LORLATINIB - Generic Drug Details
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What are the generic sources for lorlatinib and what is the scope of freedom to operate?
Lorlatinib
is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lorlatinib has one hundred and eighteen patent family members in fifty countries.
Two suppliers are listed for this compound.
Summary for LORLATINIB
International Patents: | 118 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 32 |
Patent Applications: | 102 |
What excipients (inactive ingredients) are in LORLATINIB? | LORLATINIB excipients list |
DailyMed Link: | LORLATINIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LORLATINIB
Generic Entry Date for LORLATINIB*:
Constraining patent/regulatory exclusivity:
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 LORLATINIB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Guangdong Provincial People's Hospital | Phase 2 |
Nuvalent Inc. | Phase 1/Phase 2 |
CStone Pharmaceuticals | Phase 2 |
Pharmacology for LORLATINIB
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 | ⤷ 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 | 210868-002 | Nov 2, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
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 | ||||
>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 LORLATINIB
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 LORLATINIB
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E062926 | ⤷ Try a Trial | |
Slovenia | 3328867 | ⤷ Try a Trial | |
Norway | 2019034 | ⤷ Try a Trial | |
Canada | 2863892 | DERIVES MACROCYCLIQUES POUR LE TRAITEMENT DE MALADIES PROLIFERATIVES (MACROCYCLIC DERIVATIVES FOR THE TREATMENT OF PROLIFERATIVE DISEASES) | ⤷ Try a Trial |
Morocco | 37291 | Dérivés macrocycliques pour le traitement de maladies prolifératives | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LORLATINIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2822953 | 2019C/539 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER |
2822953 | CR 2019 00041 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LORLATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1355 20190508 |
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 | 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 | 301006 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1355 20190508 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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