Lumakras is a drug owned by Amgen Inc. It is protected by 5 US drug patents filed from 2022 to 2025 out of which none have expired yet. Lumakras's patents have been open to challenges since 28 May, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 15, 2040. Details of Lumakras'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. | |||
| US11827635 | Solid state forms |
May, 2040
(14 years from now) | Active |
| US11236091 | Solid state forms |
May, 2040
(14 years from now) | Active |
| US10519146 | KRAS G12C inhibitors and methods of using the same |
May, 2038
(12 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). | |||
| US11426404 | Dosing of KRAS inhibitor for treatment of cancers |
Sep, 2040
(15 years from now) | Active |
| US12280056 | Combination therapy including a KRASG12C inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers |
Nov, 2039
(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 Lumakras's patents.
Latest Legal Activities on Lumakras's Patents
Given below is the list of recent legal activities going on the following patents of Lumakras.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 29 Nov, 2023 | US11827635 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Nov, 2023 | US11827635 |
| Mail Patent eGrant Notification | 28 Nov, 2023 | US11827635 |
| Recordation of Patent Grant Mailed Critical | 28 Nov, 2023 | US11827635 |
| Patent eGrant Notification | 28 Nov, 2023 | US11827635 |
| Recordation of Patent eGrant | 28 Nov, 2023 | US11827635 |
| Email Notification Critical | 09 Nov, 2023 | US11827635 |
| Issue Notification Mailed Critical | 08 Nov, 2023 | US11827635 |
| Application Is Considered Ready for Issue Critical | 25 Oct, 2023 | US11827635 |
| Dispatch to FDC | 25 Oct, 2023 | US11827635 |
FDA has granted several exclusivities to Lumakras. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lumakras, 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 Lumakras.
Exclusivity Information
Lumakras holds 5 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2032. Details of Lumakras's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 28, 2026 |
| New Indication(I-962) | Jan 16, 2028 |
| ODE*(ODE*) | May 28, 2028 |
| Orphan Drug Exclusivity(ODE-352) | May 28, 2028 |
| Orphan Drug Exclusivity(ODE-507) | Jan 16, 2032 |
US patents provide insights into the exclusivity only within the United States, but Lumakras 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 Lumakras's family patents as well as insights into ongoing legal events on those patents.
Lumakras's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lumakras's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 15, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lumakras Generics:
There are no approved generic versions for Lumakras as of now.
About Lumakras
Lumakras is a drug owned by Amgen Inc. It is used for treating adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least one prior systemic therapy. Lumakras uses Sotorasib as an active ingredient. Lumakras was launched by Amgen Inc in 2021.
Approval Date:
Lumakras was approved by FDA for market use on 28 May, 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 Lumakras is 28 May, 2021, its NCE-1 date is estimated to be 28 May, 2025.
Active Ingredient:
Lumakras uses Sotorasib as the active ingredient. Check out other Drugs and Companies using Sotorasib ingredient
Treatment:
Lumakras is used for treating adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least one prior systemic therapy.
Dosage:
Lumakras is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 320MG | TABLET | Prescription | ORAL |
| 120MG | TABLET | Prescription | ORAL |
| 240MG | TABLET | Prescription | ORAL |