LORBRENA Drug Patent Profile
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When do Lorbrena patents expire, and what generic alternatives are available?
Lorbrena is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and one patent family members in forty-seven countries.
The generic ingredient in LORBRENA is lorlatinib. Two suppliers are listed for this compound. Additional details are available on the lorlatinib profile page.
DrugPatentWatch® Generic Entry Outlook for Lorbrena
Lorbrena was eligible for patent challenges on November 2, 2022.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 4, 2038. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for LORBRENA
International Patents: | 101 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 58 |
Clinical Trials: | 4 |
Patent Applications: | 68 |
Drug Prices: | Drug price information for LORBRENA |
What excipients (inactive ingredients) are in LORBRENA? | LORBRENA excipients list |
DailyMed Link: | LORBRENA at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LORBRENA
Generic Entry Date for LORBRENA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for LORBRENA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Pfizer | Phase 1 |
Massachusetts General Hospital | Phase 1/Phase 2 |
Pfizer | Phase 1/Phase 2 |
Pharmacology for LORBRENA
Anatomical Therapeutic Chemical (ATC) Classes for LORBRENA
US Patents and Regulatory Information for LORBRENA
LORBRENA is protected by five US patents and six FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LORBRENA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting LORBRENA
Crystalline form of lorlatinib free base
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER, PROGRESSED ON: CRIZOTINIB + AT LEAST 1 OTHER ALK INHIBITOR FOR METASTATIC DISEASE; OR ALECTINIB, OR CERITINIB AS FIRST ALK INHIBITOR FOR METASTATIC DISEASE.
Crystalline form of lorlatinib free base
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Crystalline form of lorlatinib free base
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Crystalline form of lorlatinib free base hydrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Macrocyclic derivatives for the treatment of diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting LORBRENA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON ALECTINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE
Exclusivity Expiration: ⤷ Try a Trial
INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON CRIZOTINIB AND AT LEAST ONE OTHER ALK INHIBITOR FOR METASTATIC DIESASE
Exclusivity Expiration: ⤷ Try a Trial
INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON CERITINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE
Exclusivity Expiration: ⤷ Try a Trial
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, EXCLUDING PATIENTS WHOSE DISEASE HAS PROGRESSED ON CRIZOTINIB AND AT LEAST ONE OTHER ALK INHIBITOR FOR METASTATIC DISEASE; OR ALECTINIB OR CERITINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE
Exclusivity Expiration: ⤷ Try a Trial
EXPANDED INDICATION OF THE TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Try a Trial
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 a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868-002 | Nov 2, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868-001 | Nov 2, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868-001 | Nov 2, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 LORBRENA
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; orcrizotinib 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 LORBRENA
When does loss-of-exclusivity occur for LORBRENA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 3754
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 18349259
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2020005989
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 77508
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1201235
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 94863
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 53069
Estimated Expiration: ⤷ Try a Trial
Patent: 20536893
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 20003373
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 20113141
Estimated Expiration: ⤷ Try a Trial
Patent: 22109286
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 202002445S
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2424621
Estimated Expiration: ⤷ Try a Trial
Patent: 200051781
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 75960
Estimated Expiration: ⤷ Try a Trial
Patent: 1922753
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering LORBRENA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 201406244 | MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES | ⤷ Try a Trial |
South Korea | 20140137414 | MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES | ⤷ Try a Trial |
Singapore | 11201404451T | MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES | ⤷ Try a Trial |
European Patent Office | 3798222 | FORME CRISTALLINE DE BASE LIBRE DE LORLATINIB (CRYSTALLINE FORM OF LORLATINIB FREE BASE) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LORBRENA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2822953 | C201930063 | Spain | ⤷ Try a Trial | PRODUCT NAME: LORLATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1355; DATE OF AUTHORISATION: 20190506; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1355; DATE OF FIRST AUTHORISATION IN EEA: 20190506 |
2822953 | 19C1062 | France | ⤷ Try a Trial | 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 | 374 17-2019 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: LORLATINIB; REGISTRATION NO/DATE: EU/1/19/1355 20190508 |
2822953 | 122019000088 | Germany | ⤷ Try a Trial | PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |