Orfadin Patent Expiration

Orfadin is a drug owned by Swedish Orphan Biovitrum Ab Publ. It is protected by 2 US drug patents filed from 2013 to 2016. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 28, 2033. Details of Orfadin'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).
US9301932 Liquid pharmaceutical composition comprising nitisinone
Feb, 2033

(8 years from now)

Active
US5550165 Pharmaceutical compositions for the treatment of hereditary tyosinemia type I
Aug, 2013

(11 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 Orfadin's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 15 Sep, 2023 US9301932
Payment of Maintenance Fee, 4th Year, Large Entity 03 Sep, 2019 US9301932
Patent Issue Date Used in PTA Calculation 05 Apr, 2016 US9301932
Recordation of Patent Grant Mailed 05 Apr, 2016 US9301932
Email Notification 17 Mar, 2016 US9301932
Issue Notification Mailed 16 Mar, 2016 US9301932
Application Is Considered Ready for Issue 02 Mar, 2016 US9301932
Dispatch to FDC 02 Mar, 2016 US9301932
Issue Fee Payment Verified 23 Feb, 2016 US9301932
Issue Fee Payment Received 23 Feb, 2016 US9301932


FDA has granted several exclusivities to Orfadin. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Orfadin, 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 Orfadin.

Exclusivity Information

Orfadin holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Orfadin's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Dosing Schedule(D-169) Sep 01, 2020

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US patents provide insights into the exclusivity only within the United States, but Orfadin 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 Orfadin's family patents as well as insights into ongoing legal events on those patents.

Orfadin's Family Patents

Orfadin has patent protection in a total of 23 countries. It's US patent count contributes only to 11.5% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Orfadin.

Family Patents

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Generic Launch

Generic Release Date:

Orfadin's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 28, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Orfadin Generic API suppliers:

Nitisinone is the generic name for the brand Orfadin. 4 different companies have already filed for the generic of Orfadin, with Eton having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Orfadin's generic

Alternative Brands for Orfadin

Orfadin which is used for treating hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction 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
Cycle
Nityr

(uses Nitisinone)

Used for managing hereditary tyrosinemia type 1 (HT-1) when combined with dietary restrictions of tyrosine and phenylalanine.

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





About Orfadin

Orfadin is a drug owned by Swedish Orphan Biovitrum Ab Publ. It is used for treating hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Orfadin uses Nitisinone as an active ingredient. Orfadin was launched by Swedish Orphan in 2016.

Approval Date:

Orfadin was approved by FDA for market use on 22 April, 2016.

Active Ingredient:

Orfadin uses Nitisinone as the active ingredient. Check out other Drugs and Companies using Nitisinone ingredient

Treatment:

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

Dosage:

Orfadin is available in the following dosage forms - suspension form for oral use, capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
4MG/ML SUSPENSION Prescription ORAL
2MG CAPSULE Prescription ORAL
5MG CAPSULE Prescription ORAL
10MG CAPSULE Prescription ORAL