Details for New Drug Application (NDA): 210868

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

The generic ingredient in LORBRENA is lorlatinib. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the lorlatinib profile page.

Summary for 210868

Tradename:	LORBRENA
Applicant:	Pfizer
Ingredient:	lorlatinib
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210868

Constraining patent/regulatory exclusivity:

11,020,376

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

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 3A Inducers Kinase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors Organic Cation Transporter 1 Inhibitors P-Glycoprotein Inducers

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	0069-0227	0069-0227-03	120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Nov 2, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 3, 2028
Regulatory Exclusivity Use:	TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST, EXCLUDING PATIENTS WHOSE DISEASE HAS PROGRESSED ON CRIZOTINIB AND AT LEAST ONE OTHER ALK INHIBITOR FOR METASTATIC DISEASE; OR ALECTINIB OR CERITINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE
Patent:	10,420,749	Patent Expiration:	Jul 27, 2036	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST
Patent:	10,420,749	Patent Expiration:	Jul 27, 2036	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER, PROGRESSED ON: CRIZOTINIB + AT LEAST 1 OTHER ALK INHIBITOR FOR METASTATIC DISEASE; OR ALECTINIB, OR CERITINIB AS FIRST ALK INHIBITOR FOR METASTATIC DISEASE.

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