Serving 500+ biopharmaceutical companies globally:
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Serving 500+ biopharmaceutical companies globally:
Generated: June 23, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 1 |
| Therapeutic Class: | Antineoplastics |
| Formulation / Manufacturing: | see details |
| Mechanism of Action | Protein Kinase Inhibitors |
| 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) |
IRESSA |
gefitinib |
TABLET;ORAL | 206995 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0482 | 0310-0482-93 | 30 TABLET, COATED in 1 BOTTLE (0310-0482-93) |
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Jul 13, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 5,770,599 | Patent Expiration: | May 5, 2017 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | 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 | ||||||||
| Regulatory Exclusivity Expiration: | Jul 13, 2018 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Jul 13, 2022 | ||||||||
| Regulatory Exclusivity Use: | ORPHAN DRUG EXCLUSIVITY | ||||||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Pharms | IRESSA | gefitinib | TABLET;ORAL | 206995-001 | Jul 13, 2015 | 5,770,599 | ► Subscribe | ||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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