ARRANON Drug Patent Profile

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

Arranon is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in ARRANON is nelarabine. There are two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the nelarabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arranon

A generic version of ARRANON was approved as nelarabine by ZYDUS PHARMS on November 17^th, 2021.

Summary for ARRANON

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	13
Patent Applications:	4,292
Drug Prices:	Drug price information for ARRANON
What excipients (inactive ingredients) are in ARRANON?	ARRANON excipients list
DailyMed Link:	ARRANON at DailyMed

See drug prices for ARRANON

Recent Clinical Trials for ARRANON

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 1/Phase 2
The Leukemia and Lymphoma Society	Phase 2

See all ARRANON clinical trials

Pharmacology for ARRANON

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

US Patents and Regulatory Information for ARRANON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	AP	RX	Yes	Yes

Expired US Patents for ARRANON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005

EU/EMA Drug Approvals for ARRANON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sandoz Pharmaceuticals d.d.	Atriance	nelarabine	EMEA/H/C/000752 Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens., , Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.,	Authorised	no	no	no	2007-08-22

International Patents for ARRANON

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

Country	Patent Number	Title	Estimated Expiration
China	1031233
European Patent Office	0294114	Composés antiviraux (Antiviral compounds)
Israel	86531	ANTIVIRAL 9-ARABINOSYL- 6-SUBSTITUTED PURINE DERIVATIVES, THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM

Supplementary Protection Certificates for ARRANON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0294114	2007C/063	Belgium		PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070823
0294114	C00294114/01	Switzerland		PRODUCT NAME: NELARABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57899 08.08.2007
0294114	07C0058	France		PRODUCT NAME: NELARABINE, OU L?UN DE SES DERIVES PHYSIOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/403/001 DU 20070822; REGISTRATION NO/DATE AT EEC: EU/1/07/403/001 DU 20070822

ARRANON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ARRANON (Nelarabine)

Market Overview

ARRANON, also known as nelarabine, is a chemotherapy medication primarily used for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). These cancers are rare and aggressive, particularly affecting children and young adults, making the availability of effective treatments like ARRANON crucial[1].

Drug Mechanism and Usage

ARRANON works by interfering with the DNA synthesis process, disrupting the ability of cancer cells to divide and multiply. It is administered intravenously and has been studied in various clinical trials to establish its efficacy and safety profile[5].

Market Size and Growth

The nelarabine market, which includes ARRANON, is projected to exhibit significant growth over the forecast period from 2022 to 2030, with a Compound Annual Growth Rate (CAGR) of 5.8%. This growth is driven by several factors, including the drug's efficacy in diminishing leukemia symptoms and the increasing awareness and diagnosis of these rare cancers[1][4].

Regional Market Analysis

North America

North America, particularly the United States, is a significant market for ARRANON. The region's advanced healthcare systems, strong focus on cancer research, and favorable regulatory frameworks contribute to the high demand for this medication. Major pharmaceutical companies operating in this region further enhance market growth[1].

Europe

Europe is another key market, with countries like Germany, France, and the United Kingdom having well-established healthcare systems and a commitment to providing access to innovative cancer treatments. The aging population and increasing cancer incidence rates in these countries also drive the demand for ARRANON[1].

Asia-Pacific

The Asia-Pacific region is emerging as a promising market due to its large population and increasing healthcare expenditures. As awareness of rare cancers and access to advanced treatments improve, the demand for ARRANON is expected to grow, although challenges such as affordability and regulatory hurdles may impact market growth in some countries[1].

Financial Trajectory

Pricing and Cost

The cost of ARRANON can be significant, with a supply of 50 milliliters of the intravenous solution costing around $861, depending on the pharmacy. Generic versions of nelarabine are also available, priced lower at around $682.70 for 50 milliliters. These costs highlight the financial burden on patients and healthcare systems, but also indicate the revenue potential for pharmaceutical companies[2].

