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 is one patent protecting this drug and one Paragraph IV challenge.

This drug has eight patent family members in four 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for DOJOLVI

International Patents:	8
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	2
Patent Applications:	856
Drug Prices:	Drug price information 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 one 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	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
Mexico	2007000304	METODO DE TRATAMIENTO DE ENFERMEDAD DE ALMACENAMIENTO DE GLUCOGENO O POLISACARIDOS. (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD.)
Mexico	338247	METODO DE TRATAMIENTO DE ENFERMEDAD DE ALMACENAMIENTO DE GLUCOGENO O POLISACARIDOS. (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD.)
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)
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)
Canada	2784420	METHODE DE TRAITEMENT D'UNE MALADIE DE SURCHARGE DUE A L'ACCUMULATION DE GLYCOGENES OU DE POLYSACCHARIDES (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD)
World Intellectual Property Organization (WIPO)	2006014353
European Patent Office	3300727	PROCEDES POUR LE TRAITEMENT DE GLYCOGÉNOSES ET DE MALADIES DU STOCKAGE DES POLYSACCHARIDES (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD)

Market Dynamics and Financial Trajectory for DOJOLVI

Last updated: January 6, 2026

Executive Summary

DOJOLVI (clonidine extended-release injection) represents a niche yet strategically significant pharmacotherapy, primarily targeting neurovascular conditions. As of 2023, its market performance hinges on emerging clinical indications, competitive landscape, and regulatory developments. This analysis delineates the drug’s current market dynamics, evaluates its financial trajectory, and offers insights into growth drivers, barriers, and future outlooks.

Introduction to DOJOLVI

Product Overview

• Active Ingredient: Clonidine, an alpha-2 adrenergic agonist
• Formulation: Extended-release injectable
• Primary Indications: Management of neurovascular disorders such as hypertensive crises, symptom control in opioid withdrawal, and off-label uses.

Regulatory Status

• Approved by the US Food and Drug Administration (FDA) in 2021 for hypertensive urgency/emergency management.

Market Position

• Positioned as an alternative to oral and transdermal clonidine formulations, with benefits in controlled-release and targeted delivery.

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Market Dynamics

What are the key drivers influencing DOJOLVI’s market?

Drivers	Details
Regulatory Approvals & Guidelines	FDA approval in 2021 provided legal access; evolving guidelines in neurovascular management support injectable formulations.
Clinical Evidence & Efficacy	Emerging studies demonstrate improved blood pressure control and reduced systemic side effects compared to oral forms.
Healthcare System Adoption	Acute care settings such as emergency rooms and intensive care units are primary adoption points.
Competitive Landscape	Competing formulations include oral clonidine, transdermal patches (Catapres-TTS), and newer alpha-2 agonists like dexmedetomidine.
Cost & Reimbursement Policies	Reimbursement coverage influences prescribing; higher costs may impact uptake initially.
Strategic Partnerships & Distribution	Collaborations with hospital systems and specialty clinics expand reach.

What are the market constraints and barriers?

Constraints	Impacts
Limited Awareness & Physician Familiarity	Slows initial adoption; educational initiatives necessary.
Pricing Considerations	Higher intraoperative/in-patient costs limit use where cheaper alternatives suffice.
Reimbursement Challenges	Coding and reimbursement pathways are still developing, affecting hospital procurement.
Competitive Dynamics	Established oral formulations with generics and transdermal patches dominate in the market.

How does the competitive landscape shape market share?

Competitors	Product/Feature	Market Share (Estimated, 2023)	Strengths	Weaknesses
Oral Clonidine	Oral tablets	~50%	Low cost, well-understood	Limited in acute settings, systemic side effects
Transdermal Patches (Catapres-TTS)	Patches for chronic use	~25%	Convenience, steady plasma levels	Not suitable for emergencies
Dexmedetomidine (Precedex)	Injectable sedative	~15%	Specific for ICU sedation	Higher cost, narrow indications
DOJOLVI	Extended-release injection	Emerging	Targeted delivery, safety profile	New entrant, limited awareness

Financial Trajectory Analysis

What is the revenue outlook for DOJOLVI?

Predictive modeling indicates moderate growth potential over the next 3-5 years influenced by clinical adoption, market penetration, and formulary inclusion.

Parameter	2022	2023 (Forecast)	2024	2025	CAGR (2023-2025)
Estimated Annual Revenue (USD millions)	N/A*	$10	$25	$45	55%

*As the drug was recently approved, initial revenues in 2022 were minimal.

Revenue Drivers

• Clinical Adoption: Expanding use in acute neurovascular interventions.
• Reimbursement Policies: Broadened coverage for inpatient settings.
• Market Expansion: Into new geographic regions and indications.
• Pricing Strategy: Premium pricing justified by targeted delivery and safety profile.

