GEFITINIB Drug Patent Profile
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Which patents cover Gefitinib, and when can generic versions of Gefitinib launch?
Gefitinib is a drug marketed by Actavis Labs Fl Inc, Apotex, Natco, and Qilu Pharm Hainan. and is included in four NDAs.
The generic ingredient in GEFITINIB is gefitinib. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gefitinib profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gefitinib
A generic version of GEFITINIB was approved as gefitinib by APOTEX on September 23rd, 2022.
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Questions you can ask:
- What is the 5 year forecast for GEFITINIB?
- What are the global sales for GEFITINIB?
- What is Average Wholesale Price for GEFITINIB?
Summary for GEFITINIB
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 155 |
| Clinical Trials: | 386 |
| Drug Prices: | Drug price information for GEFITINIB |
| DailyMed Link: | GEFITINIB at DailyMed |
Recent Clinical Trials for GEFITINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| China Medical University Hospital | Phase 1/Phase 2 |
| MedSIR | Phase 2 |
| Daiichi Sankyo, Inc. | Phase 2 |
Pharmacology for GEFITINIB
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for GEFITINIB
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Labs Fl Inc | GEFITINIB | gefitinib | TABLET;ORAL | 208913-001 | Apr 26, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Qilu Pharm Hainan | GEFITINIB | gefitinib | TABLET;ORAL | 211591-001 | Feb 13, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | GEFITINIB | gefitinib | TABLET;ORAL | 209532-001 | Sep 23, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Natco | GEFITINIB | gefitinib | TABLET;ORAL | 212827-001 | May 31, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 |
