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Last Updated: November 5, 2024

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 and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lorlatinib has one hundred and twenty-one patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for LORLATINIB
International Patents:121
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 61
Clinical Trials: 34
Patent Applications: 102
What excipients (inactive ingredients) are in LORLATINIB?LORLATINIB excipients list
DailyMed Link:LORLATINIB at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LORLATINIB
Generic Entry Date for LORLATINIB*:
Constraining patent/regulatory exclusivity:
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 LORLATINIB

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

SponsorPhase
SCRI Development Innovations, LLCPhase 2
Guangdong Association of Clinical TrialsPhase 2
Guangdong Provincial People's HospitalPhase 2

See all LORLATINIB clinical trials

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes ⤷  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 ⤷  Sign Up
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  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 LORLATINIB

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

Supplementary Protection Certificates for LORLATINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2822953 301006 Netherlands ⤷  Sign Up PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1355 20190508
2822953 2019C/539 Belgium ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
2822953 2019034 Norway ⤷  Sign Up PRODUCT NAME: LORLATINIB; REG. NO/DATE: EU/1/19/1355 20190523
2822953 PA2019519 Lithuania ⤷  Sign Up PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
>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.