Question 1

Is there a generic for Triheptanoin?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Triheptanoin. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Triheptanoin?

Accepted Answer

DOJOLVI (NDA 213687, ULTRAGENYX PHARM INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Triheptanoin?

Accepted Answer

The Orange Book lists 2 patents against Triheptanoin products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Triheptanoin have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Triheptanoin. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Triheptanoin are approved?

Accepted Answer

Triheptanoin is approved in the following dosage form: liquid.

Patent	Expires	In	Type
8697748	Apr 28, 2029	in 2 yr 11 mo	Product
12551461	Nov 14, 2034	in 8 yr 6 mo	Product

Triheptanoin

Brand (NDA) products · liquid

Marketing exclusivity (1)

Listed patents (2)

Triheptanoin — frequently asked questions

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