Details for New Drug Application (NDA): 208772
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NDA 208772 describes ALUNBRIG, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ALUNBRIG profile page.
The generic ingredient in ALUNBRIG is brigatinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the brigatinib profile page.
The generic ingredient in ALUNBRIG is brigatinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the brigatinib profile page.
Summary for 208772
| Tradename: | ALUNBRIG |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | brigatinib |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208772
Generic Entry Date for 208772*:
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: 208772
| Mechanism of Action | Cytochrome P450 3A Inducers Tyrosine Kinase Inhibitors |
Suppliers and Packaging for NDA: 208772
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALUNBRIG | brigatinib | TABLET;ORAL | 208772 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-090 | 63020-090-07 | 7 TABLET, FILM COATED in 1 BOTTLE (63020-090-07) |
| ALUNBRIG | brigatinib | TABLET;ORAL | 208772 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-090 | 63020-090-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63020-090-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Apr 28, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 22, 2027 | ||||||||
| Regulatory Exclusivity Use: | FOR 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, NOT INCLUDING PATIENTS WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB | ||||||||
| Patent: | 10,385,078 | Patent Expiration: | Nov 10, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) | ||||||||
| Patent: | 9,012,462 | Patent Expiration: | Apr 28, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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