Revenue Growth

The revenue growth of the nelarabine market is expected to be substantial, driven by the increasing demand for effective treatments for T-ALL and T-LBL. The market's expansion in developed regions like North America and Europe, coupled with growing awareness and healthcare infrastructure in emerging markets, contributes to this revenue growth[4].

Opportunities and Challenges

Expanding Indications and Combination Therapies

Ongoing research and clinical trials may lead to the expansion of ARRANON's approved indications beyond T-ALL and T-LBL. If the drug demonstrates efficacy in treating other types of cancers or hematological malignancies, it could open up new market opportunities and increase the patient population eligible for treatment. Combination therapies, where ARRANON is used with other cancer drugs, could also enhance its therapeutic potential and drive market growth[1].

Emerging Markets and Healthcare Expenditure

Improving healthcare infrastructure and increasing healthcare expenditure in emerging markets, particularly in Asia-Pacific and Latin America, present significant opportunities for market expansion. However, addressing affordability concerns and establishing robust distribution channels are critical challenges that pharmaceutical companies must navigate[1].

Regulatory and Clinical Landscape

Clinical Trials and Safety Profile

ARRANON has been studied in several clinical trials, including Phase I and Phase II trials involving over 450 patients. The safety profile of the drug includes common adverse reactions such as fatigue, gastrointestinal disorders, hematologic disorders, and nervous system disorders. Severe adverse reactions, including neurologic and hematologic toxicities, have also been reported[5].

Regulatory Frameworks

Pharmaceutical companies involved in the production and distribution of ARRANON must comply with stringent regulatory requirements. Favorable regulatory frameworks in regions like North America and Europe support the market's growth, while regulatory hurdles in some emerging markets can pose challenges[1].

Impact of External Factors

COVID-19 Pandemic

The COVID-19 pandemic has had a significant impact on various business aspects, including the pharmaceutical industry. However, the nelarabine market is expected to have an optimistic outlook over the forecast period, as the drug is considered a first-in-class medication for the treatment of leukemia. Despite supply chain disruptions and other challenges, the demand for effective cancer treatments has remained robust[4].

Key Takeaways

• The nelarabine market, including ARRANON, is poised for significant growth with a CAGR of 5.8% from 2022 to 2030.
• North America and Europe are key markets due to advanced healthcare systems and favorable regulatory frameworks.
• The Asia-Pacific region is emerging as a promising market driven by increasing healthcare expenditures and awareness of rare cancers.
• Expanding indications and combination therapies offer potential for market growth.
• Addressing affordability concerns and regulatory hurdles are critical in emerging markets.
• The COVID-19 pandemic has had a minimal negative impact on the market due to the drug's critical role in cancer treatment.

FAQs

Q: What is ARRANON used for?

A: ARRANON (nelarabine) is used for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).

Q: What is the projected growth rate of the nelarabine market?

A: The nelarabine market is projected to grow at a CAGR of 5.8% from 2022 to 2030.

Q: Which regions are significant markets for ARRANON?

A: North America, particularly the United States, and Europe are significant markets for ARRANON, with the Asia-Pacific region emerging as a promising market.

Q: What are the common adverse reactions associated with ARRANON?

A: Common adverse reactions include fatigue, gastrointestinal disorders, hematologic disorders, and nervous system disorders.

Q: How does the COVID-19 pandemic impact the nelarabine market?

A: Despite the challenges posed by the COVID-19 pandemic, the nelarabine market is expected to have an optimistic outlook due to the drug's critical role in cancer treatment.

Sources

1. PharmiWeb: Nelarabine Market Poised for Significant Growth, Projected to Expand during 2022-2030, Exhibiting a CAGR of 5.8%...
2. Drugs.com: Arranon Prices, Coupons, Copay Cards & Patient Assistance
3. NBER: The Local Influence of Pioneer Investigators on Technology Adoption
4. Reports and Data: Nelarabine Market Size, Growth | Industry Analysis, 2017-2027
5. Novartis: ARRANON® (nelarabine) injection, for intravenous use - Novartis