Mirabegron Patent Expiration

Mirabegron is used for treating neurogenic detrusor overactivity in pediatric patients and overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, including in combination with solifenacin succinate for more severe cases. It was first introduced by Astellas Pharma Global Development Inc in its drug Myrbetriq on Jun 28, 2012. Another drug containing Mirabegron is Myrbetriq Granules. 5 different companies have introduced drugs containing Mirabegron.


Mirabegron Patents

Given below is the list of patents protecting Mirabegron, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Myrbetriq US10842780 Pharmaceutical composition for modified release Sep 28, 2029 Apgdi
Myrbetriq US10842780

(Pediatric)

Pharmaceutical composition for modified release Mar 28, 2030 Apgdi
Myrbetriq US11707451 Pharmaceutical composition for modified release Sep 28, 2029 Apgdi
Myrbetriq US11707451

(Pediatric)

Pharmaceutical composition for modified release Mar 28, 2030 Apgdi
Myrbetriq US6346532 Amide derivatives or salts thereof Oct 15, 2018

(Expired)

Apgdi
Myrbetriq US6346532

(Pediatric)

Amide derivatives or salts thereof Sep 27, 2022

(Expired)

Apgdi
Myrbetriq US6562375 Stable pharmaceutical composition for oral use Aug 01, 2020

(Expired)

Apgdi
Myrbetriq US6699503 Hydrogel-forming sustained-release preparation Sep 10, 2013

(Expired)

Apgdi
Myrbetriq US7342117 α-form or β-form crystal of acetanilide derivative Nov 04, 2023

(Expired)

Apgdi
Myrbetriq US7342117

(Pediatric)

α-form or β-form crystal of acetanilide derivative May 04, 2024

(Expired)

Apgdi
Myrbetriq US7750029 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Dec 18, 2023

(Expired)

Apgdi
Myrbetriq US7982049 α-form or β-form crystal of acetanilide derivative Nov 04, 2023

(Expired)

Apgdi
Myrbetriq US7982049

(Pediatric)

α-form or β-form crystal of acetanilide derivative May 04, 2024

(Expired)

Apgdi
Myrbetriq US8772315 Pharmaceutical composition for treating overactive bladder Oct 30, 2028 Apgdi
Myrbetriq US8772315

(Pediatric)

Pharmaceutical composition for treating overactive bladder Apr 30, 2029 Apgdi
Myrbetriq US8835474 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Nov 04, 2023

(Expired)

Apgdi
Myrbetriq US8835474

(Pediatric)

Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient May 04, 2024

(Expired)

Apgdi
Myrbetriq USRE44872 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Nov 04, 2023

(Expired)

Apgdi
Myrbetriq USRE44872

(Pediatric)

Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient May 04, 2024

(Expired)

Apgdi
Myrbetriq Granules US10058536 Pharmaceutical composition containing mirabegron Mar 31, 2036 Apgdi
Myrbetriq Granules US10058536

(Pediatric)

Pharmaceutical composition containing mirabegron Oct 01, 2036 Apgdi
Myrbetriq Granules US6346532 Amide derivatives or salts thereof Mar 27, 2022

(Expired)

Apgdi
Myrbetriq Granules US6346532

(Pediatric)

Amide derivatives or salts thereof Sep 27, 2022

(Expired)

Apgdi
Myrbetriq Granules US7342117 α-form or β-form crystal of acetanilide derivative Nov 04, 2023

(Expired)

Apgdi
Myrbetriq Granules US7342117

(Pediatric)

α-form or β-form crystal of acetanilide derivative May 04, 2024

(Expired)

Apgdi
Myrbetriq Granules US7982049 α-form or β-form crystal of acetanilide derivative Nov 04, 2023

(Expired)

Apgdi
Myrbetriq Granules US7982049

(Pediatric)

α-form or β-form crystal of acetanilide derivative May 04, 2024

(Expired)

Apgdi


Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response 🥳

Mirabegron Generics

Several generic applications have been filed for Mirabegron. The first generic version for Mirabegron was by Sawai Usa Inc and was approved on Dec 27, 2019. And the latest generic version is by Alkem Laboratories Ltd and was approved on Feb 12, 2024.

Given below is the list of companies who have filed for Mirabegron generic.


1. LUPIN LTD

Lupin Ltd has filed for 2 different strengths of generic version for Mirabegron. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet, extended release Prescription ORAL AB Sep 28, 2022
50MG tablet, extended release Prescription ORAL AB Sep 28, 2022


2. SAWAI USA

Sawai Usa Inc has filed for 1 generic for Mirabegron. Given below are the details of the strengths of this generic introduced by Sawai Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet, extended release Discontinued ORAL N/A Dec 27, 2019


3. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Mirabegron. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet, extended release Prescription ORAL AB Sep 29, 2022
50MG tablet, extended release Prescription ORAL AB Sep 29, 2022


4. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Mirabegron. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet, extended release Prescription ORAL AB Feb 12, 2024
50MG tablet, extended release Prescription ORAL AB Feb 12, 2024