Tagrisso is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 4 US drug patents filed from 2015 to 2022 out of which none have expired yet. Tagrisso's patents have been open to challenges since 14 November, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 02, 2035. Details of Tagrisso'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. | |||
| US8946235 | 2-(2,4,5-substituted-anilino) pyrimidine compounds |
Aug, 2032
(7 years from now) | Active |
| US9732058 | 2-(2,4,5-substituted-anilino)pyrimidine compounds |
Jul, 2032
(7 years from now) | Active |
| US11524951 | 2-(2,4,5-substituted-anilino)pyrimidine compounds |
Jul, 2032
(7 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10183020 | Pharmaceutical compositions comprising AZD9291 |
Jan, 2035
(10 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tagrisso's patents.
Latest Legal Activities on Tagrisso's Patents
Given below is the list of recent legal activities going on the following patents of Tagrisso.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 13 Dec, 2022 | US11524951 |
| Recordation of Patent Grant Mailed Critical | 13 Dec, 2022 | US11524951 |
| Email Notification Critical | 23 Nov, 2022 | US11524951 |
| Issue Notification Mailed Critical | 22 Nov, 2022 | US11524951 |
| Application Is Considered Ready for Issue Critical | 31 Oct, 2022 | US11524951 |
| Dispatch to FDC | 31 Oct, 2022 | US11524951 |
| Issue Fee Payment Received Critical | 28 Oct, 2022 | US11524951 |
| Issue Fee Payment Verified Critical | 28 Oct, 2022 | US11524951 |
| Electronic Review Critical | 21 Oct, 2022 | US11524951 |
| Mail Response to 312 Amendment (PTO-271) Critical | 20 Oct, 2022 | US11524951 |
FDA has granted several exclusivities to Tagrisso. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tagrisso, 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 Tagrisso.
Exclusivity Information
Tagrisso holds 8 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Tagrisso's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 13, 2020 |
| New Indication(I-774) | Apr 18, 2021 |
| Orphan Drug Exclusivity(ODE) | Nov 13, 2022 |
| Orphan Drug Exclusivity(ODE-102) | Nov 13, 2022 |
| New Indication(I-853) | Dec 18, 2023 |
| Orphan Drug Exclusivity(ODE-176) | Apr 18, 2025 |
| New Indication(I-941) | Feb 16, 2027 |
| Orphan Drug Exclusivity(ODE-337) | Dec 18, 2027 |
Several oppositions have been filed on Tagrisso's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tagrisso's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tagrisso patents.
Tagrisso's Oppositions Filed in EPO
Tagrisso has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 06, 2016, by Stada Arzneimittel Ag. This opposition was filed on patent number EP12759801A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15192658A | Jul, 2018 | Generics (U.K.) Limited | Opposition rejected |
| EP12759801A | Oct, 2016 | STADA Arzneimittel AG | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Tagrisso 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 Tagrisso's family patents as well as insights into ongoing legal events on those patents.
Tagrisso's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tagrisso's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 02, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tagrisso Generics:
There are no approved generic versions for Tagrisso as of now.
How can I launch a generic of Tagrisso before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tagrisso's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tagrisso's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Tagrisso -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg and 80 mg | 13 Nov, 2019 | 3 | 02 Jan, 2035 |
About Tagrisso
Tagrisso is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for treating locally advanced or metastatic non-small cell lung cancer with specific mutations in combination with chemotherapy. Tagrisso uses Osimertinib Mesylate as an active ingredient. Tagrisso was launched by Astrazeneca in 2015.
Approval Date:
Tagrisso was approved by FDA for market use on 13 November, 2015.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Tagrisso is 13 November, 2015, its NCE-1 date is estimated to be 14 November, 2019.
Active Ingredient:
Tagrisso uses Osimertinib Mesylate as the active ingredient. Check out other Drugs and Companies using Osimertinib Mesylate ingredient
Treatment:
Tagrisso is used for treating locally advanced or metastatic non-small cell lung cancer with specific mutations in combination with chemotherapy.
Dosage:
Tagrisso is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 80MG BASE | TABLET | Prescription | ORAL |
| EQ 40MG BASE | TABLET | Prescription | ORAL |