Nulibry is a drug owned by Sentynl Therapeutics Inc. It is protected by 1 US drug patent filed in 2021 out of which all have expired. Nulibry's patents have been open to challenges since 26 February, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 26, 2028. Details of Nulibry'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). | |||
| US7504095 | Method for obtaining precursor Z and use thereof for the production of a means for therapy of human molybdenum cofactor deficiency |
Jan, 2025
(5 months 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 Nulibry's patents.
Latest Legal Activities on Nulibry's Patents
Given below is the list of recent legal activities going on the following patents of Nulibry.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US7504095 |
| Second letter to regulating agency to determine regulatory review period | 14 Feb, 2023 | US7504095 |
| Letter from FDA or Dept of Agriculture re PTE application | 21 Sep, 2022 | US7504095 |
| Email Notification Critical | 11 May, 2022 | US7504095 |
| Change in Power of Attorney (May Include Associate POA) Critical | 11 May, 2022 | US7504095 |
| Correspondence Address Change Critical | 10 May, 2022 | US7504095 |
| Initial letter Re: PTE Application to regulating agency | 25 Feb, 2022 | US7504095 |
| Change in Power of Attorney (May Include Associate POA) Critical | 27 Apr, 2021 | US7504095 |
| Email Notification Critical | 27 Apr, 2021 | US7504095 |
| Correspondence Address Change Critical | 26 Apr, 2021 | US7504095 |
FDA has granted several exclusivities to Nulibry. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nulibry, 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 Nulibry.
Exclusivity Information
Nulibry holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Nulibry's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-286) | Oct 27, 2025 |
| New Chemical Entity Exclusivity(NCE) | Feb 26, 2026 |
| Orphan Drug Exclusivity(ODE-342) | Feb 26, 2028 |
US patents provide insights into the exclusivity only within the United States, but Nulibry 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 Nulibry's family patents as well as insights into ongoing legal events on those patents.
Nulibry's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nulibry's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 26, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nulibry Generics:
There are no approved generic versions for Nulibry as of now.
About Nulibry
Nulibry is a drug owned by Sentynl Therapeutics Inc. It is used for treating Molybdenum Cofactor Deficiency Type A. Nulibry uses Fosdenopterin Hydrobromide as an active ingredient. Nulibry was launched by Sentynl Theraps Inc in 2021.
Approval Date:
Nulibry was approved by FDA for market use on 26 February, 2021.
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 Nulibry is 26 February, 2021, its NCE-1 date is estimated to be 26 February, 2025.
Active Ingredient:
Nulibry uses Fosdenopterin Hydrobromide as the active ingredient. Check out other Drugs and Companies using Fosdenopterin Hydrobromide ingredient
Treatment:
Nulibry is used for treating Molybdenum Cofactor Deficiency Type A.
Dosage:
Nulibry is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 9.5MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |