FLUDARABINE PHOSPHATE - Generic Drug Details

What are the generic drug sources for fludarabine phosphate and what is the scope of patent protection?

Fludarabine phosphate is the generic ingredient in three branded drugs marketed by Genzyme Corp, Actavis Llc, Actavis Totowa, Areva Pharms, Fresenius Kabi Usa, Hikma, Hospira, Rising, Sagent Pharms Inc, Sandoz, and Sanofi Aventis Us, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for fludarabine phosphate. Five suppliers are listed for this compound.

Summary for FLUDARABINE PHOSPHATE

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	13
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	484
Patent Applications:	2,293
What excipients (inactive ingredients) are in FLUDARABINE PHOSPHATE?	FLUDARABINE PHOSPHATE excipients list
DailyMed Link:	FLUDARABINE PHOSPHATE at DailyMed

Recent Clinical Trials for FLUDARABINE PHOSPHATE

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

Sponsor	Phase
Fred Hutchinson Cancer Center	Phase 2
National Cord Blood Network	Phase 2
University Cancer Research Fund at Lineberger Comprehensive Cancer Center	Phase 1/Phase 2

See all FLUDARABINE PHOSPHATE clinical trials

Pharmacology for FLUDARABINE PHOSPHATE

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

Anatomical Therapeutic Chemical (ATC) Classes for FLUDARABINE PHOSPHATE

L01BB	Purine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for FLUDARABINE PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Areva Pharms	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	090724-001	Sep 27, 2010	AP1	RX	No	No
Sanofi Aventis Us	OFORTA	fludarabine phosphate	TABLET;ORAL	022273-001	Dec 18, 2008		DISCN	No	No
Fresenius Kabi Usa	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	078393-001	Oct 15, 2007	AP1	RX	No	No
Genzyme Corp	FLUDARA	fludarabine phosphate	INJECTABLE;INJECTION	020038-001	Apr 18, 1991		DISCN	Yes	No
Hikma	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	076349-001	Aug 28, 2003	AP	RX	No	No

Expired US Patents for FLUDARABINE PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme Corp	FLUDARA	fludarabine phosphate	INJECTABLE;INJECTION	020038-001	Apr 18, 1991
Sanofi Aventis Us	OFORTA	fludarabine phosphate	TABLET;ORAL	022273-001	Dec 18, 2008
Sanofi Aventis Us	OFORTA	fludarabine phosphate	TABLET;ORAL	022273-001	Dec 18, 2008

FLUDARABINE PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Fludarabine Phosphate

Introduction to Fludarabine Phosphate

Fludarabine phosphate, a chemotherapeutic agent, is widely used in the treatment of various types of leukemia, particularly B-cell chronic lymphocytic leukemia (CLL). Here, we delve into the market dynamics and financial trajectory of this crucial oncology drug.

Market Size and Growth

The global fludarabine phosphate market is experiencing significant growth. As of the latest reports, the market size is projected to expand substantially over the next few years. For instance, in North America, the market is expected to reach USD 1405.68 million by 2024, growing at a compound annual growth rate (CAGR)[3].

Globally, the market is segmented by application (hospital pharmacies, retail pharmacies, and online pharmacies) and product type (original drug and generic drug). These segments are further categorized by geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[1].

Key Drivers of Market Growth

Several factors are driving the growth of the fludarabine phosphate market:

Increasing Incidence of Leukemia

The rising incidence of leukemia, particularly CLL, is a major driver. As the global population ages and the prevalence of cancer increases, the demand for effective treatments like fludarabine phosphate is on the rise.

Advancements in Drug Formulations

Recent updates in drug formulations and labeling, such as those approved by the FDA under Project Renewal, enhance the drug's efficacy and safety profile. For example, the revised labeling includes new and revised indications for the treatment of adults with B-cell CLL, which can attract more patients and healthcare providers[4].

Generic and Branded Market Competition

The presence of both original and generic versions of fludarabine phosphate contributes to market growth. Generic versions, such as those distributed by Lannett Company, Inc., offer cost-effective alternatives, increasing accessibility and driving sales[2].

Financial Performance

Current Market Value

The U.S. sales of fludarabine phosphate for injection, USP, 50 mg/2mL, were approximately $4.9 million for the 12 months ended March 2022. However, due to recent market disruptions, the current market value is believed to be higher[2].

Revenue Projections

The global market is expected to grow significantly over the forecast period of 2024-2031. The market size is measured in USD million, with substantial growth rates anticipated across various segments[1].

Market Challenges and Opportunities

Market Shortages

Despite the growth, the market has faced recent shortages of fludarabine phosphate, which can impact patient access and overall market performance. Companies like Lannett are working to address these shortages by securing exclusive distribution agreements and planning to commence marketing as soon as possible[2].

Regulatory Updates

The FDA's Project Renewal initiative, which updates labeling information for older oncology drugs, presents an opportunity for fludarabine phosphate to gain new indications and improved dosing regimens. This can enhance its market position and attract more prescriptions[4].

Competitive Landscape

The fludarabine phosphate market is competitive, with several key players involved:

• Hisun Pharma
• Pude Pharma
• Jinrui Pharma
• CISEN
• LUMMY
• Aosaikang Pharma
• SANOFI
• Actavis
• Salius Pharma
• Sagent Pharma
• Bayer
• Berlex Healthcare
• TEVA
• Lannett Company, Inc.

These companies are engaged in developing, manufacturing, and distributing fludarabine phosphate, both in its original and generic forms[1].

Distribution and Marketing Strategies

Companies are adopting various strategies to enhance distribution and marketing:

• Exclusive Distribution Agreements: Lannett Company, Inc. has entered into an agreement with Areva Pharmaceuticals to be the exclusive U.S. distributor of fludarabine phosphate for injection, USP, 50 mg/2mL. This agreement includes providing sales, marketing, and distribution support[2].

• Strategic Partnerships: Collaborations between pharmaceutical companies and healthcare providers are crucial for ensuring the drug's availability and promoting its use.

Geographical Market Analysis

The market is geographically diverse, with significant growth anticipated in regions such as North America, Europe, and Asia-Pacific. Each region presents unique opportunities and challenges based on local healthcare systems, regulatory environments, and patient demographics[1].

Future Outlook

The future of the fludarabine phosphate market looks promising, driven by increasing demand for cancer treatments, advancements in drug formulations, and strategic market initiatives.

"Fludarabine Phosphate for injection represents a continuation of our push to new dosage forms with attractive market opportunities," said Tim Crew, chief executive officer of Lannett[2].

Key Takeaways

• Growing Market Size: The global fludarabine phosphate market is expected to grow significantly over the next few years.
• Increasing Demand: Rising incidence of leukemia and advancements in drug formulations drive market growth.
• Generic Competition: The presence of generic versions increases accessibility and drives sales.
• Regulatory Updates: FDA's Project Renewal initiative enhances the drug's efficacy and safety profile.
• Competitive Landscape: Multiple key players are involved in the development, manufacturing, and distribution of fludarabine phosphate.

FAQs

1. What is fludarabine phosphate used for? Fludarabine phosphate is used primarily in the treatment of B-cell chronic lymphocytic leukemia (CLL) and other types of leukemia.

2. What are the recent updates in fludarabine phosphate labeling? The FDA has approved updated drug labeling for fludarabine phosphate under Project Renewal, including new and revised indications and updated dosage regimens[4].

3. Which companies are key players in the fludarabine phosphate market? Key players include Hisun Pharma, Pude Pharma, Jinrui Pharma, CISEN, LUMMY, Aosaikang Pharma, SANOFI, Actavis, Salius Pharma, Sagent Pharma, Bayer, Berlex Healthcare, TEVA, and Lannett Company, Inc.[1].

4. What are the challenges faced by the fludarabine phosphate market? The market has faced recent shortages, which can impact patient access and overall market performance[2].

5. What is the projected market size of fludarabine phosphate in North America by 2024? The market size in North America is expected to reach USD 1405.68 million by 2024[3].

Sources

1. Market Research Intellect - Global Fludarabine Phosphate (CAS 75607-67-9) Market Trend And Forecast[1].
2. PR Newswire - LANNETT ENTERS AGREEMENT TO BE EXCLUSIVE U.S. DISTRIBUTOR OF FLUDARABINE PHOSPHATE FOR INJECTION, USP[2].
3. Cognitive Market Research - North America Fludarabine Phosphate CAS 75607 67 9 Market Report[3].
4. FDA - FDA approves updated drug labeling for fludarabine phosphate[4].