Lazcluze is a drug owned by Janssen Biotech Inc. It is protected by 5 US drug patents filed in 2024 out of which none have expired yet. Lazcluze's patents will be open to challenges from 19 August, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 01, 2041. Details of Lazcluze'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. | |||
| US11453656 | Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same |
Apr, 2038
(13 years from now) | Active |
| US9593098 | Compounds and compositions for modulating EGFR mutant kinase activities |
Oct, 2035
(10 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). | |||
| US11850248 | Therapies with 3rd generation EGFR tyrosine kinase inhibitors |
Aug, 2041
(16 years from now) | Active |
| US11879013 | Combination therapies with bispecific anti-EGFR/c-Met antibodies and third generation EGFR tyrosine kinase inhibitors |
May, 2040
(15 years from now) | Active |
| US11981659 | Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same |
Apr, 2038
(13 years from now) | Active |
FDA has granted several exclusivities to Lazcluze. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lazcluze, 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 Lazcluze.
Exclusivity Information
Lazcluze holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Lazcluze's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 19, 2029 |
US patents provide insights into the exclusivity only within the United States, but Lazcluze 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 Lazcluze's family patents as well as insights into ongoing legal events on those patents.
Lazcluze's Family Patents
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Generic Launch
Generic Release Date:
Lazcluze's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 01, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lazcluze Generics:
There are no approved generic versions for Lazcluze as of now.
About Lazcluze
Lazcluze is a drug owned by Janssen Biotech Inc. Lazcluze uses Lazertinib Mesylate as an active ingredient. Lazcluze was launched by Janssen Biotech in 2024.
Approval Date:
Lazcluze was approved by FDA for market use on 19 August, 2024.
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 Lazcluze is 19 August, 2024, its NCE-1 date is estimated to be 19 August, 2028.
Active Ingredient:
Lazcluze uses Lazertinib Mesylate as the active ingredient. Check out other Drugs and Companies using Lazertinib Mesylate ingredient
Dosage:
Lazcluze is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 80MG BASE | TABLET | Prescription | ORAL |
| EQ 240MG BASE | TABLET | Prescription | ORAL |