NULIBRY Drug Patent Profile
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When do Nulibry patents expire, and when can generic versions of Nulibry launch?
Nulibry is a drug marketed by Sentynl Theraps Inc and is included in one NDA. There is one patent protecting this drug.
This drug has ten patent family members in ten countries.
The generic ingredient in NULIBRY is fosdenopterin hydrobromide. Two suppliers are listed for this compound. Additional details are available on the fosdenopterin hydrobromide profile page.
DrugPatentWatch® Generic Entry Outlook for Nulibry
Nulibry will be eligible for patent challenges on February 26, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 26, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for NULIBRY
International Patents: | 10 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Drug Prices: | Drug price information for NULIBRY |
What excipients (inactive ingredients) are in NULIBRY? | NULIBRY excipients list |
DailyMed Link: | NULIBRY at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NULIBRY
Generic Entry Date for NULIBRY*:
Constraining patent/regulatory exclusivity:
INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A NDA:
Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NULIBRY
Drug Class | Cyclic Pyranopterin Monophosphate |
Anatomical Therapeutic Chemical (ATC) Classes for NULIBRY
US Patents and Regulatory Information for NULIBRY
NULIBRY is protected by one US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NULIBRY is ⤷ Try a Trial.
This potential generic entry date is based on INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting NULIBRY
Method for obtaining precursor Z and use thereof for the production of a means for therapy of human molybdenum cofactor deficiency
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING MOLYBDENUM COFACTOR DEFICIENCY TYPE A
FDA Regulatory Exclusivity protecting NULIBRY
INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A
Exclusivity Expiration: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sentynl Theraps Inc | NULIBRY | fosdenopterin hydrobromide | POWDER;INTRAVENOUS | 214018-001 | Feb 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Sentynl Theraps Inc | NULIBRY | fosdenopterin hydrobromide | POWDER;INTRAVENOUS | 214018-001 | Feb 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sentynl Theraps Inc | NULIBRY | fosdenopterin hydrobromide | POWDER;INTRAVENOUS | 214018-001 | Feb 26, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for NULIBRY
When does loss-of-exclusivity occur for NULIBRY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Canada
Patent: 54461
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 13960
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 64317
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 64317
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2004004642
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 64317
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 64317
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 64317
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 06733
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering NULIBRY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1113960 | ⤷ Try a Trial | |
Portugal | 1664317 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2005073387 | ⤷ Try a Trial | |
Canada | 2554461 | PROCEDE DE PRODUCTION DU PRECURSEUR Z ET SON UTILISATION POUR PRODUIRE UN AGENT SERVANT A TRAITER LA DEFICIENCE HUMAINE EN COFACTEUR MOLYBDENE (METHOD FOR OBTAINING PRECURSOR Z AND USE THEREOF FOR THE PRODUCTION OF A MEANS FOR THERAPY OF HUMAN MOLYBDENUM COFACTOR DEFICIENCY) | ⤷ Try a Trial |
Slovenia | 1664317 | ⤷ Try a Trial | |
European Patent Office | 1664317 | Utilisation du précurseur Z pour produire un agent servant à traiter la déficience humaine en cofacteur molybdène (Use of precursor Z for the production of a means for therapy of human molybdenum cofactor deficiency) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |