Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (8)

Oct 4, 2038compositionUS 11299500
Oct 4, 2038compositionUS 11299500
Jul 27, 2036compositionUS 10420749
Jul 27, 2036compositionUS 10420749
Jul 27, 2036formulationUS 11020376
Jul 27, 2036formulationUS 11020376
Mar 5, 2033compositionUS 8680111
Mar 5, 2033compositionUS 8680111

FDA exclusivities (2)

Mar 3, 2028ODE-349Orphan Drug (7y)1.5y
Mar 3, 2028ODE-349Orphan Drug (7y)1.5y

News(2)

OncLive Polls Reveal Picks for Top Lung Cancer Abstracts at ASCO 2026
Lung cancer experts rank key abstracts of interest from the upcoming ASCO Annual Meeting on OncLive’s social media.
onclive · 3mo ago
Track the Lung Cancer Abstracts That are Gaining Attention at ASCO 2026
Read on to see what data are poised to shape clinical discussions and decision-making in lung cancer at 2026 ASCO Annual Meeting in Chicago, Illinois.
onclive · 3mo ago

brand

Lorbrena

generic

lorlatinib

MOA

12.1 Mechanism of Action Lorlatinib is a kinase inhibitor with in vitro activity against ALK and ROS1 as well as TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, and ACK. Lorlatinib demonstrated in vitro activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors. In mice subcutaneously implanted with tumors harboring EML4 fusions with either ALK variant 1 or ALK mutations, including the G1202R and I1171T mutations detected in tumors at the time of disease progression on ALK inhibitors, administration of lorlatinib resulted in antitumor activity. Lorlatinib also demonstrated anti-tumor activity and prolonged survival in mice implanted intracranially with EML4-ALK-driven tumor cell lines. The overall antitumor activity of lorlatinib in in vivo models was dose-dependent and correlated with inhibition of ALK phosphorylation.

indication

Non-Small Cell Lung Cancer

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 4m ago

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drug

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lorlatinib

Marketedupdated 3mo ago

by $PFE PFIZER INC

Approved

community read0 votes

🐶 often sniffed alongside

top 3

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 5 investigational indications.

indications

investigational

NSCLC

all catalysts(7)

approval · 7

LORBRENA (LORLATINIB) — FDA approval

LORBRENA (LORLATINIB) — FDA approval

LORBRENA (LORLATINIB) — FDA approval

LORBRENA (LORLATINIB) — FDA approval

LORBRENA (LORLATINIB) — FDA approval

LORBRENA (LORLATINIB) — FDA approval

LORBRENA (LORLATINIB) — FDA approval

lorlatinib

→

Trials studying lorlatinib

phase2A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Canceractive not recruitingn=9
phase2A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphomacompletedn=9
phase1PF-07284892 in Participants With Advanced Solid Tumorsterminatedn=53
phase1AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancernot yet recruitingn=102
phase2A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Canceractive not recruitingn=70
—A Study to Learn About Study Medicine Lorlatinib, as a First-line Treatment in Chinese Adults With ALK-positive a/mNSCLCactive not recruitingn=50
N/AAnalysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Contextrecruitingn=90
EP1Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusionrecruitingn=15

more trials →

Patent cliff

source: FDA Orange Book

first barrier falls

Mar 3, 2028

~1.5 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (8)

Oct 4, 2038compositionUS 11299500
Oct 4, 2038compositionUS 11299500
Jul 27, 2036compositionUS 10420749
Jul 27, 2036compositionUS 10420749
Jul 27, 2036formulationUS 11020376
Jul 27, 2036formulationUS 11020376
Mar 5, 2033compositionUS 8680111
Mar 5, 2033compositionUS 8680111

FDA exclusivities (2)

Mar 3, 2028ODE-349Orphan Drug (7y)1.5y
Mar 3, 2028ODE-349Orphan Drug (7y)1.5y

News(2)

OncLive Polls Reveal Picks for Top Lung Cancer Abstracts at ASCO 2026
Lung cancer experts rank key abstracts of interest from the upcoming ASCO Annual Meeting on OncLive’s social media.
onclive · 3mo ago
Track the Lung Cancer Abstracts That are Gaining Attention at ASCO 2026
Read on to see what data are poised to shape clinical discussions and decision-making in lung cancer at 2026 ASCO Annual Meeting in Chicago, Illinois.
onclive · 3mo ago

brand

Lorbrena

generic

lorlatinib

MOA

indication

Non-Small Cell Lung Cancer

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 4m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

lorlatinib

🐶 often sniffed alongside

indications

all catalysts(7)

Trials studying lorlatinib

Patent cliff

patents (8)

FDA exclusivities (2)

News(2)

Report a data issue

comments(0)

lorlatinib

🐶 often sniffed alongside

indications

all catalysts(7)

Trials studying lorlatinib

Patent cliff

patents (8)

FDA exclusivities (2)

News(2)

Report a data issue

comments(0)