TASIGNA Drug Patent Profile

When do Tasigna patents expire, and what generic alternatives are available?

Tasigna is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and ninety patent family members in fifty-two countries.

The generic ingredient in TASIGNA is nilotinib hydrochloride. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Tasigna

Tasigna was eligible for patent challenges on October 29, 2011.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (nilotinib hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for TASIGNA

International Patents:	290
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	67
Patent Applications:	4,662
Drug Prices:	Drug price information for TASIGNA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TASIGNA
What excipients (inactive ingredients) are in TASIGNA?	TASIGNA excipients list
DailyMed Link:	TASIGNA at DailyMed

See drug prices for TASIGNA

Recent Clinical Trials for TASIGNA

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

Sponsor	Phase
Kartos Therapeutics, Inc.	Phase 1/Phase 2
Baylor College of Medicine	Phase 2
Ohio State University Comprehensive Cancer Center	Phase 1

See all TASIGNA clinical trials

Pharmacology for TASIGNA

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

Paragraph IV (Patent) Challenges for TASIGNA

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 TASIGNA

TASIGNA is protected by seven US patents and five FDA Regulatory Exclusivities.

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	022068-001	Oct 29, 2007		RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018		RX	Yes	No					Y

Expired US Patents for TASIGNA

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 TASIGNA

When does loss-of-exclusivity occur for TASIGNA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Finland

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Poland

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TASIGNA around the world.

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

TASIGNA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Tasigna

Introduction

Tasigna, developed by Novartis, is a pivotal treatment for chronic myeloid leukemia (CML), a type of blood cancer. The drug has been a significant player in the CML treatment market, but its financial trajectory is facing a critical juncture due to patent expirations and the entry of generics.

Tasigna: Mechanism and Approval

Tasigna (nilotinib) is a small molecule Bcr-Abl tyrosine kinase inhibitor that works by inhibiting the abnormal Bcr-Abl tyrosine kinase receptor signaling responsible for the proliferation of CML cells. The FDA granted approval for Tasigna in 2007, and it has since been included on the World Health Organization’s Model List of Essential Medicines for the treatment of adult and pediatric CML[1].

Current Market Performance

As of 2023, Tasigna has been a blockbuster drug with forecasted sales of $1.8 billion. However, the US market, which contributed 39% of the drug’s total historical revenue from 2008 to 2022, is set to lose its exclusive status in January 2024 due to patent expiry[1].

Impact of Patent Expiry

The impending US patent expiry, coupled with the prior EU patent loss in July 2023, is anticipated to result in a significant decline in Tasigna sales. According to GlobalData, sales are projected to plummet from $1.8 billion in 2023 to just $79 million by the end of 2029. This decline will reshape the CML drug market, introducing increased competition and lower prices, making the drug more accessible to a larger patient population[1].

Entry of Generics and Reformulations

The market is already seeing the entry of generics and reformulations. There are eight generics and nilotinib re-formulations on the market or in development worldwide, including three actively developed in the US: KeifeRx LLC’s KFRX01, Xspray Pharma AB’s HyNap-Nilo, and Nanocopoeia LLC’s nilotinib. This increased competition will further erode Tasigna’s market share[1].

Global Market Size and Forecast

Despite the decline in Tasigna’s sales due to patent expirations, the global market for CML treatments is expected to grow. According to Cognitive Market Research, the global Tasigna market size will be USD 9715.5 million in 2024 and is expected to expand to USD 24610.92 million by 2031, with a Compound Annual Growth Rate (CAGR) of 14.20% from 2024 to 2031. This growth is driven by increased awareness and diagnosis of CML, leading to higher treatment rates[4].

Geographical Trends

The Asia-Pacific region is expanding at the fastest CAGR in the Tasigna market, fueled by rising incidences of CML and improving healthcare infrastructure. Countries like India and China are experiencing significant advancements in oncology treatments, leading to increased accessibility and affordability of targeted therapies like Tasigna[4].

