DOJOLVI Drug Patent Profile

Which patents cover Dojolvi, and what generic alternatives are available?

Dojolvi is a drug marketed by Ultragenyx Pharm Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in seventeen countries.

The generic ingredient in DOJOLVI is triheptanoin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the triheptanoin profile page.

DrugPatentWatch^® Generic Entry Outlook for Dojolvi

Dojolvi was eligible for patent challenges on June 30, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 30, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DOJOLVI

International Patents:	36
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	2
Patent Applications:	797
Drug Prices:	Drug price information for DOJOLVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DOJOLVI
What excipients (inactive ingredients) are in DOJOLVI?	DOJOLVI excipients list
DailyMed Link:	DOJOLVI at DailyMed

See drug prices for DOJOLVI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DOJOLVI

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)

NDA:

213687

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 DOJOLVI

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

Sponsor	Phase
Jerry Vockley, MD, PhD	Phase 2
Ultragenyx Pharmaceutical Inc	Phase 2
Ultragenyx Pharmaceutical Inc	Phase 3

See all DOJOLVI clinical trials

Pharmacology for DOJOLVI

Drug Class

Medium-chain Triglyceride

Paragraph IV (Patent) Challenges for DOJOLVI

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 DOJOLVI

DOJOLVI is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on 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).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	12,551,461		Y
Ultragenyx Pharm Inc	DOJOLVI	triheptanoin	LIQUID;ORAL	213687-001	Jun 30, 2020		RX	Yes	Yes	8,697,748		Y
Ultragenyx Pharm Inc	DOJOLVI	triheptanoin	LIQUID;ORAL	213687-001	Jun 30, 2020		RX	Yes	Yes

Expired US Patents for DOJOLVI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ultragenyx Pharm Inc	DOJOLVI	triheptanoin	LIQUID;ORAL	213687-001	Jun 30, 2020	9,186,344

International Patents for DOJOLVI

See the table below for patents covering DOJOLVI around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	099353
Argentina	130666
Australia	2014348470
Canada	2929688

Last updated: June 18, 2026

DOJOLVI (triheptanoin) market dynamics and financial trajectory: pricing, reimbursement, utilization, exclusivity, and competitive threats

DOJOLVI (triheptanoin) is a dietary oil therapeutic for pediatric and adult patients with confirmed long-chain fatty acid oxidation disorders (LC-FAOD) affecting the mitochondrial oxidation of long-chain fatty acids. Commercial dynamics are driven by (1) narrow patient pools typical of rare genetic metabolic diseases, (2) payer scrutiny of ketogenic/dietary oil products, (3) high and variable patient adherence requirements, and (4) limited but meaningful near-term competitive pressure from alternative metabolic dietary regimens and any future entrants using different technology (new dietary oils, meal replacements, or gene- and enzyme-adjacent approaches).

Financial trajectory is expected to be characterized by initial peak-in-year ramp in the first full years after broad access, followed by slower growth tied to patient identification, formulary penetration, and treatment persistence. Revenue volatility comes from payer-by-payer reimbursement terms and “medical necessity” thresholds rather than from broad market share shifts typical of mainstream oncology or cardiovascular drug classes.

Data note: This analysis is limited to market-structure dynamics and does not provide quantified revenue forecasts or historical revenue figures because no numeric financial dataset for DOJOLVI was supplied in the prompt.

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What drives DOJOLVI (triheptanoin) demand in rare LC-FAOD patients?

DOJOLVI is used in long-chain fatty acid oxidation disorders where energy generation from long-chain fats is impaired. Demand hinges on diagnosing eligible disorders early enough to start dietary therapy, maintaining daily intake, and tolerating taste and gastrointestinal effects that can constrain adherence.

Key demand levers

1. Patient identification and referral

   • LC-FAOD patient pools are small and are concentrated in metabolic specialty centers.
   • Demand grows as clinicians adopt triheptanoin earlier in care pathways for eligible subtypes and as newborn screening or earlier genetic diagnosis increases the number of treatable patients.

2. Clinical positioning and standard-of-care linkage

   • Triheptanoin is often layered into dietary management alongside avoidance of triggers, carbohydrate scheduling, and emergency protocols.
   • Payer acceptance depends on evidence that it is used for confirmed LC-FAOD with demonstrable treatment need.

3. Adherence and persistence

   • Dietary oils require consistent daily dosing.
   • Persistence is influenced by GI tolerance, feasibility of meal integration, and patient/caregiver burden.

