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 twenty-one patent family members in fifty countries.
Two suppliers are listed for this compound.
Summary for LORLATINIB
International Patents: | 121 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 34 |
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 |
---|---|
SCRI Development Innovations, LLC | Phase 2 |
Guangdong Association of Clinical Trials | Phase 2 |
Guangdong Provincial People's Hospital | 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868-002 | Nov 2, 2018 | RX | Yes | Yes | ⤷ 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 | ⤷ Sign Up | ||||
Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868-001 | Nov 2, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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 |
---|---|---|---|
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 LORLATINIB
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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