MIRABEGRON - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for mirabegron and what is the scope of patent protection?
Mirabegron
is the generic ingredient in three branded drugs marketed by Apgdi, Alkem Labs Ltd, Lupin Ltd, Sawai Usa, and Zydus Pharms, and is included in six NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Mirabegron has one hundred and twenty-four patent family members in thirty-one countries.
There are nineteen drug master file entries for mirabegron. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for MIRABEGRON
International Patents: | 124 |
US Patents: | 10 |
Tradenames: | 3 |
Applicants: | 5 |
NDAs: | 6 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Clinical Trials: | 143 |
Patent Applications: | 499 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MIRABEGRON |
What excipients (inactive ingredients) are in MIRABEGRON? | MIRABEGRON excipients list |
DailyMed Link: | MIRABEGRON at DailyMed |
Recent Clinical Trials for MIRABEGRON
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Il-Yang Pharm. Co., Ltd. | Phase 2 |
Seoul National University Hospital | Phase 2 |
Cedars-Sinai Medical Center | Phase 2 |
Generic filers with tentative approvals for MIRABEGRON
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 50MG | TABLET, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for MIRABEGRON
Drug Class | beta3-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta3-Agonists Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | 202611-001 | Jun 28, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Alkem Labs Ltd | MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 215948-002 | Feb 12, 2024 | AB | RX | No | No | ⤷ 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 | 202611-001 | Jun 28, 2012 | AB | 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 | Y | ⤷ 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 MIRABEGRON
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for MIRABEGRON
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | PA05004925 | REMEDIO PARA VEJIGA HIPERACTIVA QUE INCLUYE DERIVADO DE ANILIDA DE ACIDO ACETICO COMO EL INGREDIENTE ACTIVO. (REMEDY FOR OVERACTIVE BLADDER COMPRISING ACETIC ACID ANILIDE DERIVATIVE AS THE ACTIVE INGREDIENT.) | ⤷ Sign Up |
Japan | 4688089 | ⤷ Sign Up | |
Japan | WO2004041276 | 酢酸アニリド誘導体を有効成分とする過活動膀胱治療剤 | ⤷ Sign Up |
Japan | 5849947 | ⤷ Sign Up | |
Australia | 2003284700 | REMEDY FOR OVERACTIVE BLADDER COMPRISING ACETIC ACID ANILIDE DERIVATIVE AS THE ACTIVE INGREDIENT | ⤷ Sign Up |
Norway | 20042227 | ⤷ Sign Up | |
Russian Federation | 2495666 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ МОДИФИЦИРОВАННОГО ВЫСВОБОЖДЕНИЯ (MODIFIED RELEASE PHARMACEUTICAL COMPOSITION) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MIRABEGRON
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1559427 | 300599 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107 |
1559427 | 457 | Finland | ⤷ Sign Up | |
1559427 | CR 2013 00028 | Denmark | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220 |
1559427 | 122013000047 | Germany | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON ODER EIN SALZ DAVON; NAT. REGISTRATION NO/DATE: EU /1/12/809/001-014 20121220; FIRST REGISTRATION: EU EU/1/12/809/001-014 20121220 |
1559427 | C300599 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220 |
1559427 | 132013902166933 | Italy | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON(BETMIGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/809/014, 20121220 |
1028111 | 300598 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 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.