Pentosan polysulfate sodium - Generic Drug Details

What are the generic drug sources for pentosan polysulfate sodium and what is the scope of freedom to operate?

Pentosan polysulfate sodium is the generic ingredient in one branded drug marketed by Janssen Pharms and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for pentosan polysulfate sodium. One supplier is listed for this compound.

Summary for pentosan polysulfate sodium

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
What excipients (inactive ingredients) are in pentosan polysulfate sodium?	pentosan polysulfate sodium excipients list
DailyMed Link:	pentosan polysulfate sodium at DailyMed

Recent Clinical Trials for pentosan polysulfate sodium

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

Sponsor	Phase
TCM Biotech International Corporation	Phase 2/Phase 3
National Taiwan University Hospital	Phase 2/Phase 3
Paradigm Biopharmaceuticals USA (INC)	Phase 3

See all pentosan polysulfate sodium clinical trials

Pharmacology for pentosan polysulfate sodium

Drug Class

Glycosaminoglycan

Anatomical Therapeutic Chemical (ATC) Classes for pentosan polysulfate sodium

C05BA	Heparins or heparinoids for topical use
C05B	ANTIVARICOSE THERAPY
C05	VASOPROTECTIVES
C	Cardiovascular system

G04BX	Other urologicals
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for pentosan polysulfate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	ELMIRON	pentosan polysulfate sodium	CAPSULE;ORAL	020193-001	Sep 26, 1996		RX	Yes	Yes

Expired US Patents for pentosan polysulfate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ELMIRON	pentosan polysulfate sodium	CAPSULE;ORAL	020193-001	Sep 26, 1996

EU/EMA Drug Approvals for pentosan polysulfate sodium

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
bene-Arzneimittel GmbH	Elmiron	pentosan polysulfate sodium	EMEA/H/C/004246 Elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.,	Authorised	no	no	no	2017-06-02

Market Dynamics and Financial Trajectory for Pentosan Polysulfate Sodium

Introduction

Pentosan polysulfate sodium, a semi-synthetic heparin-like macromolecular carbohydrate derivative, has been a significant player in the pharmaceutical industry, particularly in the treatment of interstitial cystitis and other chronic conditions. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Forecast

The global pentosan polysulfate sodium market is projected to experience substantial growth over the coming years. As of 2022, the market size was valued at USD 64.15 million, and it is expected to reach USD 89.55 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 4.88% from 2023 to 2029[3][5].

Key Drivers of Market Growth

Several factors are driving the growth of the pentosan polysulfate sodium market:

Growing Prevalence of Interstitial Cystitis

The increasing incidence of interstitial cystitis, also known as bladder pain syndrome, is a significant driver. This condition affects a substantial number of people, particularly women, with an estimated 400,000 cases in the UK alone[3].

Increasing Awareness and Diagnosis

Advancements in awareness and diagnostic techniques have led to more patients seeking treatment for bladder-related conditions, thereby increasing demand for pentosan polysulfate sodium[5].

Expanding Therapeutic Applications

Research into the potential therapeutic uses of pentosan polysulfate sodium, including its application in treating inflammatory diseases like osteoarthritis, is expanding market prospects[5].

Improvements in Drug Formulations

The development of more potent formulations and delivery systems enhances treatment outcomes and patient compliance, further boosting market growth[5].

Growing Healthcare Expenditure

Increased healthcare spending and improved treatment accessibility are driving the demand for specialist drugs like pentosan polysulfate sodium[5].

Regional Market Dynamics

The market is segmented geographically, with each region exhibiting unique demand dynamics:

North America

North America, particularly the United States, dominates the market due to advanced healthcare systems, significant research funding, and a high prevalence of chronic conditions. This region held the highest share in 2022[3][5].

Europe

Europe is characterized by a strong emphasis on research and development and supportive regulatory frameworks, which enhance market penetration and product innovation[5].

Asia-Pacific

The Asia-Pacific region is emerging rapidly, driven by rising healthcare expenditures, increasing awareness of chronic conditions, and the expanding pharmaceutical sector. Countries like India and China are major consumers in this region[3][5].

Latin America and Middle East & Africa

Latin America is marked by a growing demand for affordable yet effective therapies, while the Middle East & Africa faces challenges such as limited healthcare access but is poised for growth as infrastructure improves and healthcare policies evolve[5].

Challenges and Restraints

Despite the positive growth trajectory, several challenges and restraints affect the market:

Limited Awareness

Pentosan polysulfate sodium may not be well-known to many individuals or healthcare professionals, which could impede market expansion[5].

