PHEBURANE Drug Patent Profile

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

Pheburane is a drug marketed by Medunik and is included in one NDA.

The generic ingredient in PHEBURANE is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pheburane

A generic version of PHEBURANE was approved as sodium phenylbutyrate by SIGMAPHARM LABS LLC on March 22^nd, 2013.

Summary for PHEBURANE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1
Patent Applications:	1,712
Drug Prices:	Drug price information for PHEBURANE
What excipients (inactive ingredients) are in PHEBURANE?	PHEBURANE excipients list
DailyMed Link:	PHEBURANE at DailyMed

See drug prices for PHEBURANE

Recent Clinical Trials for PHEBURANE

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

Sponsor	Phase
Maastricht University	Phase 4

See all PHEBURANE clinical trials

Pharmacology for PHEBURANE

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

US Patents and Regulatory Information for PHEBURANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medunik	PHEBURANE	sodium phenylbutyrate	PELLETS;ORAL	216513-001	Jun 17, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for PHEBURANE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eurocept International B. V.	Pheburane	sodium phenylbutyrate	EMEA/H/C/002500 Treatment of chronic management of urea-cycle disorders.	Authorised	no	no	no	2013-07-30
Immedica Pharma AB	Ammonaps	sodium phenylbutyrate	EMEA/H/C/000219 Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase.It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.	Authorised	no	no	no	1999-12-07

PHEBURANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pheburane

Introduction to Pheburane

Pheburane, a formulation of sodium phenylbutyrate (NaPB), is a crucial medication for the management of urea cycle disorders (UCDs) and other metabolic conditions. Launched by Medunik USA in September 2022, Pheburane offers a unique and flavor-masking formulation, enhancing patient compliance and treatment efficacy.

Market Context: Urea Cycle Disorders

The global market for treatments of urea cycle disorders is experiencing significant growth, driven primarily by the increasing incidence of UCDs. According to the Centers for Disease Control and Prevention (CDC), the estimated incidence of UCDs is 1 in 8,500 births, which is a key factor fueling the demand for effective treatments like Pheburane[3].

Market Size and Growth

The global urea cycle disorders treatment market is projected to grow substantially. From $1.23 billion in 2022, the market is expected to reach $1.29 billion in 2023, reflecting a Compound Annual Growth Rate (CAGR) of 4.9%. By 2027, the market is anticipated to reach $1.50 billion, maintaining a robust CAGR of 3.9%[4].

Regional Insights

North America

North America dominates the global sodium phenylbutyrate market, including Pheburane, due to the presence of major market players, advanced healthcare facilities, and a growing patient population. Newborn screening programs also contribute significantly to the regional market growth[1][3].

Europe

Europe is expected to be the second-largest market for sodium phenylbutyrate, driven by rising healthcare expenditure and an increasing awareness of treatment options for UCDs[3].

Asia Pacific

The Asia Pacific region is anticipated to grow at a high rate, driven by improving healthcare infrastructure, rising medical tourism, and increasing healthcare spending. This presents lucrative opportunities for market players like Medunik USA[3].

Product Innovation and Competitive Advantage

Pheburane's launch marked a significant innovation in the UCD treatment market. The oral pellets offer a unique flavor-masking formulation, which simplifies treatment by eliminating the need for mixing or preparation. This innovation is expected to enhance patient compliance and improve the overall treatment experience[4].

Distribution Channels

The distribution of Pheburane, like other sodium phenylbutyrate drugs, is expected to be robust across various channels:

Hospital Pharmacies

Hospital pharmacies, which stock a wide range of medications, are a significant distribution channel. They ensure the availability of quality medicines directly from manufacturers, reducing the risk of counterfeit drugs[1].

Retail Pharmacies

Retail pharmacies also play a crucial role, especially for outpatient medications. They provide easy access to patients and are expected to continue contributing to the market growth[1].

Online Pharmacies

The online segment is growing rapidly due to increasing internet penetration, private investments, and government initiatives. This channel is expected to expand significantly during the forecast period[1].

Financial Trajectory

Revenue Projections

Given the growing demand for UCD treatments, Pheburane is expected to contribute significantly to the revenue of its manufacturer, Medunik USA. The global sodium phenylbutyrate market, which includes Pheburane, is projected to reach $3.02 billion by 2030 from $1.92 billion in 2023, at a CAGR of 6.7%[3].

Market Share

As a new entrant with innovative features, Pheburane is likely to capture a substantial market share. The success of Horizon Therapeutics plc, which has diversified its portfolio and seen significant growth in rare disease medicines, serves as a precedent for companies like Medunik USA[2].

Challenges and Restraints

Despite the positive outlook, the market faces several challenges:

Regulatory Approvals

Stringent regulatory approvals can delay the launch and expansion of new treatments like Pheburane. Ensuring compliance with regulatory standards is crucial for market success[3].

High R&D Costs

The high costs associated with research and development in the pharmaceutical industry can be a significant restraint. Companies must balance innovation with cost management to maintain profitability[3].

Key Takeaways

• Growing Market: The global UCD treatment market is expected to grow significantly, driven by the increasing incidence of UCDs.
• Innovation: Pheburane's unique formulation is a key innovation in the market, enhancing patient compliance and treatment efficacy.
• Regional Dominance: North America is expected to dominate the market, followed by Europe and the Asia Pacific region.
• Distribution Channels: Hospital, retail, and online pharmacies are critical distribution channels for Pheburane.
• Financial Projections: The global sodium phenylbutyrate market, including Pheburane, is projected to reach $3.02 billion by 2030.
• Challenges: Stringent regulatory approvals and high R&D costs are significant challenges for market growth.

FAQs

1. What is Pheburane used for? Pheburane is used for the treatment of urea cycle disorders (UCDs) and other metabolic conditions.

2. Who launched Pheburane? Pheburane was launched by Medunik USA in September 2022.

3. What is unique about Pheburane's formulation? Pheburane offers a unique flavor-masking formulation in oral pellets, which simplifies treatment by eliminating the need for mixing or preparation.

4. Which region dominates the sodium phenylbutyrate market? North America dominates the global sodium phenylbutyrate market, including Pheburane.

5. What are the expected growth projections for the global sodium phenylbutyrate market? The global sodium phenylbutyrate market is projected to reach $3.02 billion by 2030 from $1.92 billion in 2023, at a CAGR of 6.7%.

Sources

1. Biospace: Sodium Phenylbutyrate Drugs Market: Oral Segment Witness Highest Growth.
2. Annual Reports: 2017 Annual Report - Horizon Pharma.
3. Coherent Market Insights: Sodium Phenylbutyrate Market Size, Trends and Forecast to 2030.
4. GlobeNewswire: Urea Cycle Disorders Treatment Market Analysis 2023-2027.