Nilotinib hydrochloride - Generic Drug Details

What are the generic sources for nilotinib hydrochloride and what is the scope of freedom to operate?

Nilotinib hydrochloride is the generic ingredient in two branded drugs marketed by Apotex and Novartis, and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nilotinib hydrochloride has two hundred and ninety patent family members in fifty-two countries.

There are seven drug master file entries for nilotinib hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for nilotinib hydrochloride

International Patents:	290
US Patents:	7
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	200
Patent Applications:	248
DailyMed Link:	nilotinib hydrochloride at DailyMed

Recent Clinical Trials for nilotinib hydrochloride

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

Sponsor	Phase
H. Jean Khoury Cure CML Consortium	Phase 2
Sun Pharmaceuticals Industries Limited	Phase 3
KeifeRx, LLC	Phase 3

See all nilotinib hydrochloride clinical trials

Generic filers with tentative approvals for NILOTINIB HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		150MG	CAPSULE
		50MG	CAPSULE
		200MG	CAPSULE

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for nilotinib hydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for nilotinib hydrochloride

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for NILOTINIB HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TASIGNA	Capsules	nilotinib hydrochloride	50 mg	022068	1	2019-10-17
TASIGNA	Capsules	nilotinib hydrochloride	150 mg and 200 mg	022068	1	2013-11-08

US Patents and Regulatory Information for nilotinib hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018		RX	Yes	No
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018		RX	Yes	No					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010		RX	Yes	No					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018		RX	Yes	No
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010		RX	Yes	No
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010		RX	Yes	No					Y

Expired US Patents for nilotinib hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007

International Patents for nilotinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
Morocco	29626	FORMES CRISTALLINES DE 4-METHYL-N-[3-(4-METHYL -IMIDAZOL-1-YL)-5-TRIFLUROMETHYL-PHENYL]-3-(4- PYRIDIN-3-YL-PYRIMIDIN-2-YLAMINO)-BENZAMIDE
Montenegro	02413	POSTUPAK LEČENJA PROLIFERATIVNIH OBOLJENJA I DRUGIH PATOLOŠKIH STANJA POSREDOVANIH AKTIVNOSCU BCR-ABL, C-KIT, DDR1, DDR2 ILI PDGF-R KINAZE (METHOD OF TREATING PROLIFERATIVE DISORDERS AND OTHER PATHOLOGICAL CONDITIONS MEDIATED BY BCR-ABL, C-KIT, DDR1, DDR2 OR PDGF-R KINASE ACTIVITY)
Slovenia	1910336
European Patent Office	2284167	formes crystallines de 4-methyl-n-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide (crystalline forms of 4-methyl-n-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide)
South Korea	101598747
San Marino	P200800011	Forme cristalline di 4-metil-n-[3-(4-metil-imidazol-1-il)-5-trifluorometil-fenil]-3-(4-piridin-3-il-pirimidin-2-ilammino)-benzammide
China	1324022

Nilotinib hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nilotinib Hydrochloride

Introduction

Nilotinib hydrochloride, a second-generation tyrosine kinase inhibitor (TKI), has been a cornerstone in the treatment of chronic myeloid leukemia (CML) and is increasingly being explored for other medical applications. Here, we delve into the market dynamics and financial trajectory of nilotinib hydrochloride, highlighting key factors driving its growth and future projections.

Market Size and Projections

The nilotinib hydrochloride market was valued at USD 1.05 billion in 2023 and is anticipated to reach USD 1.79 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1][5].

Key Drivers of Market Growth

Several factors are propelling the growth of the nilotinib hydrochloride market:

Increasing Incidence of Chronic Myeloid Leukemia (CML)

The rising incidence of CML, particularly in older populations, is a significant driver. Nilotinib's efficacy in treating CML has made it a preferred choice among oncologists[1][5].

Advancements in Targeted Cancer Therapy

The growing understanding and adoption of targeted cancer therapies have boosted the demand for nilotinib. Its superior safety and efficacy profile compared to first-generation TKIs further enhance its market position[1][5].

Pharmaceutical Research and Development

Continuous research and development in pharmaceuticals, including ongoing clinical trials to explore nilotinib's potential in treating other diseases, are driving market expansion. For instance, nilotinib is being investigated as a potential disease-modifying therapy in Parkinson's disease[2][5].

Favorable Regulatory Environment

Positive regulatory approvals and favorable government policies, especially in developing nations, are facilitating greater access to nilotinib and contributing to market growth[1][5].

Market Segmentation

The nilotinib hydrochloride market is segmented based on several criteria:

By Type

The market is segmented into capsules, tablets, and powder forms. Each form has its own market share and growth prospects, with tablets being a dominant form due to ease of administration and patient compliance[1].

