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 twenty-one patent family members in fifty 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
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Summary for LORBRENA
| International Patents: | 121 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 6 |
| Patent Applications: | 221 |
| 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
*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 2 |
| SCRI Development Innovations, LLC | Phase 2 |
| Guangdong Association of Clinical Trials | Phase 2 |
Pharmacology for LORBRENA
US Patents and Regulatory Information for LORBRENA
LORBRENA is protected by five US patents and five FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LORBRENA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Crystalline form of lorlatinib free base hydrate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Macrocyclic derivatives for the treatment of diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting LORBRENA
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868-001 | Nov 2, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868-002 | Nov 2, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868-002 | Nov 2, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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
Patent: FORMA CRISTALINA DE HIDRATO DE LORLATINIB BASE LIBRE
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 18349259
Patent: Crystalline form of lorlatinib free base hydrate
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2020005989
Patent: forma cristalina de hidrato de base livre de lorlatinibe
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 77508
Patent: FORME CRISTALLINE D'HYDRATE DE BASE LIBRE DE LORLATINIB (CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1201235
Patent: 劳拉替尼游离碱水合物的结晶形式 (CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE)
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 26141
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 94863
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 94863
Patent: FORME CRISTALLINE D'HYDRATE DE BASE LIBRE DE LORLATINIB (CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 94863
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 62926
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 53069
Estimated Expiration: ⤷ Sign Up
Patent: 20536893
Patent: ロルラチニブ遊離塩基水和物の結晶形態
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 20003373
Patent: FORMA CRISTALINA DE HIDRATO DE LORLATINIB BASE LIBRE. (CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE.)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 94863
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 94863
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 20113141
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ГИДРАТА СВОБОДНОГО ОСНОВАНИЯ ЛОРЛАТИНИБА
Estimated Expiration: ⤷ Sign Up
Patent: 22109286
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ГИДРАТА СВОБОДНОГО ОСНОВАНИЯ ЛОРЛАТИНИБА
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202002445S
Patent: CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 94863
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 2001661
Patent: CRYSTALLINE FORM OF LORLATINIB FREE BASE HYDRATE
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2424621
Estimated Expiration: ⤷ Sign Up
Patent: 200051781
Patent: 로라티닙 유리 염기 수화물의 결정질 형태
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 52985
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 75960
Estimated Expiration: ⤷ Sign Up
Patent: 1922753
Patent: Crystalline form of LORLATINIB free base hydrate
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Argentina | 113754 | FORMA CRISTALINA DE HIDRATO DE LORLATINIB BASE LIBRE | ⤷ Sign Up |
| South Africa | 201406244 | MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES | ⤷ Sign Up |
| Japan | 6218253 | ⤷ Sign Up | |
| Hungary | E052790 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1355 20190508 |
| 2822953 | 2019C/539 | Belgium | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER |
| 2822953 | 2019034 | Norway | ⤷ Sign Up | PRODUCT NAME: LORLATINIB; REG. NO/DATE: EU/1/19/1355 20190523 |
| 2822953 | PA2019519 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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