Gefitinib Patent Expiration
Gefitinib is Used for treating patients with metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. It was first introduced by Astrazeneca Uk Ltd
Gefitinib Patents
Given below is the list of patents protecting Gefitinib, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Iressa | US5770599 | Quinazoline derivatives |
May 05, 2017
(Expired) | Astrazeneca |
| Iressa | US5770599 | Quinazoline derivatives |
May 05, 2017
(Expired) | Astrazeneca |
| Iressa | US5457105 | Quinazoline derivatives useful for treatment of neoplastic disease |
Jan 19, 2013
(Expired) | Astrazeneca |
| Iressa | US5616582 | Quinazoline derivatives as anti-proliferative agents |
Jan 19, 2013
(Expired) | Astrazeneca |
Gefitinib's Family Patents
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Gefitinib Generic API Manufacturers
Several generic applications have been filed for Gefitinib. The first generic version for Gefitinib was by Apotex Inc and was approved on Sep 23, 2022. And the latest generic version is by Cipla Ltd and was approved on May 16, 2025.
Given below is the list of companies who have filed for Gefitinib generic, along with the locations of their manufacturing plants worldwide.
1. ACTAVIS LABS FL INC
Actavis Laboratories Fl Inc has filed for 1 generic for Gefitinib. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | Apr 26, 2023 |
2. APOTEX
Apotex Inc has filed for 1 generic for Gefitinib. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | Sep 23, 2022 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Canada |
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| India |
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3. CIPLA
Cipla Ltd has filed for 1 generic for Gefitinib. Given below are the details of the strengths of this generic introduced by Cipla.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | May 16, 2025 |
Manufacturing Plant Locations New
Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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4. NATCO
Natco Pharma Ltd has filed for 1 generic for Gefitinib. Given below are the details of the strengths of this generic introduced by Natco.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | May 31, 2023 |
Manufacturing Plant Locations New
Natco's manufacturing plants are situated in 2 countries - United Kingdom, India. Given below are the details of these plant locations as well as the firm names of Natco as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United Kingdom |
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| India |
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5. QILU PHARM HAINAN
Qilu Pharmaceutical Hainan Co Ltd has filed for 1 generic for Gefitinib. Given below are the details of the strengths of this generic introduced by Qilu Pharm Hainan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | Feb 13, 2023 |