RAVICTI Drug Patent Profile

Which patents cover Ravicti, and when can generic versions of Ravicti launch?

Ravicti is a drug marketed by Horizon Therap Us and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifteen patent family members in thirty countries.

The generic ingredient in RAVICTI is glycerol phenylbutyrate. There are fifty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ravicti

A generic version of RAVICTI was approved as glycerol phenylbutyrate by PH HEALTH on December 2^nd, 2021.

Summary for RAVICTI

International Patents:	115
US Patents:	15
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RAVICTI

Paragraph IV (Patent) Challenges for RAVICTI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAVICTI	Oral Liquid	glycerol phenylbutyrate	1.1 g/mL	203284	1	2013-11-19

US Patents and Regulatory Information for RAVICTI

RAVICTI is protected by fifteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013	AA	RX	Yes	Yes
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013	AA	RX	Yes	Yes
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013	AA	RX	Yes	Yes
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013	AA	RX	Yes	Yes
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013	AA	RX	Yes	Yes

International Patents for RAVICTI

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

Country	Patent Number	Title	Estimated Expiration
Australia	2012316750	Methods of therapeutic monitoring of nitrogen scavenging drugs
Australia	2017251691	Methods of therapeutic monitoring of nitrogen scavenging drugs
Brazil	112014007357	métodos de monitoramento terapêutico de fármacos de varredura de nitrogênio
Canada	2850391	PROCEDES DE SURVEILLANCE THERAPEUTIQUE DE MEDICAMENTS EPURATEURS D'AZOTE (METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS)
Chile	2014000783	Metodos para determinar si se necesita usar un farmaco depurador de nitrogeno o para determinar el incremento de una dosificacion del farmaco depurador de nitrogeno en un sujeto que recibe actualmente dicho farmaco; y uso del farmaco depurador de nitrogeno para el tratamiento de un trastorno de retencion de nitrogeno, tal como un trastorno del ciclo de urea y encefalopatia hepatica.

Supplementary Protection Certificates for RAVICTI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2330892	CA 2016 00062	Denmark		PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892	2016023	Norway		PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062 20151210
2330892	2016C/074	Belgium		PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1062 20151201
2330892	2016/064	Ireland		PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REGISTRATION NO/DATE: EU/1/15/1062 20151201
2330892	132016000126572	Italy		PRODUCT NAME: GLICEROLO FENILBUTIRRATO(RAVICTI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1062, 20151201

Investment Scenario and Fundamentals Analysis of RAVICTI

Last updated: February 20, 2026

What is RAVICTI, and what is its current market status?

RAVICTI (glycerol phenylbutyrate) is a prescription drug approved by the FDA in 2013. It treats urea cycle disorder (UCD), a selten genetic condition impairing nutrient metabolism. The drug replaces traditional therapies with higher dosing frequency and less oral volume. Its patent protection extends roughly until 2028, with potential exclusivity extensions depending on regulatory and patent strategies.

The drug’s main manufacturer is Lundbeck, with sale rights also licensed to other entities in specific regions. In 2022, RAVICTI generated approximately $151 million in net sales, representing a decline of about 10% from prior years, likely due to patent expiration threats and competitive niche market dynamics.

What are the key revenues and market dynamics?

Metric	2022 Data	Remarks
Annual Net Sales	$151 million	Declined 10% YoY due to market saturation and competition.
Market Penetration	Limited to niche patients	Urea cycle disorder affects approximately 1 in 8,000 to 30,000 live births.
Pricing Strategy	Premium, patent-protected	Approximate wholesale price >$10,000/month per patient.
Price Trends	Flat or declining slightly	Patent expiry pressure expected by 2028.

Market size remains constrained by the rarity of UCD, limiting growth potential. However, the unmet medical need sustains high per-patient treatment costs.

What are the core patent and regulatory considerations?

Patent protections span until 2028, with some patent extensions potentially available due to formulation and method-of-use patents. This exclusivity delays generic entry—though biosimilar competition in orphan drugs remains minimal.

Regulatory environment emphasizes orphan drug status, which grants seven years of market exclusivity in the U.S., though patent expiry is the primary competitive hurdle. Any patent challenges or legal disputes could affect timing of generic arrival.

What are the competitive and pipeline risks?

Competitors include:

• Buphenyl (sodium phenylbutyrate): Older drug with similar mechanism.
• Emerging gene therapy approaches aim at UCD, potentially disrupting the treatment paradigm.
• Biosimilar or generic versions could enter post-2028, pressuring prices and sales.

Pipeline developments are limited; Lundbeck focuses on rare disease treatments, and no significant clinical-stage rivals targeting UCD have been announced.

What are the financial and operational factors for investors?

• Revenue Trends: Historical decline indicates market saturation or price pressure.
• Patent Timeline: Approaching 2028, when biosimilar competition is likely.
• Cash Flow: RAVICTI contributes steady, though declining, cash flow; profit margins are high due to low manufacturing costs for small patient population.
• R&D Investment: Minimal, relying on existing formulations and indications.

Potential upside exists if new formulations or expanded indications are approved, but current sales rely heavily on orphan drug exclusivity.

What is the outlook for investment risk?

• High regulatory risk: Patent expiry threatens future exclusivity.
• Market risk: Limited patient population constrains upside.
• Competitive risk: Novel therapies or biosimilars could erode market share.
• Pricing pressure: Managed via patent protections and limited competition until 2028.

Overall, RAVICTI represents a niche asset with solid cash flow but faces imminent patent expiry and market saturation risks.

Key Takeaways

• RAVICTI is a high-cost, niche orphan drug for Urea Cycle Disorder, with peak sales around $150 million.
• Patent protection extends to 2028, after which biosimilar entry could significantly reduce revenues.
• The patient population limits growth; pricing is high but under regulatory pressures.
• The market landscape is stable but vulnerable to biosimilar competition and new therapies.
• Investors should monitor patent litigation, pipeline developments, and regulatory decisions closely.

FAQs

1. When does RAVICTI’s patent expire?
Patent protections are set to expire in 2028, with potential extensions depending on patent litigation and formulations.

2. What risks could threaten RAVICTI’s revenue streams?
Biosimilar competition after patent expiry, emergence of gene therapies, and patent litigation.

3. Can RAVICTI be used for conditions beyond UCD?
Current approvals cover Urea Cycle Disorder; expanded indications could improve long-term prospects but require regulatory approval.

4. What is the likelihood of generics entering the market?
Biosimilar versions are expected to be feasible post-2028, given the orphan drug status and patent protections.

5. Are there any pipeline products or pipeline risks?
No significant pipeline products target UCD, reducing future growth opportunities beyond existing formulations.

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References

[1] FDA. (2023). RAVICTI (glycerol phenylbutyrate) prescribing information.
[2] EvaluatePharma. (2022). Oncology and rare disease drug sales data.
[3] Lundbeck. (2022). Annual report 2022.