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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 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:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	2
Patent Applications:	409
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 two US patents and two FDA Regulatory Exclusivities.

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	9,186,344		Y
Ultragenyx Pharm Inc	DOJOLVI	triheptanoin	LIQUID;ORAL	213687-001	Jun 30, 2020		RX	Yes	Yes
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

International Patents for DOJOLVI

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

Country	Patent Number	Title	Estimated Expiration
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)
Mexico	2007000304	METODO DE TRATAMIENTO DE ENFERMEDAD DE ALMACENAMIENTO DE GLUCOGENO O POLISACARIDOS. (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)
European Patent Office	1773317	METHODE DE TRAITEMENT D'UNE MALADIE DE SURCHARGE DUE A L'ACCUMULATION DE GLYCOGENES OU DE POLYSACCHARIDES (GLYCOGEN OR POLYSACCHARIDE STORAGE DISEASE TREATMENT METHOD)

DOJOLVI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dojolvi

Introduction to Dojolvi

Dojolvi, developed by Ultragenyx Pharmaceutical, is a groundbreaking treatment approved by the FDA for patients with long-chain fatty acid oxidation disorders (LC-FAOD), a group of rare and life-threatening genetic diseases. This approval marked a significant milestone as the first treatment for this condition in the U.S.[1].

Clinical Significance

Dojolvi is designed to address the severe drops in glucose levels experienced by patients with LC-FAOD, as their bodies cannot properly convert long-chain fatty acids into energy. The drug provides fatty acids for energy and replaces metabolites, thereby correcting the metabolic imbalance caused by the disorder. This treatment is crucial for the estimated 2,000 to 3,500 patients in the U.S. and up to 14,000 patients in the developed world who suffer from this condition[1].

Market Approval and Availability

Dojolvi received FDA approval in July 2020, a month ahead of the scheduled target date. Following this approval, Ultragenyx aimed to make the treatment available to patients within 30 days and has been working to secure patient access to the drug[1].

Pricing and Revenue Projections

The pricing of Dojolvi is reflective of its status as a rare disease medication, with a cost of $4,875 per vial. This translates to an average net price of $138,000 per patient per year. Despite the high cost, investment bank Piper Sandler estimates that Dojolvi could generate $270 million in sales by fiscal year 2025[1].

Financial Performance

Quarterly and Annual Revenue Growth

In the first quarter of 2024, Dojolvi revenue was $16 million, representing a 14% growth compared to the same period in 2023. By the third quarter of 2024, Dojolvi revenue increased to $21 million, showing a 29% growth year-over-year[3][5].

For the full year 2024, Ultragenyx has reaffirmed its revenue guidance for Dojolvi to be in the range of $75 million to $80 million[3][5].

Total Revenue and Operating Expenses

Ultragenyx reported a total revenue of $139 million for the third quarter of 2024, a 42% increase from the same period in 2023. The company's total revenue for the first nine months of 2024 was $395 million, with Dojolvi contributing significantly to this growth[2][5].

Despite the revenue growth, Ultragenyx incurred a net loss of $134 million in the third quarter of 2024, although this is an improvement from the $160 million net loss in the same period of 2023. The company's operating expenses, including research and development, selling, general, and administrative costs, totaled $271 million for the third quarter of 2024[2][5].

Cash Position and Net Cash Usage

As of September 30, 2024, Ultragenyx had a strong cash position of $825 million. However, the company anticipates net cash usage of around $400 million for the full year 2024, primarily due to ongoing research and development activities and operational expenses[2][5].

Clinical Milestones and Pipeline

In addition to Dojolvi, Ultragenyx has a robust pipeline of treatments for rare genetic diseases. The company has received Breakthrough Therapy Designation for setrusumab in osteogenesis imperfecta and has reported positive Phase 3 data for DTX401, among other clinical milestones[2][3].

Market Impact and Competition

The approval and commercial success of Dojolvi highlight Ultragenyx's commitment to addressing unmet medical needs in the rare disease space. The company's strong financial performance and expanding pipeline position it well against competitors in the biopharmaceutical industry.

Future Outlook

Given the positive revenue growth and the expanding patient base for Dojolvi, Ultragenyx is poised for continued success. The company's financial guidance for 2024, which includes total revenue in the range of $530 million to $550 million, indicates a strong financial trajectory. As the market for rare disease treatments continues to grow, Dojolvi is expected to remain a significant contributor to Ultragenyx's revenue and market presence.

Key Takeaways

• FDA Approval: Dojolvi is the first FDA-approved treatment for long-chain fatty acid oxidation disorders.
• Revenue Growth: Dojolvi revenue has shown significant growth, with a 29% increase in the third quarter of 2024 compared to the same period in 2023.
• Pricing: The drug is priced at $4,875 per vial, translating to an average net price of $138,000 per patient per year.
• Financial Projections: Estimated to generate $270 million in sales by fiscal year 2025.
• Cash Position: Ultragenyx has a strong cash position of $825 million as of September 30, 2024.
• Clinical Pipeline: The company has a robust pipeline with several treatments in various stages of development.

FAQs

Q: What is Dojolvi used for? A: Dojolvi is used for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD)[1].

Q: When was Dojolvi approved by the FDA? A: Dojolvi was approved by the FDA in July 2020[1].

Q: How much does Dojolvi cost? A: Dojolvi costs $4,875 per vial, which translates to an average net price of $138,000 per patient per year[1].

Q: What are the revenue projections for Dojolvi? A: Dojolvi is estimated to generate $270 million in sales by fiscal year 2025 and is projected to earn between $75 million to $80 million in revenue for the full year 2024[1][3].

Q: What is the current financial status of Ultragenyx? A: As of September 30, 2024, Ultragenyx had a cash position of $825 million and reported a total revenue of $139 million for the third quarter of 2024[2][5].

Cited Sources

1. BioPharma Dive: "Ultragenyx wins early approval for rare disease drug"
2. Stock Titan: "Ultragenyx Reports Third Quarter 2024 Financial Results and Corporate Update"
3. BioSpace: "Ultragenyx Reports First Quarter 2024 Financial Results and Corporate Update"
4. GlobalData: "Net Present Value Model: Dojolvi"
5. BioSpace: "Ultragenyx Reports Third Quarter 2024 Financial Results and Corporate Update"