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Last Updated: January 27, 2023

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

Lorlatinib has ninety-six patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for lorlatinib
International Patents:96
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 56
Clinical Trials: 31
Patent Applications: 93
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
Nuvalent Inc.Phase 1/Phase 2
CStone PharmaceuticalsPhase 2
Centre Hospitalier Universitaire VaudoisPhase 1

See all lorlatinib clinical trials

Pharmacology for lorlatinib

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 210868-002 Nov 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-001 Nov 2, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer LORBRENA lorlatinib TABLET;ORAL 210868-002 Nov 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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; or, crizotinib 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 lorlatinib

Country Patent Number Title Estimated Expiration
Taiwan 201718600 Crystalline form of lorlatinib free base See Plans and Pricing
Taiwan 201350484 Macrocyclic derivatives for the treatment of diseases See Plans and Pricing
Lithuania PA2019519 See Plans and Pricing
Hungary S1900040 See Plans and Pricing
Norway 2019034 See Plans and Pricing
New Zealand 627900 Macrocyclic derivatives for the treatment of proliferative diseases See Plans and Pricing
European Patent Office 3798222 FORME CRISTALLINE DE BASE LIBRE DE LORLATINIB (CRYSTALLINE FORM OF LORLATINIB FREE BASE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lorlatinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2822953 19C1062 France See Plans and Pricing PRODUCT NAME: LORLATINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/19/1355 20190508; FIRST REGISTRATION: - EU/1/19/1355 20190508
2822953 PA2019519 Lithuania See Plans and Pricing PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953 301006 Netherlands See Plans and Pricing PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1355 20190508
2822953 PA2019519,C2822953 Lithuania See Plans and Pricing PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953 122019000088 Germany See Plans and Pricing PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506
2822953 41/2019 Austria See Plans and Pricing PRODUCT NAME: LORLATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 (MITTEILUNG) 20190508
2822953 C20190036 00302 Estonia See Plans and Pricing PRODUCT NAME: LORLATINIIB;REG NO/DATE: EU/1/19/1355 08.05.2019
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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