NULIBRY Drug Patent Profile

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

See drug prices for NULIBRY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NULIBRY

Constraining patent/regulatory exclusivity:

INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A

NDA:

214018

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

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for NULIBRY

NULIBRY is protected by one US patents and two FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting NULIBRY

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			Y
Sentynl Theraps Inc	NULIBRY	fosdenopterin hydrobromide	POWDER;INTRAVENOUS	214018-001	Feb 26, 2021		RX	Yes	Yes
Sentynl Theraps Inc	NULIBRY	fosdenopterin hydrobromide	POWDER;INTRAVENOUS	214018-001	Feb 26, 2021		RX	Yes	Yes

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

Cyprus

Denmark

European Patent Office

Germany

Poland

Portugal

Slovenia

Spain

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
Portugal	1664317
World Intellectual Property Organization (WIPO)	2005073387
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)
Slovenia	1664317
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)