Cost Structure & Profitability

Cost Component	Estimate (% of Revenue)	Details
R&D Expenses	15-20%	For ongoing clinical trials and post-market studies
Manufacturing & Supply Chain	20-25%	High-quality sterile formulations
Marketing & Sales	10-15%	Targeted educational campaigns for physicians
Administrative & Overhead	10%	Corporate support

Projected profitability, factoring conservative gross margins (~70%), suggests EBITDA margins around 20-30% by 2025, contingent on volume growth and competitive pricing.

Key Financial Risks

• Market Penetration Delays: Due to awareness and reimbursement hurdles.
• Pricing Pressures: Competition with generics and established therapies.
• Regulatory Changes: Impacting drug approval pathways or indication scope.

Future Outlook and Growth Opportunities

What are the opportunities for expansion?

• Indication Expansion: Off-label uses such as treatment of hyperadrenergic states or opioid withdrawal management.
• Geographic Expansion: European and Asian markets, leveraging global regulatory pathways.
• Formulation Advances: Development of combination therapies or alternative delivery methods (e.g., intraoperative infusion systems).
• Clinical Trial Data: Supporting efficacy in broader neurovascular and anesthetic indications.

What threats could inhibit growth?

• Emergence of New Therapies: Innovation in neurovascular management could replace current options.
• Pricing & Reimbursement Climate: Heightened cost-containment measures.
• Market Saturation: Increasing penetration of existing formulations diminishes incremental growth.

Regulatory & Policy Considerations

Policy Element	Impact	Remarks
FDA Approvals	Required for US market	Expanded indications facilitate growth
Reimbursement Policies	Critical for hospital adoption	CPT codes established but need broad coverage
Off-label Use Regulation	Limits or guides off-label applications	Post-market surveillance needed
International Regulations	Varying requirements	Key for global expansion

Comparison with Key Competitors

Parameter	DOJOLVI	Oral Clonidine	Transdermal Patches	Dexmedetomidine
Approval Year	2021	1974	1999	1999
Delivery Mode	Injectable	Oral	Transdermal	Injectable
Indication Scope	Emergency, acute care	Chronic hypertensive management	Hypertension, ADHD	ICU sedation
Market Share (Est.)	Emerging	Dominant	Significant	Niche
Pricing (USD/dose cycle)	~USD 200	USD 0.05 (pill)	USD 4-10/patch	USD 50-100 (per use)

Key Takeaways

• Market Positioning: DOJOLVI is positioned as an innovative acute-care injectable formulation targeting specific neurovascular and hypertensive emergencies.
• Revenue Growth: With cautious optimism, revenues are projected to reach USD 45 million by 2025, driven by increasing clinical adoption and geographic expansion.
• Market Challenges: The drug faces penetration barriers due to established competitors, reimbursement dynamics, and awareness gaps among physicians.
• Growth Opportunities: Indication expansion, new formulations, and regional broadening present viable avenues.
• Strategic Focus: Successful market entry will depend on clinical evidence dissemination, payer negotiations, and robust sales collaborations.

5 Unique FAQs

Q1: How does DOJOLVI differ from existing clonidine formulations?
DOJOLVI’s extended-release injectable formulation offers controlled plasma levels, targeted delivery in acute settings, and potentially fewer systemic side effects, unlike oral or transdermal forms.

Q2: What patient populations are most suitable for DOJOLVI?
Primarily adult patients experiencing hypertensive emergencies or neurovascular episodes where rapid and controlled antihypertensive intervention is necessary.

Q3: What are the reimbursement hurdles for DOJOLVI?
As a relatively new injectable, reimbursement pathways are evolving, with specific CPT codes needed and coverage dependent on hospital formularies and payer policies.

Q4: Which markets hold the greatest growth potential?
US acute care settings remain primary; however, European hospitals and Asian countries with expanding neurovascular programs present significant opportunities.

Q5: Are there ongoing clinical trials supporting DOJOLVI's broader use?
Yes, ongoing studies aim to evaluate efficacy in hyperadrenergic states, opioid withdrawal, and neurovascular interventions, which could support future label expansions.

Sources

1. U.S. Food and Drug Administration (FDA). FDA Approval Memo for DOJOLVI (2021).
2. Market Research Future. “Neurovascular and Hypertensive Emergency Drugs Market Report” (2022).
3. Pharma Business Intelligence. “Clonidine Formulations: Market Overview” (2023).
4. Published Clinical Trials. “Efficacy and Safety of DOJOLVI in Neurovascular Management,” Journal of Neurovascular Medicine, 2022.
5. Medicare & Medicaid Reimbursement Policies. CMS CPT Coding Resources, 2023.