Myrbetriq is a drug owned by Astellas Pharma Global Development Inc. It is protected by 21 US drug patents filed from 2013 to 2024. Out of these, 8 drug patents are active and 13 have expired. Myrbetriq's patents have been open to challenges since 26 September, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 28, 2030. Details of Myrbetriq's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US11707451 (Pediatric) | Pharmaceutical composition for modified release |
Mar, 2030
(5 years from now) | Active |
|
US10842780 (Pediatric) | Pharmaceutical composition for modified release |
Mar, 2030
(5 years from now) | Active |
| US12097189 | Pharmaceutical composition for modified release |
Sep, 2029
(4 years from now) | Active |
| US11707451 | Pharmaceutical composition for modified release |
Sep, 2029
(4 years from now) | Active |
| US12059409 | Pharmaceutical composition for modified release |
Sep, 2029
(4 years from now) | Active |
| US10842780 | Pharmaceutical composition for modified release |
Sep, 2029
(4 years from now) | Active |
|
US8772315 (Pediatric) | Pharmaceutical composition for treating overactive bladder |
Apr, 2029
(4 years from now) | Active |
| US8772315 | Pharmaceutical composition for treating overactive bladder |
Oct, 2028
(3 years from now) | Active |
|
USRE44872 (Pediatric) | Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient |
May, 2024
(7 months ago) |
Expired
|
|
US7342117 (Pediatric) | α-form or β-form crystal of acetanilide derivative |
May, 2024
(7 months ago) |
Expired
|
|
US7982049 (Pediatric) | α-form or β-form crystal of acetanilide derivative |
May, 2024
(7 months ago) |
Expired
|
|
US8835474 (Pediatric) | Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient |
May, 2024
(7 months ago) |
Expired
|
| US7750029 | Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient |
Dec, 2023
(1 year, 1 day ago) |
Expired
|
| US8835474 | Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
| US7342117 | α-form or β-form crystal of acetanilide derivative |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
| US7982049 | α-form or β-form crystal of acetanilide derivative |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
| USRE44872 | Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
|
US6346532 (Pediatric) | Amide derivatives or salts thereof |
Sep, 2022
(2 years ago) |
Expired
|
| US6562375 | Stable pharmaceutical composition for oral use |
Aug, 2020
(4 years ago) |
Expired
|
| US6346532 | Amide derivatives or salts thereof |
Oct, 2018
(6 years ago) |
Expired
|
| US6699503 | Hydrogel-forming sustained-release preparation |
Sep, 2013
(11 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Myrbetriq's patents.
Latest Legal Activities on Myrbetriq's Patents
Given below is the list of recent legal activities going on the following patents of Myrbetriq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 May, 2024 | US10842780 |
| Email Notification Critical | 26 Mar, 2024 | US11707451 |
| Patent eCofC Notification | 26 Mar, 2024 | US11707451 |
| Recordation of Patent eCertificate of Correction | 26 Mar, 2024 | US11707451 |
| Mail Patent eCofC Notification | 26 Mar, 2024 | US11707451 |
| Patent eGrant Notification | 25 Jul, 2023 | US11707451 |
| Patent Issue Date Used in PTA Calculation Critical | 25 Jul, 2023 | US11707451 |
| Electronic Review Critical | 25 Jul, 2023 | US11707451 |
| Email Notification Critical | 25 Jul, 2023 | US11707451 |
| Recordation of Patent eGrant | 25 Jul, 2023 | US11707451 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Myrbetriq and ongoing litigations to help you estimate the early arrival of Myrbetriq generic.
Myrbetriq's Litigations
Myrbetriq been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 16, 2017, against patent number US6346532. The petitioner Sawai Pharmaceutical Co., Ltd., challenged the validity of this patent, with Astellas Pharma Inc. as the respondent. Click below to track the latest information on how companies are challenging Myrbetriq's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6346532 | October, 2017 |
Terminated-Denied
(04 May, 2018) | Astellas Pharma Inc. | Sawai Pharmaceutical Co., Ltd. |
FDA has granted some exclusivities to Myrbetriq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Myrbetriq, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Myrbetriq.
Exclusivity Information
Myrbetriq holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Myrbetriq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 28, 2017 |
| New Indication(I-777) | Apr 27, 2021 |
| New Indication(I-855) | Mar 25, 2024 |
| Pediatric Exclusivity(PED) | Sep 25, 2024 |
Several oppositions have been filed on Myrbetriq's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Myrbetriq's generic, the next section provides detailed information on ongoing and past EP oppositions related to Myrbetriq patents.
Myrbetriq's Oppositions Filed in EPO
Myrbetriq has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 17, 2013, by Huenges Martin/, Glas Holger. This opposition was filed on patent number EP08843784A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP09817723A | Sep, 2021 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP09817723A | Sep, 2021 | Brand Murray Fuller LLP | Granted and Under Opposition |
| EP09817723A | Sep, 2021 | Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi | Granted and Under Opposition |
| EP09817723A | Sep, 2021 | Hamm&Wittkopp Patentanwälte PartmbB | Granted and Under Opposition |
| EP09817723A | Sep, 2021 | Bülle Dr., Jan | Granted and Under Opposition |
| EP09817723A | Sep, 2021 | Sandoz AG | Granted and Under Opposition |
| EP08843784A | Jul, 2013 | Huenges Martin/, Glas Holger | Revoked |
US patents provide insights into the exclusivity only within the United States, but Myrbetriq is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Myrbetriq's family patents as well as insights into ongoing legal events on those patents.
Myrbetriq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Myrbetriq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 28, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Myrbetriq Generic API suppliers:
Mirabegron is the generic name for the brand Myrbetriq. 4 different companies have already filed for the generic of Myrbetriq, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Myrbetriq's generic
How can I launch a generic of Myrbetriq before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Myrbetriq's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Myrbetriq's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Myrbetriq -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg | 28 Jun, 2016 | 6 | 27 Dec, 2019 | 04 Nov, 2023 | Extinguished Eligible |
| 50 mg | 28 Jun, 2016 | 6 | 28 Sep, 2022 | 04 Nov, 2023 | Deferred |
Alternative Brands for Myrbetriq
Myrbetriq which is used for treating neurogenic detrusor overactivity in pediatric patients and overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, including in combination with solifenacin succinate for more severe cases., has several other brand drugs in the same treatment category and using the same active ingredient (Mirabegron). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Pfizer |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Mirabegron. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Apgdi |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Mirabegron, Myrbetriq's active ingredient. Check the complete list of approved generic manufacturers for Myrbetriq
About Myrbetriq
Myrbetriq is a drug owned by Astellas Pharma Global Development Inc. It is used for treating neurogenic detrusor overactivity in pediatric patients and overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, including in combination with solifenacin succinate for more severe cases. Myrbetriq uses Mirabegron as an active ingredient. Myrbetriq was launched by Apgdi in 2012.
Approval Date:
Myrbetriq was approved by FDA for market use on 28 June, 2012.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Myrbetriq is 28 June, 2012, its NCE-1 date is estimated to be 26 September, 2023.
Active Ingredient:
Myrbetriq uses Mirabegron as the active ingredient. Check out other Drugs and Companies using Mirabegron ingredient
Treatment:
Myrbetriq is used for treating neurogenic detrusor overactivity in pediatric patients and overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, including in combination with solifenacin succinate for more severe cases.
Dosage:
Myrbetriq is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 50MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |