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Last Updated: August 11, 2022

DOJOLVI Drug Patent 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. 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
Raw Ingredient (Bulk) Api Vendors: 54
Patent Applications: 549
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

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DOJOLVI is See Plans and Pricing.

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

Glycogen or polysaccharide storage disease treatment method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Glycogen or polysaccharide storage disease treatment method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting DOJOLVI

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)
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
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 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 DOJOLVI

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

Country Patent Number Title Estimated Expiration
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) See Plans and Pricing
Mexico 338247 METODO DE TRATAMIENTO DE ENFERMEDAD DE ALMACENAMIENTO DE GLUCOGENO O POLISACARIDOS. (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD.) See Plans and Pricing
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) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006014353 See Plans and Pricing
European Patent Office 3300727 PROCEDES POUR LE TRAITEMENT DE GLYCOG√ČNOSES ET DE MALADIES DU STOCKAGE DES POLYSACCHARIDES (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD) See Plans and Pricing
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) See Plans and Pricing
Canada 2573054 METHODE DE TRAITEMENT D'UNE MALADIE DE SURCHARGE DUE A L'ACCUMULATION DE GLYCOGENES OU DE POLYSACCHARIDES (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Harvard Business School
Johnson and Johnson
AstraZeneca
Medtronic

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.