896 | ⤷ Try a Trial | |
Japan | 2016512814 | 腫瘍の標的型画像化のために用いられる化合物にコンジュゲートされたアミノ酸連結基の製造および合成の方法 | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2014149069 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |