Myrbetriq Granules Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Myrbetriq Granules.

Activity Date Patent Number
Patent litigations
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 28 Aug, 2018 US10058536
Patent Issue Date Used in PTA Calculation 28 Aug, 2018 US10058536
Email Notification 10 Aug, 2018 US10058536
Issue Notification Mailed 08 Aug, 2018 US10058536
Dispatch to FDC 26 Jul, 2018 US10058536
Application Is Considered Ready for Issue 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.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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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

Myrbetriq Granules has patent protection in a total of 23 countries. It's US patent count contributes only to 8.6% of its total global patent coverage. 8 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Myrbetriq Granules.

Family Patents

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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
Myrbetriq


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