NIPENT Drug Patent Profile

Which patents cover Nipent, and what generic alternatives are available?

Nipent is a drug marketed by Hospira Inc and is included in one NDA.

The generic ingredient in NIPENT is pentostatin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pentostatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nipent

A generic version of NIPENT was approved as pentostatin by WEST-WARD PHARMS INT on August 7^th, 2007.

Summary for NIPENT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	19
Patent Applications:	4,504
What excipients (inactive ingredients) are in NIPENT?	NIPENT excipients list
DailyMed Link:	NIPENT at DailyMed

Recent Clinical Trials for NIPENT

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
City of Hope Medical Center	Phase 1
California Institute for Regenerative Medicine (CIRM)	Phase 1

See all NIPENT clinical trials

Pharmacology for NIPENT

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

US Patents and Regulatory Information for NIPENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira Inc	NIPENT	pentostatin	INJECTABLE;INJECTION	020122-001	Oct 11, 1991	AP	RX	Yes	Yes

Expired US Patents for NIPENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hospira Inc	NIPENT	pentostatin	INJECTABLE;INJECTION	020122-001	Oct 11, 1991	3,923,785

International Patents for NIPENT

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5848160
Netherlands	186868
Netherlands	7504710
Belgium	828183
Japan	S50145590
France	2311552

Market Dynamics and Financial Trajectory for NIPENT (Pentostatin)

Last updated: July 28, 2025

Introduction

NIPENT, with the generic name pentostatin, is a chemotherapeutic agent approved primarily for treating hairy cell leukemia (HCL) and other lymphoid malignancies. Since its FDA approval in 1991, NIPENT has maintained a niche in hematological oncology, with evolving market dynamics shaped by therapeutic developments, patent status, competitive landscape, and healthcare policy shifts. This comprehensive analysis explores NIPENT's current market trajectory and future financial outlook within the broader pharmaceutical ecosystem.

Product Overview

Pentostatin operates as a potent adenosine deaminase (ADA) inhibitor, disrupting lymphocyte proliferation in malignant and immune-compromised states. Its pharmacological efficacy in HCL has resulted in sustained clinical use, although newer agents may offer competing mechanisms and safety profiles. NIPENT is marketed under the brand name by aid companies such as Taiho Oncology in specific regions, with its composition remaining under patent protection or off-patent status depending on jurisdiction and formulation patents.

Market Landscape & Competitive Dynamics

The phosphorescent landscape surrounding NIPENT encompasses several factors:

• Therapeutic Positioning: NIPENT's primary indication remains HCL, a rare disease with an estimated prevalence of 2,000-3,000 cases annually in the US [1]. Historically, pentostatin stood as a frontline therapy, but the advent of rituximab and combination regimens like cladribine has shifted treatment paradigms, reducing monotherapy reliance.

• Competitive Agents: Cladribine (Leustatin) and newer targeted agents, such as BRAF inhibitors (e.g., vemurafenib), have challenged NIPENT's market positioning. These agents often demonstrate higher response rates, fewer adverse effects, or simplified administration protocols, influencing prescriber preferences.

• Remission and Survival Data: While pentostatin maintains acceptable efficacy, the emergence of combination therapies has improved remission duration and overall survival, subtly decreasing demand for NIPENT as a monotherapy.

• Regulatory and Patent Considerations: The expiration of existing patents, coupled with the potential for biosimilar or generic competition, accelerates price erosion, introducing downward pressure on revenue streams.

Market Demand and Utilization Trends

Given the rarity of HCL, the overall market size remains modest. It is estimated that annual U.S. prescriptions for NIPENT hover between 200-500 units [2], constrained further by evolving treatment strategies favoring combination regimens or biologics.

Recent trends indicate:

• Slowed or Declining Use: As newer treatments demonstrate superior safety and efficacy profiles, clinicians favor combination therapies over monotherapy with pentostatin, leading to stagnant or declining demand.

• Off-label Use: Some off-label or investigational uses of pentostatin in other lymphoproliferative disorders sustain minimal additional market activity.

• Global Market Variability: Development status and regulatory approvals vary globally, with emerging markets potentially maintaining limited niche demand due to cost considerations and limited access to advanced biologics.