HCP buying behavior pattern

• In rare disease, “buying” is physician-driven but “access” is payer-driven. The practical bottlenecks are prior authorization, benefit exceptions, and documentation of diagnosis and dosing rationale.

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How does reimbursement typically impact DOJOLVI revenue and access?

For rare disease oral/enteral dietary products, revenue depends on reimbursement coverage and contract terms rather than list price alone.

Reimbursement mechanics that shape net sales

• Prior authorization and medical-necessity criteria

  • Coverage is usually conditioned on confirmed diagnosis, dosing regimen documentation, and evidence of need.

• Formulary status and specialty channel placement

  • A subset of commercial payers require specialty pharmacy routing and may restrict patient copays through assistance programs.
  • Coverage can be broadened or tightened after payer policy updates, creating step-changes in utilization.

• Net price variability

  • Rebates and patient assistance can produce large gaps between gross and net revenue.
  • For dietary products, payer scrutiny can increase when cheaper dietary alternatives exist in a patient’s benefit configuration.

Financial trajectory implications

• Early commercial performance is typically constrained by access friction.
• As formularies stabilize and specialty pharmacy onboarding expands, utilization ramps more steadily.
• Patient turnover and dose changes can later drive “flattening” growth once the addressable pool saturates in each territory.

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When does DOJOLVI face exclusivity expiration or patent loss of exclusivity?

Without Orange Book listings or patent-expiration data provided in the prompt, an exclusivity timeline cannot be stated accurately. DOJOLVI is not a biologic; it is a small-molecule/nutritional oil product, so exclusivity typically hinges on:

• New Drug Application (NDA) exclusivity (if applicable to the reference listed drug)
• Patent estate coverage listed in the FDA Orange Book for drug product, use, or manufacturing
• Potential pediatric exclusivity extensions if triggered

No timeline is provided here because specific Orange Book/Patent numbers and dates are not included in the input.

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What patents protect DOJOLVI (triheptanoin) and how strong is the patent estate?

A robust “who owns what” assessment requires Orange Book patent identifiers and assignees, plus any district court validity/infringement rulings. Those are not present in the prompt.

What a DOJOLVI patent estate is likely to include (framework)

• Composition-of-matter (triheptanoin itself or specific forms)
• Method-of-use patents for long-chain fatty acid oxidation disorders and specific patient subtypes
• Formulation or manufacturing patents (processing conditions, stability, delivery form)
• Combination regimens (dietary protocols)

No count of patents, no expiration dates, and no strength scoring is provided because no specific patent list was supplied.

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Is there Paragraph IV (Hatch-Waxman) risk for DOJOLVI generic entry?

Paragraph IV challenges apply to ANDA filings for small molecules. DOJOLVI is triheptanoin, which can in principle support generic entry if:

• The sponsor can supply an ANDA showing bioequivalence and adequate sameness in key quality attributes.
• The generic can navigate patent barriers via non-infringement, invalidity, or “carve-outs” tied to specific claims.

Why the Paragraph IV risk may be lower than mainstream generics

• Dietary oils can face formulation standardization and excipient manufacturing constraints that affect ANDA feasibility.
• Rare disease formularies can also be conservative, and substitutions may require payer acceptance and physician comfort.

No specific Paragraph IV case list is provided because no litigation docket or Paragraph IV notice data is included in the prompt.

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Which companies could compete with DOJOLVI (triheptanoin) via generics, dietary alternatives, or new therapies?

In rare metabolic diseases, competition typically falls into three buckets:

1. Direct generics of triheptanoin

   • If patents expire and an ANDA competitor can satisfy quality and manufacturing requirements.

2. Indirect competitors

   • Alternative dietary oils or dietary protocols aimed at improving energy balance and supporting mitochondrial metabolism.
   • These can compete even without generic equivalence, depending on clinician and payer acceptance.

3. New-modality therapy entrants

   • Gene therapy or enzyme replacement for certain LC-FAOD subtypes can displace dietary oil demand if disease-modifying outcomes become routine.
   • This depends on developmental pipelines and label expansions, not on immediate substitution.

No company roster is provided because names and competitive candidates were not supplied.

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How does DOJOLVI compare with other treatments for long-chain fatty acid oxidation disorders?

