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
Sponsor | Phase |
---|---|
Jerry Vockley, MD, PhD | Phase 2 |
Areeg El-Gharbawy | Early Phase 1 |
Ultragenyx Pharmaceutical Inc | Early Phase 1 |
Pharmacology for triheptanoin
Drug Class | Medium-chain Triglyceride |
Anatomical Therapeutic Chemical (ATC) Classes 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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