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 ninety-six patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for lorlatinib

International Patents:	96
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	31
Patent Applications:	93
What excipients (inactive ingredients) are in lorlatinib?	lorlatinib excipients list
DailyMed Link:	lorlatinib at DailyMed

Recent Clinical Trials for lorlatinib

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

Sponsor	Phase
Nuvalent Inc.	Phase 1/Phase 2
CStone Pharmaceuticals	Phase 2
Centre Hospitalier Universitaire Vaudois	Phase 1

See all lorlatinib clinical trials

Pharmacology for lorlatinib

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

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	210868-002	Nov 2, 2018		RX	Yes	Yes			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			Y
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No			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	210868-002	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; or, crizotinib and at least one other ALK TKI., , , , , ,	Authorised	no	no	no	2019-05-06

International Patents for lorlatinib

Country	Patent Number	Title	Estimated Expiration
Taiwan	201718600	Crystalline form of lorlatinib free base
Taiwan	201350484	Macrocyclic derivatives for the treatment of diseases
Lithuania	PA2019519
Hungary	S1900040
Norway	2019034
New Zealand	627900	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 lorlatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2019519	Lithuania		PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	301006	Netherlands		PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION 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	122019000088	Germany		PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953	41/2019	Austria		PRODUCT NAME: LORLATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 (MITTEILUNG) 20190508
2822953	C20190036 00302	Estonia		PRODUCT NAME: LORLATINIIB;REG NO/DATE: EU/1/19/1355 08.05.2019