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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
Summary for NULIBRY
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| DailyMed Link: | NULIBRY at DailyMed |
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 |
