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Last Updated: June 13, 2021

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DOJOLVI Drug Profile


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Which patents cover Dojolvi, and what generic alternatives are available?

Dojolvi is a drug marketed by Ultragenyx Pharm Inc and is included in one NDA. There are two patents protecting this drug.

This drug has eight patent family members in four countries.

The generic ingredient in DOJOLVI is triheptanoin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the triheptanoin profile page.

DrugPatentWatch® Generic Entry Outlook for Dojolvi

Dojolvi will be eligible for patent challenges on June 30, 2024. 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 June 30, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DOJOLVI
International Patents:8
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in DOJOLVI?DOJOLVI excipients list
DailyMed Link:DOJOLVI at DailyMed
Drug patent expirations by year for DOJOLVI
DrugPatentWatch® Estimated Generic Entry Opportunity Date for DOJOLVI
Generic Entry Date for DOJOLVI*:
Constraining patent/regulatory exclusivity:
INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS FOR THE TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH MOLECULARLY CONFIRMED LONG-CHAIN FATTY ACID OXIDATION DISORDERS (LC-FAOD)
NDA:
Dosage:
LIQUID;ORAL

*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 DOJOLVI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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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