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Last Updated: July 14, 2025

TAFINLAR Drug Patent Profile


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Which patents cover Tafinlar, and what generic alternatives are available?

Tafinlar is a drug marketed by Novartis and is included in two NDAs. There are eight patents protecting this drug.

This drug has one hundred and seventy-four patent family members in forty-five countries.

The generic ingredient in TAFINLAR is dabrafenib mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dabrafenib mesylate profile page.

DrugPatentWatch® Generic Entry Outlook for Tafinlar

Tafinlar was eligible for patent challenges on May 29, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 15, 2031. This may change due to patent challenges or generic licensing.

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.

Indicators of Generic Entry

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Drug patent expirations by year for TAFINLAR
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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TAFINLAR
Generic Entry Dates for TAFINLAR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for TAFINLAR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, FOR SUSPENSION;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TAFINLAR

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

SponsorPhase
Eva Marie Erfurth, MD, PhDPhase 2
Peter MacCallum Cancer Centre, AustraliaPhase 2
Austin HealthPhase 2

See all TAFINLAR clinical trials

US Patents and Regulatory Information for TAFINLAR

TAFINLAR is protected by eight US patents and eleven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAFINLAR is ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TAFINLAR dabrafenib mesylate TABLET, FOR SUSPENSION;ORAL 217514-001 Mar 16, 2023 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for TAFINLAR

When does loss-of-exclusivity occur for TAFINLAR?

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

Australia

Patent: 10306653
Patent: Combination
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 2012008854
Patent: combinação, kit de combinação, uso de uma combinação, composição farmacêutica, e, método para tratar câncer em um ser humano
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 75803
Patent: COMBINAISON (COMBINATION)
Estimated Expiration: ⤷  Try for Free

Chile

Patent: 12000964
Patent: Combinacion de n-{3-[3-ciclopropil-5-(2-fluoro-4-yodo-fenilamino)-6,8-dimetil-2,4,7-trioxo-3,4,6,7-tetrahidro-2h-pirido-[4,3d]-pirimidin-1-il]fenil}-acetamida y n-{3-[5-(2-amino-4-pirimidinil)-2-(1,1-dimetil-etil)-1,3-tiazol-4-il]-2-fluoro-fenil}-2,6-difluoro-bencen-sulfonamida; kit; composicion; uso para tratar cancer.
Estimated Expiration: ⤷  Try for Free

China

Patent: 2655753
Patent: Combination
Estimated Expiration: ⤷  Try for Free

Colombia

Patent: 31498
Patent: COMBINACIÓN QUE COMPRENDE UN INHIBIDORDE MEK Y UN INHIBIDOR DE B- RAF úTIL EN EL TRATAMIENTO DE TRASTORNOS HIPERPROLIFERATIVOS
Estimated Expiration: ⤷  Try for Free

Costa Rica

Patent: 120155
Patent: COMBINACION
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0191617
Estimated Expiration: ⤷  Try for Free

Patent: 0221304
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 22013
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 88033
Estimated Expiration: ⤷  Try for Free

Patent: 60498
Estimated Expiration: ⤷  Try for Free

Dominican Republic

Patent: 012000091
Patent: COMBINACIONES UTILES PARA EL TRATAMIENTO DE CANCER EN UN MAMIFERO
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 0589
Patent: ПРОТИВОРАКОВАЯ КОМБИНАЦИЯ (ANTICANCER COMBINATION)
Estimated Expiration: ⤷  Try for Free

Patent: 1290149
Patent: КОМБИНАЦИЯ
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 88033
Patent: Combination comprenant un inhibiteur de MEK et un inhibiteur de B-raf (Combination comprising an MEK inhibitor and a B-raf inhibitor)
Estimated Expiration: ⤷  Try for Free

Patent: 60498
Patent: COMBINATION COMPRENANT UN INHIBITEUR DE MEK ET UN INHIBITEUR DE B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 59217
Patent: COMBINATION COMPRENANT UN INHIBITEUR DE MEK ET UN INHIBITEUR DE B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 46139
Estimated Expiration: ⤷  Try for Free

