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LORBRENA Drug Profile

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Which patents cover Lorbrena, and when can generic versions of Lorbrena launch?

Lorbrena is a drug marketed by Pfizer Inc and is included in one NDA. There is one patent protecting this drug.

This drug has fifty patent family members in forty-two countries.

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 LORBRENA

International Patents:	50
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
DailyMed Link:	LORBRENA at DailyMed

Generic Entry Opportunity Date for LORBRENA

Constraining patent/regulatory exclusivity:

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

NDA:

210868

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.

US Patents and Regulatory Information for LORBRENA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No			Y	Y
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No

International Patents for LORBRENA

Country	Document Number	Estimated Expiration
New Zealand	627900
Uruguay	34657
World Intellectual Property Organization (WIPO)	2013132376
Croatia	P20170287