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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. One supplier is 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

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Summary for NULIBRY

International Patents:	10
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for NULIBRY
What excipients (inactive ingredients) are in NULIBRY?	NULIBRY excipients list
DailyMed Link:	NULIBRY at DailyMed

Drug patent expirations by year for NULIBRY

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

Generic Entry Date for NULIBRY^: ⤷ Sign Up* 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

US Patents and Regulatory Information for NULIBRY

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NULIBRY is ⤷ Sign Up.

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM STUDY ORGN001-102
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

See the table below for patents covering NULIBRY around the world.

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Country	Patent Number	Title	Estimated Expiration
Slovenia	1664317		⤷ Sign Up
Germany	102004004642	Produktion, Gewinnung und therapeutischer Einsatz des Molybdopterin-Derivats Precursor Z zur Therapie der Stoffwechselerkrankung humaner Molybdäncofaktor-Defizienz und anderer assoziierter Krankheiten	⤷ Sign Up
Poland	1664317		⤷ Sign Up
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)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005073387		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration