UCEPHAN Drug Patent Profile

When do Ucephan patents expire, and what generic alternatives are available?

Ucephan is a drug marketed by B Braun and is included in one NDA.

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

Summary for UCEPHAN

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	UCEPHAN at DailyMed

US Patents and Regulatory Information for UCEPHAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	UCEPHAN	sodium benzoate; sodium phenylacetate	SOLUTION;ORAL	019530-001	Dec 23, 1987		DISCN	No	No

Expired US Patents for UCEPHAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
B Braun	UCEPHAN	sodium benzoate; sodium phenylacetate	SOLUTION;ORAL	019530-001	Dec 23, 1987	4,284,647

International Patents for UCEPHAN

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

Country	Patent Number	Title	Estimated Expiration
Canada	1175750	METHODE POUR ELIMINER LES DECHETS AZOTES (PROCESS FOR WASTE NITROGEN REMOVAL)

Supplementary Protection Certificates for UCEPHAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
0579826	SPC/GB02/042	United Kingdom		PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422

UCEPHAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Pharmaceutical Industry: Lessons for UCEPHAN

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by a myriad of factors including regulatory changes, market trends, and financial incentives. For a drug like UCEPHAN, understanding these dynamics is crucial for navigating the market successfully. Here, we will delve into the key trends and financial aspects that shape the pharmaceutical industry, providing insights that can be applied to UCEPHAN.

Regulatory Environment and Market Access

Asia's Biopharmaceutical Market

In regions like Asia, regulatory changes can significantly impact market access and drug approvals. For instance, reforms by the Chinese Food and Drug Administration (CFDA) have led to a surge in new product launches and approvals. In 2017, China saw 37 new product launches, a substantial increase from the previous years. This rapid approval process, especially with priority-review status, can expedite a drug's market entry, as seen with AstraZeneca's Tagrisso, which was approved in China just 15 months after its US approval[1].

Orphan Drug Designations

In the context of orphan drugs, regulatory designations can offer substantial financial and market advantages. The FDA's orphan drug designation provides a 50% tax break on research and development (R&D) and access to federal grants. This can significantly boost a company's financials and stock performance, as observed with BioMarin, which received $32.6 million in tax credits in 2012[2][5].

Financial Incentives and Monopolies

Tax Credits and Grants

The financial incentives associated with orphan drug designations are a key driver for many pharmaceutical companies. These incentives can fuel extensive research into rare diseases, creating a lucrative market segment. For example, the U.S. government could grant nearly $50 billion in tax credits from 2016 to 2025 for orphan drug development[2][5].

Monopoly Creation

Companies often leverage orphan drug designations to create extended monopolies. By stacking multiple orphan approvals, companies can extend their exclusivity periods, as seen with Sigma-Tau Pharmaceuticals' Carnitor, which maintained exclusivity for over 20 years[2][5].

Market Trends and Growth

Oncology Drugs Market

The oncology drugs market is a prime example of rapid growth driven by increasing cancer prevalence and the adoption of targeted therapies. This market is projected to grow from $231.56 billion in 2024 to $532.91 billion by 2031, with a CAGR of 12.6%. Targeted therapies and immunotherapies are expected to drive this growth, offering higher efficacy and reduced side effects[4].

Generic and Biosimilar Markets

In contrast, the generic and biosimilar markets face challenges such as drug shortages, largely due to low prices and price erosion. These markets are often unattractive due to low-profit margins, leading to oligopolies and increased risk of shortages. The concentration of manufacturers in these markets exacerbates the issue, as there is limited bandwidth to absorb demand increases or supply disruptions[3].

Pricing and Reimbursement

Pricing Pressure

In many regions, including Southeast Asia, governments are introducing universal healthcare coverage, which, while beneficial, also brings pricing pressure and restrictions. For example, Thailand's National List of Essential Medicines (NLEM) and Indonesia's national health-insurance system (BPJS) have stringent processes and pricing controls, making market access challenging for innovative drugs[1].

Public Funding Pools

Access to public funding pools, such as Thailand's Civil Servant Medical Benefit Scheme (CSMBS) and NLEM, is crucial for pharmaceutical companies. However, these pools often come with strict budget controls and median pricing, which can limit the profitability of drugs[1].

Drug Shortages and Their Impact

Causes of Shortages

Drug shortages are a significant issue globally, particularly in the generic and biosimilar markets. Low prices, market concentration, and price erosion are key drivers of these shortages. The lack of competition and the reliance on a few manufacturers make these markets vulnerable to supply disruptions[3].

Economic and Health Impact

Drug shortages have substantial economic and health implications. Patients may face higher out-of-pocket payments, and healthcare resources are diverted to manage shortages rather than other critical needs. The use of substitute drugs can also lead to side effects and prescribing errors[3].

Strategic Implications for UCEPHAN

Market Access Strategies

For UCEPHAN to succeed, it is crucial to develop robust market access strategies. This includes navigating regulatory environments, particularly in regions like Asia where reforms can significantly impact approval timelines. Leveraging public funding pools and understanding the reimbursement landscape will be essential[1].

Financial Planning

UCEPHAN's financial trajectory can be significantly enhanced by exploring financial incentives such as orphan drug designations. These designations not only provide tax credits and grants but also offer extended market exclusivity, which can be a powerful tool in creating a monopoly[2][5].

Innovation and Targeted Therapies

Given the growth trends in the oncology drugs market, UCEPHAN could benefit from focusing on innovative, targeted therapies. These therapies offer higher efficacy and reduced side effects, which are driving the growth in the oncology market[4].

Key Takeaways

• Regulatory Environment: Understanding and adapting to regulatory changes, especially in regions like Asia, is crucial for rapid market access.
• Financial Incentives: Leveraging orphan drug designations and other financial incentives can significantly boost a drug's financial trajectory.
• Market Trends: Focusing on growing markets such as oncology and adopting targeted therapies can drive growth.
• Pricing and Reimbursement: Navigating pricing pressure and accessing public funding pools are essential for market success.
• Drug Shortages: Addressing the root causes of drug shortages, such as price erosion and market concentration, is vital to ensure sustained supply.

FAQs

Q: What are the key financial incentives for developing orphan drugs? A: Orphan drug designations offer a 50% tax break on R&D, access to federal grants, and extended market exclusivity, which can significantly boost a company's financials[2][5].

Q: How do regulatory changes in Asia impact the biopharmaceutical market? A: Regulatory reforms in Asia, such as those by the CFDA, can lead to rapid approvals and increased market access, as seen with the surge in new product launches in China[1].

Q: What drives the growth in the oncology drugs market? A: The growth in the oncology drugs market is driven by the increasing prevalence of cancer and the adoption of targeted therapies and immunotherapies[4].

Q: Why are drug shortages more common in generic and biosimilar markets? A: Drug shortages in these markets are often due to low prices, market concentration, and price erosion, making them commercially unattractive and vulnerable to supply disruptions[3].

Q: How can pharmaceutical companies mitigate the impact of drug shortages? A: Companies can mitigate shortages by understanding the root causes, such as price erosion and market concentration, and applying a framework to quantify and forecast shortages. Policy initiatives and better resource allocation can also help[3].

Sources

1. McKinsey & Company: "Asia on the move: Five trends shaping the Asia biopharmaceutical market"
2. California Healthline: "Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies"
3. Office of Health Economics: "The Dynamics of Drug Shortages"
4. Biospace: "Oncology Drugs Market to Reach USD 532.91 Billion by 2031"
5. KFF Health News: "Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies"