MYRBETRIQ Drug Patent Profile
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Which patents cover Myrbetriq, and when can generic versions of Myrbetriq launch?
Myrbetriq is a drug marketed by Apgdi and is included in two NDAs. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and eleven patent family members in thirty countries.
The generic ingredient in MYRBETRIQ 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
A generic version of MYRBETRIQ was approved as mirabegron by LUPIN LTD on September 28th, 2022.
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Summary for MYRBETRIQ
| International Patents: | 111 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 51 |
| Patent Applications: | 217 |
| Drug Prices: | Drug price information for MYRBETRIQ |
| Drug Sales Revenues: | Drug sales revenues for MYRBETRIQ |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MYRBETRIQ |
| What excipients (inactive ingredients) are in MYRBETRIQ? | MYRBETRIQ excipients list |
| DailyMed Link: | MYRBETRIQ at DailyMed |
Paragraph IV (Patent) Challenges for MYRBETRIQ
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MYRBETRIQ | Extended-release Tablets | mirabegron | 50 mg | 202611 | 6 | 2016-06-28 |
US Patents and Regulatory Information for MYRBETRIQ
MYRBETRIQ is protected by ten US patents and two FDA Regulatory Exclusivities.
Patents protecting MYRBETRIQ
Pharmaceutical composition for modified release
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Patented Use: ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
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Patented Use: ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER AND WEIGHING 35 KG OR MORE
.alpha.-form or .beta.-form crystal of acetanilide derivative
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.alpha.-form or .beta.-form crystal of acetanilide derivative
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Pharmaceutical composition for treating overactive bladder
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Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
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Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
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FDA Regulatory Exclusivity protecting MYRBETRIQ
TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
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 | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | AB | 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 |
Expired US Patents for MYRBETRIQ
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for MYRBETRIQ
| 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
When does loss-of-exclusivity occur for MYRBETRIQ?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Canada
Patent: 04298
Patent: COMPOSITION PHARMACEUTIQUE POUR TRAITER UNE VESSIE HYPERACTIVE (PHARMACEUTICAL COMPOSITION FOR TREATING OVERACTIVE BLADDER)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0121078
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Cyprus
Patent: 13670
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Denmark
Patent: 16021
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European Patent Office
Patent: 16021
Patent: COMPOSITION PHARMACEUTIQUE POUR TRAITER UNE VESSIE HYPERACTIVE (PHARMACEUTICAL COMPOSITION FOR TREATING OVERACTIVE BLADDER)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 2009057685
Patent: 過活動膀胱治療用医薬組成物
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Patent: 63170
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Poland
Patent: 16021
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Portugal
Patent: 16021
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Slovenia
Patent: 16021
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Spain
Patent: 93525
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Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering MYRBETRIQ around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1373673 | ⤷ Sign Up | |
| Bulgaria | 99503 | ⤷ Sign Up | |
| Israel | 168121 | REMEDY FOR OVERACTIVE BLADDER COMPRISING ACETIC ACID ANILIDE DERIVATIVE AS THE ACTIVE INGREDIENT | ⤷ Sign Up |
| New Zealand | 255579 | SUSTAINED RELEASE HYDROGEL PHARMACEUTICAL FORMULATION | ⤷ Sign Up |
| China | 1711085 | Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MYRBETRIQ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1028111 | C300598 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220 |
| 1559427 | 2013/026 | Ireland | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220 |
| 1559427 | C20130015 00094 | Estonia | ⤷ Sign Up | PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012 |
| 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 | CA 2013 00028 | Denmark | ⤷ Sign Up | |
| >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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