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Last Updated: June 13, 2024

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LORBRENA Drug Patent Profile


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When do Lorbrena patents expire, and what generic alternatives are available?

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

This drug has one hundred and nineteen patent family members in fifty countries.

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

DrugPatentWatch® Generic Entry Outlook for Lorbrena

Lorbrena was eligible for patent challenges on November 2, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 4, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for LORBRENA
International Patents:119
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 61
Clinical Trials: 4
Patent Applications: 221
Drug Prices: Drug price information for LORBRENA
What excipients (inactive ingredients) are in LORBRENA?LORBRENA excipients list
DailyMed Link:LORBRENA at DailyMed
Drug patent expirations by year for LORBRENA
Drug Prices for LORBRENA

See drug prices for LORBRENA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LORBRENA
Generic Entry Date for LORBRENA*:
Constraining patent/regulatory exclusivity:
NDA:
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 LORBRENA

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

SponsorPhase
PfizerPhase 1
PfizerPhase 1/Phase 2
Array BioPharmaPhase 1/Phase 2

See all LORBRENA clinical trials

US Patents and Regulatory Information for LORBRENA

LORBRENA is protected by five US patents and five FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LORBRENA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting LORBRENA

Crystalline form of lorlatinib free base
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER, PROGRESSED ON: CRIZOTINIB + AT LEAST 1 OTHER ALK INHIBITOR FOR METASTATIC DISEASE; OR ALECTINIB, OR CERITINIB AS FIRST ALK INHIBITOR FOR METASTATIC DISEASE.

Crystalline form of lorlatinib free base
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST

Crystalline form of lorlatinib free base
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystalline form of lorlatinib free base hydrate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Macrocyclic derivatives for the treatment of diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting LORBRENA

INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON ALECTINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE
Exclusivity Expiration: ⤷  Sign Up

INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON CRIZOTINIB AND AT LEAST ONE OTHER ALK INHIBITOR FOR METASTATIC DIESASE
Exclusivity Expiration: ⤷  Sign Up

INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON CERITINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST, EXCLUDING PATIENTS WHOSE DISEASE HAS PROGRESSED ON CRIZOTINIB AND AT LEAST ONE OTHER ALK INHIBITOR FOR METASTATIC DISEASE; OR ALECTINIB OR CERITINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE
Exclusivity Expiration: ⤷  Sign Up

EXPANDED INDICATION OF THE TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷  Sign Up

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

EU/EMA Drug Approvals for LORBRENA

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for LORBRENA

When does loss-of-exclusivity occur for LORBRENA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 3754
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 18349259
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2020005989
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 77508
Estimated Expiration: ⤷  Sign Up

China

Patent: 1201235
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 26141
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 94863
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 94863
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 94863
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 62926
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 53069
Estimated Expiration: ⤷  Sign Up

Patent: 20536893
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 20003373
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 94863
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 94863
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 20113141
Estimated Expiration: ⤷  Sign Up

Patent: 22109286
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 202002445S
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 94863
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 2001661
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2424621
Estimated Expiration: ⤷  Sign Up

Patent: 200051781
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 52985
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 75960
Estimated Expiration: ⤷  Sign Up

Patent: 1922753
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LORBRENA around the world.

Country Patent Number Title Estimated Expiration
Slovenia 3328867 ⤷  Sign Up
Poland 3328867 ⤷  Sign Up
Mexico 350844 DERIVADOS MACROCÍCLICOS PARA EL TRATAMIENTO DE ENFERMEDADES PROLIFERATIVAS. (MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LORBRENA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2822953 C201930063 Spain ⤷  Sign Up 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 2019C/539 Belgium ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
2822953 LUC00131 Luxembourg ⤷  Sign Up PRODUCT NAME: LORLATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/19/1355 20190508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.