Fyarro is a drug owned by Aadi Biosciences Inc. It is protected by 7 US drug patents filed from 2021 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 28, 2040. Details of Fyarro's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11497737 | Pharmaceutical compositions of albumin and rapamycin |
Oct, 2040
(14 years from now) | Active |
| US12133844 | Methods of treating epithelioid cell tumors |
Jun, 2036
(9 years from now) | Active |
| US10973806 | Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin |
Jun, 2036
(9 years from now) | Active |
| US10705070 | Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug |
Mar, 2036
(9 years from now) | Active |
| US12061183 | Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug |
Mar, 2036
(9 years from now) | Active |
| US10206887 | Prion free nanoparticle compositions and methods of making thereof |
Apr, 2030
(3 years from now) | Active |
| US8911786 | Nanoparticle comprising rapamycin and albumin as anticancer agent |
Feb, 2029
(2 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 Fyarro's patents.
Latest Legal Activities on Fyarro's Patents
Given below is the list of recent legal activities going on the following patents of Fyarro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Notice of Final Determination -Eligible | 08 Jul, 2025 | US8911786 |
| FDA Final Eligibility Letter | 21 May, 2025 | US8911786 |
| Mail Patent eCofC Notification | 25 Feb, 2025 | US12133844 |
| Mail Patent eCofC Notification | 25 Feb, 2025 | US12061183 |
| Patent eCofC Notification | 25 Feb, 2025 | US12061183 |
| Recordation of Patent eCertificate of Correction | 25 Feb, 2025 | US12061183 |
| Email Notification | 25 Feb, 2025 | US12133844 |
| Patent eCofC Notification | 25 Feb, 2025 | US12133844 |
| Email Notification | 25 Feb, 2025 | US12061183 |
| Recordation of Patent eCertificate of Correction | 25 Feb, 2025 | US12133844 |
FDA has granted several exclusivities to Fyarro. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Fyarro, 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
Fyarro.
Exclusivity Information
Fyarro holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Fyarro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 22, 2024 |
| Orphan Drug Exclusivity(ODE-386) | Nov 22, 2028 |
US patents provide insights into the exclusivity only within the United States, but
Fyarro 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 Fyarro's family patents as well as insights into
ongoing legal events
on those patents.
Fyarro's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Fyarro:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Fyarro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 28, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fyarro Generic API suppliers:
Sirolimus is the generic name for the brand Fyarro. 11 different companies have already filed for the generic of Fyarro, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fyarro's generic
Alternative Brands for Fyarro
Fyarro which is used for treating locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumors (PECOMA) in adults., has several other brand drugs using the same active ingredient (Sirolimus). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Sirolimus, Fyarro's active ingredient. Check the complete list of approved generic manufacturers for Fyarro
About Fyarro
Fyarro is a drug owned by Aadi Biosciences Inc. It is used for treating locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumors (PECOMA) in adults. Fyarro uses Sirolimus as an active ingredient. Fyarro was launched by Aadi in 2021.
Approval Date:
Fyarro was approved by FDA for market use on 22 November, 2021.
Active Ingredient:
Fyarro uses Sirolimus as the active ingredient. Check out other Drugs and Companies using Sirolimus ingredient
Treatment:
Fyarro is used for treating locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumors (PECOMA) in adults.
Dosage:
Fyarro is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/VIAL | POWDER | Prescription | INTRAVENOUS |