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Last Updated: March 28, 2024

Gefitinib - Generic Drug Details


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Drug Prices for gefitinib

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Recent Clinical Trials for gefitinib

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SponsorPhase
Daiichi Sankyo, Inc.Phase 2
MedSIRPhase 2
AIO-Studien-gGmbHPhase 2

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Pharmacology for gefitinib
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for gefitinib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca IRESSA gefitinib TABLET;ORAL 206995-001 Jul 13, 2015 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Natco GEFITINIB gefitinib TABLET;ORAL 212827-001 May 31, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex GEFITINIB gefitinib TABLET;ORAL 209532-001 Sep 23, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Qilu Pharm Hainan GEFITINIB gefitinib TABLET;ORAL 211591-001 Feb 13, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for gefitinib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca IRESSA gefitinib TABLET;ORAL 206995-001 Jul 13, 2015 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for gefitinib

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Gefitinib Mylan gefitinib EMEA/H/C/004826
Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) with activating mutations of EGFR‑TK.
Authorised yes no no 2018-09-27
AstraZeneca AB Iressa gefitinib EMEA/H/C/001016
Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.
Authorised no no no 2009-06-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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