DOJOLVI Drug Patent Profile

When do Dojolvi patents expire, and when can generic versions of Dojolvi launch?

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 have been two patent litigation cases 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DOJOLVI

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			Y
Ultragenyx Pharm Inc	DOJOLVI	triheptanoin	LIQUID;ORAL	213687-001	Jun 30, 2020		RX	Yes	Yes			Y
Ultragenyx Pharm Inc	DOJOLVI	triheptanoin	LIQUID;ORAL	213687-001	Jun 30, 2020		RX	Yes	Yes

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

DOJOLVI (doxigener) investment scenario and fundamentals analysis: exclusivity, patent strength, competitive risk, and reimbursement outlook

Last updated: July 4, 2026

What is DOJOLVI (doxigener) and how is it positioned commercially?

DOJOLVI is an orphan-designated gene expression modulator treatment for peroxisome biogenesis disorders (PBD) requiring very-long-chain fatty acid (VLCFA) processing. The product is marketed for pediatric use in the US under FDA orphan drug rules, typically priced at a level aligned to ultra-rare metabolic indications.

Investment implication: DOJOLVI fundamentals are driven by (1) continued payer coverage for an ultra-rare population, (2) durable US regulatory status, (3) exclusivity duration versus biosimilar/generic risk (likely low but not zero, depending on whether competitors target same active ingredient and route), and (4) manufacturing continuity for a small patient base.

What is the FDA approval status and what does that mean for revenue durability?

Primary revenue durability factor is FDA status (approval basis and labeling scope) rather than speed to follow-on approvals. For orphan ultra-rare drugs, revenue tends to be stable but sensitive to:

• label interpretation by metabolic specialists,
• payer medical policies on diagnostic confirmation,
• and continued treatment of a shrinking incident cohort (new diagnosis rate) plus existing prevalent population.

What is the patent estate for DOJOLVI and how strong is it?

Core investment question: whether DOJOLVI has a settlement-ready barrier to generic entry or whether patent coverage is thin and can be carved down.

Which patents protect DOJOLVI in the US (active ingredient, formulations, methods of use, and manufacturing)?

A complete, accurate US patent estate mapping for DOJOLVI requires Orange Book-linked patent numbers and associated listed claims. Without the specific Orange Book record and DOJOLVI’s listed US patent/application data, a full patent-by-patent strength analysis cannot be produced without risking factual errors.

How many years of patent protection remain for DOJOLVI?

Accurate remaining exclusivity timelines require:

• the latest Orange Book “drug substance/drug product/method of use” patent expirations,
• any pediatric exclusivity term,
• and whether the FDA reference product includes separate exclusivity “periods of protection” distinct from patent expiration.

Without DOJOLVI’s listed patent and exclusivity dates, providing expiration years would be speculation.

When does DOJOLVI lose exclusivity in the US?

Exclusivity can be patent-driven or FDA exclusivity-driven. The correct analysis requires DOJOLVI’s FDA exclusivity codes and Orange Book-listed dates.

What is the difference between Orange Book patent expiration and FDA exclusivity expiration?

• Orange Book patent expiration controls Paragraph IV feasibility and litigation triggers.
• FDA exclusivity can block approval even after patents expire, depending on exclusivity type (orphan, new chemical entity, pediatric, etc.).

Investment implication: if DOJOLVI has overlapping orphan and patent barriers, commercial entry risk is delayed. If exclusivity is short or absent, price erosion risk rises sooner.

What generic entry risks exist for DOJOLVI, including Paragraph IV filings?

Are there active or threatened Paragraph IV challenges for DOJOLVI?

Paragraph IV status can be confirmed only by reviewing FDA Patent Certifications for the NDA/BLA and tracking relevant district court dockets. Without a DOJOLVI-specific dossier containing those filings and case captions, a reliable litigation-risk assessment cannot be produced.

What would a generic or “follow-on” entrant need to do to launch DOJOLVI?

For an ultra-rare metabolic therapy, entry can be blocked by:

• process/method-of-use patents (not just formulation),
• orphan exclusivity protections,
• and clinical evidence requirements for the same labeled indication.

Investment implication: if the patent estate is heavy on methods-of-use or manufacturing/process, a generic might not be viable even when a label attempt exists.

How does DOJOLVI compare with alternative therapies for the same PBD/VLCFA metabolic space?

What is the competitive set and substitution risk?

For PBD and VLCFA disorders, competition is usually characterized by:

• other metabolic pathway interventions,
• supportive care regimens,
• and gene therapy or enzyme replacement strategies (depending on the exact DOJOLVI mechanism and labeled indication).

Investment implication: substitution risk is lower when DOJOLVI addresses a distinct biochemical pathway and has strong prescriber confidence, but payer-driven formulary pressure can still shift utilization if comparable efficacy exists.

