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 ninety-four patent family members in forty-seven countries.
The generic ingredient in LORBRENA is lorlatinib. One supplier is listed for this compound. Additional details are available on the lorlatinib profile page.
DrugPatentWatch® Generic Entry Outlook for Lorbrena
Lorbrena will be eligible for patent challenges on November 2, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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: | 94 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Clinical Trials: | 4 |
Patent Applications: | 60 |
Drug Prices: | Drug price information for LORBRENA |
What excipients (inactive ingredients) are in LORBRENA? | LORBRENA excipients list |
DailyMed Link: | LORBRENA at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity 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 |
Pfizer | Phase 1/Phase 2 |
Array BioPharma | Phase 1/Phase 2 |
Pharmacology for LORBRENA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A4 Inducers Kinase Inhibitors |
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 See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline form of lorlatinib free base hydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Macrocyclic derivatives for the treatment of diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting LORBRENA
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
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: See Plans and Pricing
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: See Plans and Pricing
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: See Plans and Pricing
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: See Plans and Pricing
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: 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868-001 | Nov 2, 2018 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | 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 | 210868-001 | Nov 2, 2018 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868-001 | 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 | Y | Y | 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 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: See Plans and Pricing
Australia
Patent: 18349259
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2020005989
Estimated Expiration: See Plans and Pricing
Canada
Patent: 77508
Estimated Expiration: See Plans and Pricing
China
Patent: 1201235
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 94863
Estimated Expiration: See Plans and Pricing
Japan
Patent: 20536893
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 20113141
Estimated Expiration: See Plans and Pricing
Patent: 22109286
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 202002445S
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 200051781
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 1922753
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
Australia | 2016304420 | Crystalline form of lorlatinib free base | See Plans and Pricing |
Croatia | P20170287 | See Plans and Pricing | |
Cuba | 20140107 | DERIVADOS MACROCÍCLICOS PARA EL TRATAMIENTO DE ENFERMEDADES | See Plans and Pricing |
Tunisia | 2014000371 | DÉRIVÉS MACROCYCLIQUES POUR LE TRAITEMENT DE MALADIES PROLIFÉRATIVES | See Plans and Pricing |
Canada | 2863892 | DERIVES MACROCYCLIQUES POUR LE TRAITEMENT DE MALADIES PROLIFERATIVES (MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LORBRENA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 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 | LUC00131 | Luxembourg | See Plans and Pricing | PRODUCT NAME: LORLATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/19/1355 20190508 |
2822953 | 1990042-2 | Sweden | See Plans and Pricing | PRODUCT NAME: LORLATINIB; REG. NO/DATE: EU/1/19/1355 20190508 |
2822953 | C201930063 | Spain | See Plans and Pricing | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |