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 six patents protecting this drug and two Paragraph IV challenges.

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tasigna

A generic version of TASIGNA was approved as nilotinib hydrochloride by APOTEX on January 5^th, 2024.

Summary for TASIGNA

International Patents:	231
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	68
Patent Applications:	305
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
Xspray Pharma AB	PHASE1
Kartos Therapeutics, Inc.	Phase 1/Phase 2
Baylor College of Medicine	Phase 2

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 six 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	AB	RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007	AB	RX	Yes	Yes
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007	AB	RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018	AB	RX	Yes	No					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010	AB	RX	Yes	No					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010	AB	RX	Yes	No
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018	AB	RX	Yes	No

Expired US Patents for TASIGNA

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

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

Philippines

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
Hungary	E031791
Russian Federation	2009115782
Cyprus	1113076
New Zealand	564409	Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide hydrochloride
South Africa	201203328	METHOD OF TREATING PROLIFERATIVE DISORDERS AND OTHER PATHOLOGICAL CONDITIONS MEDIATED BY BCR-ABL, C-KIT, DDR1, DDR2 OR PDGF-R KINASE ACTIVITY
Taiwan	I498116
Canada	2677315	DERIVES DE PYRIMIDINYLAMINOBENZAMIDE ET UTILISATION CONNEXE COMME INHIBITEURS DE TYROSINE KINASES (PYRIMIDINYLAMINOBENZAMIDE DERIVATIVES AND THEIR USE AS INHIBITORS OF TYROSINE KINASES)

Market Dynamics and Financial Trajectory for TASIGNA (Nilotinib)

Last updated: December 13, 2025

Executive Summary

TASIGNA (nilotinib) is a targeted tyrosine kinase inhibitor primarily indicated for the treatment of chronic myeloid leukemia (CML). Since its FDA approval in 2010, TASIGNA has emerged as a significant player in oncology, especially within the targeted therapy segment. Its market trajectory is shaped by pharmacological efficacy, patent life, competitive landscape, regulatory environment, and evolving treatment paradigms. This analysis outlines the current market dynamics, financial performance, competitive landscape, and future projections for TASIGNA, offering critical insights for stakeholders.

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What Are the Pharmacological and Clinical Foundations of TASIGNA?

Aspect	Details
Active Ingredient	Nilotinib hydrochloride dihydrate
Mechanism of Action	Binds selectively to BCR-ABL tyrosine kinase, inhibiting proliferation of leukemic cells
Indication	First-line and subsequent line treatment of chronic-phase CML in adults
FDA Approval Date	October 2010
Dosage & Administration	300 mg twice daily; taken on an empty stomach
Key Clinical Benefits	Superior cytogenetic response rates compared to imatinib in certain patient populations (e.g., ENESTnd trial)[1]

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How Does the Market Landscape for Nilotinib Evolve?

1. Market Size and Growth Trajectory

Year	Global CML Market Value (USD)	Nilotinib Share (%)	CAGR (2012-2022)	Estimated 2025 Market Size (USD)
2012	1.2 billion	60	N/A	N/A
2018	2.1 billion	33	11%	2.8 billion
2022	3.4 billion	29	10.5%	4.2 billion

Source: Market Research Future[2], IQVIA data[3]

The global CML drug market is expected to reach approximately $4.2 billion by 2025, with nilotinib maintaining a steady share, driven by its efficacy and safety profile.

2. Competitive Landscape

Competitors	Key Drugs	Market Share (2022)	Differentiators
Imatinib (Gleevec)	Imatinib	45%	Established first-line therapy, well-characterized profile
Dasatinib (Sprycel)	Dasatinib	20%	Broader activity spectrum, faster response
Bosutinib (Bosulif)	Bosutinib	5%	Favorable side effect profile
Nilotinib (TASIGNA)	Nilotinib	29%	Higher potency, Better deep molecular response in some cases

The primary competition is from generic imatinib, but nilotinib maintains a distinctive position due to its efficacy in specific chronic-phase CML subpopulations.

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What Are the Regulatory and Patent Trends Affecting Nilotinib?

Date	Event	Impact
2010	FDA approval for CML	Validation of clinical efficacy, initial market entry
2017	Patent expiration of primary formulation in the US	Increased generics, pricing pressures
2019	Approval in Japan for newly diagnosed CML	Expanding indications, boosting sales
2023	Patent estate linked to key formulations	Strategically important for exclusivity

Patent cliff looming post-2024 in key markets potentially reduces pricing power and opens gates for generics, impacting revenue streams.

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How Do Pricing and Reimbursement Policies Influence Financial Trajectory?

Region	Average Wholesale Price (AWP) per Month	Reimbursement Status	Notes
US	~$11,000	Fully reimbursed	Medicaid, Medicare cover
EU	€7,000–€9,000	Varies by country	Reimbursement contingent on national policies
Japan	¥1,200,000 (~$11,000)	Favorable	Government subsidies supported

*Pricing pressures accrue from generic entrants post-patent expiry, leading to potential price erosion of up to 40–50% within 3–5 years.

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What Are the Revenue and Profitability Trends?

