Details for New Drug Application (NDA): 210868
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NDA 210868 describes LORBRENA, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the LORBRENA profile page.
The generic ingredient in LORBRENA is lorlatinib. Two suppliers are listed for this compound. Additional details are available on the lorlatinib profile page.
The generic ingredient in LORBRENA is lorlatinib. Two suppliers are listed for this compound. Additional details are available on the lorlatinib profile page.
Summary for 210868
| Tradename: | LORBRENA |
| Applicant: | Pfizer |
| Ingredient: | lorlatinib |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210868
Generic Entry Date for 210868*:
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.
Pharmacology for NDA: 210868
Suppliers and Packaging for NDA: 210868
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LORBRENA | lorlatinib | TABLET;ORAL | 210868 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0227 | 0069-0227-01 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0227-01) |
| LORBRENA | lorlatinib | TABLET;ORAL | 210868 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0227 | 0069-0227-03 | 120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Nov 2, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 3, 2028 | ||||||||
| Regulatory Exclusivity 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, 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 | ||||||||
| Patent: | 10,420,749 | Patent Expiration: | Jul 27, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| 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 | ||||||||
| Patent: | 10,420,749 | Patent Expiration: | Jul 27, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| 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. | ||||||||
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