Lorlatinib Patent Expiration

Lorlatinib is Used for treating adult patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. It was first introduced by Pfizer Inc in its drug Lorbrena on Nov 2, 2018.


Lorlatinib Patents

Given below is the list of patents protecting Lorlatinib, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Lorbrena US11299500 Crystalline form of lorlatinib free base hydrate Oct 04, 2038 Pfizer
Lorbrena US10420749 Crystalline form of lorlatinib free base Jul 27, 2036 Pfizer
Lorbrena US11020376 Crystalline form of lorlatinib free base Jul 27, 2036 Pfizer
Lorbrena US8680111 Macrocyclic derivatives for the treatment of diseases Mar 05, 2033 Pfizer



Lorlatinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Lorlatinib:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) Astellas Pharma Global Development, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE1
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC TRIANA Biomedicines, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer Chugai Pharmaceutical NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Lorlatinib Plus Sacituzumab Tirumotecan With Peripheral ctDNA Guidance as First-Line Therapy for ALK Fusion-Positive NSCLC Guangdong Association of Clinical Trials NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib University of Chicago NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Study of NXP900 With Lorlatinib in ALK+ Lung Cancer Nuvectis Pharma, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma University of Milano Bicocca NA COMPLETED
(May 1, 2026)
PHASE2
Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer M.D. Anderson Cancer Center NA RECRUITING
(Apr 1, 2026)
PHASE2


Lorlatinib Generic API Manufacturers

Given below is the list of companies who have filed for Lorlatinib generic, along with the locations of their manufacturing plants worldwide.