Krazati is a drug owned by Bristol Myers Squibb Co. It is protected by 1 US drug patent filed in 2022 out of which none have expired yet. Krazati's patents will be open to challenges from 12 December, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be May 17, 2037. Details of Krazati'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. | |||
| US10689377 | KRas G12C inhibitors |
May, 2037
(12 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 Krazati's patents.
Latest Legal Activities on Krazati's Patents
Given below is the list of recent legal activities going on the following patents of Krazati.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail O.P. Petition Decision | 21 Mar, 2024 | US10689377 |
| Email Notification Critical | 21 Mar, 2024 | US10689377 |
| Mail-Record Petition Decision of Granted to Make Entity Status large | 19 Mar, 2024 | US10689377 |
| Record Petition Decision of Granted to Make Entity Status large | 18 Mar, 2024 | US10689377 |
| O.P. Petition Decision | 16 Mar, 2024 | US10689377 |
| Payment of Maintenance Fee under 1.28(c) | 09 Jan, 2024 | US10689377 |
| Petition Entered | 09 Jan, 2024 | US10689377 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 09 Jan, 2024 | US10689377 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 26 Dec, 2023 | US10689377 |
| Electronic Review Critical | 24 Jul, 2023 | US10689377 |
FDA has granted several exclusivities to Krazati. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Krazati, 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 Krazati.
Exclusivity Information
Krazati holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Krazati's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 12, 2027 |
| Orphan Drug Exclusivity(ODE-352) | Dec 12, 2029 |
US patents provide insights into the exclusivity only within the United States, but Krazati 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 Krazati's family patents as well as insights into ongoing legal events on those patents.
Krazati's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Krazati's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 17, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Krazati Generics:
There are no approved generic versions for Krazati as of now.
About Krazati
Krazati is a drug owned by Bristol Myers Squibb Co. It is used for treating locally advanced or metastatic non-small cell lung cancer in adult patients with a specific KRAS mutation who have already undergone prior systemic therapy. Krazati uses Adagrasib as an active ingredient. Krazati was launched by Bristol in 2022.
Approval Date:
Krazati was approved by FDA for market use on 12 December, 2022.
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 Krazati is 12 December, 2022, its NCE-1 date is estimated to be 12 December, 2026.
Active Ingredient:
Krazati uses Adagrasib as the active ingredient. Check out other Drugs and Companies using Adagrasib ingredient
Treatment:
Krazati is used for treating locally advanced or metastatic non-small cell lung cancer in adult patients with a specific KRAS mutation who have already undergone prior systemic therapy.
Dosage:
Krazati is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | TABLET | Prescription | ORAL |