Iressa is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 3 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 13, 2022. Details of Iressa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US5770599 | Quinazoline derivatives |
May, 2017
(7 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5770599 | Quinazoline derivatives |
May, 2017
(7 years ago) |
Expired
|
| US5616582 | Quinazoline derivatives as anti-proliferative agents |
Jan, 2013
(11 years ago) |
Expired
|
| US5457105 | Quinazoline derivatives useful for treatment of neoplastic disease |
Jan, 2013
(11 years ago) |
Expired
|
FDA has granted several exclusivities to Iressa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Iressa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Iressa.
Exclusivity Information
Iressa holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Iressa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 13, 2018 |
| Orphan Drug Exclusivity(ODE) | Jul 13, 2022 |
| Orphan Drug Exclusivity(ODE-95) | Jul 13, 2022 |
US patents provide insights into the exclusivity only within the United States, but Iressa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Iressa's family patents as well as insights into ongoing legal events on those patents.
Iressa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Iressa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 13, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Iressa Generic API suppliers:
Gefitinib is the generic name for the brand Iressa. 4 different companies have already filed for the generic of Iressa, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Iressa's generic
About Iressa
Iressa is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for treating patients with metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. Iressa uses Gefitinib as an active ingredient. Iressa was launched by Astrazeneca in 2015.
Approval Date:
Iressa was approved by FDA for market use on 13 July, 2015.
Active Ingredient:
Iressa uses Gefitinib as the active ingredient. Check out other Drugs and Companies using Gefitinib ingredient
Treatment:
Iressa is used for treating patients with metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations.
Dosage:
Iressa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG | TABLET | Discontinued | ORAL |