Nityr is a drug owned by Cycle Pharmaceuticals Ltd. It is protected by 1 US drug patent filed in 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 05, 2035. Details of Nityr'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10328029 | Pharmaceutical composition |
Jan, 2035
(10 years from now) | Active |
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 Nityr's patents.
Latest Legal Activities on Nityr's Patents
Given below is the list of recent legal activities going on the following patents of Nityr.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 01 Dec, 2022 | US10328029 |
| Email Notification | 17 Nov, 2020 | US10328029 |
| Change in Power of Attorney (May Include Associate POA) | 17 Nov, 2020 | US10328029 |
| Correspondence Address Change | 13 Nov, 2020 | US10328029 |
| Recordation of Patent Grant Mailed | 25 Jun, 2019 | US10328029 |
| Patent Issue Date Used in PTA Calculation | 25 Jun, 2019 | US10328029 |
| Email Notification | 06 Jun, 2019 | US10328029 |
| Issue Notification Mailed | 05 Jun, 2019 | US10328029 |
| Dispatch to FDC | 20 May, 2019 | US10328029 |
| Application Is Considered Ready for Issue | 08 May, 2019 | US10328029 |
US patents provide insights into the exclusivity only within the United States, but Nityr 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 Nityr's family patents as well as insights into ongoing legal events on those patents.
Nityr's family patents
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Generic Launch
Generic Release Date:
Nityr's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 05, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nityr Generics:
Nitisinone is the generic name for the brand Nityr. 4 different companies have already filed for the generic of Nityr, with Eton having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nityr's generic
About Nityr
Nityr is a drug owned by Cycle Pharmaceuticals Ltd. It is used for managing hereditary tyrosinemia type 1 (HT-1) when combined with dietary restrictions of tyrosine and phenylalanine. Nityr uses Nitisinone as an active ingredient. Nityr was launched by Cycle in 2017.
Market Authorisation Date:
Nityr was approved by FDA for market use on 26 July, 2017.
Active Ingredient:
Nityr uses Nitisinone as the active ingredient. Check out other Drugs and Companies using Nitisinone ingredient
Treatment:
Nityr is used for managing hereditary tyrosinemia type 1 (HT-1) when combined with dietary restrictions of tyrosine and phenylalanine.
Dosage:
Nityr is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |