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 | 0069-0231 | 0069-0231-01 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01) |
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, 2024 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Regulatory Exclusivity Expiration: | Nov 2, 2025 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Regulatory Exclusivity Expiration: | Nov 2, 2025 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
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