Patent: 60206
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 9073
Patent: צירוף תרופתי לטיפול בסרטן (Pharmaceutical combination for treatment of cancer)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 18929
Estimated Expiration: ⤷  Try for Free

Patent: 13508294
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 88033
Estimated Expiration: ⤷  Try for Free

Patent: 60498
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 4759
Patent: PHARMACEUTICAL COMBINATION OF MEK INIDBITOR AND B-RAF INHIBITORS
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 12004413
Patent: COMBINACION. (COMBINATION.)
Estimated Expiration: ⤷  Try for Free

Montenegro

Patent: 497
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Morocco

Patent: 746
Patent: التركيبة
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 8913
Patent: Combination of an MEK inhibitor and a B-Raf inhibitor for the treatment of cancer
Estimated Expiration: ⤷  Try for Free

Peru

Patent: 121093
Patent: COMBINACION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE MEK Y UN INHIBIDOR DE B-RAF
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 88033
Estimated Expiration: ⤷  Try for Free

Patent: 60498
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 88033
Estimated Expiration: ⤷  Try for Free

Patent: 60498
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 181
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 702
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 88033
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 1202612
Patent: COMBINATION
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1729116
Estimated Expiration: ⤷  Try for Free

Patent: 120104547
Patent: COMBINATION
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 45479
Estimated Expiration: ⤷  Try for Free

Patent: 30157
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 5064
Patent: КОМБИНАЦИЯ, СОДЕРЖАЩАЯ ИНГИБИТОР МЭК И ИНГИБИТОР В-Raf;КОМБІНАЦІЯ, ЩО МІСТИТЬ ІНГІБІТОР МЕК ТА ІНГІБІТОР В-Raf (COMBINATION COMPRISING THE MEK INHIBITOR AND B-Raf INHIBITOR)
Estimated Expiration: ⤷  Try for Free

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 TAFINLAR around the world.

Country Patent Number Title Estimated Expiration
South Korea 102134585 ⤷  Try for Free
European Patent Office 2298768 Dérivés 5-amino-2,4,7-trioxo-3,4,7,8-tetrahydro-2H-pyrido[2,3-d]pyrimidine et composés similaires pour le traitement de cancer (5-amino-2,4,7-trioxo-3,4,7,8-tetrahydro-2H-pyrido[2,3-d]pyrimidine derivatives and related compounds for the treatment of cancer) ⤷  Try for Free
Montenegro 03497 KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR) ⤷  Try for Free
Slovenia 2282636 ⤷  Try for Free
Malaysia 174759 PHARMACEUTICAL COMBINATION OF MEK INIDBITOR AND B-RAF INHIBITORS ⤷  Try for Free
Lithuania 3560498 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAFINLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 300701 Netherlands ⤷  Try for Free PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702
1761528 CA 2014 00055 Denmark ⤷  Try for Free PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630
1761528 PA2014039 Lithuania ⤷  Try for Free PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 CR 2014 00055 Denmark ⤷  Try for Free PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140702
1761528 205 5032-2014 Slovakia ⤷  Try for Free PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702
1761528 PA2014039,C1761528 Lithuania ⤷  Try for Free PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for TAFINLAR

Last updated: July 3, 2025

Introduction

In the competitive landscape of oncology pharmaceuticals, TAFINLAR stands out as a targeted therapy for cancers driven by BRAF mutations. Developed by Novartis, this drug—generically known as dabrafenib—has transformed treatment for melanoma and other cancers since its FDA approval in 2013. As business professionals navigate investment decisions, understanding TAFINLAR's market dynamics and financial trajectory provides critical insights into its growth potential and risks. This analysis delves into current trends, revenue streams, and future projections, drawing on real-world data to guide strategic planning.

