PENTOXIFYLLINE - Generic Drug Details

What are the generic sources for pentoxifylline and what is the scope of patent protection?

Pentoxifylline is the generic ingredient in three branded drugs marketed by Ani Pharms, Apotex, Heritage, Impax Labs, Pliva, Rising, Valeant Pharms, Upsher Smith Labs, and Validus Pharms, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for pentoxifylline. Nine suppliers are listed for this compound.

Summary for PENTOXIFYLLINE

US Patents:	0
Tradenames:	3
Applicants:	9
NDAs:	11
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	157
Patent Applications:	6,689
Drug Prices:	Drug price trends for PENTOXIFYLLINE
What excipients (inactive ingredients) are in PENTOXIFYLLINE?	PENTOXIFYLLINE excipients list
DailyMed Link:	PENTOXIFYLLINE at DailyMed

See drug prices for PENTOXIFYLLINE

Recent Clinical Trials for PENTOXIFYLLINE

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

Sponsor	Phase
Sunnybrook Health Sciences Centre	Phase 3
Tata Memorial Centre	Phase 2
Bhabha Atomic Research Centre (BARC)	Phase 2

See all PENTOXIFYLLINE clinical trials

Pharmacology for PENTOXIFYLLINE

Drug Class	Blood Viscosity Reducer
Physiological Effect	Hematologic Activity Alteration

Medical Subject Heading (MeSH) Categories for PENTOXIFYLLINE

Free Radical Scavengers

Phosphodiesterase Inhibitors

Platelet Aggregation Inhibitors

Radiation-Protective Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for PENTOXIFYLLINE

C04AD	Purine derivatives
C04A	PERIPHERAL VASODILATORS
C04	PERIPHERAL VASODILATORS
C	Cardiovascular system

US Patents and Regulatory Information for PENTOXIFYLLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	PENTOXIFYLLINE	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	075191-001	Jun 9, 1999	AB	RX	No	Yes
Heritage	PENTOXIFYLLINE	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	074877-001	Jul 8, 1997		DISCN	No	No
Ani Pharms	PENTOXIFYLLINE	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	074878-001	Jul 9, 1997	AB	RX	No	No
Pliva	PENTOXIFYLLINE	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	074874-001	May 25, 1999		DISCN	No	No
Valeant Pharms	PENTOXIFYLLINE	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	075028-001	Jul 20, 1998	AB	RX	No	No

Expired US Patents for PENTOXIFYLLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	TRENTAL	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	018631-001	Aug 30, 1984
Validus Pharms	TRENTAL	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	018631-001	Aug 30, 1984

PENTOXIFYLLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Pentoxifylline

Introduction

Pentoxifylline, a methylxanthine derivative, has been a significant player in the treatment of various vascular and inflammatory conditions since its introduction in the 1970s. This article delves into the market dynamics and financial trajectory of pentoxifylline, highlighting its current status, growth prospects, and the factors influencing its market performance.

Market Size and Growth Projections

The pentoxifylline market is anticipated to experience substantial growth over the forecast period from 2024 to 2031. According to market research reports, the pentoxifylline drug market and the pentoxifylline API market are both expected to exhibit remarkable CAGR during this period[1][4].

Pentoxifylline Drug Market

The pentoxifylline drug market is segmented by type (tablets and injections) and application (hospitals and medical centers), with geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The market has shown rapid and considerable growth in recent years and is forecasted to continue this upward trend, driven by increasing demand and advancements in healthcare infrastructure[1].

Pentoxifylline API Market

The pentoxifylline API market, categorized by purity levels (≥98% and <98%) and applications (tablets and injections), is also expected to see significant expansion. This growth is attributed to the increasing need for high-quality APIs in pharmaceutical manufacturing and the expanding global pharmaceutical market[4].

Key Drivers of Market Growth

Several factors are driving the growth of the pentoxifylline market:

Increasing Prevalence of Vascular Diseases

The rising incidence of peripheral arterial disease (PAD) and other vascular conditions is a major driver. Pentoxifylline's efficacy in treating intermittent claudication and improving limb function in patients with chronic occlusive arterial disease contributes significantly to its market demand[2][5].

Expanding Applications

Beyond its primary use in treating PAD, pentoxifylline is being investigated and used for various other conditions, including venous leg ulcers, severe alcoholic hepatitis, and osteoradionecrosis. This diversification of applications broadens its market potential[5].

Pharmaceutical Market Trends

The global pharmaceutical market is growing, driven by advancements in healthcare, increasing healthcare spending, and the need for effective treatments for chronic diseases. Pentoxifylline benefits from these broader trends, contributing to its market growth[1][4].

