Brilinta is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 10 US drug patents filed from 2015 to 2022. Out of these, 5 drug patents are active and 5 have expired. Brilinta's patents have been open to challenges since 09 November, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 27, 2036. Details of Brilinta'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. | |||
| USRE46276 | Triazolo(4,5-D)pyrimidine compounds |
Oct, 2024
(a month ago) |
Expired
|
| US7265124 | Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound |
Jul, 2021
(3 years ago) |
Expired
|
| US6525060 | Triazolo(4,5-d)pyrimidine compounds |
Dec, 2019
(5 years ago) |
Expired
|
| US7250419 | Trisubstituted triazolopyrimidines for use in platelet aggregation inhibition |
Dec, 2019
(5 years ago) |
Expired
|
| US6251910 | 1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor antagonists |
Jul, 2018
(6 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US10300065 (Pediatric) | Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction |
Jul, 2036
(11 years from now) | Active |
| US10300065 | Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction |
Jan, 2036
(11 years from now) | Active |
|
US8425934 (Pediatric) | Pharmaceutical compositions |
Oct, 2030
(5 years from now) | Active |
| US8425934 | Pharmaceutical compositions |
Apr, 2030
(5 years from now) | Active |
|
USRE46276 (Pediatric) | Triazolo(4,5-D)pyrimidine compounds |
Apr, 2025
(4 months from now) | Active |
| US7265124 | Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound |
Jul, 2021
(3 years ago) |
Expired
|
| US6525060 | Triazolo(4,5-d)pyrimidine compounds |
Dec, 2019
(5 years ago) |
Expired
|
| US7250419 | Trisubstituted triazolopyrimidines for use in platelet aggregation inhibition |
Dec, 2019
(5 years ago) |
Expired
|
| US6251910 | 1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor antagonists |
Jul, 2018
(6 years ago) |
Expired
|
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 Brilinta's patents.
Latest Legal Activities on Brilinta's Patents
Given below is the list of recent legal activities going on the following patents of Brilinta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Nov, 2022 | US10300065 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Sep, 2020 | US8425934 |
| Patent Issue Date Used in PTA Calculation Critical | 28 May, 2019 | US10300065 |
| Recordation of Patent Grant Mailed Critical | 28 May, 2019 | US10300065 |
| Email Notification Critical | 09 May, 2019 | US10300065 |
| Issue Notification Mailed Critical | 08 May, 2019 | US10300065 |
| Dispatch to FDC | 05 Apr, 2019 | US10300065 |
| Application Is Considered Ready for Issue Critical | 05 Apr, 2019 | US10300065 |
| Issue Fee Payment Verified Critical | 04 Apr, 2019 | US10300065 |
| Issue Fee Payment Received Critical | 04 Apr, 2019 | US10300065 |
FDA has granted several exclusivities to Brilinta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Brilinta, 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 Brilinta.
Exclusivity Information
Brilinta holds 7 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Brilinta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 20, 2016 |
| New Indication(I-714) | Sep 03, 2018 |
| New Strength(NS) | Sep 03, 2018 |
| New Indication(I-851) | May 28, 2023 |
| New Indication(I-848) | Nov 05, 2023 |
| M(M-283) | May 09, 2025 |
| Pediatric Exclusivity(PED) | Nov 09, 2025 |
Several oppositions have been filed on Brilinta'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 Brilinta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Brilinta patents.
Brilinta's Oppositions Filed in EPO
Brilinta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 18, 2017, by Wittkopp, Alexander. This opposition was filed on patent number EP07794121A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP07794121A | Dec, 2017 | Generics [UK] Limited (trading as Mylan) | Revoked |
| EP07794121A | Dec, 2017 | Hexal Biotech GmbH | Revoked |
| EP07794121A | Dec, 2017 | Wittkopp, Alexander | Revoked |
US patents provide insights into the exclusivity only within the United States, but Brilinta 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 Brilinta's family patents as well as insights into ongoing legal events on those patents.
Brilinta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Brilinta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 27, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Brilinta Generic API suppliers:
Ticagrelor is the generic name for the brand Brilinta. 9 different companies have already filed for the generic of Brilinta, with Watson Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Brilinta's generic
How can I launch a generic of Brilinta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Brilinta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Brilinta'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 Brilinta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 90 mg | 20 Jul, 2015 | 16 | 04 Sep, 2018 | 17 Apr, 2030 | Eligible |
| 60 mg | 30 Sep, 2015 | 3 | 04 Sep, 2018 | 17 Apr, 2030 | Eligible |
About Brilinta
Brilinta is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for reducing the rate of cardiovascular events, including myocardial infarction and stroke, in patients with coronary artery disease or who had acute coronary syndrome. Brilinta uses Ticagrelor as an active ingredient. Brilinta was launched by Astrazeneca in 2015.
Approval Date:
Brilinta was approved by FDA for market use on 03 September, 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 Brilinta is 03 September, 2015, its NCE-1 date is estimated to be 09 November, 2024.
Active Ingredient:
Brilinta uses Ticagrelor as the active ingredient. Check out other Drugs and Companies using Ticagrelor ingredient
Treatment:
Brilinta is used for reducing the rate of cardiovascular events, including myocardial infarction and stroke, in patients with coronary artery disease or who had acute coronary syndrome.
Dosage:
Brilinta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG | TABLET | Prescription | ORAL |
| 90MG | TABLET | Prescription | ORAL |