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DOJOLVI Drug Patent Profile

When do Dojolvi patents expire, 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 and one Paragraph IV challenge.

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 was eligible for patent challenges on June 30, 2024.

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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for DOJOLVI

International Patents:	8
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	2
Patent Applications:	393
Drug Prices:	Drug price information for DOJOLVI
What excipients (inactive ingredients) are in DOJOLVI?	DOJOLVI excipients list
DailyMed Link:	DOJOLVI at DailyMed

See drug prices for DOJOLVI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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:

213687

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.

Recent Clinical Trials for DOJOLVI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Jerry Vockley, MD, PhD	Phase 2
Ultragenyx Pharmaceutical Inc	Phase 2
Ultragenyx Pharmaceutical Inc	Phase 3

See all DOJOLVI clinical trials

Pharmacology for DOJOLVI

Drug Class

Medium-chain Triglyceride

Paragraph IV (Patent) Challenges for DOJOLVI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DOJOLVI	Oral Liquid	triheptanoin	100% w/w	213687	3	2024-07-01

US Patents and Regulatory Information for DOJOLVI

DOJOLVI is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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).

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 DOJOLVI

FDA Regulatory Exclusivity protecting 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			Y
Ultragenyx Pharm Inc	DOJOLVI	triheptanoin	LIQUID;ORAL	213687-001	Jun 30, 2020		RX	Yes	Yes
Ultragenyx Pharm Inc	DOJOLVI	triheptanoin	LIQUID;ORAL	213687-001	Jun 30, 2020		RX	Yes	Yes			Y
Ultragenyx Pharm Inc	DOJOLVI	triheptanoin	LIQUID;ORAL	213687-001	Jun 30, 2020		RX	Yes	Yes

International Patents for DOJOLVI

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

Country	Patent Number	Title	Estimated Expiration
Mexico	338247	METODO DE TRATAMIENTO DE ENFERMEDAD DE ALMACENAMIENTO DE GLUCOGENO O POLISACARIDOS. (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD.)
World Intellectual Property Organization (WIPO)	2006014353
Canada	2784420	METHODE DE TRAITEMENT D'UNE MALADIE DE SURCHARGE DUE A L'ACCUMULATION DE GLYCOGENES OU DE POLYSACCHARIDES (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD)
Canada	2784585	METHODE DE TRAITEMENT D'UNE MALADIE DE SURCHARGE DUE A L'ACCUMULATION DE GLYCOGENES OU DE POLYSACCHARIDES (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD)
Mexico	2007000304	METODO DE TRATAMIENTO DE ENFERMEDAD DE ALMACENAMIENTO DE GLUCOGENO O POLISACARIDOS. (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD.)
European Patent Office	1773317	METHODE DE TRAITEMENT D'UNE MALADIE DE SURCHARGE DUE A L'ACCUMULATION DE GLYCOGENES OU DE POLYSACCHARIDES (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD)
European Patent Office	3300727	PROCEDES POUR LE TRAITEMENT DE GLYCOGÉNOSES ET DE MALADIES DU STOCKAGE DES POLYSACCHARIDES (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD)