Myrbetriq Granules is a drug owned by Astellas Pharma Global Development Inc. It is protected by 8 US drug patents filed in 2021. Out of these, 2 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 01, 2036. Details of Myrbetriq Granules'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. | |||
| US7342117 | α-form or β-form crystal of acetanilide derivative |
Nov, 2023
(11 months ago) |
Expired
|
| US6346532 | Amide derivatives or salts thereof |
Mar, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US10058536 (Pediatric) | Pharmaceutical composition containing mirabegron |
Oct, 2036
(11 years from now) | Active |
| US10058536 | Pharmaceutical composition containing mirabegron |
Mar, 2036
(11 years from now) | Active |
|
US7982049 (Pediatric) | α-form or β-form crystal of acetanilide derivative |
May, 2024
(5 months ago) |
Expired
|
|
US7342117 (Pediatric) | α-form or β-form crystal of acetanilide derivative |
May, 2024
(5 months ago) |
Expired
|
| US7982049 | α-form or β-form crystal of acetanilide derivative |
Nov, 2023
(11 months ago) |
Expired
|
|
US6346532 (Pediatric) | Amide derivatives or salts thereof |
Sep, 2022
(2 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 Myrbetriq Granules's patents.
Latest Legal Activities on Myrbetriq Granules's Patents
Given below is the list of recent legal activities going on the following patents of Myrbetriq Granules.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Jan, 2023 | US7982049 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Feb, 2022 | US10058536 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Aug, 2019 | US7342117 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jan, 2019 | US7982049 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 28 Aug, 2018 | US10058536 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Aug, 2018 | US10058536 |
| Email Notification Critical | 10 Aug, 2018 | US10058536 |
| Issue Notification Mailed Critical | 08 Aug, 2018 | US10058536 |
| Dispatch to FDC | 26 Jul, 2018 | US10058536 |
| Application Is Considered Ready for Issue Critical | 25 Jul, 2018 | US10058536 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Myrbetriq Granules and ongoing litigations to help you estimate the early arrival of Myrbetriq Granules generic.
Myrbetriq Granules's Litigations
Myrbetriq Granules been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 16, 2017, against patent number US6346532. The petitioner Sawai Pharmaceutical Co., Ltd., challenged the validity of this patent, with Astellas Pharma Inc. as the respondent. Click below to track the latest information on how companies are challenging Myrbetriq Granules's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6346532 | October, 2017 |
Terminated-Denied
(04 May, 2018) | Astellas Pharma Inc. | Sawai Pharmaceutical Co., Ltd. |
FDA has granted some exclusivities to Myrbetriq Granules. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Myrbetriq Granules, 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 Myrbetriq Granules.
Exclusivity Information
Myrbetriq Granules holds 2 exclusivities. All of its exclusivities have expired in 2024. Details of Myrbetriq Granules's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 25, 2024 |
| Pediatric Exclusivity(PED) | Sep 25, 2024 |
US patents provide insights into the exclusivity only within the United States, but Myrbetriq Granules 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 Myrbetriq Granules's family patents as well as insights into ongoing legal events on those patents.
Myrbetriq Granules's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Myrbetriq Granules's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 01, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Myrbetriq Granules Generics:
Mirabegron is the generic name for the brand Myrbetriq Granules. 4 different companies have already filed for the generic of Myrbetriq Granules, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Myrbetriq Granules's generic
Alternative Brands for Myrbetriq Granules
Myrbetriq Granules which is used for treating neurogenic detrusor overactivity in pediatric patients aged 3 years and older., has several other brand drugs using the same active ingredient (Mirabegron). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Apgdi |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Mirabegron, Myrbetriq Granules's active ingredient. Check the complete list of approved generic manufacturers for Myrbetriq Granules
About Myrbetriq Granules
Myrbetriq Granules is a drug owned by Astellas Pharma Global Development Inc. It is used for treating neurogenic detrusor overactivity in pediatric patients aged 3 years and older. Myrbetriq Granules uses Mirabegron as an active ingredient. Myrbetriq Granules was launched by Apgdi in 2021.
Approval Date:
Myrbetriq Granules was approved by FDA for market use on 25 March, 2021.
Active Ingredient:
Myrbetriq Granules uses Mirabegron as the active ingredient. Check out other Drugs and Companies using Mirabegron ingredient
Treatment:
Myrbetriq Granules is used for treating neurogenic detrusor overactivity in pediatric patients aged 3 years and older.
Dosage:
Myrbetriq Granules is available in for suspension, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 8MG/ML | FOR SUSPENSION, EXTENDED RELEASE | Prescription | ORAL |