Safety and Adverse Reactions Concerns

Possible adverse effects, such as gastrointestinal problems and bleeding concerns, may discourage patients from using this drug[5].

Competition from Alternative Therapies

The availability of alternative therapies for conditions like interstitial cystitis may restrict consumer demand for pentosan polysulfate sodium[5].

Regulatory Obstacles

Stringent regulations and prolonged approval processes for new formulations or indications can slow innovation and market entry[5].

High Treatment Cost

The cost of administering pentosan polysulfate sodium can be a barrier for patients, especially if their insurance does not cover it[5].

Market Segmentation

The global pentosan polysulfate sodium market is segmented based on several criteria:

By Drug Type

Human drugs and pet care drugs are the primary segments[3].

By Form

The market is segmented into powder and tablets[3].

By Type

The market is categorized based on purity levels: above 99% and below 99%[1][3].

By Distribution Channel

B2B, B2C, store-based retailing, pharmaceutical stores, medical and healthcare stores, and online retailing are the key distribution channels[3].

Key Players

Several major players are active in the pentosan polysulfate sodium market, including:

• Janssen Pharmaceuticals, Inc.
• Caps Pharma Limited
• Swati Spentose Pvt Ltd
• RAVI Specialities Pharma Pvt Ltd
• Life Relay Health Care Solutions Inc.
• Navamedic ASA
• Allcarepharmacy Limited
• Reva Pharmachem (P) Ltd.
• Ortho McNeil Pharmaceutical
• Arthropharm PTY Ltd
• Ogene Systems (I) Pvt.
• CVS Pharmaceuticals Private Limited
• NORDIC DRUGS
• Alembic
• Bene Pharmachem
• GVK BIO
• CF Pharma[3].

Financial Trajectory

The financial trajectory of the pentosan polysulfate sodium market is characterized by steady growth. Here are some key financial highlights:

• Market Size in 2022: USD 64.15 million[3][5].
• Projected Market Size by 2029: USD 89.55 million[3][5].
• CAGR: 4.88% from 2023 to 2029[3][5].

Impact of COVID-19

The COVID-19 pandemic had a temporary impact on the market, causing a slowdown in 2022. However, the market is expected to recover throughout the forecast period as economic and healthcare systems stabilize[3].

Safety Concerns

Recent studies have highlighted safety concerns associated with long-term use of pentosan polysulfate sodium, including the risk of maculopathy, a vision-threatening condition. This has led to increased scrutiny and monitoring of patients using this drug[2][4].

Conclusion

The pentosan polysulfate sodium market is poised for significant growth driven by increasing demand for effective treatments for interstitial cystitis and other chronic conditions. Despite challenges such as limited awareness, safety concerns, and regulatory obstacles, the market is expected to expand steadily over the forecast period.

Key Takeaways

• The global pentosan polysulfate sodium market is projected to grow at a CAGR of 4.88% from 2023 to 2029.
• North America dominates the market, followed by Europe and the Asia-Pacific region.
• Increasing awareness and diagnosis of interstitial cystitis are key drivers of market growth.
• Safety concerns and regulatory obstacles are significant challenges.
• The market is segmented by drug type, form, type, and distribution channel.

FAQs

1. What is the projected market size of pentosan polysulfate sodium by 2029?

   • The market is expected to reach USD 89.55 million by 2029[3][5].

2. What is the CAGR of the pentosan polysulfate sodium market from 2023 to 2029?

   • The market is growing at a CAGR of 4.88% during this period[3][5].

3. Which region dominates the pentosan polysulfate sodium market?

   • North America, particularly the United States, dominates the market[3][5].

4. What are the primary drivers of the pentosan polysulfate sodium market?

   • Growing prevalence of interstitial cystitis, increasing awareness and diagnosis, and expanding therapeutic applications are key drivers[5].

5. What are the major challenges facing the pentosan polysulfate sodium market?

   • Limited awareness, safety concerns, competition from alternative therapies, and regulatory obstacles are significant challenges[5].

Sources

1. Market Research Intellect - Pentosan Polysulfate Sodium Market Size And Forecast[1].
2. JAMA Ophthalmology - Disease Course in Patients With Pentosan Polysulfate Sodium–Associated Maculopathy[2].
3. Maximize Market Research - Global Pentosan Polysulfate Sodium Market: Global Industry Analysis 2029[3].
4. ScienceDirect - Pentosan polysulfate sodium maculopathy: Final analysis of a case series[4].
5. Verified Market Research - Pentosan Polysulfate Sodium Market Size, Share & Forecast[5].

Last updated: 2024-12-18