NELARABINE - Generic Drug Details

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

Nelarabine is the generic ingredient in two branded drugs marketed by Sandoz, Alembic, Amneal, Dr Reddys, Gland Pharma Ltd, Meitheal, MSN, Nexus, Shorla, Xgen Pharms, and Zydus Pharms, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for nelarabine. Thirteen suppliers are listed for this compound.

Summary for NELARABINE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	30
Patent Applications:	5,608
What excipients (inactive ingredients) are in NELARABINE?	NELARABINE excipients list
DailyMed Link:	NELARABINE at DailyMed

Recent Clinical Trials for NELARABINE

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

Sponsor	Phase
CellSight Technologies, Inc.	Phase 2
University of Iowa Hospitals & Clinics	Phase 2
Nanjing Children's Hospital	Phase 3

See all NELARABINE clinical trials

Pharmacology for NELARABINE

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

Anatomical Therapeutic Chemical (ATC) Classes for NELARABINE

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

US Patents and Regulatory Information for NELARABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meitheal	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216038-001	Jan 10, 2023	AP	RX	No	No
Alembic	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	218554-001	Aug 1, 2024	AP	RX	No	No
Amneal	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216346-001	Apr 4, 2023	AP	RX	No	No
Xgen Pharms	NELARABINE	nelarabine	INJECTABLE;INTRAVENOUS	216510-001	Sep 5, 2024	AP	RX	No	No

Expired US Patents for NELARABINE

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
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005

EU/EMA Drug Approvals for NELARABINE

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

NELARABINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nelarabine

Introduction

Nelarabine, a purine analog with T-cell specific action, has been a significant player in the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (LBL) since its approval in 2005. Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Regulatory Status

Nelarabine was first approved globally in October 2005, with the United States being the first country to grant approval. It underwent a priority review process and received accelerated approval, indicating its potential to significantly improve the treatment of serious conditions. Additionally, it was designated as an orphan drug, reflecting its focus on rare diseases[4].

Market Share and Clinical Utility

The market share of nelarabine may be underestimated, particularly in the context of its addition to first-line treatments. The Children’s Oncology Group (COG) AALL0434 study demonstrated that nelarabine, when added to the augmented Berlin-Frankfurt-Münster (aBFM) multidrug chemotherapy, showed a clinically meaningful and statistically significant benefit in improving disease-free survival (DFS) for newly diagnosed pediatric, adolescent, and young adult patients with T-ALL[1].

Cost-Effectiveness Analysis

Incorporating nelarabine into the aBFM protocol has been shown to be cost-effective. The incremental cost-effectiveness ratio (ICER) for nelarabine plus standard of care (SOC) versus SOC alone was estimated to be around $26,362 per quality-adjusted life-year (QALY) gained. This is well within the willingness-to-pay threshold of $50,000 per QALY, making it a viable option for public and private payers[1][3].

Financial Impact

The addition of nelarabine to the aBFM protocol increases costs by approximately $51,670 per patient in Canadian dollars. However, this increase is offset by the gain of 1.97 more QALYs, resulting in an ICER of $26,184 per QALY. The majority of these costs and benefits are accrued within the first 11 years post-diagnosis, primarily while patients are in the relapse-free health state[3].

Patient and Clinical Expert Feedback

Surveys and clinical expert feedback indicate that nelarabine is well-tolerated and has minimal side effects compared to other treatments for ALL. Patients and experts hope for treatments that offer improved prognosis, fewer and less severe long-term adverse effects, and better treatment logistics. Direct experience with nelarabine has been positive, with respondents noting its beneficial impact on their treatment[1].

Efficacy in Relapsed/Refractory Cases

In relapsed or refractory T-ALL/LBL, nelarabine has shown impressive single-drug activity. A phase 2 study in adults demonstrated that 36% of patients achieved complete remission after one or two cycles, with 80% of these patients being transferred to stem cell transplantation (SCT). The overall survival at one year was 24%, and relapse-free survival at three years was 37% post-SCT[2].

Neurologic Toxicities

One of the significant side effects of nelarabine is neurologic toxicity, which can range from grade I to grade IV. However, these toxicities are generally manageable, and the drug is well-tolerated even in heavily pretreated patients[2][5].

Development and Commercialization

Nelarabine was developed and commercialized by GSK Plc, a multinational pharmaceutical company. The drug's success in clinical trials and its regulatory approvals underscore its safety and efficacy in treating T-ALL and LBL[4].

Current Market Position

Given its approval and the positive outcomes from clinical trials, nelarabine holds a significant position in the treatment landscape for T-ALL and LBL. Its cost-effectiveness and clinical benefits make it a preferred option for both newly diagnosed and relapsed/refractory cases.

Future Perspectives

The use of nelarabine in earlier stages of relapse, in front-line therapy, and in combination with other treatments is being explored. These potential applications could further enhance its market position and financial trajectory[2].

Key Takeaways

• Cost-Effectiveness: Nelarabine is cost-effective when added to the aBFM protocol, with an ICER of around $26,000 per QALY gained.
• Clinical Utility: It demonstrates significant benefits in DFS and has a positive impact on patients with T-ALL.
• Regulatory Status: Approved globally since 2005, with priority review and accelerated approval.
• Side Effects: Manageable neurologic toxicities are a notable side effect.
• Market Position: Holds a significant position in the treatment of T-ALL and LBL.

FAQs

Q: What is nelarabine used for? A: Nelarabine is used for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (LBL), particularly in relapsed or refractory cases.

Q: How was nelarabine approved? A: Nelarabine underwent a priority review process and received accelerated approval, and it was designated as an orphan drug.

Q: What are the key side effects of nelarabine? A: The major side effect is neurologic toxicity, which can range from grade I to grade IV, but is generally manageable.

Q: Is nelarabine cost-effective? A: Yes, incorporating nelarabine into the aBFM protocol is cost-effective, with an ICER of around $26,000 per QALY gained.

Q: Who developed and commercialized nelarabine? A: Nelarabine was developed and commercialized by GSK Plc.

Cited Sources

1. Pharmacoeconomic Review - Nelarabine (Atriance) - NCBI Bookshelf
2. High single-drug activity of nelarabine in relapsed T-lymphoblastic ... - ASH Publications
3. Cost-utility of nelarabine for the first-line treatment of newly ... - PubMed
4. Nelarabine: Detailed Review of its Transformative R&D Success - Synapse
5. Nelarabine: when and how to use in the treatment of T-cell acute ... - ASH Publications