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Last Updated: June 23, 2021

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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 and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-six patent family members in forty-seven countries.

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

DrugPatentWatch® 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
International Patents:76
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 49
Clinical Trials: 1
Patent Applications: 54
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 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
Array BioPharmaPhase 1/Phase 2
PfizerPhase 1/Phase 2
Massachusetts General HospitalPhase 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 LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No   Get Started Free   Get Started Free   Get Started Free
>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 C20190036 00302 Estonia   Get Started Free PRODUCT NAME: LORLATINIIB;REG NO/DATE: EU/1/19/1355 08.05.2019
2822953 122019000088 Germany   Get Started Free PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953 2019034 Norway   Get Started Free PRODUCT NAME: LORLATINIB; REG. NO/DATE: EU/1/19/1355 20190523
2822953 CA 2019 00041 Denmark   Get Started Free 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

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
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AstraZeneca

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