MIRABEGRON Drug Patent Profile
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Which patents cover Mirabegron, and what generic alternatives are available?
Mirabegron is a drug marketed by Alkem Labs Ltd, Lupin Ltd, Sawai Usa, and Zydus Pharms. and is included in four NDAs.
The generic ingredient in MIRABEGRON is mirabegron. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mirabegron
A generic version of MIRABEGRON was approved as mirabegron by LUPIN LTD on September 28th, 2022.
Summary for MIRABEGRON
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 135 |
| Patent Applications: | 57 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MIRABEGRON |
| DailyMed Link: | MIRABEGRON at DailyMed |
Recent Clinical Trials for MIRABEGRON
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The University of Texas Medical Branch, Galveston | Early Phase 1 |
| University of California, San Diego | Phase 1 |
| Benha University | N/A |
Pharmacology for MIRABEGRON
Anatomical Therapeutic Chemical (ATC) Classes for MIRABEGRON
Paragraph IV (Patent) Challenges for MIRABEGRON
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MYRBETRIQ GRANULES | Granules for Extended-release Suspension | mirabegron | 8 mg/mL | 213801 | 1 | 2024-01-12 |
| MYRBETRIQ | Extended-release Tablets | mirabegron | 50 mg | 202611 | 6 | 2016-06-28 |
US Patents and Regulatory Information for MIRABEGRON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 215948-001 | Feb 12, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209488-002 | Sep 29, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209485-002 | Sep 28, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for MIRABEGRON
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Astellas Pharma Europe B.V. | Betmiga | mirabegron | EMEA/H/C/002388 Symptomatic treatment of urgency.Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome. |
Authorised | no | no | no | 2012-12-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
