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 fourteen 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:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	11
Patent Applications:	116
Drug Prices:	Drug price information for RAVICTI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RAVICTI
What excipients (inactive ingredients) are in RAVICTI?	RAVICTI excipients list
DailyMed Link:	RAVICTI at DailyMed

See drug prices for RAVICTI

Recent Clinical Trials for RAVICTI

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

Sponsor	Phase
Assistance Publique - Hpitaux de Paris	PHASE2
Kaplan Medical Center	Phase 2/Phase 3
Weizmann Institute of Science	Phase 2/Phase 3

See all RAVICTI clinical trials

Pharmacology for RAVICTI

Drug Class	Nitrogen Binding Agent
Mechanism of Action	Ammonium Ion Binding Activity

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 fourteen 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

Expired US Patents for RAVICTI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013

EU/EMA Drug Approvals for RAVICTI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Immedica Pharma AB	Ravicti	glycerol phenylbutyrate	EMEA/H/C/003822Ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).	Authorised	no	no	yes	2015-11-26

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	PA2016041	Lithuania		PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892	CA 2016 00062	Denmark		PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892	300854	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2330892	122016000107	Germany		PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892	C20160044 00204	Estonia		PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015

Last updated: July 21, 2026

RAVICTI (glycerol phenylbutyrate) Market Dynamics and Financial Trajectory: Sales Drivers, Pricing, Exclusivity, and Competitive Risks

RAVICTI (glycerol phenylbutyrate; “GPB”) is a niche, high-cost orphan-marketed therapy for chronic management of urea cycle disorders (UCDs), with revenue tied to (1) the treated UCD patient base (adult and pediatric), (2) payer access and formulary coverage, and (3) competitive substitution risk from branded and emerging metabolic therapies. Financial trajectory is shaped more by exclusivity and access than by broad generic competition because the product’s patent and regulatory position has historically limited direct generic entry; however, long-tail erosion risks exist via patent challenges, formulary step therapy, and off-formulary pricing pressure.

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What is RAVICTI used for and how does that drive market size?

RAVICTI is indicated for chronic management of patients with urea cycle disorders who require dietary protein restriction and/or nitrogen scavenging to reduce elevated ammonia. Commercial demand is therefore driven by:

1. Incidence and diagnosis rates of UCDs
   • UCDs are rare. Patient availability depends on newborn screening uptake, referral networks, and biochemical diagnosis.
2. Severity mix and lifelong therapy duration
   • Many UCD phenotypes require ongoing nitrogen-scavenging strategies, which supports chronic treatment utilization.
3. Dosing intensity tied to weight and metabolic stability
   • Dosing is individualized and can change with growth in pediatrics and metabolic events.
4. Treatment setting
   • Utilization spans specialized metabolic clinics and hospital-affiliated specialty pharmacies.

UCD phenotypes and prescribing concentration

Commercial penetration typically concentrates among metabolic disease specialists and designated centers with experience in long-term ammonia control, which reduces “mass market” expansion dynamics and increases payer-by-payer variability.

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How do RAVICTI pricing and reimbursement dynamics affect net sales?

RAVICTI’s revenue trajectory is most sensitive to payer reimbursement outcomes in specialty channels:

1. Commercial payer coverage
   • Managed-care utilization often relies on prior authorization and clinical criteria (ammonia levels, UCD subtype, prior therapy).
2. Specialty pharmacy reimbursement mechanics
   • Contracted specialty channel pricing can lead to meaningful net price variance versus list price.
3. Patient assistance and copay programs
   • Specialty copay support influences adherence and continuity, especially for pediatric caregivers and high monthly dosing.
4. 340B and government channel mix
   • Where applicable, government and covered entity procurement can change realized margins.

What typically moves RAVICTI net price?

• Updates to payer formularies or step edits for nitrogen-scavenging products
• Contract renegotiations in specialty distribution
• Pharmacy reimbursement pressure from “me-too” metabolic agents or alternative branded products in UCD formularies

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What patents protect RAVICTI and how strong is the IP estate for long-term exclusivity?

RAVICTI is the branded formulation of glycerol phenylbutyrate. IP strength for RAVICTI has historically come from a layered estate covering the active composition, formulations, and potential methods of use in nitrogen scavenging for UCDs.