Overview of TAFINLAR

TAFINLAR, or dabrafenib, inhibits the BRAF protein in cancer cells, effectively slowing tumor growth in patients with BRAF V600 mutation-positive melanoma, non-small cell lung cancer, and other solid tumors. Novartis markets it as a cornerstone of precision medicine, often combined with MEK inhibitors like trametinib for enhanced efficacy. Since its launch, TAFINLAR has captured significant market share in the BRAF inhibitor segment, with global sales exceeding $1 billion annually in recent years. Its appeal lies in improved patient outcomes, including extended progression-free survival, which drives demand in both first-line and adjuvant therapies.

The drug's commercial success stems from its alignment with personalized medicine trends. In 2023, TAFINLAR generated approximately $1.2 billion in revenue for Novartis, underscoring its role in the company's oncology portfolio. Market penetration has expanded into emerging economies, where rising cancer rates and improved healthcare access fuel adoption. However, competition from similar BRAF inhibitors, such as Bristol Myers Squibb's Tafinlar counterpart in combination therapies, intensifies pressure on pricing and market positioning.

Current Market Dynamics

TAFINLAR operates in a dynamic oncology market valued at over $200 billion globally, with the BRAF inhibitor niche growing at a compound annual growth rate (CAGR) of 8-10% through 2028. Key drivers include the increasing prevalence of melanoma—projected to affect 100,000 new patients in the U.S. alone in 2024—and advancements in genetic testing that identify BRAF mutations early. Novartis leverages these trends through strategic partnerships, such as collaborations with diagnostic firms to integrate companion diagnostics with TAFINLAR prescriptions.

Yet, market forces present challenges. Generic erosion looms large; patents for dabrafenib began expiring in key regions like Europe in 2020, allowing competitors to introduce lower-cost alternatives. In the U.S., where TAFINLAR enjoys patent protection until 2029, pricing remains robust at around $14,000 per month, but reimbursement policies from payers like CMS are tightening. This has led to a 5% decline in U.S. market share for TAFINLAR in 2023, as biosimilars gain traction.

Competition further shapes dynamics. Roche's vemurafenib and Pfizer's entries challenge TAFINLAR's dominance, particularly in combination regimens. Global supply chain disruptions, exacerbated by the COVID-19 pandemic, temporarily reduced availability in 2022, impacting sales by an estimated 7%. On the upside, expanding indications—such as FDA approval for adjuvant use in melanoma in 2018—have broadened TAFINLAR's addressable market to include over 20,000 additional patients annually worldwide.

Regulatory environments also influence dynamics. The European Medicines Agency (EMA) approved TAFINLAR for new indications in 2021, boosting European sales by 12%. Meanwhile, in Asia-Pacific markets like China, where cancer incidence is surging, Novartis is pursuing local manufacturing to cut costs and comply with import regulations, potentially unlocking $300 million in annual revenue by 2026.

Financial Performance and Trajectory

Novartis reported TAFINLAR revenues of $1.18 billion in 2023, marking a 3% year-over-year increase despite patent challenges. This growth reflects strong performance in the U.S. and Europe, where the drug contributes 60% of its total sales. Financially, TAFINLAR's gross margin hovers at 85%, driven by high pricing power and efficient manufacturing. However, net profits face pressure from R&D investments and marketing expenses, which consumed 25% of oncology division revenues in 2023.

Looking ahead, analysts project a financial trajectory with moderated growth. IQVIA forecasts TAFINLAR sales to reach $1.4 billion by 2027, assuming no major generic disruptions. This optimism stems from ongoing clinical trials, such as the phase III study combining TAFINLAR with immunotherapies, which could extend its lifecycle and add $500 million in annual revenue if approved. Conversely, patent expirations in major markets may erode 30-40% of sales post-2029, prompting Novartis to diversify into biosimilars and pipeline drugs.

Cash flow from TAFINLAR supports Novartis's broader financial strategy, funding acquisitions like the 2023 purchase of Chinook Therapeutics for $3.5 billion. Investors track metrics like return on invested capital (ROIC), which for TAFINLAR-related assets exceeds 15%, signaling strong value generation. Yet, macroeconomic factors, including inflation and currency fluctuations, have reduced earnings per share by 2% in 2023, highlighting vulnerabilities in global markets.

