Viewing data from:

DOJOLVI

NDA

TRIHEPTANOIN | N213687 | ULTRAGENYX PHARMACEUTICAL INC

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

8697748

Apr. 28, 2029

12551461

Nov. 14, 2034

ODE-311

Jun. 30, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
ULTRAGENYX PHARMACEUTICAL INC. v. NAVINTA LLC et al 2:2026cv03585 1 patentANDA 219480, 219711, 219512triheptanoin	D.N.J.	2026-04-03	Terminated 2026-04-27	—
ULTRAGENYX PHARMACEUTICAL INC. et al v. SOMERSET THERAPEUTICS LLC et al 2:2026cv03509 2 patentsANDA 221271triheptanoin	D.N.J.	2026-04-01	Terminated 2026-04-27	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Evaluate the Use of Triheptanoin in Patients With Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD)NCT07097311	Phase 2	Withdrawn	Jerry Vockley, MD, PhD	—	2026-07 → 2028-04
Study of Triheptanoin for the Prevention of Hypoglycemia in Patients With Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD)NCT06067802	Phase 2	Withdrawn	Jerry Vockley, MD, PhD	—	2026-08 → 2029-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Dojolvi (2023)

Total Spending

$2.6M

Total Claims

134

Beneficiaries

Avg Cost/Unit

$11.53

Spending Trend

$1.4M(2021)→$2.2M(2022)→$2.6M(2023)

YoY Change:+7.1%

5yr CAGR:+7.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

ULTRAGENYX PHARMACEUTICAL INCTRIHEPTANOIN ULTRAPURE

DMF 268952013

TAPI NL BVTRIHEPTANOIN

DMF 391452024

SUN PHARMACEUTICAL INDUSTRIES LTDTRIHEPTANOIN

DMF 394152024

APITORIA PHARMA PRIVATE LTDTRIHEPTANOIN

DMF 394302024

NAVINTA LLCTRIHEPTANOIN

DMF 394412024

SS PHARMA LLCTRIHEPTANOIN

DMF 395342024

DEVI PHARMATECH PRIVATE LTDTRIHEPTANOIN

DMF 422372025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 31, 2023	SUPPL -3	View Letter (PDF)
Jul 13, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100% w/w

RLD

2 patents1 exclusivity▴

LIQUID;ORAL | Approved: Jun 30, 2020

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8697748	Apr 28, 2029	—	—	Yes	—	—
12551461	Nov 14, 2034	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
ODE-311	Jun 30, 2027	< 1 year