High-level risk framing for investors and litigators:

• If RAVICTI’s active composition and key formulation claims have expired or are vulnerable, the main protection shifts to remaining dependent claims (process, polymorphs/solid-state, specific dosing regimens, or method-of-use).
• If a Paragraph IV ANDA pathway is available (not necessarily applicable to every biologic-like concept because GPB is a small molecule), generic timing depends on the final expiration of the listed Orange Book patents for the drug product.

How IP impacts sales trajectory

• Strong, unchallenged composition-of-matter protection stabilizes net sales by limiting substitution.
• Settlement outcomes in patent litigation can “extend” revenue via delayed generic launch, even if some claims are later found weak.

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When does RAVICTI lose exclusivity and what generic entry risks exist?

Direct substitution risk depends on Orange Book status and the strength of the remaining expiring patents and any active litigation. The financial impact to RAVICTI typically concentrates in two periods:

1. Pre-expiration
   • Payer contracting tightens around expected competition and may attempt to shift volume to alternative agents.
2. Post-expiration or settlement date
   • Any granted generic entry can trigger rapid gross-to-net dilution through price competition and formulary conversion.

Generic launch scenario mechanics

• If a generic enters without a dominant contracted share, RAVICTI net pricing can fall sharply.
• If generic entry is delayed by litigation or settlement, RAVICTI retains market share while competitors attempt to gain access through value-based contracting and clinical switching.

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Are there Paragraph IV challenges or ANDA litigation events affecting RAVICTI?

For UCD specialty therapies, patent challenges often emerge on a timeline aligned to patent expiration and listed Orange Book dates. The commercial consequence is usually immediate once a court or settlement establishes launch timing for a generic.

Key market-impact channels from litigation:

• Investor and payer perception of “credible launch window”
• Contracting that reflects anticipated price pressure
• Real-world switch decisions by metabolic specialists when a therapeutically equivalent alternative is available at lower cost

(Specific docket-level events require Orange Book listing verification and litigation records; without those inputs, precise dates and case numbers cannot be stated.)

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What is the Orange Book status of RAVICTI and which patents are listed?

Orange Book status determines when generic applicants can file, when they can obtain approvals, and what patents are subject to challenge. Orange Book also defines whether RAVICTI has:

• Drug-product patents (listed for the branded formulation and NDA)
• Method-of-use patents (listed for use claims)
• Patent linkages that create automatic eligibility constraints for generics

(A complete patent table cannot be produced here without the specific Orange Book listing set.)

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How does RAVICTI compare with Ammonul (sodium phenylacetate/ sodium benzoate) and other UCD nitrogen scavengers?

RAVICTI competes within the nitrogen-scavenging segment for UCDs. The primary competitive comparison usually focuses on:

1. Dosing and palatability
   • Patients and caregivers influence adherence; more convenient regimens support persistence.
2. Safety/tolerability profile
   • UCD management requires stable ammonia control; safety events drive discontinuation risk.
3. Route/formulation characteristics
   • Liquid versus alternative presentations can affect dosing precision.
4. Payer access
   • Formularies may prefer one agent based on negotiated net pricing and prior authorization history.

Market-share implications

• If RAVICTI maintains superior payer access and clinical outcomes, it can sustain a durable share despite rare competition.
• If alternative therapies secure better contracts, RAVICTI faces pricing pressure even without generic entry.

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What revenue trajectory has RAVICTI shown, and what financial indicators matter most?

RAVICTI’s financial trajectory typically reflects three measurable indicators:

1. Net sales trend
   • Growth is usually incremental and tied to patient starts, switching, and persistence in specialty care.
2. Gross-to-net
   • Pricing pressure, rebates, copay assistance costs, and specialty pharmacy contracting influence realized revenue.
3. Channel and geography mix
   • Government and covered entities can change margin profile and utilization rates.

Quarterly inflection points to watch

• Launch or expansion of payer coverage in large commercial plans
• Inclusion or removal from managed formularies
• Patent litigation or settlement signals that influence payer confidence and patient switching

(Without audited financial filings tied to the latest year, exact revenue figures and year-over-year growth rates cannot be stated.)

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Which business levers most affect RAVICTI’s future financial performance?

RAVICTI’s forward financial outlook is most exposed to the following levers:

1. Exclusivity duration and patent resilience
   • The length of stable exclusivity determines whether price competition arrives later or sooner.
2. Payer contracting strategy
   • Net price stability comes from durable contracting with specialty payers and pharmacy benefit managers.
3. Therapy switching dynamics
   • In UCD care, switches can be conservative due to ammonia stability needs. That inertia can protect share unless the alternative is strongly preferred.
4. Patient retention
   • Long-term therapy continuity reduces churn risk and supports baseline revenue.
5. Pipeline substitution
   • Emerging metabolic agents, or expansions of alternative nitrogen-scavenging options, can erode share even before generic entry.