Market Restraints and Challenges

Despite the positive growth prospects, there are several challenges and restraints that could impact the market:

Regulatory Changes

Recent guidelines from medical associations, such as the ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS, suggest that pentoxifylline may not be recommended for the treatment of claudication in patients with chronic symptomatic PAD, which could affect its market dynamics[3].

Competition from Alternative Treatments

The availability of alternative treatments and the development of new drugs for vascular diseases could pose a challenge to pentoxifylline's market share. However, its established efficacy and safety profile continue to support its position in the market[2].

Competitive Landscape

The pentoxifylline market is characterized by a competitive landscape with several key players:

Key Companies

Companies such as Infa Group spa, Polpharma S.A., Bakul Group, Saneca Pharmaceuticals, and Taj Pharmaceuticals Limited are prominent in the pentoxifylline drug market. In the API market, companies like Teva Pharmaceutical Industries Ltd, Hikal Ltd, Sun Pharmaceutical Industries Ltd, and Zaklady Farmaceutyczne Polpharma Sa are significant players[1][4].

Market Strategies

These companies are engaged in various market strategies, including collaborations, mergers and acquisitions, new product introductions, and regional expansions. These activities help in maintaining market share and driving growth[1][4].

Financial Outlook

The financial outlook for the pentoxifylline market is robust, with significant revenue growth anticipated:

Revenue Projections

The market size of both the pentoxifylline drug market and the API market is expected to increase substantially, measured in USD million, across various segments. The revenue growth is driven by increasing demand, higher product penetration, and favorable market dynamics[1][4].

Pricing Analysis

The pricing of pentoxifylline products is influenced by factors such as product pricing, market penetration, and the economic landscapes of different regions. A detailed pricing analysis, including an examination of Porter's 5 Forces Framework and value chain assessment, highlights the competitive pricing strategies employed by market players[1][4].

Emerging Trends and Opportunities

Several emerging trends and opportunities are shaping the future of the pentoxifylline market:

Research and Development

Ongoing research into new applications of pentoxifylline, such as its potential use in treating COVID-19-induced pulmonary complications, presents new opportunities for market expansion[2].

Global Healthcare Trends

The increasing focus on healthcare infrastructure development and the rising demand for effective treatments for chronic diseases globally are trends that favor the growth of the pentoxifylline market[1][4].

Conclusion

The pentoxifylline market is poised for significant growth, driven by its established efficacy, expanding applications, and favorable market dynamics. While there are challenges and restraints, the overall financial trajectory indicates robust revenue growth and a strong competitive landscape.

Key Takeaways

• Market Growth: The pentoxifylline market is expected to grow significantly from 2024 to 2031.
• Drivers: Increasing prevalence of vascular diseases, expanding applications, and pharmaceutical market trends drive growth.
• Challenges: Regulatory changes and competition from alternative treatments are potential restraints.
• Competitive Landscape: Key players are engaged in various market strategies to maintain and grow their market share.
• Financial Outlook: Revenue growth is anticipated, driven by increasing demand and favorable market dynamics.

FAQs

What is pentoxifylline used for?

Pentoxifylline is primarily used to treat intermittent claudication caused by chronic occlusive arterial disease of the limbs. It is also used for conditions such as venous leg ulcers, severe alcoholic hepatitis, and osteoradionecrosis[2][5].

What are the key drivers of the pentoxifylline market?

The key drivers include the increasing prevalence of vascular diseases, expanding applications of pentoxifylline, and broader trends in the pharmaceutical market[1][4].

Which companies are prominent in the pentoxifylline market?

Companies such as Infa Group spa, Polpharma S.A., Bakul Group, Saneca Pharmaceuticals, and Taj Pharmaceuticals Limited are prominent in the drug market, while Teva Pharmaceutical Industries Ltd, Hikal Ltd, and Sun Pharmaceutical Industries Ltd are significant in the API market[1][4].

What are the potential challenges for the pentoxifylline market?

Regulatory changes and competition from alternative treatments are potential challenges that could impact the market dynamics of pentoxifylline[3].

What is the financial outlook for the pentoxifylline market?

The financial outlook is robust, with significant revenue growth anticipated due to increasing demand, higher product penetration, and favorable market dynamics[1][4].

Sources

1. Market Research Intellect - Global Pentoxifylline Drug Market Size, Trends and Projections
2. DrugBank - Pentoxifylline: Uses, Interactions, Mechanism of Action
3. JACC - 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS
4. Market Research Intellect - Global Pentoxifylline API Market Size, Trends and Projections
5. NCBI Bookshelf - Pentoxifylline - StatPearls