Financial Trajectory and Revenue Outlook

The financial prospects for NIPENT are influenced by multiple intertwined factors:

• Revenue Trends: Historical data suggests NIPENT's sales have plateaued or declined modestly, influenced by market saturation and competitive pressures. In 2021, estimates indicated US sales of approximately $50 million, with potential for a slight decrease in subsequent years [3].

• Pricing Dynamics: Price reductions driven by patent expiry, generic entry, and healthcare cost containment policies further depress revenue potential. For instance, generic pentostatin available since the late 2000s has exerted downward pressure on pricing.

• Potential for Growth: Limited prospects exist for significant growth absent new indications or formulation innovations. However, niche markets or orphan drug status could mitigate decline.

• Pipeline & Regulatory Landscape: Currently, no significant pipeline developments directly involve NIPENT, and the drug’s off-patent status diminishes incentives for investment in marketing or formulation improvements.

• Impact of Healthcare Policy: Reforms emphasizing cost-effective treatments and increased biosimilar acceptance threaten future revenue streams, reinforcing the importance of strategic repositioning, if feasible.

Strategic Considerations for Stakeholders

Manufacturers face decisions regarding product lifecycle management, such as:

• Extending Market Share: Through strategic alliances or clinical research supporting new indications.

• Cost Optimization: Managing manufacturing costs amidst declining revenues.

• Patent and Exclusivity Management: Exploiting orphan drug status or potential patent extensions where relevant.

• Market Diversification: Expanding into emerging markets where pricing and access barriers are lower.

Future Outlook and Market Projections

Based on current data, NIPENT’s financial trajectory indicates a gradual decline rather than growth:

• Short-term (Next 2-3 Years): Market share will likely diminish modestly, with revenues stabilizing due to existing demand in niche patient segments.

• Medium-term (3-7 Years): As generic competition intensifies, revenues are expected to decline at a compounded annual rate (CAR) of approximately 5-8%. The absence of new indications or formulations limits upside potential.

• Long-term (Beyond 7 Years): The drug may sustain a residual market through legacy use, but significant revenue contributions are improbable without lifecycle extension strategies.

Conclusion

NIPENT's market dynamics are shaped by its niche status, evolving treatment standards, and market pressures stemming from generic competition and policy reforms. While it remains relevant for certain patient populations, its financial trajectory indicates steady decline unless strategic repositioning occurs. Stakeholders must navigate a landscape characterized by limited growth opportunities, necessitating innovative approaches or diversification to sustain profitability.

---

Key Takeaways

• NIPENT's primary indication, hairy cell leukemia, represents a small, niche market with limited growth prospects.

• Competitors and newer therapies have displaced NIPENT from a frontline monotherapy role, contributing to declining demand.

• Generic entries and patent expirations exert downward pressure on prices and revenue.

• Without new indications or formulations, NIPENT's sales are projected to gradually decline over the next decade.

• Strategic lifecycle management and market diversification are vital for stakeholders aiming to preserve value.

---

FAQs

1. What are the main competitors to NIPENT in the treatment of hairy cell leukemia?
Cladribine (Leustatin) and Rituximab are primary competitors, often preferred due to higher efficacy and more convenient dosing. Targeted therapies like BRAF inhibitors also challenge NIPENT's role, especially for refractory cases.

2. How does patent expiration impact NIPENT’s market?
Patent expiration allows generic manufacturers to produce lower-cost versions, leading to significant price erosion and reduced revenue for original developers.

3. Are there ongoing clinical trials for new uses of pentostatin?
Current clinical trials focus mostly on its use in combination therapies or exploring resistance mechanisms. No major trials are poised to significantly extend NIPENT’s indications.

4. How does healthcare policy influence NIPENT’s market trajectory?
Cost containment policies and emphasis on biosimilars accelerate generic entry and reduce reimbursement levels, further constraining profitability.

5. What strategies can manufacturers adopt to prolong NIPENT’s market presence?
Options include seeking orphan drug designation for new indications, developing improved formulations, or establishing regional partnerships to expand access.

---

References
[1] National Cancer Institute, "Hairy Cell Leukemia," [Online]. Available: https://www.cancer.gov/types/leukemia/hp/hairy-cell-leukemia.
[2] IQVIA, "US Oncology Commercial Drug Trends," 2022.
[3] Evaluate Pharma, "Pharmaceutical Sales Data," 2021.