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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 213687


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NDA 213687 describes DOJOLVI, which is a drug marketed by Ultragenyx Pharm Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the DOJOLVI profile page.

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.
Summary for 213687
Tradename:DOJOLVI
Applicant:Ultragenyx Pharm Inc
Ingredient:triheptanoin
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213687
Generic Entry Date for 213687*:
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)
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 NDA: 213687
Suppliers and Packaging for NDA: 213687
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOJOLVI triheptanoin LIQUID;ORAL 213687 NDA Ultragenyx Pharmaceutical Inc. 69794-050 69794-050-50 1 BOTTLE, GLASS in 1 CARTON (69794-050-50) / 500 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;ORALStrength100% w/w
Approval Date:Jun 30, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 30, 2027
Regulatory Exclusivity Use: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)
Regulatory Exclusivity Expiration:Jun 30, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Apr 28, 2029Product Flag?YSubstance Flag?Delist Request?

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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.