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 fourteen patent family members in twenty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Ravicti

There have been five 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.

There is one tentative approval for the generic drug (glycerol phenylbutyrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for RAVICTI

International Patents:	114
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	10
Patent Applications:	51
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
Kaplan Medical Center	Phase 2/Phase 3
Weizmann Institute of Science	Phase 2/Phase 3
Johns Hopkins University	Phase 1/Phase 2

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 fifteen US patents and one FDA Regulatory Exclusivity.

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		RX	Yes	Yes	9,962,359
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes	8,642,012
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes	10,183,002
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes	10,183,005
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes	10,045,959
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes	10,045,958

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	5,968,979

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/003822 Ravicti 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
Canada	2735218	PROCEDES DE TRAITEMENT A L'AIDE DE MEDICAMENTS DESACTIVANT L'AMMONIAC (METHODS OF TREATMENT USING AMMONIA-SCAVENGING DRUGS)
Mexico	2014012694	METODOS DE MONITOREO TERAPEUTICO DE PROFARMACOS DE ACIDO FENILACETICO. (METHODS OF THERAPEUTIC MONITORING OF PHENYLACETIC ACID PRODRUGS.)
Netherlands	300854
European Patent Office	3263102	PROCÉDÉS DE SURVEILLANCE THÉRAPEUTIQUE DE MÉDICAMENTS À RÉCUPÉRATION D'AZOTE (METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS)
United Kingdom	2465250	Dosing and monitoring patients on nitrogen-scavenging drugs
Japan	6234436
Lithuania	2330892

Supplementary Protection Certificates for RAVICTI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2330892	2016C/074	Belgium		PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; AUTHORISATION NUMBER AND 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
2330892	122016000107	Germany		PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892	PA2016041,C2330892	Lithuania		PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892	635	Finland
2330892	C20160044 00204	Estonia		PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
2330892	PA2016041	Lithuania		PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127

RAVICTI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ravicti

Introduction to Ravicti

Ravicti, also known as glycerol phenylbutyrate, is a medication used to treat urea cycle disorders (UCDs), a group of rare genetic diseases that can lead to the accumulation of toxic levels of ammonia in the blood. Here, we delve into the market dynamics and financial trajectory of Ravicti, highlighting its current status, growth drivers, challenges, and future prospects.

Global Market Size and Growth

The global Ravicti market is experiencing significant growth. As of 2024, the market size is estimated to be USD 105.20 million, with a projected compound annual growth rate (CAGR) of 26.20% from 2024 to 2031. This rapid growth is expected to boost sales to USD 536.33 million by 2031[1].

Regional Market Performance

North America

North America holds the largest market share, accounting for more than 40% of the global revenue, with a market size of USD 42.08 million in 2024. This dominance is attributed to the region's advanced healthcare infrastructure, high awareness of rare diseases, robust diagnostic capabilities, and significant investments in research and development for orphan drugs[1].

Asia-Pacific

The Asia-Pacific region is growing at the fastest CAGR due to increasing awareness of rare diseases, improvements in healthcare infrastructure, rising disposable incomes, and expanding access to healthcare services. These factors, combined with a growing population and higher prevalence of UCDs, contribute to the region's rapid market expansion[1].

Market Segmentation

By Application

The Ravicti market is segmented by application, with the hospital segment holding the largest share. Hospitals play a critical role in diagnosing and treating rare diseases like UCDs, having access to advanced diagnostic tools and specialized medical teams. This segment is followed by the pharmacy application, which is growing rapidly due to increased patient access to medications and the rise of specialty pharmacies focusing on rare diseases[1].

By Distribution Channel

The pharmacy distribution channel is also seeing significant growth, driven by the expansion of online pharmacies and home delivery services, which enhance convenience for patients. Specialty pharmacies provide tailored services, including patient education and support, which improve treatment adherence[1].

Drivers of Market Growth

Increasing Awareness of UCDs

Growing awareness of urea cycle disorders is a key driver of the Ravicti market. As awareness increases, so do diagnosis rates and the demand for effective treatments like Ravicti[1].

Research and Development

Rising investment in rare disease research is significantly driving the market. This investment supports the development of specialized treatments, enhances drug efficacy, and accelerates regulatory approvals. It also leads to better diagnostic tools and more precise treatment options, expanding the market for Ravicti[1].

Regulatory Support

Orphan drug incentives and regulatory support for rare diseases further boost the market. These incentives encourage pharmaceutical companies to develop and market treatments for rare conditions, which otherwise might not be economically viable[1].

Financial Performance of Key Players

Horizon Therapeutics

Horizon Therapeutics, the manufacturer of Ravicti, reported notable financial results. In 2022, Ravicti sales were USD 325.6 million, representing a 12% increase from the previous year. This growth reflects the increasing demand for the drug and the company's strong position in the rare disease treatment market[2].

Challenges and Opportunities

High Treatment Costs

One of the significant challenges facing the Ravicti market is the high cost of treatment. This can limit access to the drug, especially in regions with less robust healthcare systems and reimbursement policies[1].

Impact of Global Events

Events like the COVID-19 pandemic can disrupt market dynamics by affecting supply chains, healthcare resource allocation, and patient access to treatments. However, the pandemic has also accelerated the adoption of telehealth and online pharmacy services, which can mitigate some of these disruptions[1].

Future Prospects

Personalized Medicine and Targeted Therapies

The market is trending towards personalized medicine and targeted therapies, which align well with the specialized nature of Ravicti. As these trends continue, the demand for Ravicti is expected to grow, driven by its efficacy in treating UCDs[1].

Expanding Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in the Asia-Pacific region, will continue to drive market growth. Rising disposable incomes and expanding access to healthcare services will make Ravicti more accessible to a broader patient population[1].

Key Takeaways

• The global Ravicti market is projected to grow significantly, driven by increasing awareness of UCDs and investments in rare disease research.
• North America holds the largest market share due to its advanced healthcare infrastructure and robust diagnostic capabilities.
• The Asia-Pacific region is growing at the fastest CAGR due to improving healthcare infrastructure and rising awareness of rare diseases.
• Hospitals and pharmacies are key distribution channels, with the latter seeing rapid growth due to the rise of specialty pharmacies.
• High treatment costs and global events like the COVID-19 pandemic pose challenges, but trends towards personalized medicine and targeted therapies offer opportunities for growth.

FAQs

What is the current global market size of Ravicti?

The global Ravicti market size is estimated to be USD 105.20 million as of 2024[1].

What is the projected CAGR of the Ravicti market from 2024 to 2031?

The Ravicti market is expected to grow at a CAGR of 26.20% from 2024 to 2031[1].

Which region holds the largest market share for Ravicti?

North America holds the largest market share, accounting for more than 40% of the global revenue[1].

What are the key drivers of the Ravicti market?

Key drivers include increasing awareness of UCDs, rising investment in rare disease research, and regulatory support for rare diseases[1].

What challenges does the Ravicti market face?

High treatment costs and potential disruptions from global events like the COVID-19 pandemic are significant challenges[1].

How is the Asia-Pacific region contributing to the growth of the Ravicti market?

The Asia-Pacific region is growing at the fastest CAGR due to increasing awareness of rare diseases, improvements in healthcare infrastructure, and rising disposable incomes[1].

Sources

1. Cognitive Market Research: "Global Ravicti Market Report 2024"
2. Business Wire: "Horizon Therapeutics plc Reports Fourth-Quarter and Full-Year 2022 Financial Results"
3. Market Research Intellect: "Ravicti Market: Growth Trends and Key Insights"
4. PR Newswire: "AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS"
5. Valuates Reports: "Global Ravicti Market Research Report 2024"