TRENTAL Drug Patent Profile

When do Trental patents expire, and when can generic versions of Trental launch?

Trental is a drug marketed by Validus Pharms and is included in one NDA.

The generic ingredient in TRENTAL is pentoxifylline. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the pentoxifylline profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Trental

A generic version of TRENTAL was approved as pentoxifylline by RISING on July 8^th, 1997.

Summary for TRENTAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	45
Patent Applications:	4,106
DailyMed Link:	TRENTAL at DailyMed

Recent Clinical Trials for TRENTAL

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

Sponsor	Phase
Tanta University	Phase 4
Tanta University	Early Phase 1
Misr University for Science and Technology	Phase 2

See all TRENTAL clinical trials

US Patents and Regulatory Information for TRENTAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	TRENTAL	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	018631-001	Aug 30, 1984		DISCN	Yes	No

Expired US Patents for TRENTAL

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	3,737,433
Validus Pharms	TRENTAL	pentoxifylline	TABLET, EXTENDED RELEASE;ORAL	018631-001	Aug 30, 1984	4,189,469

International Patents for TRENTAL

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

Country	Patent Number	Title	Estimated Expiration
Finland	45049
Switzerland	540275	Verfahren zur Herstellung von (w-1)-Oxoalkyl)-dimethylxanthinen (1((w-1)-oxoalkyl)-3,7-dimethylxanthines - and 7((w-1)oxoalkyl)-1,3-dimethylxanthines)
Norway	123349
Denmark	126255
Cyprus	1153	PHARMACEUTICAL COMPOSITIONS

TRENTAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trental (Pentoxifylline)

Overview of Trental (Pentoxifylline)

Trental, known generically as pentoxifylline, is a xanthine derivative used primarily to treat symptoms of intermittent claudication due to peripheral vascular disease. It works by decreasing the viscosity of blood, thereby improving blood flow.

Market Size and Growth

The global pentoxifylline drug market, which includes Trental, has experienced significant growth in recent years. The market size was valued at USD XX million in 2022 and is expected to expand at a notable CAGR during the forecast period from 2023 to 2031[1][4].

Market Drivers

Several factors drive the growth of the pentoxifylline market:

• Increasing Prevalence of Peripheral Vascular Disease: The rising incidence of peripheral vascular diseases, particularly among the aging population, drives the demand for pentoxifylline.
• Advancements in Healthcare: Improvements in healthcare infrastructure and increased access to medical treatments contribute to the market's expansion.
• Economic Growth: Growing economies in various regions, especially in Asia Pacific, increase the purchasing power of consumers, leading to higher demand for pharmaceutical products[1][4].

Market Opportunities

• Expanding into Emerging Markets: There is a significant opportunity for pharmaceutical companies to expand their presence in emerging markets where healthcare infrastructure is developing rapidly.
• Generic and Biosimilar Versions: The expiration of patents for branded drugs like Trental opens up opportunities for generic and biosimilar versions, which can capture a substantial market share[4].

Market Challenges

• Regulatory Hurdles: Stricter regulatory requirements and the need for extensive clinical trials pose significant challenges and increase the cost of bringing new drugs to market[2].
• Competition from Alternatives: The presence of alternative treatments and the development of new drugs can reduce the market share of existing drugs like Trental.
• Macro-Economic Factors: Global events such as inflation and regional conflicts can impact the supply chain and pricing of pharmaceutical products[4].

Financial Trajectory

Revenue and Sales

The revenue from pentoxifylline is expected to grow substantially over the forecast period. The market is segmented by product type (tablets, injections, and others) and by application (hospitals, medical centers, and others). The tablet form of pentoxifylline remains a dominant segment due to its ease of administration[4].

Cost and Pricing

The cost of developing and marketing pentoxifylline is significant. However, the generic versions of the drug, which are now available, offer a more affordable alternative to patients. This has led to a competitive pricing landscape, where companies must balance profitability with affordability[4].

Return on Investment (ROI)

The ROI for pharmaceutical R&D, including drugs like pentoxifylline, has been declining in recent years. According to Deloitte's analysis, the projected ROI for the 20 largest pharmaceutical companies dropped to 1.2% in 2022, down from 1.9% in 2021. This decline is attributed to increasing R&D costs, shorter exclusivity periods, and the impact of generic and biosimilar competitors[2].

Competitive Landscape

The pentoxifylline market is competitive, with several key players:

• Teva Pharmaceutical Industries Ltd
• Hikal Ltd
• Liberton
• Saneca Pharmaceuticals

These companies compete based on factors such as product quality, pricing, and market reach. The introduction of generic versions of pentoxifylline has increased competition, forcing companies to innovate and expand their product portfolios[4].

Regional Market Analysis

The market for pentoxifylline is global, with significant presence in regions such as North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. The Asia Pacific region is expected to show high growth rates due to the expanding healthcare sector and increasing demand for pharmaceutical products[4].

Adverse Reactions and Safety Profile

Clinical trials and post-marketing surveillance have identified several adverse reactions associated with pentoxifylline, including digestive and nervous system side effects. The incidence of these side effects varies between the extended-release tablets and immediate-release capsules, with higher rates observed in the capsule studies[5].

Conclusion

The market for Trental (pentoxifylline) is poised for significant growth driven by increasing demand for treatments of peripheral vascular diseases. However, the market faces challenges such as regulatory hurdles, competition from generics and biosimilars, and declining ROI for pharmaceutical R&D. Companies must strategize to balance profitability with the need to innovate and expand their market reach.

Key Takeaways

• The global pentoxifylline market is expected to grow significantly from 2023 to 2031.
• Market drivers include the increasing prevalence of peripheral vascular diseases and advancements in healthcare.
• Regulatory hurdles and competition from generics and biosimilars are key challenges.
• The ROI for pharmaceutical R&D is declining due to increasing costs and shorter exclusivity periods.
• The market is competitive, with several key players competing on product quality, pricing, and market reach.

FAQs

What is Trental (pentoxifylline) used for?

Trental, or pentoxifylline, is used primarily to treat symptoms of intermittent claudication due to peripheral vascular disease by decreasing the viscosity of blood and improving blood flow.

What are the main drivers of the pentoxifylline market?

The main drivers include the increasing prevalence of peripheral vascular diseases, advancements in healthcare, and economic growth in various regions.

What are the significant challenges facing the pentoxifylline market?

Challenges include regulatory hurdles, competition from generic and biosimilar versions, and declining ROI for pharmaceutical R&D.

How does the competitive landscape of the pentoxifylline market look?

The market is competitive with key players such as Teva Pharmaceutical Industries Ltd, Hikal Ltd, Liberton, and Saneca Pharmaceuticals competing on product quality, pricing, and market reach.

What are the common adverse reactions associated with pentoxifylline?

Common adverse reactions include digestive and nervous system side effects, such as abdominal discomfort, dizziness, and nausea, with higher incidence rates observed in immediate-release capsule studies.

Sources

1. Market Research Intellect: Global Pentoxifylline Drug Market Size, Trends and Projections
2. DrugBank Blog: Investment Trends in Pharmaceutical Research
3. PharmaKB: Financial Analysis of Competitive Drugs
4. Market Reports World: Pentoxifylline Drug Market by Industry Analysis : 2032
5. Drugs.com: Trental: Package Insert / Prescribing Information