LANOXIN PEDIATRIC Drug Patent Profile

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

Lanoxin Pediatric is a drug marketed by Covis and is included in one NDA.

The generic ingredient in LANOXIN PEDIATRIC is digoxin. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lanoxin Pediatric

A generic version of LANOXIN PEDIATRIC was approved as digoxin by RISING on December 23^rd, 1999.

Summary for LANOXIN PEDIATRIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	18
DailyMed Link:	LANOXIN PEDIATRIC at DailyMed

Recent Clinical Trials for LANOXIN PEDIATRIC

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

Sponsor	Phase
Turning Point Therapeutics, Inc.	Phase 1
Yale University	Phase 2
Jean Grem, MD	Phase 2

See all LANOXIN PEDIATRIC clinical trials

Pharmacology for LANOXIN PEDIATRIC

Drug Class

Cardiac Glycoside

US Patents and Regulatory Information for LANOXIN PEDIATRIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	LANOXIN PEDIATRIC	digoxin	INJECTABLE;INJECTION	009330-004	Approved Prior to Jan 1, 1982		RX	Yes	Yes

LANOXIN PEDIATRIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lanoxin in the Pediatric Sector

Introduction

Lanoxin, also known as digoxin, is a cardiac glycoside used to treat heart failure and certain heart rhythm disorders. When it comes to the pediatric sector, the market dynamics and financial trajectory of Lanoxin are influenced by several key factors, including regulatory initiatives, research developments, and the growing need for pediatric-specific healthcare solutions.

Global Pediatric Drugs Market Overview

The global pediatric drugs market is experiencing significant growth, driven by increasing prevalence of chronic diseases among children, advancements in pediatric medicine, and a strengthened global focus on child healthcare. The market is projected to grow from USD 129.13 billion in 2023 to USD 363.86 billion by 2032, at a CAGR of 12.2%[1].

Regulatory Initiatives

Regulatory frameworks play a crucial role in the development and marketing of pediatric drugs, including Lanoxin. The Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) are key laws that encourage pharmaceutical companies to invest in research and development for pediatric medications. These initiatives have been instrumental in promoting the development of child-specific drug formulations, including those for heart conditions like congenital heart disease[1].

Research Developments in Pediatrics

The Pediatric Trial Network's (PTN) study on digoxin is a prime example of ongoing research aimed at improving treatment options for pediatric patients. This study focuses on determining the appropriate dosing and safety measures of digoxin in infants with single ventricle congenital heart disease, a critical area where there was previously a lack of safety and efficacy data[5].

Market Growth Drivers

Several factors are driving the growth of the pediatric drugs market, which in turn impact the financial trajectory of Lanoxin:

Rising Prevalence of Pediatric Diseases

The increasing incidence of pediatric illnesses such as heart failure, congenital heart disease, and other chronic conditions is a significant driver. Lanoxin, being a treatment for heart failure, benefits from this trend[1][3].

Advancements in Pediatric Medicine

Continuous advancements in pediatric research and the development of novel drugs and therapies are improving treatment options for children. This includes better formulations and delivery systems, which can enhance the efficacy and safety of drugs like Lanoxin[1].

Focus on Rare Childhood Diseases

Pharmaceutical companies are increasingly focusing on rare pediatric disorders, which includes conditions treated by Lanoxin. This focus is driven by regulatory support and the need for specialized treatments[1].

Parental Awareness and Advocacy

Increased awareness and advocacy among parents regarding their children’s healthcare needs are also driving the demand for pediatric drugs, including Lanoxin[1].

Regional Market Dynamics

North America

North America, particularly the U.S., is a major market for pediatric drugs, including Lanoxin. The region accounted for 37% of the global market share in 2022 and is expected to continue growing at a CAGR of 12.3% from 2023 to 2032. The strong healthcare infrastructure, robust economy, and favorable regulatory frameworks in this region support the market growth[1].

Asia-Pacific

The Asia-Pacific region is expected to grow at the fastest rate, with a CAGR of 18.3% during the forecast period. This growth is driven by the large and growing pediatric population, economic growth, and increasing accessibility and affordability of pediatric drugs in the region[1].

Financial Trajectory

Given the overall growth of the pediatric drugs market, the financial trajectory for Lanoxin is positive:

• Market Size: The global pediatric drugs market, which includes Lanoxin, is projected to reach USD 363.86 billion by 2032 from USD 129.13 billion in 2023[1].
• CAGR: The market is growing at a CAGR of 12.2%, indicating a steady and significant increase in revenue over the forecast period[1].
• Regional Growth: The U.S. pediatric drugs market, where Lanoxin is widely used, is expected to reach USD 78.78 billion by 2032, growing at a CAGR of 12.3% from 2023 to 2032[1].

Key Takeaways

• The global pediatric drugs market, including Lanoxin, is driven by rising pediatric diseases, advancements in pediatric research, and regulatory support.
• North America leads the market, but the Asia-Pacific region is expected to grow at the fastest rate.
• The financial trajectory for Lanoxin is positive, with the market expected to expand significantly over the forecast period.
• Continuous research and development, such as the PTN's study on digoxin, are crucial for improving treatment options and safety profiles for pediatric patients.

FAQs

1. What is the projected growth rate of the global pediatric drugs market?

   • The global pediatric drugs market is expected to grow at a CAGR of 12.2% from 2023 to 2032[1].

2. Which region leads the global pediatric drugs market?

   • North America leads the global pediatric drugs market, accounting for 37% of the market share in 2022[1].

3. What are the key drivers of the pediatric drugs market?

   • Key drivers include the rising prevalence of pediatric diseases, advancements in pediatric research, and regulatory initiatives such as PREA and BPCA[1].

4. What is the focus of the Pediatric Trial Network's (PTN) study on digoxin?

   • The PTN's study focuses on determining the appropriate dosing and safety measures of digoxin in infants with single ventricle congenital heart disease[5].

5. How is the Asia-Pacific region contributing to the growth of the pediatric drugs market?

   • The Asia-Pacific region is expected to grow at the fastest rate, driven by a large and growing pediatric population, economic growth, and increasing accessibility and affordability of pediatric drugs[1].

Sources

1. Biospace - Pediatric Drugs Market Size to Garner Around USD 363.86 Billion by 2032
2. FDA - PRESCRIBING INFORMATION Lanoxin (digoxin) Injection Pediatric
3. Market.US - Pediatric Drugs Market Expected US$ 95.4 Billion Valuation by 2033
4. Data Bridge Market Research - Global Pediatric Heart Failure Market
5. Pediatric Trial Network - PTN Digoxin Study Reaches Enrollment Goal