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Last Updated: August 15, 2020

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LORBRENA Drug Profile

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

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

This drug has seventy-one patent family members in forty-five 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, 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, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for LORBRENA
Drug patent expirations by year for LORBRENA
Drug Prices for LORBRENA

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Generic Entry Opportunity 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
Massachusetts General HospitalPhase 1/Phase 2
Array BioPharmaPhase 1/Phase 2
PfizerPhase 1/Phase 2

See all LORBRENA clinical trials

Pharmacology for LORBRENA

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   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
>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 LORBRENA

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: LORVIQUA - IORLATINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1355 20190508
2822953 122019000088 Germany   Start Trial PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Johnson and Johnson
Express Scripts
McKesson
AstraZeneca

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.