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 in its drug Iressa on May 5, 2003. 5 different companies have introduced drugs containing Gefitinib.


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

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List

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 Natco Pharma Ltd and was approved on May 31, 2023.

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.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
Toronto Apotex Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Brantford Apotex Pharmachem Inc.
India
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre





3. 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
Buckingham Natco Foods Ltd
Hayes Natco Cash and Carry
India
Paravada Natco Pharma Limited
Hyderabad Natco Pharma Limited
Rangareddy NATCO Pharma Limited
Rangareddy District Natco Pharma Ltd. - Chemical Division
Hyderabad NATCO PHARMA LTD
Chennai NATCO Pharma Limited Chemical Division Chennai





4. 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