MYRBETRIQ GRANULES Drug Patent Profile
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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.
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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: | 217 |
| 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
.alpha.-form or .beta.-form crystal of acetanilide derivative
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
.alpha.-form or .beta.-form crystal of acetanilide derivative
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting MYRBETRIQ GRANULES
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
|---|---|---|---|
| Australia | 2002344419 | ⤷ Sign Up | |
| Brazil | 9804500 | derivado de amida, referida composição farmacêutica e agente terapêutico. | ⤷ Sign Up |
| Mexico | PA04003936 | CRISTAL EN FORMA ALFA O EN FORMA BETA DE DERIVADO DE ACETANILIDA. (alpha-FORM OR ß-FORM CRYSTAL OF ACETANILIDE DERIVATIVE.) | ⤷ Sign Up |
| Spain | 2404071 | ⤷ Sign Up | |
| Brazil | 0213570 | ⤷ Sign Up | |
| Portugal | 3278801 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 03037881 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MYRBETRIQ GRANULES
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1028111 | 300598 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220 |
| 1559427 | 1390028-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220 |
| 1559427 | 132013902166933 | Italy | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON(BETMIGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/809/014, 20121220 |
| 1559427 | 2013C/040 | Belgium | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON OU L'UN DES SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/12/809/001 20130107 |
| 1559427 | 92218 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON OU UN DE SES SELS |
| 1559427 | 168 5014-2013 | Slovakia | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220 |
| 1559427 | C01559427/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: SWISSMEDIC 62755 19.05.2014 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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