➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Merck
AstraZeneca
McKesson
Colorcon

Last Updated: October 25, 2020

DrugPatentWatch Database Preview

Lorlatinib - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Lorlatinib has seventy-two patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for lorlatinib
International Patents:72
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 48
Clinical Trials: 20
Patent Applications: 64
DailyMed Link:lorlatinib at DailyMed
Recent Clinical Trials for lorlatinib

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

SponsorPhase
National Cancer Institute (NCI)Phase 1
University of Colorado, DenverPhase 1
European Organisation for Research and Treatment of Cancer - EORTCPhase 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 LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No   Start Trial   Start Trial Y Y   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 LUC00131 Luxembourg   Start Trial PRODUCT NAME: LORLATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/19/1355 20190508
2822953 2019/042 Ireland   Start Trial 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)
2822953 PA2019519 Lithuania   Start Trial PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953 C201930063 Spain   Start Trial 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 CR 2019 00041 Denmark   Start Trial PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Dow
Baxter
AstraZeneca
McKesson

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.