Drug
Who makes mirabegron?
9 companies list mirabegron as a human prescription drug, including under the names Myrbetriq, Mirabgeorn. Forms: for suspension, extended release; granule, for suspension, extended release; tablet, extended release; tablet, film coated, extended release. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing mirabegron
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet, film coated, extended release | ANDAANDA209485 | 4 | 1 |
| Astellas Pharma US, Inc.Japan | granule, for suspension, extended release; tablet, film coated, extended release | NDANDA202611, NDA213801 | 3 | 8 |
| RemedyRepack, IncUnited States | tablet, extended release; tablet, film coated, extended release | ANDAANDA209485, ANDA209488 | 3 | 1 |
| Lupin LimitedIndia | tablet, film coated, extended release | ANDAANDA209485 | 2 | 14 |
| Zydus Lifesciences LimitedIndia | tablet, extended release | ANDAANDA209488 | 2 | 12 |
| Qilu Pharmaceutical Co., Ltd.China | tablet, film coated, extended release | ANDAANDA217989 | 2 | 5 |
| Zydus Pharmaceuticals USA Inc.India | tablet, extended release | ANDAANDA209488 | 2 | 1 |
| Amneal Pharmaceuticals NY LLC | tablet, film coated, extended release | ANDAANDA218543 | 2 | 0 |
| ASCEND Therapeutics US, LLC | for suspension, extended release | ANDAANDA219323 | 1 | 0 |
Bulk ingredient listings
- Astellas Pharma US, Inc.Japan · 2 NDC
- Dr. Reddy's Laboratories LimitedIndia · 2 NDC
- Hetero Drugs LimitedIndia · 2 NDC
- MSN Laboratories Private Limited,India · 2 NDC
- ALMON HEALTHCARE PRIVATE LIMITEDIndia · 1 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Alivus Life Sciences Limited · 1 NDC
- Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)India · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Biocon Biologics LimitedIndia · 1 NDC
- Calyx Chemicals & Pharmaceuticals LimitedIndia · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Jiangxi Synergy Pharmaceutical Co., Ltd.China · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- Metrochem API Private LimitedIndia · 1 NDC
- Neuland Laboratories LimitedIndia · 1 NDC
- Piramal Healthcare (Canada) LimitedIndia · 1 NDC
- RAKSHIT DRUGS PRIVATE LIMITEDIndia · 1 NDC
- Sumitomo Chemical Company, LimitedJapan · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
12 unexpired patents list mirabegron as the active ingredient, expiring between Oct 2028 and Sept 2036. Application holder: ASTELLAS PHARMA GLOBAL DEVELOPMENT INC.
Enquiry
Common questions
- Who makes mirabegron?
- 9 companies list mirabegron as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Astellas Pharma US, Inc., RemedyRepack, Inc, Lupin Limited, Zydus Lifesciences Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Myrbetriq?
- 8 companies list mirabegron under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies mirabegron active ingredient?
- 20 companies list mirabegron as a bulk ingredient, including Astellas Pharma US, Inc., Dr. Reddy's Laboratories Limited, Hetero Drugs Limited, MSN Laboratories Private Limited,.