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
(7 years from now) | Active |
| US5550165 | Pharmaceutical compositions for the treatment of hereditary tyosinemia type I |
Aug, 2013
(12 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.
Latest 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 |
|---|---|---|
 | ||
| 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
Critical | 05 Apr, 2016 | US9301932 |
| Recordation of Patent Grant Mailed
Critical | 05 Apr, 2016 | US9301932 |
| Email Notification
Critical | 17 Mar, 2016 | US9301932 |
| Issue Notification Mailed
Critical | 16 Mar, 2016 | US9301932 |
| Application Is Considered Ready for Issue
Critical | 02 Mar, 2016 | US9301932 |
| Dispatch to FDC | 02 Mar, 2016 | US9301932 |
| Issue Fee Payment Verified
Critical | 23 Feb, 2016 | US9301932 |
| Issue Fee Payment Received
Critical | 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 |
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
Explore Our Curated Drug Screens
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 |
| |||
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 |