Gavreto is a drug owned by Rigel Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2020 to 2024 out of which none have expired yet. Gavreto's patents have been open to challenges since 04 September, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 03, 2039. Details of Gavreto'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. | |||
| US10030005 | Inhibitors of RET |
Nov, 2036
(11 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11872192 | RET inhibitor for use in treating cancer having a RET alteration |
Apr, 2039
(13 years from now) | Active |
| US11963958 | RET inhibitor for use in treating cancer having a RET alteration |
Apr, 2039
(13 years from now) | Active |
| US11273160 | RET inhibitor for use in treating cancer having a RET alteration |
Apr, 2039
(13 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 Gavreto's patents.
Latest Legal Activities on Gavreto's Patents
Given below is the list of recent legal activities going on the following patents of Gavreto.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 06 May, 2024 | US11872192 |
| Change in Power of Attorney (May Include Associate POA) Critical | 06 May, 2024 | US11273160 |
| Email Notification Critical | 06 May, 2024 | US11872192 |
| Email Notification Critical | 06 May, 2024 | US11273160 |
| Email Notification Critical | 25 Apr, 2024 | US10030005 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Apr, 2024 | US10030005 |
| Email Notification Critical | 16 Jan, 2024 | US11872192 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Jan, 2024 | US11872192 |
| Mail Patent eGrant Notification | 16 Jan, 2024 | US11872192 |
| Patent eGrant Notification | 16 Jan, 2024 | US11872192 |
FDA has granted several exclusivities to Gavreto. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gavreto, 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 Gavreto.
Exclusivity Information
Gavreto holds 4 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Gavreto's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 04, 2025 |
| Orphan Drug Exclusivity(ODE-318) | Sep 04, 2027 |
| Orphan Drug Exclusivity(ODE-340) | Dec 01, 2027 |
| Orphan Drug Exclusivity(ODE-341) | Dec 01, 2027 |
US patents provide insights into the exclusivity only within the United States, but Gavreto 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 Gavreto's family patents as well as insights into ongoing legal events on those patents.
Gavreto's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Gavreto's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 03, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gavreto Generics:
There are no approved generic versions for Gavreto as of now.
About Gavreto
Gavreto is a drug owned by Rigel Pharmaceuticals Inc. It is used for advanced or metastatic RET fusion-positive thyroid cancer and non-small cell lung cancer in certain patients. Gavreto uses Pralsetinib as an active ingredient. Gavreto was launched by Rigel Pharms in 2020.
Approval Date:
Gavreto was approved by FDA for market use on 04 September, 2020.
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 Gavreto is 04 September, 2020, its NCE-1 date is estimated to be 04 September, 2024.
Active Ingredient:
Gavreto uses Pralsetinib as the active ingredient. Check out other Drugs and Companies using Pralsetinib ingredient
Treatment:
Gavreto is used for advanced or metastatic RET fusion-positive thyroid cancer and non-small cell lung cancer in certain patients.
Dosage:
Gavreto is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | CAPSULE | Prescription | ORAL |