For LC-FAOD, the competitive set typically includes:

• High-carbohydrate strategies and dietary management frameworks
• Other medium-chain triglyceride-based or structured triglyceride dietary therapies (depending on subtype and protocol)
• Supportive interventions for acute metabolic decompensation
• Specialty emergency feeding plans

DOJOLVI positioning

• Triheptanoin-based therapy is generally used to improve metabolic control by providing a unique substrate profile intended to support energy metabolism when long-chain fat oxidation is impaired.

A detailed head-to-head comparison requires specifying which comparator drug(s) and which endpoints (hypoglycemia frequency, metabolic stability, hospitalization rates), which were not included in the prompt.

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What does the FDA regulatory status imply for market access and timing?

Regulatory status can determine market uptake through:

• The label scope that defines eligible patients
• Any risk evaluation and mitigation measures
• Updates to dosing and formulation that improve tolerability and persistence

However, the prompt did not supply DOJOLVI’s FDA milestones (approval date, label indications, REMS, supplement history). No regulatory timeline is included.

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What DOJOLVI litigation, settlements, or exclusivity disputes affect commercialization?

Patent and exclusivity litigation affects:

• Launch timing of competing products
• Potential “carve-out” designs for at-risk generic products
• Settlement-driven “non-entry” or delayed launch

No litigation docket details are provided because the prompt includes no case list, court, filing dates, or settlement descriptions.

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How sensitive is DOJOLVI revenue to pricing, payer mix, and patient persistence?

For rare disease dietary products, net sales typically show sensitivity to four factors:

1. Commercial payer mix

   • Higher proportion of insured patients with restrictive PA policies can slow initial ramp.
   • Broader payer coverage increases accessible patient pool.

2. Copay and assistance structures

   • High list price with patient cost-sharing can reduce adherence without strong assistance.

3. Persistence

   • GI intolerance or regimen fatigue can reduce continuity, lowering annualized treatment duration per patient.

4. Switching

   • If alternative dietary therapies become preferred by payers or clinicians, persistence can drop for DOJOLVI even without generic entry.

Financial trajectory implication

• Once a stable patient base is reached, growth often shifts from “net new patients” to “dose intensity and persistence,” which tends to be slower.

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What generic launch scenarios could change DOJOLVI market dynamics?

Generic launch impact depends on:

• Whether competitors launch at parity or discount versus net price
• Whether formularies automatically substitute
• Whether physicians remain comfortable due to diet tolerability and stability considerations
• Whether patent settlements impose delayed or partial entry

Scenario framework (non-quantified)

• Scenario A: Early generic with strong coverage leads to fast price pressure in markets that support substitution.
• Scenario B: Delayed generic with partial coverage sustains brand revenue longer.
• Scenario C: Settlement carve-outs create staggered substitution by indication or patient subset.

No specific scenario is mapped to DOJOLVI dates without Orange Book or litigation data.

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Key Takeaways

• DOJOLVI’s market dynamics are governed by rare-disease demand formation: diagnosis rate, treatment initiation timing, prior authorization friction, and long-term dietary persistence.
• Financial trajectory is expected to ramp with formulary penetration and patient identification, then moderate as the addressable pool saturates and growth becomes persistence- and dose-driven.
• Specific exclusivity expiration, patent counts, Paragraph IV risk, litigation, settlement outcomes, and competitor names cannot be grounded in hard dates or identifiers because none were provided in the prompt.

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FAQs

1. How do prior authorizations typically affect DOJOLVI uptake in commercial insurance plans?
   By delaying initiation until diagnosis confirmation and medical-necessity documentation are accepted, creating ramp delays and uneven quarter-to-quarter utilization.

2. Does DOJOLVI face biosimilar-like competition risk?
   No. DOJOLVI is not a biologic; competition is via generic or dietary-alternative substitution rather than biosimilars.

3. What drives annualized net sales for rare dietary products like DOJOLVI?
   Patient persistence, adherence, payer net pricing terms, and treatment duration in specialty-center populations.

4. What is the most common competitive threat to DOJOLVI short of generic entry?
   Indirect competition from alternative dietary regimens and protocols that meet clinician goals within payer constraints.

5. How can patent settlements affect the timing of competitors entering the DOJOLVI market?
   Settlements can delay launches, limit entry to non-covered claims, or impose staged market entry that sustains brand share longer than generic filing alone would suggest.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA: Drug information search. U.S. Food and Drug Administration.
3. FDA. Hatch-Waxman Act overview and ANDA regulatory pathway. U.S. Food and Drug Administration.