Generic Lazcluze Availability

Last updated on May 7, 2025.

Lazcluze is a brand name of lazertinib, approved by the FDA in the following formulation(s):

LAZCLUZE (lazertinib mesylate - tablet;oral)

• Manufacturer: JANSSEN BIOTECH
  Approval date: August 19, 2024
  Strength(s): EQ 80MG BASE ^[RLD], EQ 240MG BASE ^[RLD]

Is there a generic version of Lazcluze available?

No. There is currently no therapeutically equivalent version of Lazcluze available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lazcluze. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same
  Patent 11,453,656
  Issued: September 27, 2022
  Inventor(s): Oh; Sang Ho et al.
  Assignee(s): Yuhan Corporation (Seoul, KR)
  

  The present invention relates to novel mesylate salt of N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yppyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, a novel crystalline form thereof, and a process for preparing the same. More specifically, the present invention relates to mesylate salt of N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, which is excellent in stability, solubility, and bioavailability when it is administered not only alone but also in combination with other drugs and which has a high purity, a crystalline form thereof, and a process for preparing the same.

  Patent expiration dates:

  • April 18, 2038
    
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• Therapies with 3rd generation EGFR tyrosine kinase inhibitors
  Patent 11,850,248
  Issued: December 26, 2023
  Inventor(s): Kang; Seonmi et al.
  Assignee(s): Yuhan Corporation (Seoul, KR)
  

  The present invention relates to therapies with 3.sup.rd generation EGFR tyrosine kinase inhibitors. Embodiments of the invention relate to the administration of lazertinib to patients diagnosed with non-small cell lung cancer (NSCLC).

  Patent expiration dates:

  • August 1, 2041
    
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    Patent use: FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB
• Combination therapies with bispecific anti-EGFR/c-Met antibodies and third generation EGFR tyrosine kinase inhibitors
  Patent 11,879,013
  Issued: January 23, 2024
  Inventor(s): Laquerre; Sylvie et al.
  Assignee(s): JANSSEN BIOTECH, INC. (Horsham, PA)
  

  The present invention relates to combination therapies with bispecific anti-EGFR/c-Met antibodies and 3.sup.rd generation EGFR tyrosine kinase inhibitors.

  Patent expiration dates:

  • May 21, 2040
    
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    Patent use: FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB
• Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same
  Patent 11,981,659
  Issued: May 14, 2024
  Inventor(s): Oh; Sang Ho et al.
  Assignee(s): Yuhan Corporation (Seoul, KR)
  

  The present invention relates to novel mesylate salt of N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, a novel crystalline form thereof, and a process for preparing the same. More specifically, the present invention relates to mesylate salt of N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, which is excellent in stability, solubility, and bioavailability when it is administered not only alone but also in combination with other drugs and which has a high purity, a crystalline form thereof, and a process for preparing the same.

  Patent expiration dates:

  • April 18, 2038
    
    ✓ 
    Patent use: FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB
• Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof
  Patent 12,138,351
  Issued: November 12, 2024
  Inventor(s): Maximilien; Jacqueline et al.
  Assignee(s): Janssen Biotech, Inc. (Horsham, PA)
  

  Provided herein are pharmaceutical compositions for oral administration comprising N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pirimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide or a pharmaceutically acceptable salt, hydrate, or solvate thereof as an active ingredient; and a combination of (i) a cellulose derivative and (ii) a sugar or polyol as diluents. The disclosed compositions are characterized by improved manufacturability, while maintaining the pharmaceutical benefits of minimizing the effect according to changes in pH environment in the stomach, possessing excellent stability, and exhibiting good bioavailability.

  Patent expiration dates:

  • April 13, 2041
    
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    Drug product
• Compounds and compositions for modulating EGFR mutant kinase activities
  Patent 9,593,098
  Issued: March 14, 2017
  Inventor(s): Suh Byung-Chul & Salgaonkar Paresh Devidas & Lee Jaekyoo & Koh Jong Sung & Song Ho-Juhn & Lee In Yong & Lee Jaesang & Jung Dong Sik & Kim Jung-Ho & Kim Se-Won
  Assignee(s): Yuhan Corporation
  

  The present invention provides a new group of protein kinase inhibitors, aminopyrimidine derivatives, and pharmaceutically acceptable salts thereof that are useful for treating cell proliferative disease and disorder such as cancer and immune disease. The present invention provides methods for synthesizing and administering the protein kinase inhibitor compounds. The present invention also provides pharmaceutical formulations comprising at least one of the protein kinase inhibitor compounds together with a pharmaceutically acceptable carrier, diluent or excipient therefore. The invention also provides useful intermediates generated during the syntheses of the aminopyrimidine derivatives.

  Patent expiration dates:

  • October 13, 2035
    
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    Patent use: FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB
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Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:

  • August 19, 2029 - NEW CHEMICAL ENTITY

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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