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Last Updated: June 28, 2022

Gefitinib - Generic Drug Details


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What are the generic sources for gefitinib and what is the scope of patent protection?

Gefitinib is the generic ingredient in one branded drug marketed by Astrazeneca and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for gefitinib. One supplier is listed for this compound.

Summary for gefitinib
Recent Clinical Trials for gefitinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AIO-Studien-gGmbHPhase 2
European Thoracic Oncology PlatformPhase 2
Forward Pharmaceuticals Co., Ltd.Phase 1/Phase 2

See all gefitinib clinical trials

Pharmacology for gefitinib
Drug ClassKinase Inhibitor
Mechanism of Action Protein 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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 206995-001 Jul 13, 2015 See Plans and Pricing See Plans and Pricing
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 See Plans and Pricing See Plans and Pricing
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 See Plans and Pricing See Plans and Pricing
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 See Plans and Pricing See Plans and Pricing
>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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