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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210868

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NDA 210868 describes LORBRENA, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the LORBRENA profile page.

The generic ingredient in LORBRENA is lorlatinib. One supplier is listed for this compound. Additional details are available on the lorlatinib profile page.
Summary for 210868
Tradename:LORBRENA
Applicant:Pfizer Inc
Ingredient:lorlatinib
Patents:1
Generic Entry Opportunity Date for 210868
Generic Entry Date for 210868*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 210868
Suppliers and Packaging for NDA: 210868
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORBRENA lorlatinib TABLET;ORAL 210868 NDA Pfizer Laboratories Div Pfizer Inc 0069-0227 0069-0227-01 30 TABLET, FILM COATED in 1 BOTTLE (0069-0227-01)
LORBRENA lorlatinib TABLET;ORAL 210868 NDA Pfizer Laboratories Div Pfizer Inc 0069-0231 0069-0231-01 30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Nov 2, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 2, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON ALECTINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE
Regulatory Exclusivity Expiration:Nov 2, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON CERITINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE
Regulatory Exclusivity Expiration:Nov 2, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON CRIZOTINIB AND AT LEAST ONE OTHER ALK INHIBITOR FOR METASTATIC DIESASE

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