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LORBRENA Drug Profile

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When do Lorbrena patents expire, and what generic alternatives are available?

Lorbrena is a drug marketed by Pfizer and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-six patent family members in forty-seven countries.

The generic ingredient in LORBRENA is lorlatinib. One supplier is listed for this compound. Additional details are available on the lorlatinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Lorbrena

Lorbrena will be eligible for patent challenges on November 2, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 27, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LORBRENA

International Patents:	76
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	1
Patent Applications:	54
Drug Prices:	Drug price information for LORBRENA
What excipients (inactive ingredients) are in LORBRENA?	LORBRENA excipients list
DailyMed Link:	LORBRENA at DailyMed

See drug prices for LORBRENA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for LORBRENA

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.

Recent Clinical Trials for LORBRENA

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

Sponsor	Phase
Array BioPharma	Phase 1/Phase 2
Pfizer	Phase 1/Phase 2
Massachusetts General Hospital	Phase 1/Phase 2

See all LORBRENA clinical trials

Pharmacology for LORBRENA

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

ATC Classes for LORBRENA

L01ED	Anaplastic lymphoma kinase (ALK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No			Y	Y
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
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No

International Patents for LORBRENA

Country	Patent Number	Estimated Expiration
Hungary	S1900040
Slovenia	2822953
Singapore	11201404451T
Japan	2015510879

Supplementary Protection Certificates for LORBRENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822953	C20190036 00302	Estonia		PRODUCT NAME: LORLATINIIB;REG NO/DATE: EU/1/19/1355 08.05.2019
2822953	122019000088	Germany		PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	2019034	Norway		PRODUCT NAME: LORLATINIB; REG. NO/DATE: EU/1/19/1355 20190523
2822953	CA 2019 00041	Denmark		PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508