myrbetriq granules Drug Patent Profile
✉ Email this page to a colleague
When do Myrbetriq Granules patents expire, and what generic alternatives are available?
Myrbetriq Granules is a drug marketed by Apgdi and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has forty patent family members in twenty-three countries.
The generic ingredient in MYRBETRIQ GRANULES 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 Myrbetriq Granules
A generic version of myrbetriq granules was approved as mirabegron by LUPIN LTD on September 28th, 2022.
Summary for myrbetriq granules
| International Patents: | 40 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Patent Applications: | 57 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for myrbetriq granules |
| DailyMed Link: | myrbetriq granules at DailyMed |
Paragraph IV (Patent) Challenges for MYRBETRIQ GRANULES
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MYRBETRIQ GRANULES | Granules for Extended-release Suspension | mirabegron | 8 mg/mL | 213801 | 1 | 2024-01-12 |
US Patents and Regulatory Information for myrbetriq granules
myrbetriq granules is protected by three US patents and two FDA Regulatory Exclusivities.
Patents protecting myrbetriq granules
Pharmaceutical composition containing mirabegron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
.alpha.-form or .beta.-form crystal of acetanilide derivative
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
.alpha.-form or .beta.-form crystal of acetanilide derivative
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting myrbetriq granules
NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | ⤷ 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 myrbetriq granules
| 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 |
International Patents for myrbetriq granules
See the table below for patents covering myrbetriq granules around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2221204 | ⤷ Try a Trial | |
| Poland | 369874 | ⤷ Try a Trial | |
| Spain | 2404071 | ⤷ Try a Trial | |
| China | 1136193 | ⤷ Try a Trial | |
| Japan | 3193706 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2016159267 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for myrbetriq granules
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1559427 | 33/2013 | Austria | ⤷ Try a Trial | PRODUCT NAME: MIRABEGRON ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220 |
| 1559427 | C 2013 020 | Romania | ⤷ Try a Trial | PRODUCT NAME: MIRABEGRON SAU O SARE A ACESTUIA(2-(2-AMINO-1,3-TRIAZOL-4-IL)-N-[4-(2-{[(2R)-2-HIDROXI9/014; DATE OF NATIONAL AUTHORISATION: 20121220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/809/001 - EU/1/12/809/014; DATE OF FIRST AUTHORISATION IN EEA: 20121220 -2-FENILETIL]AMINO}ETIL)FENIL]ACETAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/12/809/001 - EU/1/12/80 |
| 1559427 | 300599 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107 |
| 1028111 | 300598 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220 |
| 1559427 | 92218 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: MIRABEGRON OU UN DE SES SELS |
| 1559427 | 1390028-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
