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Last Updated: July 4, 2020

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Lorlatinib - Generic Drug Details

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What are the generic sources for lorlatinib and what is the scope of freedom to operate?

Lorlatinib is the generic ingredient in one branded drug marketed by Pfizer Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lorlatinib has seventy patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for lorlatinib
International Patents:70
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 47
Clinical Trials: 18
Patent Applications: 64
DailyMed Link:lorlatinib at DailyMed
Recent Clinical Trials for lorlatinib

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

SponsorPhase
European Organisation for Research and Treatment of Cancer - EORTCPhase 2
Roche Pharma AGPhase 2
Ulrik LassenPhase 2

See all lorlatinib clinical trials

Pharmacology for lorlatinib

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 Inc LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pfizer Inc LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer Inc LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer Inc LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pfizer Inc LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pfizer Inc LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer Inc LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for lorlatinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2822953 301006 Netherlands   Start Trial PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1355 20190508
2822953 CR 2019 00041 Denmark   Start Trial PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508
2822953 CA 2019 00041 Denmark   Start Trial PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508
2822953 132019000000116 Italy   Start Trial PRODUCT NAME: LORLATINIB(LORVIQUA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1355, 20190508
2822953 PA2019519 Lithuania   Start Trial PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953 122019000088 Germany   Start Trial PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953 LUC00131 Luxembourg   Start Trial PRODUCT NAME: LORVIQUA - IORLATINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1355 20190508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
AstraZeneca
Dow
Colorcon
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.