Details for New Drug Application (NDA): 208065
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NDA 208065 describes TAGRISSO, which is a drug marketed by Astrazeneca 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 TAGRISSO profile page.
The generic ingredient in TAGRISSO is osimertinib mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the osimertinib mesylate profile page.
The generic ingredient in TAGRISSO is osimertinib mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the osimertinib mesylate profile page.
Summary for 208065
| Tradename: | TAGRISSO |
| Applicant: | Astrazeneca |
| Ingredient: | osimertinib mesylate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208065
Generic Entry Date for 208065*:
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: 208065
Suppliers and Packaging for NDA: 208065
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065 | NDA | AstraZeneca Pharmaceuticals LP | 0310-1349 | 0310-1349-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-1349-30) |
| TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065 | NDA | AstraZeneca Pharmaceuticals LP | 0310-1350 | 0310-1350-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-1350-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Nov 13, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 18, 2027 | ||||||||
| Regulatory Exclusivity Use: | FOR ADJUVANT THERAPY AFTER TUMOR RESECTION IN ADULT PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Feb 16, 2027 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE EGFR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Apr 18, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
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