By Application

The primary applications include CML treatment, oncology, and pharmaceutical research. CML treatment remains the largest segment due to the drug's proven efficacy in this area[1][4].

By Geography

North America and Europe currently dominate the market due to their advanced healthcare systems and higher incidence of CML. However, emerging economies in Asia-Pacific and other regions are expected to show significant growth as healthcare infrastructure improves[1][4].

Competitive Landscape

The nilotinib hydrochloride market is characterized by the presence of several key players:

Major Players

Companies such as Novartis International AG, Sun Pharmaceutical Industries Ltd., Natco Pharma Limited, and others are prominent in the market. These companies are involved in various strategies including product development, partnerships, and market expansion to maintain their market share[1][4].

Financial Performance and Projections

The financial trajectory of nilotinib hydrochloride is robust, driven by increasing demand and expanding applications:

Revenue Growth

The market is expected to grow from USD 1.05 billion in 2023 to USD 1.79 billion by 2031, reflecting a steady increase in revenue. This growth is attributed to the increasing adoption of nilotinib in CML treatment and its potential use in other diseases[1][5].

Regional Contributions

North America and Europe are the largest contributors to the market revenue, but the Asia-Pacific region is expected to grow at a faster rate due to improving healthcare infrastructure and increasing awareness of targeted cancer therapies[1][4].

Safety and Efficacy

Clinical trials have demonstrated the safety and efficacy of nilotinib hydrochloride:

Clinical Trials

A Phase 2 trial on the use of nilotinib in Parkinson's disease showed that doses of 150 mg and 300 mg were reasonably safe and altered exploratory cerebrospinal fluid biomarkers, indicating potential as a disease-modifying therapy[2].

Side Effects

Common side effects include skin and subcutaneous disorders, gastrointestinal symptoms, and cardiac issues, but these are generally manageable and less frequent compared to first-generation TKIs[2][3].

Regulatory Approvals

Nilotinib hydrochloride has received regulatory approvals in various regions:

European Medicines Agency (EMA)

Tasigna (nilotinib) is approved by the EMA for the treatment of adult and pediatric patients with newly diagnosed Philadelphia chromosome-positive CML[3].

Future Outlook

The future outlook for nilotinib hydrochloride is promising, driven by several factors:

Expanding Applications

Ongoing research into its potential use in diseases other than CML, such as Parkinson's disease, could significantly expand its market[2].

Personalized Medicine

Advancements in personalized medicine and continuous clinical trials will further fuel the market growth of nilotinib hydrochloride[5].

Emerging Markets

Improving healthcare infrastructure and increasing healthcare spending in emerging economies will provide new growth opportunities for the drug[1][4].

Key Takeaways

• The nilotinib hydrochloride market is expected to grow from USD 1.05 billion in 2023 to USD 1.79 billion by 2031.
• The market is driven by the increasing incidence of CML, advancements in targeted cancer therapy, and favorable regulatory environments.
• North America and Europe dominate the market, but Asia-Pacific is expected to show significant growth.
• Key players include Novartis International AG, Sun Pharmaceutical Industries Ltd., and Natco Pharma Limited.
• Ongoing research into new applications and advancements in personalized medicine will further drive market growth.

FAQs

What is the current market size of nilotinib hydrochloride?

The nilotinib hydrochloride market was valued at USD 1.05 billion in 2023[1].

What is the expected growth rate of the nilotinib hydrochloride market?

The market is expected to grow at a CAGR of 5% from 2024 to 2031[1].

What are the primary applications of nilotinib hydrochloride?

The primary applications include CML treatment, oncology, and pharmaceutical research[1][4].

Which regions dominate the nilotinib hydrochloride market?

North America and Europe currently dominate the market, but the Asia-Pacific region is expected to grow significantly[1][4].

What are the potential new applications of nilotinib hydrochloride being explored?

Nilotinib is being investigated as a potential disease-modifying therapy in Parkinson's disease[2].

Sources

1. Market Research Intellect, "Global Nilotinib Hydrochloride Market Size and Projections", November 2024.
2. JAMA Network, "Nilotinib Effects on Safety, Tolerability, and Potential Biomarkers in Parkinson Disease", December 16, 2019.
3. European Medicines Agency, "Tasigna, INN-nilotinib - EPAR - Product Information".
4. Market Research Intellect, "Nilotinib Drug Sales Market Size, Share, Outlook, and Forecast", December 2024.
5. Market Research Intellect, "Nilotinib Market Size, Share | Growth Report, 2031".