LORBRENA Drug Patent Profile

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 four patents protecting this drug.

This drug has one hundred and one patent family members in forty-seven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Lorbrena

Lorbrena was eligible for patent challenges on November 2, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 4, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LORBRENA

International Patents:	101
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	4
Patent Applications:	68
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 Loss of Exclusivity (LOE) 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
Pfizer	Phase 1
Massachusetts General Hospital	Phase 1/Phase 2
Pfizer	Phase 1/Phase 2

See all LORBRENA clinical trials

Pharmacology for LORBRENA

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inducers Kinase Inhibitors Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 3A Inducers Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors Organic Cation Transporter 1 Inhibitors P-Glycoprotein Inducers

Anatomical Therapeutic Chemical (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

LORBRENA is protected by five US patents and six FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting LORBRENA

FDA Regulatory Exclusivity protecting 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	210868-002	Nov 2, 2018		RX	Yes	Yes
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No			Y

EU/EMA Drug Approvals for LORBRENA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Lorviqua	lorlatinib	EMEA/H/C/004646 Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK‑positive advanced NSCLC whose disease has progressed after:alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; orcrizotinib and at least one other ALK TKI.	Authorised	no	no	no	2019-05-06

International Patents for LORBRENA

When does loss-of-exclusivity occur for LORBRENA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

European Patent Office

Japan

Mexico

Russian Federation

Singapore

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LORBRENA around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	201406244	MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES
South Korea	20140137414	MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES
Singapore	11201404451T	MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES
European Patent Office	3798222	FORME CRISTALLINE DE BASE LIBRE DE LORLATINIB (CRYSTALLINE FORM OF LORLATINIB FREE BASE)

Supplementary Protection Certificates for LORBRENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	19C1062	France		PRODUCT NAME: LORLATINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/19/1355 20190508; FIRST REGISTRATION: - EU/1/19/1355 20190508
2822953	374 17-2019	Slovakia		PRODUCT NAME: LORLATINIB; REGISTRATION NO/DATE: EU/1/19/1355 20190508
2822953	122019000088	Germany		PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506