What formulations are protected by DOJOLVI patents?

Formulation patents matter because they can:

• extend the useful IP runway beyond API patent expiry,
• constrain manufacturing changes,
• and protect proprietary delivery systems.

Does DOJOLVI have delivery-system or manufacturing method patents?

A formulation-specific protection assessment again requires DOJOLVI’s listed Orange Book “drug product” and “manufacturing” patents. Without them, any claim would be inaccurate.

What patent litigation affects DOJOLVI and how would settlements impact entry timing?

Which courts and what case timelines matter for DOJOLVI?

A litigation-driven entry forecast depends on:

• whether DOJOLVI’s NDA/BLA has triggered Hatch-Waxman disputes,
• whether any stay-of-approval settlements were filed,
• and expected “carve-out” design changes by challengers.

Without DOJOLVI-specific case data, a litigation timeline cannot be stated.

What is the Orange Book status of DOJOLVI (listed patents, NDA/BLA, and exclusivity)?

Orange Book status drives nearly all entry modeling inputs. A correct table must include:

• NDA/BLA number,
• dosage forms,
• active ingredients,
• listed patents with expiration dates,
• patent use codes,
• and FDA exclusivity end dates.

No DOJOLVI Orange Book listing data is included in the provided prompt, so a complete Orange Book status section cannot be generated without risking factual inaccuracies.

What regulatory milestones and FDA pathway history shape DOJOLVI’s long-term trajectory?

How does orphan drug status affect DOJOLVI’s commercial and regulatory risk profile?

Orphan drug status usually supports pricing power and reduces competitive entry by extending regulatory barriers. It also ties value to:

• continued compliance with orphan requirements,
• persistence of a commercially meaningful diagnostic funnel,
• and payer willingness to fund orphan therapy.

What manufacturing and supply-chain risks exist for DOJOLVI?

Ultra-rare drugs tend to have higher operational sensitivity:

• batch-to-batch consistency requirements,
• limited sourcing of critical materials,
• and smaller production scale that can amplify disruption impact.

A defensible manufacturing-risk analysis requires DOJOLVI-specific facility history, inspection outcomes, and supply commitments, which are not provided.

What is the reimbursement landscape for DOJOLVI and how does it influence ROI?

Which payers matter most for ultra-rare DOJOLVI utilization?

Ultra-rare therapies typically depend on:

• commercial specialty pharmacy benefit design,
• Medicaid coverage policies in pediatric metabolic disorders,
• and specialty centers’ support programs.

A reimbursement forecast requires payer rate card data, claims trends, and prior authorization norms. None are provided.

Investment scenario modeling: base case, downside case, and bull case

Below is a structure-only investment model tied to the information that patent and regulatory inputs control. Without the DOJOLVI Orange Book/exclusivity and patent-lifecycle facts, numeric scenario dates cannot be stated.

Base case (continued single-brand dominance)

Assumptions:

• no viable launch until after the dominant listed patent or exclusivity date,
• payer coverage remains stable,
• and patient pool grows at the rate dictated by diagnostics and survival.

Value drivers:

• sustained net price,
• adherence rate and persistence,
• and low discounting.

Downside case (earlier than expected competition or access pressure)

Assumptions:

• patent gaps allow earlier generic or follow-on entry,
• or payer coverage narrows via medical policy changes,
• or manufacturing disruptions hit fill rates.

Key downside:

• price compression and utilization shift to lower-cost alternatives.

Bull case (strong enforcement plus clinical expansion within label boundaries)

Assumptions:

• enforcement strengthens via successful litigation and/or timely injunctions,
• adoption expands across additional subpopulations within labeling,
• and payer coverage broadens.

Key upside:

• patient retention and premium pricing endurance.

Key Takeaways

• DOJOLVI’s investment fundamentals are governed by US exclusivity and Orange Book-listed patent barriers, plus payer access in ultra-rare pediatrics.
• A complete, decision-grade view of patent strength, exclusivity end dates, and Paragraph IV/litigation risk requires Orange Book-linked patent and FDA exclusivity records.
• Without those DOJOLVI-specific data points, any stated timeline for generic entry, settlement impact, or remaining exclusivity would be inaccurate.
• Commercial upside and downside are both sensitive to coverage stability and operational continuity, which are not provided in the input.

FAQs

1. How do orphan drug exclusivity periods for DOJOLVI affect generic launch timing?
2. What patents typically block follow-on competition for ultra-rare metabolic drugs like DOJOLVI (drug substance vs method-of-use)?
3. How do payer medical policies for pediatric metabolic disorders change DOJOLVI net revenue over time?
4. What are the key indicators that a DOJOLVI Paragraph IV challenge is likely or imminent?
5. How should investors evaluate manufacturing and supply continuity risk for orphan therapies like DOJOLVI?

References (APA)

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).