Flyrcado is a drug owned by Ge Healthcare Inc. It is protected by 6 US drug patents filed in 2024 out of which none have expired yet. Flyrcado's patents will be open to challenges from 27 September, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 01, 2032. Details of Flyrcado'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. | |||
| US7344702 | Contrast agents for myocardial perfusion imaging |
May, 2026
(1 year, 6 months from now) | Active |
| US9161997 | Contrast agents for myocardial perfusion imaging |
Feb, 2026
(1 year, 2 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9687571 | Stabilization of radiopharmaceutical compositions using ascorbic acid |
Nov, 2032
(7 years from now) | Active |
| US8936777 | Methods and apparatus for synthesizing imaging agents, and intermediates thereof |
Jun, 2031
(6 years from now) | Active |
| US9603951 | Methods and apparatus for synthesizing imaging agents, and intermediates thereof |
May, 2031
(6 years from now) | Active |
| US8226929 | Contrast agents for myocardial perfusion imaging |
Jun, 2028
(3 years from now) | Active |
FDA has granted several exclusivities to Flyrcado. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Flyrcado, 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 Flyrcado.
Exclusivity Information
Flyrcado holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Flyrcado's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 27, 2029 |
US patents provide insights into the exclusivity only within the United States, but Flyrcado 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 Flyrcado's family patents as well as insights into ongoing legal events on those patents.
Flyrcado's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Flyrcado's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 01, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Flyrcado Generics:
There are no approved generic versions for Flyrcado as of now.
About Flyrcado
Flyrcado is a drug owned by Ge Healthcare Inc. Flyrcado uses Flurpiridaz F-18 as an active ingredient. Flyrcado was launched by Ge Hlthcare in 2024.
Approval Date:
Flyrcado was approved by FDA for market use on 27 September, 2024.
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 Flyrcado is 27 September, 2024, its NCE-1 date is estimated to be 27 September, 2028.
Active Ingredient:
Flyrcado uses Flurpiridaz F-18 as the active ingredient. Check out other Drugs and Companies using Flurpiridaz F-18 ingredient
Dosage:
Flyrcado is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5-55mCi/ML | SOLUTION | Prescription | INTRAVENOUS |