PEPTAVLON Drug Patent Profile

Which patents cover Peptavlon, and what generic alternatives are available?

Peptavlon is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in PEPTAVLON is pentagastrin. Additional details are available on the pentagastrin profile page.

Summary for PEPTAVLON

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1
DailyMed Link:	PEPTAVLON at DailyMed

Recent Clinical Trials for PEPTAVLON

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

Sponsor	Phase
International Centre for Diarrhoeal Disease Research, Bangladesh	N/A

See all PEPTAVLON clinical trials

US Patents and Regulatory Information for PEPTAVLON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	PEPTAVLON	pentagastrin	INJECTABLE;INJECTION	017048-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for PEPTAVLON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	PEPTAVLON	pentagastrin	INJECTABLE;INJECTION	017048-001	Approved Prior to Jan 1, 1982	3,896,103

International Patents for PEPTAVLON

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

Country	Patent Number	Title	Estimated Expiration
Denmark	126589
Sweden	333378
Switzerland	554840	VERFAHREN ZUR HERSTELLUNG VON ACYLIERTEN TETRAPEPTIDDERIVATEN.

PEPTAVLON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PEPTAVLON and Similar Drugs

Introduction

The pharmaceutical industry is undergoing significant transformations, driven by advances in technology, changing regulatory landscapes, and evolving market dynamics. For drugs like PEPTAVLON, which are part of the newer classes of treatments, understanding these dynamics is crucial for predicting their market success and financial trajectory.

Pharmaceutical Market Overview

The global pharmaceutical market is projected to reach $1.15 trillion in 2024 and is expected to exceed $1.4 trillion by 2028, driven by the escalating global burden of chronic diseases[3].

Emerging Trends in Pharmaceutical Research and Development

High Development Costs and Risks

The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved[3].

Market Access Trends

Pharmacy Biosimilar Adoption

Biosimilars, like those for adalimumab, are gaining traction but face significant barriers. Despite discounts of up to 85% off the list price of the reference product Humira, biosimilars have only captured around 1% of the market share. However, changes in rebate structures and vertical integration among pharmacy benefit managers (PBMs) and specialty pharmacies may accelerate the adoption of biosimilars in 2024[1].

Challenges in Drug Launches

Modern Launch Challenges

New drug launches are facing significant hurdles, including lagging payer coverage, physician adoption, and patient activation. This has resulted in a decline in average first-year revenues for launch products reimbursed under the pharmacy benefit, from $140 million in 2018 to $60 million in 2022[1].

Financial Strategies and Support Programs

Transition Assistance Programs

Manufacturers are increasingly using transition assistance programs to subsidize patient demand and smooth the prescriber experience. Over 50% of year-one demand for new drugs is now fully subsidized by manufacturers, which helps in overcoming payer hurdles but also adds to the financial burden on the manufacturer[1].

Impact of Price Controls and Rebate Structures

Net Price Pressure

The combination of price controls and changing rebate structures is pressuring manufacturers to increase list prices at launch to account for the inevitable net price decline over the product's lifecycle. This strategic lever is crucial as manufacturers navigate the complex landscape of discounts and list prices[1].

Specific Market Opportunities: Obesity Drugs

Growing Demand and Market Expansion

The global market for obesity drugs, which could include drugs like PEPTAVLON if it targets obesity, is expected to expand significantly. Morgan Stanley forecasts this market to reach $105 billion by 2030, driven by the broadening use of these drugs beyond weight loss to treat a range of obesity-related illnesses[4].

Clinical Pipeline and Development

Palatin Technologies Example

Companies like Palatin Technologies, which are in the midst of clinical trials for various indications, illustrate the challenges and opportunities. Palatin's focus on obesity, dry eye disease, and other high-value indications highlights the potential for significant market impact if their clinical trials are successful. The company's financial trajectory, marked by net losses and reduced operating expenses, underscores the financial risks and uncertainties involved in drug development[2].

Balancing Profit and Public Health

Addressing Unmet Medical Needs

Pharmaceutical companies must balance the need for profit with the imperative to address unmet medical needs. This is particularly evident in areas like antimicrobial resistance and neglected tropical diseases, where the market demand can be unpredictable and subject to significant fluctuations[3].

Investment Landscape

Economic Models and Funding Initiatives

The development of new drugs, especially in high-risk areas like antibiotics, requires innovative economic models and funding initiatives. The AMR Action Fund is an example of a global initiative aimed at incentivizing investment in new antibiotics despite the financial risks involved[3].

Regulatory and Supply Chain Challenges

340B Program Impact

The 340B program continues to pose challenges for manufacturers, impacting their net prices and supply chain dynamics. Despite efforts to limit the program's reach, its utilization has accelerated in certain channels, affecting manufacturer revenues and insurance premiums[1].

Key Takeaways

• The pharmaceutical market is expected to grow significantly, driven by chronic diseases.
• Biosimilars face adoption challenges but may see increased uptake due to changes in rebate structures.
• New drug launches are hindered by payer and physician adoption issues.
• Manufacturers are using financial support programs to overcome these hurdles.
• Obesity drugs represent a significant market opportunity.
• Balancing profit with public health needs is crucial, especially in high-risk areas like antimicrobial resistance.
• Innovative economic models and funding initiatives are necessary to support high-risk drug development.

FAQs

What are the main challenges facing new drug launches in 2024?

New drug launches are facing challenges such as lagging payer coverage, physician adoption, and patient activation, leading to a decline in average first-year revenues.

How are biosimilars expected to impact the market in 2024?

Biosimilars are expected to see increased adoption in 2024 due to changes in rebate structures and the vertical integration of pharmacy benefit managers and specialty pharmacies.

What is the projected growth of the obesity drug market?

The global market for obesity drugs is expected to reach $105 billion by 2030, driven by the broadening use of these drugs beyond weight loss to treat various obesity-related illnesses.

What are the financial risks involved in drug development?

The financial risks include high development costs, a long development timeline, and a low probability of success. Additionally, changes in rebate structures and price controls can impact a drug's financial trajectory.

How are pharmaceutical companies addressing unmet medical needs?

Pharmaceutical companies are strategically aligning their R&D investments to address unmet medical needs, particularly in areas like chronic diseases, antimicrobial resistance, and neglected tropical diseases.

Cited Sources:

1. IQVIA, "Top 10 U.S. Market Access Trends for 2024," February 15, 2024.
2. Palatin Technologies, Inc., "Palatin Reports Fourth Quarter and Fiscal Year Ended 2024 Financial Results, Provides Update on Clinical Programs, Strategic Priorities, and Anticipated Milestones," October 1, 2024.
3. DrugBank Blog, "Investment Trends in Pharmaceutical Research," August 9, 2024.
4. Morgan Stanley, "Scaling Up the Impact of Obesity Drugs," May 7, 2024.