Aptensio Xr is a drug owned by Rhodes Pharmaceuticals Lp. It is protected by 17 US drug patents filed from 2015 to 2019 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 16, 2020. Details of Aptensio Xr'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). | |||
|
US8580310 (Pediatric) | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Jun, 2020
(5 years ago) |
Expired
|
|
US9801823 (Pediatric) | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Jun, 2020
(5 years ago) |
Expired
|
|
US9066869 (Pediatric) | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Jun, 2020
(5 years ago) |
Expired
|
|
US10039719 (Pediatric) | Methods of treating attention deficit hyperactivity disorder |
Jun, 2020
(5 years ago) |
Expired
|
|
US6419960 (Pediatric) | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Jun, 2020
(5 years ago) |
Expired
|
|
US7438930 (Pediatric) | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Jun, 2020
(5 years ago) |
Expired
|
|
US7083808 (Pediatric) | Controlled/modified release oral methylphenidate formulations |
Jun, 2020
(5 years ago) |
Expired
|
|
US7247318 (Pediatric) | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Jun, 2020
(5 years ago) |
Expired
|
| US8580310 | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Dec, 2019
(5 years ago) |
Expired
|
| US10463624 | Controlled release formulations |
Dec, 2019
(5 years ago) |
Expired
|
| US7438930 | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Dec, 2019
(5 years ago) |
Expired
|
| US6419960 | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Dec, 2019
(5 years ago) |
Expired
|
| US9801823 | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Dec, 2019
(5 years ago) |
Expired
|
| US10039719 | Methods of treating attention deficit hyperactivity disorder |
Dec, 2019
(5 years ago) |
Expired
|
| US9066869 | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Dec, 2019
(5 years ago) |
Expired
|
| US7083808 | Controlled/modified release oral methylphenidate formulations |
Dec, 2019
(5 years ago) |
Expired
|
| US7247318 | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
Dec, 2019
(5 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 Aptensio Xr's patents.
Latest Legal Activities on Aptensio Xr's Patents
Given below is the list of recent legal activities going on the following patents of Aptensio Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 11 Dec, 2023 | US10463624 |
| Expire Patent
Critical | 07 Aug, 2023 | US9066869 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 26 Jun, 2023 | US10463624 |
| Maintenance Fee Reminder Mailed
Critical | 20 Feb, 2023 | US9066869 (Litigated) |
| Expire Patent
Critical | 12 Sep, 2022 | US10039719 |
| Maintenance Fee Reminder Mailed
Critical | 28 Mar, 2022 | US10039719 |
| Expire Patent
Critical | 06 Dec, 2021 | US9801823 |
| Maintenance Fee Reminder Mailed
Critical | 21 Jun, 2021 | US9801823 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Apr, 2021 | US8580310 (Litigated) |
| Expire Patent
Critical | 23 Nov, 2020 | US7438930 (Litigated) |
FDA has granted several exclusivities to Aptensio Xr. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Aptensio Xr, 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
Aptensio Xr.
Exclusivity Information
Aptensio Xr holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Aptensio Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 17, 2018 |
US patents provide insights into the exclusivity only within the United States, but
Aptensio Xr 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 Aptensio Xr's family patents as well as insights into
ongoing legal events
on those patents.
Aptensio Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aptensio Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 16, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aptensio Xr Generic API suppliers:
Methylphenidate Hydrochloride is the generic name for the brand Aptensio Xr. 41 different companies have already filed for the generic of Aptensio Xr, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aptensio Xr's generic
How can I launch a generic of Aptensio Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aptensio Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aptensio Xr'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 Aptensio Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 60 mg | 23 Dec, 2015 | 1 | 13 Dec, 2018 | 16 Dec, 2019 | Eligible |
| 10 mg | 24 Dec, 2015 | 1 | 13 Dec, 2018 | 16 Dec, 2019 | Eligible |
| 15 mg, 20 mg, 40 mg and 50 mg | 28 Dec, 2015 | 1 | 13 Dec, 2018 | 16 Dec, 2019 | Eligible |
| 30 mg | 28 Mar, 2016 | 1 | 13 Dec, 2018 | 16 Dec, 2019 | Eligible |
Alternative Brands for Aptensio Xr
Aptensio Xr which is used for managing Attention Deficit Hyperactivity Disorder (ADHD)., has several other brand drugs in the same treatment category and using the same active ingredient (Methylphenidate Hydrochloride). 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 | ||
|---|---|---|---|---|
| Ironshore Pharms |
| |||
| Purdue Pharma Lp |
| |||
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. Methylphenidate Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |||
|---|---|---|---|---|
| Aytu Biopharma |
| |||
| Commave Therap |
| |||
| Janssen Pharms |
| |||
| Nextwave |
| |||
| Nextwave Pharms |
| |||
| Osmotica Pharm Us |
| |||
| Sandoz |
| |||
| Specgx Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Methylphenidate Hydrochloride, Aptensio Xr's active ingredient. Check the complete list of approved generic manufacturers for Aptensio Xr
About Aptensio Xr
Aptensio Xr is a drug owned by Rhodes Pharmaceuticals Lp. It is used for managing Attention Deficit Hyperactivity Disorder (ADHD). Aptensio Xr uses Methylphenidate Hydrochloride as an active ingredient. Aptensio Xr was launched by Rhodes Pharms in 2015.
Approval Date:
Aptensio Xr was approved by FDA for market use on 17 April, 2015.
Active Ingredient:
Aptensio Xr uses Methylphenidate Hydrochloride as the active ingredient. Check out other Drugs and Companies using Methylphenidate Hydrochloride ingredient
Treatment:
Aptensio Xr is used for managing Attention Deficit Hyperactivity Disorder (ADHD).
Dosage:
Aptensio Xr is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 30MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 15MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 60MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 10MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 40MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 50MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |