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. 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
Summary for DOJOLVI
International Patents: | 8 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 62 |
Patent Applications: | 452 |
What excipients (inactive ingredients) are in DOJOLVI? | DOJOLVI excipients list |
DailyMed Link: | DOJOLVI at DailyMed |

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Pharmacology for DOJOLVI
Drug Class | Medium-chain Triglyceride |
Anatomical Therapeutic Chemical (ATC) Classes for DOJOLVI
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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Glycogen or polysaccharide storage disease treatment method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ultragenyx Pharm Inc | DOJOLVI | triheptanoin | LIQUID;ORAL | 213687-001 | Jun 30, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ultragenyx Pharm Inc | DOJOLVI | triheptanoin | LIQUID;ORAL | 213687-001 | Jun 30, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ultragenyx Pharm Inc | DOJOLVI | triheptanoin | LIQUID;ORAL | 213687-001 | Jun 30, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2006014353 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
Mexico | 2007000304 | METODO DE TRATAMIENTO DE ENFERMEDAD DE ALMACENAMIENTO DE GLUCOGENO O POLISACARIDOS. (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD.) | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
Mexico | 338247 | METODO DE TRATAMIENTO DE ENFERMEDAD DE ALMACENAMIENTO DE GLUCOGENO O POLISACARIDOS. (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD.) | ⤷ Try a Trial |
European Patent Office | 3300727 | PROCEDES POUR LE TRAITEMENT DE GLYCOGÉNOSES ET DE MALADIES DU STOCKAGE DES POLYSACCHARIDES (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |