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Details for New Drug Application (NDA): 206995
NDA 206995 describes IRESSA, which is a drug marketed by Astrazeneca and Astrazeneca Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the IRESSA profile page.
The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gefitinib profile page.
The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gefitinib profile page.
Summary for 206995
| Tradename: | IRESSA |
| Applicant: | Astrazeneca Pharms |
| Ingredient: | gefitinib |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 206995
Generic Entry Date for 206995*:
Constraining patent/regulatory exclusivity:
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) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST 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: 206995
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 206995
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IRESSA | gefitinib | TABLET;ORAL | 206995 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0482 | 0310-0482-30 | 30 TABLET, COATED in 1 BOTTLE (0310-0482-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Jul 13, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 13, 2022 | ||||||||
| Regulatory Exclusivity Use: | 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) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
Expired US Patents for NDA 206995
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Pharms | IRESSA | gefitinib | TABLET;ORAL | 206995-001 | Jul 13, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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