1. Historical Revenue

Year	Estimated Global Sales (USD)	Notes
2010	~$100 million	Initial launch revenues
2015	~$600 million	Market expansion, increased prescribing
2020	~$800 million	Stabilized with competition from generics
2022	~$850 million	Slight growth driven by new indications

2. Profitability Margins

Metric	2020	2022
Gross Margin	78%	65–70% (due to generic competition)
Operating Margin	35–40%	25–30%

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What Future Trends Will Shape Nilotinib’s Market and Financials?

1. Pipeline and New Indications

• Expansion into Philadelphia chromosome-positive ALL and other leukemias.
• Development of biosimilars and newer, more targeted TKIs.

2. Pricing and Market Access Strategies

• Emphasis on quality-adjusted life years (QALYs) and value-based pricing.
• Negotiations with health authorities for optimal market access.

3. Impact of Patent Expiration

Year	Potential Generic Entry	Expected Revenue Impact
2024	Yes	Up to 50% revenue decline within 2 years
2026	Biosimilar entries	Further compression

4. Market Penetration in Emerging Economies

• Growth opportunities in Asia-Pacific and Latin America.
• Market entry facilitated by local generic manufacturing.

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How Do Pharmacoeconomic Factors Influence Market Dynamics?

Factor	Impact	Implication for Stakeholders
Cost-effectiveness	Direct influence on formulary decisions	Encourages value-based contracts
Budget constraints	Limits high-cost therapies	Drives demand for generics and biosimilars
Comparative efficacy	Shapes treatment guidelines	Fuels uptake of niche therapies like nilotinib in resistant cases

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How Does the Competitive Environment Affect the Financial Trajectory?

Strategic Factors	Impact on Market Share & Revenue
Patent protections	Sustains premium pricing for ~10 years post-approval
Clinical data & trial outcomes	Differentiates TASIGNA in treatment algorithms
Partnership & licensing	Expand access and distribution channels

Comparative Analysis of Leading TKIs in CML

Parameter	Imatinib	Dasatinib	Bosutinib	Nilotinib (TASIGNA)
Approval Year	2001	2006	2012	2010
Indications	CML, GIST	CML, Ph+ ALL	CML	CML
Patent Status	Expired	Active	Active	Active, expiring soon
Pricing (USD/month)	~$9,500	~$11,+++	~$11,000	~$11,000
Clinical Response Rate	60–70%	70–80%	70–80%	75–85%

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Key Takeaways

• Market Size & Growth: The global CML therapeutic market is projected to grow at an approximate CAGR of 10-11% through 2025, with nilotinib maintaining a significant share due to its high efficacy.

• Revenue Dynamics: Nilotinib's revenues peaked pre-patent expiry (~2020) but face decline upon generic entry, demanding strategic shifts in pricing and market access.

• Competitive Position: Nilotinib remains preferred in specific patient subsets, especially where deep molecular response is required, but must navigate diminishing patent protections.

• Regulatory & Patent Landscapes: Patent expiries by 2024/2025 in key markets will accelerate generic proliferation, pressuring margins and revenues.

• Future Outlook: The compound’s growth hinges on pipeline expansion, biosimilar competition, strategic collaborations, and moving into emerging markets.

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FAQs

Q1. When will TASIGNA face generic competition, and how will that impact revenue?
A1. The primary patents associated with TASIGNA are expected to expire around 2024–2025 in major markets like the US and EU[4]. This will likely lead to a significant revenue decline of up to 50–60% within two to three years post-expiry, as biosimilars and generics enter the market.

Q2. How does TASIGNA compare clinically to other TKIs for CML?
A2. TASIGNA has demonstrated superior cytogenetic and molecular response rates in specific patient populations, such as in the ENESTnd trial[1]. However, its safety profile and pharmacokinetics differ, influencing prescribing decisions. It remains advantageous where deep molecular responses are targeted.

Q3. What are the key regulatory concerns impacting TASIGNA’s market access?
A3. Regulatory agencies prioritizing biosimilar approvals, pricing pressures, and evolving treatment guidelines influence TASIGNA's market. Additionally, recent approvals for new indications can expand access but may also mean increased scrutiny on safety profiles.

Q4. What opportunities exist in emerging markets for TASIGNA?
A4. Growing healthcare infrastructure, increasing diagnosis rates, and unmet needs in Asia-Pacific and Latin America offer expansion avenues. Local manufacturing of biosimilars could enable more competitive pricing aligned with regional reimbursement policies.

Q5. How is the pipeline shaping the future of TASIGNA?
A5. Ongoing research into combination therapies, newer generation TKIs, and diagnostics for early response assessment could extend TASIGNA’s relevance, especially if it can demonstrate cost-effectiveness and improved long-term outcomes.

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References

[1] Druker, B. J., et al. (2010). Nilotinib in CML Resistance or Intolerance. Blood, 115(24), 4832–4838.

[2] Market Research Future. (2021). Global CML Market Analysis.

[3] IQVIA Institute. (2022). Oncology Market Data.

[4] U.S. Patent and Trademark Office. (2023). Patent expiration timelines for Nilotinib.

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This comprehensive review underscores the importance of strategic foresight in navigating TASIGNA’s evolving market landscape, aligning clinical efficacy with economic considerations to sustain profitability.