Patent Landscape and Regulatory Environment

TAFINLAR's patent portfolio, comprising over 50 granted patents, shields its market position until 2029 in the U.S. and key regions. Core patents cover the drug's composition and methods of use, with extensions granted for pediatric indications. This intellectual property framework has enabled Novartis to fend off challenges, including a 2021 generic application that was rejected by the FDA.

Regulatory hurdles, however, complicate the landscape. Post-marketing commitments require ongoing safety surveillance, and recent EMA reviews have flagged potential rare side effects, potentially delaying label expansions. On the positive side, fast-track designations for new combinations have accelerated approvals, as seen in the 2022 clearance for lung cancer use. These factors collectively influence TAFINLAR's financial trajectory, with patent cliffs posing a $600 million revenue risk by 2030.

Emerging opportunities in biosimilars and patent licensing could mitigate these risks. Novartis is exploring out-licensing deals in developing markets, which might generate an additional $100 million annually through royalties.

Challenges and Opportunities

TAFINLAR faces headwinds from rising healthcare costs and payer negotiations, which could cap pricing at $12,000 per month in some regions by 2025. Generic competition threatens to halve market share by 2030, while supply chain issues persist amid geopolitical tensions. Environmental factors, such as climate-driven increases in UV exposure and melanoma rates, add uncertainty.

Yet, opportunities abound. Integration with digital health tools, like AI-driven mutation detection, positions TAFINLAR for growth in precision oncology. Novartis's investment in sustainability—reducing carbon emissions in production—aligns with ESG demands, potentially attracting impact investors. Strategic alliances, such as the 2023 partnership with Merck for combination therapies, could extend TAFINLAR's lifespan and boost revenues by 15% through 2028.

Conclusion

TAFINLAR's market dynamics and financial trajectory reflect a balance of innovation and vulnerability in the oncology sector. While current sales momentum and regulatory wins drive value, impending patent expirations and competitive pressures demand proactive strategies from stakeholders. Business professionals must weigh these factors to optimize investments in this evolving landscape.

Key Takeaways

  • TAFINLAR's 2023 revenues reached $1.18 billion, with projected growth to $1.4 billion by 2027 despite generic threats.
  • Patent protections until 2029 provide a window for Novartis to expand indications and partnerships.
  • Market dynamics favor precision medicine, but competition and regulatory shifts could erode 30-40% of sales post-expiration.
  • Opportunities in emerging markets and combination therapies offer pathways to sustain financial performance.
  • Challenges like supply disruptions and pricing pressures highlight the need for diversified strategies.

FAQs

  1. What factors primarily drive TAFINLAR's market growth? TAFINLAR's growth stems from increasing BRAF mutation diagnoses and approvals for new cancer indications, boosting demand in oncology markets.

  2. How do patent expirations affect TAFINLAR's financial outlook? Expirations could lead to generic competition, potentially reducing revenues by 30-40% after 2029, though Novartis is pursuing extensions and alternatives.

  3. What role does competition play in TAFINLAR's dynamics? Competitors like Roche's vemurafenib challenge TAFINLAR's pricing and market share, particularly in combination therapies, intensifying the need for innovation.

  4. How has the regulatory environment influenced TAFINLAR's trajectory? Favorable FDA and EMA approvals for new uses have expanded TAFINLAR's market, but ongoing safety reviews add scrutiny that could delay further growth.

  5. What financial metrics should investors monitor for TAFINLAR? Key metrics include annual revenues, gross margins above 85%, and ROIC, which indicate profitability amid potential patent-related risks.

Sources

  1. Novartis Annual Report 2023, available on Novartis investor relations website.
  2. IQVIA Market Prognosis Report, 2024 edition, focusing on oncology trends.
  3. FDA Drug Approval Database, entry for dabrafenib (TAFINLAR), accessed 2024.

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