Mydayis is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 5 US drug patents filed in 2017. Out of these, 2 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 24, 2029. Details of Mydayis'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). | |||
| US8846100 | Controlled dose drug delivery system |
Aug, 2029
(3 years from now) | Active |
| US9173857 | Controlled dose drug delivery system |
May, 2026
(6 months from now) | Active |
| US6913768 | Sustained release delivery of amphetamine salts |
May, 2023
(2 years ago) |
Expired
|
| USRE41148 | Oral pulsed dose drug delivery system |
Oct, 2018
(7 years ago) |
Expired
|
| USRE42096 | Oral pulsed dose drug delivery system |
Oct, 2018
(7 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 Mydayis's patents.
Latest Legal Activities on Mydayis's Patents
Given below is the list of recent legal activities going on the following patents of Mydayis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9173857 |
| Review Certificate Mailed | 04 Jun, 2020 | US9173857 |
| Review Certificate | 15 May, 2020 | US9173857 |
| Termination or Final Written Decision | 03 Jul, 2019 | US9173857 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Apr, 2019 | US9173857 |
| Request for Trial Granted
Critical | 06 Jul, 2018 | US9173857 |
| Email Notification
Critical | 28 Feb, 2018 | US6913768 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 28 Feb, 2018 | US6913768 |
| Correspondence Address Change
Critical | 27 Feb, 2018 | US6913768 |
| Email Notification
Critical | 28 Dec, 2017 | US9173857 |
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 Mydayis and ongoing
litigations to
help you estimate the early arrival of Mydayis generic.
Mydayis's Litigations
Mydayis been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 13, 2017, against patent number US8846100. The petitioner Amerigen Pharmaceuticals Limited, challenged the validity of this patent, with Shire, LLC as the respondent. Click below to track the latest information on how companies are challenging Mydayis's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8846100 | December, 2017 |
Final Written Decision
(03 Jul, 2019) | Shire LLC et al. | KVK-Tech, Inc. et al. |
| US8846100 | December, 2017 |
FWD Entered
(03 Jul, 2019) | Shire LLC | KVK-Tech, Inc. |
| US9173857 | December, 2017 |
Final Written Decision
(03 Jul, 2019) | Shire, LLC et al. | KVK-Tech, Inc. et al. |
| US9173857 | December, 2017 |
FWD Entered
(03 Jul, 2019) | Shire, LLC | KVK-Tech, Inc. |
| US8846100 | January, 2017 |
Terminated-Settled
(02 May, 2017) | Shire, LLC | Amerigen Pharmaceuticals Limited |
FDA has granted some exclusivities to Mydayis. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Mydayis,
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
Mydayis.
Exclusivity Information
Mydayis holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Mydayis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 20, 2020 |
| M(M-248) | Sep 13, 2022 |
| Pediatric Exclusivity(PED) | Mar 13, 2023 |
US patents provide insights into the exclusivity only within the United States, but
Mydayis 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 Mydayis's family patents as well as insights into
ongoing legal events
on those patents.
Mydayis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mydayis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 24, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mydayis Generic API suppliers:
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate is the generic name for the brand Mydayis. 29 different companies have already filed for the generic of Mydayis, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mydayis's generic
How can I launch a generic of Mydayis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mydayis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mydayis'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 Mydayis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 37.5 mg and 50 mg | 03 Aug, 2017 | 1 | 31 Jan, 2022 | 24 Aug, 2029 | Deferred |
| 12.5 mg and 25 mg | 07 Aug, 2017 | 1 | 31 Jan, 2022 | 24 Aug, 2029 | Deferred |
Alternative Brands for Mydayis
Mydayis which is used for managing symptoms of Attention Deficit Hyperactivity Disorder., has several other brand drugs using the same active ingredient (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate). 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa |
| |||||||
| Teva Womens |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate, Mydayis's active ingredient. Check the complete list of approved generic manufacturers for Mydayis
About Mydayis
Mydayis is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for managing symptoms of Attention Deficit Hyperactivity Disorder. Mydayis uses Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate as an active ingredient. Mydayis was launched by Takeda Pharms Usa in 2017.
Approval Date:
Mydayis was approved by FDA for market use on 20 June, 2017.
Active Ingredient:
Mydayis uses Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate as the active ingredient. Check out other Drugs and Companies using Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate ingredient
Treatment:
Mydayis is used for managing symptoms of Attention Deficit Hyperactivity Disorder.
Dosage:
Mydayis is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |