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Last Updated: October 25, 2021

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Lorlatinib - Generic Drug Details

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

Lorlatinib has eighty-one patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for lorlatinib
International Patents:81
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 50
Clinical Trials: 22
Patent Applications: 87
What excipients (inactive ingredients) are in lorlatinib?lorlatinib excipients list
DailyMed Link:lorlatinib at DailyMed
Recent Clinical Trials for lorlatinib

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

SponsorPhase
University of Colorado, DenverPhase 1
National Cancer Institute (NCI)Phase 1
European Organisation for Research and Treatment of Cancer - EORTCPhase 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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it 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 lorlatinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2822953 122019000088 Germany ⤷  Try it Free PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953 PA2019519,C2822953 Lithuania ⤷  Try it Free PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953 2019C/539 Belgium ⤷  Try it Free PRODUCT NAME: LORLATINIB; AUTHORISATION NUMBER AND 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:

Express Scripts
Boehringer Ingelheim
Dow
Baxter
AstraZeneca
McKesson

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