Lorlatinib - Generic Drug Details

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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lorlatinib has one hundred and seventeen patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for lorlatinib

International Patents:	117
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	32
Patent Applications:	102
What excipients (inactive ingredients) are in lorlatinib?	lorlatinib excipients list
DailyMed Link:	lorlatinib at DailyMed

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

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 lorlatinib

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

Sponsor	Phase
Guangdong Provincial People's Hospital	Phase 2
Nuvalent Inc.	Phase 1/Phase 2
CStone Pharmaceuticals	Phase 2

See all lorlatinib clinical trials

Pharmacology for lorlatinib

Drug Class	Kinase Inhibitor
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

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			Y
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
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

EU/EMA Drug Approvals for lorlatinib

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 lorlatinib

Country	Patent Number	Title	Estimated Expiration
Moldova, Republic of	20140086	Derivaţi macrociclici pentru tratamentul bolilor proliferative;Derivaţi macrociclici pentru tratamentul bolilor proliferative (Macrocyclic derivatives for the treatment of proliferative diseases)
China	116063322	劳拉替尼游离碱的结晶形式 (Crystalline forms of loratinib free base)
Hungary	S1900040
Tunisia	2014000371	DÉRIVÉS MACROCYCLIQUES POUR LE TRAITEMENT DE MALADIES PROLIFÉRATIVES
Taiwan	201350484	Macrocyclic derivatives for the treatment of diseases
Norway	2019034

Supplementary Protection Certificates for lorlatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822953	1990042-2	Sweden		PRODUCT NAME: LORLATINIB; REG. NO/DATE: EU/1/19/1355 20190508
2822953	CA 2019 00041	Denmark		PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508
2822953	PA2019519,C2822953	Lithuania		PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	132019000000116	Italy		PRODUCT NAME: LORLATINIB(LORVIQUA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1355, 20190508
2822953	CR 2019 00041	Denmark		PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/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)