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Last Updated: March 11, 2025

PROSTIN VR PEDIATRIC Drug Patent Profile


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When do Prostin Vr Pediatric patents expire, and what generic alternatives are available?

Prostin Vr Pediatric is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in PROSTIN VR PEDIATRIC is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prostin Vr Pediatric

A generic version of PROSTIN VR PEDIATRIC was approved as alprostadil by HIKMA on January 20th, 1998.

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Recent Clinical Trials for PROSTIN VR PEDIATRIC

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SponsorPhase
University Medical Centre MariborPhase 4
Aswan University HospitalN/A
Ministry of Health, SingaporeN/A

See all PROSTIN VR PEDIATRIC clinical trials

Pharmacology for PROSTIN VR PEDIATRIC

US Patents and Regulatory Information for PROSTIN VR PEDIATRIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer PROSTIN VR PEDIATRIC alprostadil INJECTABLE;INJECTION 018484-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for PROSTIN VR PEDIATRIC

Introduction to PROSTIN VR PEDIATRIC

PROSTIN VR PEDIATRIC, containing alprostadil (prostaglandin E1), is a critical medication used to temporarily maintain the patency of the ductus arteriosus in neonates with congenital heart defects. This drug is essential for ensuring adequate blood flow to the body until corrective or palliative surgery can be performed[2][4][5].

Clinical Indications and Usage

PROSTIN VR PEDIATRIC is indicated for neonates with congenital heart defects such as pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, and other severe heart defects. The drug is administered intravenously and requires careful monitoring, especially for respiratory status, as apnea can occur in about 10-12% of treated neonates[2][4][5].

Market Context: Pediatric Drugs Market

The global pediatric drugs market is experiencing significant growth, driven by several key factors. The market was valued at USD 115.6 billion in 2022 and is projected to reach USD 363.86 billion by 2032, growing at a CAGR of 12.2% between 2023 and 2032. This expansion is attributed to the increasing prevalence of pediatric disorders, advancements in pediatric research, and rising investment in healthcare infrastructure[3].

Demand and Growth Drivers

Increasing Prevalence of Pediatric Disorders

The rise in pediatric disorders, including congenital heart defects, autoimmune diseases, and other conditions, is a major driver for the demand of drugs like PROSTIN VR PEDIATRIC. As the pediatric population grows, so does the need for specialized medications[3].

Advancements in Pediatric Research

Continuous research and development in pediatric pharmaceuticals are leading to more effective and targeted treatments. Initiatives such as the WHO's list of priority pediatric antibiotic compositions and the FDA's approval of new drugs for rare diseases contribute to market growth[3].

Healthcare Investment and Infrastructure

Substantial investments in healthcare infrastructure and government initiatives to enhance pediatric care are crucial for the market's expansion. These investments facilitate better access to specialized medications and improve the overall quality of care for pediatric patients[3].

Financial Trajectory

Market Size and Revenue

The pediatric drugs market, which includes PROSTIN VR PEDIATRIC, is expected to see significant revenue growth. The projected increase from USD 115.6 billion in 2022 to USD 363.86 billion by 2032 indicates a robust financial trajectory for drugs catering to pediatric needs[3].

Competitive Landscape

The pediatric drugs market is competitive, with several major pharmaceutical companies dominating the market. Companies like Pfizer, which manufactures PROSTIN VR PEDIATRIC, are continuously innovating and expanding their product lines to meet the growing demand for pediatric medications. Strategic partnerships, contract manufacturing services, and innovative drug delivery methods further support market growth[3].

Regional Market Dynamics

Asia-Pacific Region

The Asia-Pacific region is poised for significant growth in the pediatric drugs market. Factors such as a substantial and expanding pediatric population, economic prosperity, and increased regional healthcare investments drive this growth. This region is emerging as a central hub for research, development, and distribution of pediatric pharmaceuticals[3].

Challenges and Considerations

Safety and Monitoring

PROSTIN VR PEDIATRIC requires careful administration and monitoring, particularly due to the risk of apnea and other side effects like gastric outlet obstruction and cortical proliferation of the long bones. These safety considerations necessitate the drug's use in facilities with pediatric intensive care capabilities[2][4].

Cost and Accessibility

While the drug is crucial for neonates with congenital heart defects, its cost and the need for specialized care can be barriers to access. However, initiatives to increase healthcare investment and improve infrastructure are helping to address these issues[3].

Key Takeaways

  • Growing Demand: The pediatric drugs market, including PROSTIN VR PEDIATRIC, is driven by increasing prevalence of pediatric disorders and advancements in research.
  • Financial Growth: The market is projected to grow significantly, from USD 115.6 billion in 2022 to USD 363.86 billion by 2032.
  • Regional Expansion: The Asia-Pacific region is a key growth area due to its expanding pediatric population and healthcare investments.
  • Safety and Monitoring: PROSTIN VR PEDIATRIC requires careful administration and monitoring due to potential side effects.
  • Accessibility: Efforts to improve healthcare infrastructure and reduce costs are essential for increasing access to this critical medication.

FAQs

Q: What is PROSTIN VR PEDIATRIC used for?

A: PROSTIN VR PEDIATRIC is used to temporarily maintain the patency of the ductus arteriosus in neonates with congenital heart defects until corrective or palliative surgery can be performed[2][4][5].

Q: What are the potential side effects of PROSTIN VR PEDIATRIC?

A: Potential side effects include apnea, gastric outlet obstruction, and cortical proliferation of the long bones. The drug also inhibits platelet aggregation, which requires caution in neonates with bleeding tendencies[2][4].

Q: How is the pediatric drugs market expected to grow?

A: The global pediatric drugs market is expected to grow from USD 115.6 billion in 2022 to USD 363.86 billion by 2032, at a CAGR of 12.2% between 2023 and 2032[3].

Q: What drives the growth of the pediatric drugs market?

A: The growth is driven by the increasing prevalence of pediatric disorders, advancements in pediatric research, and rising investment in healthcare infrastructure[3].

Q: Which region is expected to see significant growth in the pediatric drugs market?

A: The Asia-Pacific region is expected to see significant growth due to its expanding pediatric population, economic prosperity, and increased regional healthcare investments[3].

Sources:

  1. Elsevier Health - Alprostadil
  2. Pfizer - PROSTIN VR PEDIATRIC alprostadil injection, USP
  3. Towards Healthcare - Pediatric Drugs Market Size Envisioned at USD 363.86 Billion by 2032
  4. Pfizer - PROSTIN VR Alprostadil 0.5 mg/ml concentrate Reference market
  5. NPS MedicineWise - Prostin VR - NPS MedicineWise

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