Ayvakit is a drug owned by Blueprint Medicines Corp. It is protected by 7 US drug patents filed from 2020 to 2024 out of which none have expired yet. Ayvakit's patents have been open to challenges since 10 January, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 08, 2042. Details of Ayvakit'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. | |||
| US11964980 | Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1- f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making |
Apr, 2040
(14 years from now) | Active |
| US9200002 | Compositions useful for treating disorders related to KIT |
Oct, 2034
(9 years from now) | Active |
| US9994575 | Compositions useful for treating disorders related to kit |
Oct, 2034
(9 years from now) | Active |
| US11827642 | Compositions useful for treating disorders related to KIT |
Oct, 2034
(9 years from now) | Active |
| US9944651 | Compositions useful for treating disorders related to kit |
Oct, 2034
(9 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). | |||
| US12060354 | Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making |
Mar, 2042
(16 years from now) | Active |
| US11999744 | Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making |
Apr, 2040
(14 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 Ayvakit's patents.
Latest Legal Activities on Ayvakit's Patents
Given below is the list of recent legal activities going on the following patents of Ayvakit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Electronic Review Critical | 07 Jun, 2024 | US11964980 |
| Recordation of Patent eGrant | 23 Apr, 2024 | US11964980 |
| Patent Issue Date Used in PTA Calculation Critical | 23 Apr, 2024 | US11964980 |
| Recordation of Patent Grant Mailed Critical | 23 Apr, 2024 | US11964980 |
| Patent eGrant Notification | 23 Apr, 2024 | US11964980 |
| Mail Patent eGrant Notification | 23 Apr, 2024 | US11964980 |
| Email Notification Critical | 23 Apr, 2024 | US11964980 |
| Email Notification Critical | 04 Apr, 2024 | US11964980 |
| Issue Notification Mailed Critical | 03 Apr, 2024 | US11964980 |
| Email Notification Critical | 21 Mar, 2024 | US11964980 |
FDA has granted several exclusivities to Ayvakit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ayvakit, 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 Ayvakit.
Exclusivity Information
Ayvakit holds 7 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Ayvakit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-863) | Jun 16, 2024 |
| New Indication(I-864) | Jun 16, 2024 |
| New Chemical Entity Exclusivity(NCE) | Jan 09, 2025 |
| New Indication(I-912) | May 22, 2026 |
| Orphan Drug Exclusivity(ODE-366) | Jan 09, 2027 |
| Orphan Drug Exclusivity(ODE-356) | Jun 16, 2028 |
| Orphan Drug Exclusivity(ODE-434) | May 22, 2030 |
US patents provide insights into the exclusivity only within the United States, but Ayvakit 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 Ayvakit's family patents as well as insights into ongoing legal events on those patents.
Ayvakit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ayvakit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 08, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ayvakit Generics:
There are no approved generic versions for Ayvakit as of now.
About Ayvakit
Ayvakit is a drug owned by Blueprint Medicines Corp. It is used for treating advanced systemic mastocytosis, including aggressive types, and unresectable or metastatic gastrointestinal stromal tumors with a specific mutation. Ayvakit uses Avapritinib as an active ingredient. Ayvakit was launched by Blueprint Medicines in 2021.
Approval Date:
Ayvakit was approved by FDA for market use on 16 June, 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 Ayvakit is 16 June, 2021, its NCE-1 date is estimated to be 10 January, 2024.
Active Ingredient:
Ayvakit uses Avapritinib as the active ingredient. Check out other Drugs and Companies using Avapritinib ingredient
Treatment:
Ayvakit is used for treating advanced systemic mastocytosis, including aggressive types, and unresectable or metastatic gastrointestinal stromal tumors with a specific mutation.
Dosage:
Ayvakit is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 300MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |
| 25MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |