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Last Updated: February 28, 2024

Triheptanoin - Generic Drug Details


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What are the generic drug sources for triheptanoin and what is the scope of patent protection?

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: 32
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
Ultragenyx Pharmaceutical IncEarly Phase 1
Areeg El-GharbawyEarly Phase 1
Richard Bedlack, M.D., Ph.D.Phase 1/Phase 2

See all triheptanoin clinical trials

Pharmacology for triheptanoin

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 ⤷  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 triheptanoin

Country Patent Number Title Estimated Expiration
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 338247 METODO DE TRATAMIENTO DE ENFERMEDAD DE ALMACENAMIENTO DE GLUCOGENO O POLISACARIDOS. (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD.) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006014353 ⤷  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

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