PENTOSTATIN - Generic Drug Details

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

Pentostatin is the generic ingredient in two branded drugs marketed by Hospira Inc, Rising, and West-ward Pharms Int, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for pentostatin. One supplier is listed for this compound.

Summary for PENTOSTATIN

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	63
Patent Applications:	6,885
Drug Prices:	Drug price trends for PENTOSTATIN
What excipients (inactive ingredients) are in PENTOSTATIN?	PENTOSTATIN excipients list
DailyMed Link:	PENTOSTATIN at DailyMed

See drug prices for PENTOSTATIN

Recent Clinical Trials for PENTOSTATIN

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

Sponsor	Phase
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Phase 1
Scripps Health	Phase 2
California Institute for Regenerative Medicine (CIRM)	Phase 1

See all PENTOSTATIN clinical trials

Pharmacology for PENTOSTATIN

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

Medical Subject Heading (MeSH) Categories for PENTOSTATIN

Adenosine Deaminase Inhibitors

Antineoplastic Agents

Anatomical Therapeutic Chemical (ATC) Classes for PENTOSTATIN

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for PENTOSTATIN

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
West-ward Pharms Int	PENTOSTATIN	pentostatin	INJECTABLE;INJECTION	077841-001	Aug 7, 2007	AP	RX	No	No
Rising	PENTOSTATIN	pentostatin	INJECTABLE;INJECTION	203554-001	Sep 19, 2014		DISCN	No	No

Expired US Patents for PENTOSTATIN

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

PENTOSTATIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pentostatin

Introduction

Pentostatin, a potent adenosine deaminase inhibitor, is a crucial drug in the treatment of various hematological malignancies, including hairy cell leukemia, B-cell non-Hodgkin lymphoma, and chronic lymphocytic leukemia. Understanding the market dynamics and financial trajectory of pentostatin is essential for pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The pentostatin market is projected to experience significant growth over the next few years. As of 2023, the market size was valued at approximately USD 343.1 million and is expected to reach USD 541.9 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.3% from 2024 to 2031[4].

Market Segmentation

The pentostatin market can be segmented in several ways to understand its dynamics better:

By Type

• Injectable: This is the most common form of pentostatin administration, given its efficacy and ease of use.
• Oral: Although less common, oral formulations are also available, offering an alternative for patients who prefer or require this route of administration[1].

By Route of Administration

• Intravenous: This route is often used in clinical settings for acute treatments.
• Intramuscular: Used for certain types of therapies where a slower release is beneficial.
• Subcutaneous: Common for chronic conditions requiring regular dosing[1].

By Treatment

• B-Cell Non-Hodgkin Lymphoma: Pentostatin is effective in treating this type of lymphoma.
• Cutaneous T-Cell Lymphoma: It is also used in the management of cutaneous T-cell lymphoma.
• Chronic Lymphocytic Leukemia: Another key indication for pentostatin[1].

By Distribution Channel

• Hospital Pharmacies: A significant portion of pentostatin is distributed through hospital pharmacies due to its use in inpatient settings.
• Retail Pharmacies: Available in retail pharmacies for outpatient use.
• Online Pharmacies: Increasingly available through online channels, offering convenience to patients[1].

Competitive Landscape

The pentostatin market is highly competitive, with several major pharmaceutical companies involved:

• Takeda: Known for its extensive portfolio of oncology drugs.
• Roche: A leading player in the global pharmaceutical market.
• Sanofi: Offers a wide range of therapeutic solutions, including oncology treatments.
• Amgen: Specializes in biotechnology and has a strong presence in the oncology market.
• Merck Co., Pfizer, Novartis, AbbVie, Celgene, Bristol-Myers Squibb, Johnson & Johnson, AstraZeneca: These companies also play significant roles in the pentostatin market[1].

Regional Analysis

The market is geographically segmented into several key regions:

• North America (United States, Canada, Mexico): A significant market due to high healthcare spending and advanced medical infrastructure.
• Europe (Germany, France, UK, Russia, Italy): Another major market with a strong focus on healthcare and pharmaceutical research.
• Asia-Pacific (China, Japan, Korea, India, Southeast Asia): Rapidly growing due to increasing healthcare expenditure and a large patient population.
• South America (Brazil, Argentina, Colombia): Emerging market with growing demand for oncology treatments.
• Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, South Africa): Also showing growth, driven by improving healthcare systems and increasing awareness of cancer treatments[1].

Technological Trends and New Product Developments

The pentostatin market is influenced by technological advancements and new product developments:

• Kinase Inhibitors and Gene Therapies: There is a growing trend towards more targeted and advanced therapies, which can impact the demand for traditional drugs like pentostatin[1].
• Generic Drug Market: The entry of generic versions can significantly affect the pricing and market share of branded pentostatin. Generic drug prices fall with the number of competitors, approaching long-run marginal costs when there are 8 or more competitors[3].

Financial Trajectory

The financial trajectory of the pentostatin market is characterized by steady growth driven by several factors:

• Increasing Prevalence of Blood Cancers: The global increase in blood cancer cases necessitates the development and use of advanced therapies, including pentostatin[1].
• CAGR of 6.23%: The market is expected to grow at a CAGR of 6.23% from 2024 to 2032, indicating a robust financial outlook[1].
• Market Value Projections: The market is projected to rise from USD 58.7 billion in 2023 to USD 100 billion by 2032, reflecting significant financial growth[1].

Impact of Regulatory and Policy Changes

Regulatory and policy changes can significantly impact the pentostatin market:

• FDA Scrutiny: Increased scrutiny by the FDA on generic drug applications can raise the cost of obtaining approval, affecting market dynamics[3].
• Medicare and Insurance Coverage: Programs like the Medicare Replacement Drug Demonstration (MRDD) can influence patient access and financial outcomes for pentostatin users. For instance, the MRDD provided financial assistance and reduced out-of-pocket spending for beneficiaries, which can impact market demand[2].

Key Takeaways

• The pentostatin market is expected to grow significantly, driven by increasing prevalence of blood cancers and technological advancements.
• The market is segmented by type, route of administration, treatment, and distribution channel.
• Major pharmaceutical companies dominate the competitive landscape.
• Regional analysis shows growth potential in various parts of the world.
• Regulatory and policy changes can impact market dynamics and financial outcomes.

FAQs

What is the projected market size of pentostatin by 2031?

The pentostatin market is expected to reach USD 541.9 million by 2031, growing at a CAGR of 6.3% from 2024 to 2031[4].

Which companies are key players in the pentostatin market?

Key players include Takeda, Roche, Sanofi, Amgen, Merck Co., Pfizer, Novartis, AbbVie, Celgene, Bristol-Myers Squibb, Johnson & Johnson, and AstraZeneca[1].

What are the main routes of administration for pentostatin?

Pentostatin can be administered intravenously, intramuscularly, and subcutaneously[1].

How does the generic drug market affect pentostatin prices?

Generic drug prices fall with the number of competitors, approaching long-run marginal costs when there are 8 or more competitors, which can impact the pricing of branded pentostatin[3].

What is the impact of regulatory changes on the pentostatin market?

Regulatory changes, such as increased FDA scrutiny on generic drug applications, can raise the cost of obtaining approval and affect market dynamics[3].

Sources

1. Pentostatin Market Overall Study Report 2024-2032 | Takeda, Roche, Sanofi, Amgen, Merck Co., Pfizer, Novartis, AbbVie, Celgene - OpenPR
2. Evaluation of the Medicare Replacement Drug Demonstration - CMS
3. Generic Drug Industry Dynamics - Federal Trade Commission
4. Pentostatin Market Size and Projections - Market Research Intellect