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Lorlatinib - Generic Drug Details

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What are the generic drug sources for lorlatinib and what is the scope of patent protection?

Lorlatinib is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lorlatinib has seventy-two patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for lorlatinib

International Patents:	72
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	48
Clinical Trials:	20
Patent Applications:	64
DailyMed Link:	lorlatinib at DailyMed

Recent Clinical Trials for lorlatinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
University of Colorado, Denver	Phase 1
European Organisation for Research and Treatment of Cancer - EORTC	Phase 2

See all lorlatinib clinical trials

Pharmacology for lorlatinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for lorlatinib

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

International Patents for lorlatinib

Country	Patent Number	Estimated Expiration
Cuba	20140107
Taiwan	201350484
Argentina	090230
Peru	20142339
Nicaragua	201400102
Luxembourg	C00131

Supplementary Protection Certificates for lorlatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822953	301006	Netherlands		PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1355 20190508
2822953	LUC00131	Luxembourg		PRODUCT NAME: LORLATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/19/1355 20190508
2822953	2019/042	Ireland		PRODUCT NAME: LORLATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/19/1355/001 EU/1/19/1355/002 20190506; FIRST REGISTRATION NO/DATE: EU/1/19/1355/001 EU/1/19/1355/002 20190506 (20207080)
2822953	PA2019519	Lithuania		PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	C201930063	Spain		PRODUCT NAME: LORLATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1355; DATE OF AUTHORISATION: 20190506; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1355; DATE OF FIRST AUTHORISATION IN EEA: 20190506
2822953	CR 2019 00041	Denmark		PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508