Astagraf Xl is a drug owned by Astellas Pharma Us Inc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 24, 2025. Details of Astagraf Xl'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). | |||
| US6884433 | Sustained release formulation containing tacrolimus |
Mar, 2019
(7 years ago) |
Expired
|
| US6576259 | Sustained release formulations containing tacrolimus |
Mar, 2019
(7 years ago) |
Expired
|
| US6440458 | Sustained release preparations |
Mar, 2019
(7 years ago) |
Expired
|
| US8551522 | Sustained-release formulation |
Mar, 2019
(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 Astagraf Xl's patents.
Latest Legal Activities on Astagraf Xl's Patents
Given below is the list of recent legal activities going on the following patents of Astagraf Xl.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 15 Nov, 2021 | US8551522 |
| Maintenance Fee Reminder Mailed
Critical | 31 May, 2021 | US8551522 |
| Recordation of Patent Grant Mailed
Critical | 08 Oct, 2013 | US8551522 |
| Patent Issue Date Used in PTA Calculation
Critical | 08 Oct, 2013 | US8551522 |
| Email Notification
Critical | 19 Sep, 2013 | US8551522 |
| Issue Notification Mailed
Critical | 18 Sep, 2013 | US8551522 |
| Dispatch to FDC | 07 Sep, 2013 | US8551522 |
| Application Is Considered Ready for Issue
Critical | 06 Sep, 2013 | US8551522 |
| Issue Fee Payment Verified
Critical | 05 Sep, 2013 | US8551522 |
| Issue Fee Payment Received
Critical | 05 Sep, 2013 | US8551522 |
FDA has granted several exclusivities to Astagraf Xl. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Astagraf Xl, 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
Astagraf Xl.
Exclusivity Information
Astagraf Xl holds 2 exclusivities. All of its exclusivities have expired in 2025. Details of Astagraf Xl's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jul 19, 2016 |
| ODE*(ODE*) | May 24, 2025 |
US patents provide insights into the exclusivity only within the United States, but
Astagraf Xl 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 Astagraf Xl's family patents as well as insights into
ongoing legal events
on those patents.
Astagraf Xl's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Astagraf Xl:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Astagraf Xl's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 24, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Astagraf Xl Generic API suppliers:
Tacrolimus is the generic name for the brand Astagraf Xl. 18 different companies have already filed for the generic of Astagraf Xl, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Astagraf Xl's generic
How can I launch a generic of Astagraf Xl before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Astagraf Xl's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Astagraf Xl'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 Astagraf Xl -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 24 Sep, 2013 | 25 Mar, 2019 | Extinguished | Less |
Alternative Brands for Astagraf Xl
Astagraf Xl which is used for daily administration of medication., has several other brand drugs using the same active ingredient (Tacrolimus). 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 | |
|---|---|---|
| Leo Pharma As |
| |
| Veloxis Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tacrolimus, Astagraf Xl's active ingredient. Check the complete list of approved generic manufacturers for Astagraf Xl
About Astagraf Xl
Astagraf Xl is a drug owned by Astellas Pharma Us Inc. It is used for daily administration of medication. Astagraf Xl uses Tacrolimus as an active ingredient. Astagraf Xl was launched by Astellas in 2013.
Approval Date:
Astagraf Xl was approved by FDA for market use on 19 July, 2013.
Active Ingredient:
Astagraf Xl uses Tacrolimus as the active ingredient. Check out other Drugs and Companies using Tacrolimus ingredient
Treatment:
Astagraf Xl is used for daily administration of medication.
Dosage:
Astagraf Xl is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.5MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| EQ 1MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| EQ 5MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |