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. 6 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.

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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

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Clinical Trials

Recent Clinical Trials on Gefitinib:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Lenvatinib Plus Tislelizumab With or Without Gefitinib for Advanced Liver Cancer First Affiliated Hospital of Wenzhou Medical University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE) European Organisation for Research and Treatment of Cancer - EORTC NA COMPLETED
(May 1, 2026)
PHASE2
Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions Hunan Kelun Pharmaceutical Co., Ltd. NA COMPLETED
(May 1, 2026)
PHASE1
Bioequivalence Study of Gefitinib Tablets Under Fed Conditions Hunan Kelun Pharmaceutical Co., Ltd. NA COMPLETED
(May 1, 2026)
PHASE1
Ningetinib (CT053PTSA) Plus Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative Sunshine Lake Pharma Co., Ltd. NA COMPLETED
(May 1, 2026)
PHASE1, PHASE2
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301) Yuhan Corporation NA COMPLETED
(May 1, 2026)
PHASE3
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer AstraZeneca NA COMPLETED
(Apr 1, 2026)
PHASE3
Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme Centre Antoine Lacassagne NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer Dana-Farber Cancer Institute NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations Instituto Nacional de Cancerologia de Mexico NA RECRUITING
(Apr 1, 2026)
PHASE3


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.