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
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 Granules |
US10058536 (Pediatric) | Pharmaceutical composition containing mirabegron | Sep 30, 2036 | Apgdi |
| Myrbetriq Granules | US10058536 | Pharmaceutical composition containing mirabegron | Mar 31, 2036 | Apgdi |
| Myrbetriq |
US10842780 (Pediatric) | Pharmaceutical composition for modified release | Mar 28, 2030 | Apgdi |
| Myrbetriq |
US11707451 (Pediatric) | Pharmaceutical composition for modified release | Mar 28, 2030 | Apgdi |
| Myrbetriq |
US12059409 (Pediatric) | Pharmaceutical composition for modified release | Mar 28, 2030 | Apgdi |
| Myrbetriq |
US12097189 (Pediatric) | Pharmaceutical composition for modified release | Mar 28, 2030 | Apgdi |
| Myrbetriq | US10842780 | Pharmaceutical composition for modified release | Sep 28, 2029 | Apgdi |
| Myrbetriq | US11707451 | Pharmaceutical composition for modified release | Sep 28, 2029 | Apgdi |
| Myrbetriq | US12059409 | Pharmaceutical composition for modified release | Sep 28, 2029 | Apgdi |
| Myrbetriq | US12097189 | Pharmaceutical composition for modified release | Sep 28, 2029 | Apgdi |
| Myrbetriq |
US8772315 (Pediatric) | Pharmaceutical composition for treating overactive bladder | Apr 30, 2029 | Apgdi |
| Myrbetriq | US8772315 | Pharmaceutical composition for treating overactive bladder | Oct 30, 2028 | Apgdi |
| Myrbetriq |
US7342117 (Pediatric) | α-form or β-form crystal of acetanilide derivative |
May 04, 2024
(Expired) | Apgdi |
| Myrbetriq |
US7982049 (Pediatric) | α-form or β-form crystal of acetanilide derivative |
May 04, 2024
(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 (Pediatric) | Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient |
May 04, 2024
(Expired) | Apgdi |
| Myrbetriq Granules |
US7342117 (Pediatric) | α-form or β-form crystal of acetanilide derivative |
May 04, 2024
(Expired) | Apgdi |
| Myrbetriq Granules |
US7982049 (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 | US7342117 | α-form or β-form crystal of acetanilide derivative |
Nov 04, 2023
(Expired) | Apgdi |
| Myrbetriq | US7982049 | α-form or β-form crystal of acetanilide derivative |
Nov 04, 2023
(Expired) | Apgdi |
| Myrbetriq | US8835474 | Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient |
Nov 04, 2023
(Expired) | Apgdi |
| Myrbetriq | USRE44872 | Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient |
Nov 04, 2023
(Expired) | Apgdi |
| Myrbetriq Granules | US7342117 | α-form or β-form crystal of acetanilide derivative |
Nov 04, 2023
(Expired) | Apgdi |
| Myrbetriq Granules | US7982049 | α-form or β-form crystal of acetanilide derivative |
Nov 04, 2023
(Expired) | Apgdi |
| Myrbetriq |
US6346532 (Pediatric) | Amide derivatives or salts thereof |
Sep 27, 2022
(Expired) | Apgdi |
| Myrbetriq Granules |
US6346532 (Pediatric) | Amide derivatives or salts thereof |
Sep 27, 2022
(Expired) | Apgdi |
| Myrbetriq Granules | US6346532 | Amide derivatives or salts thereof |
Mar 27, 2022
(Expired) | Apgdi |
| Myrbetriq | US6562375 | Stable pharmaceutical composition for oral use |
Aug 01, 2020
(Expired) | Apgdi |
| Myrbetriq | US6346532 | Amide derivatives or salts thereof |
Oct 15, 2018
(Expired) | Apgdi |
| Myrbetriq | US6699503 | Hydrogel-forming sustained-release preparation |
Sep 10, 2013
(Expired) | Apgdi |
Mirabegron's Family Patents
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Mirabegron Generic API Manufacturers
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 Sawai Usa Inc and was approved on May 6, 2025.
Given below is the list of companies who have filed for Mirabegron generic, along with the locations of their manufacturing plants worldwide.
1. 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 |
2. APOTEX
Apotex 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 Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | tablet, extended release | Discontinued | ORAL | N/A | Jan 2, 2025 |
| 50MG | tablet, extended release | Discontinued | ORAL | N/A | Jan 2, 2025 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Canada |
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| India |
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3. 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 |
|---|---|---|---|---|---|
| 50MG | tablet, extended release | Prescription | ORAL | AB | Sep 28, 2022 |
| 25MG | tablet, extended release | Prescription | ORAL | AB | Sep 28, 2022 |
Manufacturing Plant Locations New
Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
4. SAWAI USA
Sawai 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 Sawai Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | tablet, extended release | Discontinued | ORAL | N/A | Dec 27, 2019 |
| 50MG | tablet, extended release | Prescription | ORAL | AB | May 6, 2025 |
5. 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 |
|---|---|---|---|---|---|
| 50MG | tablet, extended release | Prescription | ORAL | AB | Sep 29, 2022 |
| 25MG | tablet, extended release | Prescription | ORAL | AB | Sep 29, 2022 |