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LORBRENA Drug Profile

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Which patents cover Lorbrena, and when can generic versions of Lorbrena launch?

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

This drug has sixty-seven patent family members in forty-four countries.

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

US ANDA Litigation and Generic Entry Outlook for Lorbrena

Lorbrena will be eligible for patent challenges on November 2^nd, 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^th, 2036. This may change due to patent challenges or generic licensing.

Summary for LORBRENA

International Patents:	67
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	44
Patent Applications:	34
Drug Prices:	Drug price information for LORBRENA
DailyMed Link:	LORBRENA at DailyMed

See drug prices for LORBRENA

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.

Pharmacology for LORBRENA

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

Synonyms for LORBRENA

(10R)-7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-2H-4,8-methenopyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile

(10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-4,8-methenopyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile

(10R)-7-Amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo[4,3-H][2,5,11]-benzoxadiazacyclotetradecine-3-carbonitrile

(10r)-7-Amino-12-Fluoro-2,10,16-Trimethyl-15-Oxo-10,15,16,17-Tetrahydro-2h-8,4-(Metheno)pyrazolo[4,3-H][2,5,11]benzoxadiazacyclotetradecine-3-Carbonitrile

1454846-35-5

2641AH

2H-4,8-Methenopyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-

2H-4,8-Methenopyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-

4cli

4clj

7-Amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo(4,3-h)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile

A14207

AK175603

AKOS027250753

BC600707

BCP10287

BDBM50018830

CHEBI:143117

CHEMBL3286830

CS-3983

D11012

DB12130

EX-A828

FT-0700455

GTPL7476

HY-12215

J-690185

KS-00000T6C

Loratinib

Lorbrena (TN)

Lorlatinib

Lorlatinib (JAN/USAN/INN)

Lorlatinib (PF-6463922)

Lorlatinib [USAN:INN]

Lorlatinib,PF-06463922

lorlatinibum

Lorviqua

MFCD28144520

NCGC00386417-02

NCGC00386417-13

OSP71S83EU

PF 06463922

PF-06463922

PF-6463922

PF06463922

PF06463922(Lorlatinib)

PFE-PKIS 10

Q27285820

s7536

SB16884

SCHEMBL15261807

UNII-OSP71S83EU

ZINC98208524

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 Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No			Y	Y
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes			Y	Y
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes			Y	Y
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No			Y	Y
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-001	Nov 2, 2018		RX	Yes	No

International Patents for LORBRENA

Country	Patent Number	Estimated Expiration
Moldova, Republic of	20140086
Tunisia	2014000371
Lithuania	2822953
Eurasian Patent Organization	201491394
Morocco	37291
Serbia	55814

Supplementary Protection Certificates for LORBRENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822953	LUC00131	Luxembourg		PRODUCT NAME: LORVIQUA - IORLATINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1355 20190508
2822953	2019C/539	Belgium		PRODUCT NAME: LORLATINIB; AUTHORISATION NUMBER AND 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
2822953	CA 2019 00041	Denmark		PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508
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	Lithuania		PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506