Nityr Patent Expiration

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 drug 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.

Given below is the list of recent legal activities going on the following patents of Nityr.

Activity Date Patent Number
Patent litigations
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

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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

Nityr has patent protection in a total of 13 countries. It's US patent count contributes only to 7.1% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Nityr.

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 Generic API suppliers:

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

Alternative Brands for Nityr

Nityr which is used for managing hereditary tyrosinemia type 1 (HT-1) when combined with dietary restrictions of tyrosine and phenylalanine., has several other brand drugs in the same treatment category and using the same active ingredient (Nitisinone). 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
Swedish Orphan
Orfadin

(uses Nitisinone)

Used for treating hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Nitisinone, Nityr's active ingredient. Check the complete list of approved generic manufacturers for Nityr





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.

Approval 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