Cytalux is a drug owned by On Target Laboratories Inc. It is protected by 6 US drug patents filed in 2022 out of which none have expired yet. Cytalux's patents will be open to challenges from 29 November, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 04, 2033. Details of Cytalux's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9254341 | Methods of manufacture of pteroyl-amino acid-fluorescent dyes |
Oct, 2033
(8 years from now) | Active |
| US9333270 | Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors |
Aug, 2033
(8 years from now) | Active |
| US9061057 | Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors |
Aug, 2033
(8 years from now) | Active |
| US10881747 | Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors |
Aug, 2033
(8 years from now) | Active |
| US9789208 | Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors |
Aug, 2033
(8 years from now) | Active |
| US9341629 | Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors |
Aug, 2033
(8 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Cytalux's patents.
Latest Legal Activities on Cytalux's Patents
Given below is the list of recent legal activities going on the following patents of Cytalux.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 26 Jun, 2024 | US10881747 |
| transaction for FDA Determination of Regulatory Review Period | 27 Dec, 2023 | US9061057 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US9061057 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 20 Oct, 2023 | US9341629 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 17 Oct, 2023 | US9333270 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 28 Jul, 2023 | US9254341 |
| Second letter to regulating agency to determine regulatory review period | 25 Jan, 2023 | US9061057 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 07 Dec, 2022 | US9061057 |
| Letter from FDA or Dept of Agriculture re PTE application | 21 Sep, 2022 | US9061057 |
| Initial letter Re: PTE Application to regulating agency | 24 Feb, 2022 | US9061057 |
FDA has granted several exclusivities to Cytalux. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cytalux, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Cytalux.
Exclusivity Information
Cytalux holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Cytalux's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-905) | Dec 16, 2025 |
| New Chemical Entity Exclusivity(NCE) | Nov 29, 2026 |
| Orphan Drug Exclusivity(ODE-390) | Nov 29, 2028 |
US patents provide insights into the exclusivity only within the United States, but Cytalux is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Cytalux's family patents as well as insights into ongoing legal events on those patents.
Cytalux's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cytalux's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 04, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cytalux Generics:
There are no approved generic versions for Cytalux as of now.
About Cytalux
Cytalux is a drug owned by On Target Laboratories Inc. It is used for aiding in the intraoperative identification of malignant lesions in adult patients with ovarian cancer. Cytalux uses Pafolacianine Sodium as an active ingredient. Cytalux was launched by On Target Labs in 2021.
Approval Date:
Cytalux was approved by FDA for market use on 29 November, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Cytalux is 29 November, 2021, its NCE-1 date is estimated to be 29 November, 2025.
Active Ingredient:
Cytalux uses Pafolacianine Sodium as the active ingredient. Check out other Drugs and Companies using Pafolacianine Sodium ingredient
Treatment:
Cytalux is used for aiding in the intraoperative identification of malignant lesions in adult patients with ovarian cancer.
Dosage:
Cytalux is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |