Lorlatinib - Generic Drug Details
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What are the generic drug sources for lorlatinib and what is the scope of patent protection?
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 ninety-six patent family members in forty-seven countries.
One supplier is listed for this compound.
Summary for lorlatinib
International Patents: | 96 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Clinical Trials: | 31 |
Patent Applications: | 93 |
What excipients (inactive ingredients) are in lorlatinib? | lorlatinib excipients list |
DailyMed Link: | lorlatinib at DailyMed |
Recent Clinical Trials for lorlatinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Nuvalent Inc. | Phase 1/Phase 2 |
CStone Pharmaceuticals | Phase 2 |
Centre Hospitalier Universitaire Vaudois | Phase 1 |
Pharmacology for lorlatinib
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A4 Inducers Kinase Inhibitors |
US Patents and Regulatory Information for lorlatinib
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; or, crizotinib 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 |
---|---|---|---|
Taiwan | 201718600 | Crystalline form of lorlatinib free base | See Plans and Pricing |
Taiwan | 201350484 | Macrocyclic derivatives for the treatment of diseases | See Plans and Pricing |
Lithuania | PA2019519 | See Plans and Pricing | |
Hungary | S1900040 | See Plans and Pricing | |
Norway | 2019034 | See Plans and Pricing | |
New Zealand | 627900 | Macrocyclic derivatives for the treatment of proliferative diseases | See Plans and Pricing |
European Patent Office | 3798222 | FORME CRISTALLINE DE BASE LIBRE DE LORLATINIB (CRYSTALLINE FORM OF LORLATINIB FREE BASE) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lorlatinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | PA2019519 | Lithuania | See Plans and Pricing | PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506 |
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 | PA2019519,C2822953 | Lithuania | See Plans and Pricing | PRODUCT NAME: LORLATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/19/1355 20190506 |
2822953 | 122019000088 | Germany | See Plans and Pricing | PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506 |
2822953 | 41/2019 | Austria | See Plans and Pricing | PRODUCT NAME: LORLATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 (MITTEILUNG) 20190508 |
2822953 | C20190036 00302 | Estonia | See Plans and Pricing | PRODUCT NAME: LORLATINIIB;REG NO/DATE: EU/1/19/1355 08.05.2019 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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