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Last Updated: June 27, 2022

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. 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
What excipients (inactive ingredients) are in NULIBRY?NULIBRY excipients list
DailyMed Link:NULIBRY at DailyMed
Drug patent expirations by year for NULIBRY
DrugPatentWatch® Estimated Generic Entry Opportunity 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.

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 See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sentynl Theraps Inc NULIBRY fosdenopterin hydrobromide POWDER;INTRAVENOUS 214018-001 Feb 26, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sentynl Theraps Inc NULIBRY fosdenopterin hydrobromide POWDER;INTRAVENOUS 214018-001 Feb 26, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Cyprus

Patent: 13960
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 64317
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 64317
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004004642
Estimated Expiration: See Plans and Pricing

Poland

Patent: 64317
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 64317
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 64317
Estimated Expiration: See Plans and Pricing

Spain

Patent: 06733
Estimated Expiration: See Plans and Pricing

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
World Intellectual Property Organization (WIPO) 2005073387 See Plans and Pricing
Denmark 1664317 See Plans and Pricing
Spain 2406733 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Boehringer Ingelheim
Baxter
AstraZeneca
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.