Nourianz is a drug owned by Kyowa Kirin Inc. It is protected by 4 US drug patents filed in 2019. Out of these, 2 drug patents are active and 2 have expired. Nourianz's patents have been open to challenges since 28 August, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 28, 2028. Details of Nourianz's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7541363 | Microcrystal |
Nov, 2024
(11 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7727993 | Administering adenosine A2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy |
Jan, 2028
(2 years from now) | Active |
| US8318201 | Method of stabilizing diarylvinylene compound |
Sep, 2027
(1 year, 10 months from now) | Active |
| US7727994 | Methods of treating patients suffering from movement disorders |
Jan, 2023
(2 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 Nourianz's patents.
Latest Legal Activities on Nourianz's Patents
Given below is the list of recent legal activities going on the following patents of Nourianz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 May, 2024 | US8318201 |
| Patent Term Extension Certificate
Critical | 17 Oct, 2023 | US7727993 |
| Notice of Final Determination -Eligible | 18 Jul, 2023 | US7727993 |
| FDA Final Eligibility Letter
Critical | 13 Jul, 2023 | US7727994 |
| FDA Final Eligibility Letter
Critical | 13 Jul, 2023 | US7727993 |
| Withdrawal of Application for PTE
Critical | 22 Feb, 2023 | US7727994 |
| Interim Patent Term Extension Granted
Critical | 22 Feb, 2023 | US7727993 |
| transaction for FDA Determination of Regulatory Review Period | 07 Nov, 2022 | US7727993 |
| transaction for FDA Determination of Regulatory Review Period | 07 Nov, 2022 | US7727994 |
| Interim Patent Term Extension Granted
Critical | 21 Sep, 2022 | US7727993 |
FDA has granted several exclusivities to Nourianz. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Nourianz, 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
Nourianz.
Exclusivity Information
Nourianz holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Nourianz's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 27, 2024 |
US patents provide insights into the exclusivity only within the United States, but
Nourianz 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 Nourianz's family patents as well as insights into
ongoing legal events
on those patents.
Nourianz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nourianz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 28, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nourianz Generics:
There are no approved generic versions for Nourianz as of now.
About Nourianz
Nourianz is a drug owned by Kyowa Kirin Inc. It is used for managing off time in patients with Parkinson's disease undergoing L-DOPA therapy. Nourianz uses Istradefylline as an active ingredient. Nourianz was launched by Kyowa Kirin in 2019.
Approval Date:
Nourianz was approved by FDA for market use on 27 August, 2019.
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 Nourianz is 27 August, 2019, its NCE-1 date is estimated to be 28 August, 2023.
Active Ingredient:
Nourianz uses Istradefylline as the active ingredient. Check out other Drugs and Companies using Istradefylline ingredient
Treatment:
Nourianz is used for managing off time in patients with Parkinson's disease undergoing L-DOPA therapy.
Dosage:
Nourianz is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | TABLET | Prescription | ORAL |
| 40MG | TABLET | Prescription | ORAL |