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Last Updated: May 13, 2021

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NULIBRY Drug Profile

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When do Nulibry patents expire, and when can generic versions of Nulibry launch?

Nulibry is a drug marketed by Origin and is included in one NDA. There is one patent protecting this drug.

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, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for NULIBRY
US Patents:1
Applicants:1
NDAs:1
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:
FDA exclusivity
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Origin NULIBRY fosdenopterin hydrobromide POWDER;INTRAVENOUS 214018-001 Feb 26, 2021 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Origin NULIBRY fosdenopterin hydrobromide POWDER;INTRAVENOUS 214018-001 Feb 26, 2021 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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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.