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Last Updated: November 4, 2024

Triheptanoin - Generic Drug Details


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What are the generic drug sources for triheptanoin and what is the scope of freedom to operate?

Triheptanoin is the generic ingredient in one branded drug marketed by Ultragenyx Pharm Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Triheptanoin has eight patent family members in four countries.

There is one drug master file entry for triheptanoin. One supplier is listed for this compound.

Summary for triheptanoin
International Patents:8
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 64
Clinical Trials: 34
Patent Applications: 899
What excipients (inactive ingredients) are in triheptanoin?triheptanoin excipients list
DailyMed Link:triheptanoin at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for triheptanoin
Generic Entry Date for triheptanoin*:
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.

Recent Clinical Trials for triheptanoin

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

SponsorPhase
Jerry Vockley, MD, PhDPhase 2
Areeg El-GharbawyEarly Phase 1
Ultragenyx Pharmaceutical IncEarly Phase 1

See all triheptanoin clinical trials

Pharmacology for triheptanoin
Paragraph IV (Patent) Challenges for TRIHEPTANOIN
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 triheptanoin

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ultragenyx Pharm Inc DOJOLVI triheptanoin LIQUID;ORAL 213687-001 Jun 30, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 triheptanoin

Country Patent Number Title Estimated Expiration
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) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2006014353 ⤷  Sign Up
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) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.