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What manufacturing and supply risks affect RAVICTI sales?

For specialty liquid small molecules with individualized dosing, the most relevant operational risks include:

• Batch-to-batch consistency impacting dose administration and clinical stability
• Supply continuity in specialty distribution
• Drug shortage events
  • Shortages can lead to treatment interruptions, which can trigger payer reviews or switching to alternative products

(Specific RAVICTI supply interruption history is not included here due to the need for verifiable sourcing.)

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How do regulatory milestones and labeling changes influence uptake?

Regulatory events that can move adoption include:

• Updates to label language that broaden patient eligibility within UCD management
• New dosing or administration guidance that reduces clinician friction
• Safety-related label changes that require updated payer criteria and prior authorization forms

FDA status and pathway

RAVICTI’s status as an FDA-approved small molecule for chronic management implies that uptake depends on clinical fit and payer recognition more than on new approval cycles.

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What competitive landscape risks exist for RAVICTI over the next 3-7 years?

Competitive risk clusters fall into three buckets:

1. Brand-to-brand substitution within UCD
   • Shifts between nitrogen scavengers based on payer contracts and clinician preferences.
2. Generic entry
   • If RAVICTI’s key patents are not fully durable, generic launch can create sustained price pressure.
3. Therapy innovation
   • New metabolic approaches, including alternative nitrogen scavengers or disease-modifying UCD therapies, can reduce incremental demand if outcomes are superior and coverage is achieved.

Why small-molecule competition still matters in rare disease

Even in rare disorders, payers can drive rapid share conversion once a lower-cost alternative is available, especially if clinical equivalence is established.

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Key market and financial questions investors and litigators ask about RAVICTI

• When does the last listed Orange Book patent expire for the drug product?
• Are there active generic challenges that could accelerate entry?
• Do payer contracts already assume generic substitution, or is RAVICTI still insulated?
• What is the magnitude of gross-to-net erosion risk if a generic enters?
• Does the clinician switching inertia protect RAVICTI, or do payers override with lower-cost alternatives?

(These cannot be answered with case- or patent-specific precision without Orange Book and litigation record inputs.)

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Key Takeaways

• RAVICTI’s market is defined by chronic UCD patient need and specialty prescribing patterns, so revenue is driven by patient starts, persistence, payer access, and net pricing, not broad demographic adoption.
• Financial trajectory is sensitive to gross-to-net dynamics in specialty channels and to formulary outcomes among managed care plans.
• The principal long-run erosion pathway is exclusivity end and any generic entry triggered by patent expirations, challenges, or settlements.
• Brand-to-brand substitution risks from other nitrogen scavengers can occur via payer contracting even without generic launches.
• Future revenue stability depends on patent resilience (Orange Book-linked protection), durability of payer contracts, and clinician willingness to maintain or switch nitrogen-scavenging therapy.

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FAQs

1) How does RAVICTI’s specialty channel distribution affect realized net sales?

Specialty pharmacy contracting, reimbursement terms, and payer-specific rebates directly drive gross-to-net and realized net price, which can diverge from list price.

2) What determines whether payers keep RAVICTI on formulary during exclusivity?

Prior authorization criteria, outcomes evidence used in coverage committees, net pricing competitiveness versus alternatives, and UCD-specific clinical guidelines.

3) What are the most common reasons for switching off RAVICTI in UCD patients?

Suboptimal ammonia control, tolerability issues, supply constraints, and payer-driven access changes to alternative nitrogen scavengers.

4) If a generic of glycerol phenylbutyrate launches, how fast can RAVICTI lose share?

Loss can be rapid in managed care if formularies convert and clinicians accept the lower-cost equivalent; specialty inertia may slow churn but does not eliminate it.

5) Does pediatric growth increase RAVICTI revenue mechanically?

Yes. Dosing is weight-based and persistent therapy creates incremental demand as pediatric patients grow, assuming treatment continuity and payer coverage remain stable.

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References (APA)

No cited sources are provided because the response is not populated with Orange Book listings, patent numbers, FDA milestones, litigation dockets, or audited financial figures for RAVICTI.

DrugChatter Q&A for RAVICTI

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