Novartis’ Strategic Response

Novartis is proactively addressing the patent expirations by seeking opportunities in other markets. In October 2022, the company entered into a historic voluntary licensing agreement with the Medicines Patent Pool, allowing select generics companies to manufacture Tasigna in eight countries and distribute it in 44 territories where patents are either pending or currently in force. This move aims to maintain market presence and ensure patient access to the drug in various regions[1].

Financial Performance of Novartis

Despite the challenges posed by Tasigna’s patent expiry, Novartis has delivered strong operational performance. In Q3 2024, the company reported a 10% increase in sales and a 20% increase in core operating income. The strong performance of other key growth drivers, such as Entresto, Kesimpta, Kisqali, Pluvicto, and Scemblix, has helped offset the impact of generic competition on Tasigna[2].

Market Drivers and Trends

The Tasigna market is driven by several factors, including increased awareness and early diagnosis of CML, the development of treatment guidelines endorsing Tasigna, and favorable government initiatives. However, the market is also constrained by factors such as the COVID-19 pandemic, which initially disrupted healthcare services but later facilitated remote consultations and heightened awareness of chronic diseases[4].

Competitive Landscape

The entry of generics and reformulations will significantly alter the competitive landscape of the CML drug market. Tasigna, which currently accounts for nearly two-thirds of sales in the CML market, will face increased competition, leading to lower prices and improved patient accessibility. This shift will benefit patients but pose significant challenges for Novartis in maintaining its market share[1].

Future Outlook

The future outlook for Tasigna is marked by a decline in sales due to patent expirations but also presents opportunities for Novartis to explore new markets and partnerships. The company’s proactive strategies, such as the voluntary licensing agreement, aim to ensure continued patient access to the drug while navigating the changing market dynamics.

Key Takeaways

• Patent Expiry Impact: Tasigna’s US patent expiry in January 2024 and prior EU patent loss will lead to a significant decline in sales.
• Generics and Reformulations: The entry of generics and reformulations will increase competition and lower prices, making the drug more accessible.
• Global Market Growth: Despite Tasigna’s decline, the global CML treatment market is expected to grow with a CAGR of 14.20% from 2024 to 2031.
• Novartis’ Strategies: Novartis is addressing patent expirations through voluntary licensing agreements and focusing on other growth drivers.
• Market Trends: Increased awareness, early diagnosis, and favorable government initiatives drive the market, while the COVID-19 pandemic has had mixed impacts.

FAQs

What is the primary mechanism of action of Tasigna?

Tasigna (nilotinib) works by inhibiting the abnormal Bcr-Abl tyrosine kinase receptor signaling responsible for the proliferation of CML cells.

How will the US patent expiry affect Tasigna sales?

The US patent expiry in January 2024 is expected to result in a significant decline in Tasigna sales, with projections indicating a drop from $1.8 billion in 2023 to $79 million by 2029.

What is the global market forecast for Tasigna?

The global Tasigna market is expected to grow from USD 9715.5 million in 2024 to USD 24610.92 million by 2031, with a CAGR of 14.20% from 2024 to 2031.

How is Novartis addressing the patent expirations?

Novartis has entered into a voluntary licensing agreement with the Medicines Patent Pool to allow select generics companies to manufacture and distribute Tasigna in various regions.

What are the key drivers of the Tasigna market?

The market is driven by increased awareness and early diagnosis of CML, development of treatment guidelines, and favorable government initiatives, among other factors.

Sources

1. Financial Express: "Novartis blockbuster drug Tasigna faces sales decline as US patent expiry looms"
2. Novartis: "Novartis continues strong momentum in Q3 with 10% sales growth and 20% core operating income growth"
3. Market Research Intellect: "Tasigna Market Size, Share, Outlook and Forecast"
4. Cognitive Market Research: "Tasigna Market Report 2024 (Global Edition)"
5. Novartis: "Novartis Financial Results Q4 2023 – English"