Lorbrena Patent Expiration

Can you believe LORBRENA received compensation for the extended wait time during the regulatory approval process?
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8680111 PFIZER Macrocyclic derivatives for the treatment of diseases
Mar, 2033

(8 years from now)

US10420749 PFIZER Crystalline form of lorlatinib free base
Jul, 2036

(12 years from now)

US11299500 PFIZER Crystalline form of lorlatinib free base hydrate
Oct, 2038

(14 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11020376 PFIZER Crystalline form of lorlatinib free base
Jul, 2036

(12 years from now)



Lorbrena is a drug owned by Pfizer Inc. It is used for treating adult patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. Lorbrena uses Lorlatinib as an active ingredient. Lorbrena was launched by Pfizer in 2018. It is is available in tablet form for oral use. Its generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 04, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Nov 02, 2023
New Indication(I-847) Mar 03, 2024
Orphan Drug Exclusivity(ODE-218) Nov 02, 2025
Orphan Drug Exclusivity(ODE-219) Nov 02, 2025
Orphan Drug Exclusivity(ODE-217) Nov 02, 2025
Orphan Drug Exclusivity(ODE-349) Mar 03, 2028

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Drugs and Companies using LORLATINIB ingredient

NCE-1 date: 02 November, 2022

Market Authorisation Date: 02 November, 2018

Treatment: Treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive as detected by an fda-approved test

Dosage: TABLET

More Information on Dosage

LORBRENA family patents

Family Patents