Lexiscan is a drug owned by Astellas Pharma Us Inc. It is protected by 19 US drug patents filed from 2013 to 2019. Out of these, 3 drug patents are active and 16 have expired. Lexiscan's patents have been open to challenges since 10 April, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 02, 2027. Details of Lexiscan'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. | |||
| US8106183 | Process for preparing an A2A-adenosine receptor agonist and its polymorphs |
Feb, 2027
(2 years from now) | Active |
| USRE47351 | 2-(N-pyrazolo)adenosines with application as adenosine A2A receptor agonists |
Jun, 2019
(5 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9085601 | Process for preparing an A2A-adenosine receptor agonist and its polymorphs |
Feb, 2027
(2 years from now) | Active |
| USRE47301 | Process for preparing an A2A-adenosine receptor agonist and its polymorphs |
Feb, 2027
(2 years from now) | Active |
| US6403567 | N-pyrazole A2A adenosine receptor agonists |
Apr, 2022
(2 years ago) |
Expired
|
| US7683037 | Myocardial perfusion imaging method |
Jun, 2019
(5 years ago) |
Expired
|
| US7655636 | Use of A2A adenosine receptor agonists |
Jun, 2019
(5 years ago) |
Expired
|
| US7582617 | Myocardial perfusion imaging method |
Jun, 2019
(5 years ago) |
Expired
|
| US9289446 | Myocardial perfusion imaging methods and compositions |
Jun, 2019
(5 years ago) |
Expired
|
| US7144872 | N-pyrazole A2A receptor agonists |
Jun, 2019
(5 years ago) |
Expired
|
| US8536150 | Methods of myocardial perfusion imaging |
Jun, 2019
(5 years ago) |
Expired
|
| US9045519 | N-pyrazole A2A receptor agonists |
Jun, 2019
(5 years ago) |
Expired
|
| US8183226 | Myocardial perfusion imaging method |
Jun, 2019
(5 years ago) |
Expired
|
| US7183264 | N-pyrazole A2A receptor agonists |
Jun, 2019
(5 years ago) |
Expired
|
| US8133879 | Myocardial perfusion imaging methods and compositions |
Jun, 2019
(5 years ago) |
Expired
|
| US6642210 | 2-(N-pyrazolo)adenosines with application as adenosine A2A receptor agonists |
Jun, 2019
(5 years ago) |
Expired
|
| US8470801 | Myocardial perfusion imaging methods and compositions |
Jun, 2019
(5 years ago) |
Expired
|
| US8106029 | Use of A2A adenosine receptor agonists |
Jun, 2019
(5 years ago) |
Expired
|
| US7655637 | N-pyrazole A2A receptor agonists |
Jun, 2019
(5 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 Lexiscan's patents.
Latest Legal Activities on Lexiscan's Patents
Given below is the list of recent legal activities going on the following patents of Lexiscan.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Jul, 2023 | US8106183 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Jul, 2023 | US8106029 |
| Expire Patent Critical | 10 Jul, 2023 | US9045519 |
| Maintenance Fee Reminder Mailed Critical | 23 Jan, 2023 | US9045519 |
| Expire Patent Critical | 25 Apr, 2022 | US7683037 |
| Expire Patent Critical | 07 Mar, 2022 | US7655637 |
| Expire Patent Critical | 07 Mar, 2022 | US7655636 |
| Maintenance Fee Reminder Mailed Critical | 08 Nov, 2021 | US7683037 |
| Expire Patent Critical | 25 Oct, 2021 | US8536150 |
| Expire Patent Critical | 04 Oct, 2021 | US7582617 |
FDA has granted several exclusivities to Lexiscan. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lexiscan, 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 Lexiscan.
Exclusivity Information
Lexiscan holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Lexiscan's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 10, 2013 |
| M(M-194) | Jan 17, 2020 |
US patents provide insights into the exclusivity only within the United States, but Lexiscan 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 Lexiscan's family patents as well as insights into ongoing legal events on those patents.
Lexiscan's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lexiscan's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 02, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lexiscan Generic API suppliers:
Regadenoson is the generic name for the brand Lexiscan. 13 different companies have already filed for the generic of Lexiscan, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lexiscan's generic
How can I launch a generic of Lexiscan before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lexiscan's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lexiscan'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 Lexiscan -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.08 mg/mL, 5 mL vial | 10 Apr, 2012 | 1 | 02 Feb, 2027 | Extinguished |
About Lexiscan
Lexiscan is a drug owned by Astellas Pharma Us Inc. It is used for cardiac imaging and increasing coronary blood flow. Lexiscan uses Regadenoson as an active ingredient. Lexiscan was launched by Astellas in 2008.
Approval Date:
Lexiscan was approved by FDA for market use on 10 April, 2008.
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 Lexiscan is 10 April, 2008, its NCE-1 date is estimated to be 10 April, 2012.
Active Ingredient:
Lexiscan uses Regadenoson as the active ingredient. Check out other Drugs and Companies using Regadenoson ingredient
Treatment:
Lexiscan is used for cardiac imaging and increasing coronary blood flow.
Dosage:
Lexiscan is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.4MG/5ML (0.08MG/ML) | SOLUTION | Prescription | INTRAVENOUS |