TRIKAFTA (COPACKAGED) Drug Patent Profile

When do Trikafta (copackaged) patents expire, and when can generic versions of Trikafta (copackaged) launch?

Trikafta (copackaged) is a drug marketed by Vertex Pharms Inc and is included in two NDAs. There are thirty-five patents protecting this drug.

This drug has five hundred and twenty-three patent family members in forty-eight countries.

The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. One supplier is listed for this compound. Additional details are available on the elexacaftor, ivacaftor, tezacaftor; ivacaftor profile page.

DrugPatentWatch^® Generic Entry Outlook for Trikafta (copackaged)

Trikafta (copackaged) was eligible for patent challenges on October 21, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2037. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases 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

Summary for TRIKAFTA (COPACKAGED)

International Patents:	523
US Patents:	35
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIKAFTA (COPACKAGED)
DailyMed Link:	TRIKAFTA (COPACKAGED) at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TRIKAFTA (COPACKAGED)

Constraining patent/regulatory exclusivity:

10,793,547

NDA:

212273

Dosage:

TABLET, TABLET;ORAL

Constraining patent/regulatory exclusivity:

10,793,547

NDA:

217660

Dosage:

GRANULES;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.

US Patents and Regulatory Information for TRIKAFTA (COPACKAGED)

TRIKAFTA (COPACKAGED) is protected by ninety-one US patents and nine FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,793,547.

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
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No	10,272,046		Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes	10,022,352		Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No	7,495,103		Y	Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes	11,426,407		Y	Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes

Expired US Patents for TRIKAFTA (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023	8,629,162
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021	8,629,162
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019	8,629,162
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023	8,629,162

International Patents for TRIKAFTA (COPACKAGED)

When does loss-of-exclusivity occur for TRIKAFTA (COPACKAGED)?

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

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hungary

Israel

Japan

Jordan

Lithuania

Mexico

Moldova, Republic of

Morocco

New Zealand

Peru

Portugal

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 TRIKAFTA (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
China	109966264	药物组合物及其施用 (Pharmaceutical composition and administration thereof)
New Zealand	730794
European Patent Office	3654969	MÉTHODES DE TRAITEMENT DE LA FIBROSE KYSTIQUE (METHODS OF TREATMENT FOR CYSTIC FIBROSIS)
Russian Federation	2012109390	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И СПОСОБЫ ЕЕ ВВЕДЕНИЯ
Spain	2659364

Supplementary Protection Certificates for TRIKAFTA (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2826776	2190015-4	Sweden		PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2- METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1306 20181106
2826776	CR 2021 00013	Denmark		PRODUCT NAME: EN KOMBINATION AF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) ....; REG. NO/DATE: EU/1/18/1306 20181106
2826776	122021000025	Germany		PRODUCT NAME: EINE KOMBINATION VON (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANCARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1306 20181031
1773816	2015C/040	Belgium		PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/12/782/001-002 20120725
2826776	CA 2021 00013	Denmark		PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) ....; REG. NO/DATE: EU/1/18/1306 20181106

Market Dynamics and Financial Trajectory for TRIKAFTA (COPACKAGED)

Last updated: November 7, 2025

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Introduction

TRIKAFTA, a groundbreaking combination therapy for cystic fibrosis (CF), exemplifies the evolving landscape of personalized medicine within the pharmaceutical industry. The drug, developed and marketed by Vertex Pharmaceuticals, integrates three active ingredients—elexacaftor, tezacaftor, and ivacaftor—delivering targeted treatment for specific CF patient populations. As of recent years, TRIKAFTA’s market position and financial trajectory have been shaped by a confluence of factors, including scientific advances, regulatory environment, competitive dynamics, and clinical adoption rates. This analysis delineates these elements to provide comprehensive insight into the current and projected commercial landscape of TRIKAFTA.

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Market Overview and Growth Drivers

Cystic Fibrosis Market Landscape

The global cystic fibrosis market is characterized by limited treatment options historically, emphasizing symptomatic management rather than curative solutions. However, recent therapeutic innovations, notably CFTR modulators like TRIKAFTA, have transformed treatment paradigms. The global CF market was valued at approximately USD 5 billion in 2022 and is projected to reach USD 8 billion by 2030, exhibiting a CAGR of around 6-8% (source: Grand View Research)[1].

Unmet Medical Need and Patient Population Expansion

The principal driver for TRIKAFTA’s market growth is its superior efficacy in reducing pulmonary exacerbations and improving lung function among eligible CF patients, notably those with at least one F508del mutation. The estimated eligible patient pool for TRIKAFTA in the U.S. is approximately 20,000–25,000, with similar expansions globally as genetic testing and diagnosis improve. Growing awareness and improved screening techniques have increased diagnosed cases, enlarging the potential market.

Regulatory Approvals and Expansions

TRIKAFTA received FDA approval in 2019 for patients aged 12 and older with approximately 90% of CF mutations, solidifying its position as a first-line therapy. Subsequent approvals for younger populations and additional mutations have expanded its accessible market. Regulatory bodies worldwide, including the EMA, Japan’s PMDA, and others, have granted approvals, facilitating broader adoption.

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Market Dynamics and Competitive Landscape

Key Differentiators and Clinical Efficacy

TRIKAFTA’s robust clinical data, demonstrating significant improvements in lung function (FEV1), quality of life scores, and reduction in pulmonary exacerbations, underpin its market dominance. It offers a substantial advantage over previous therapies like Kalydeco (ivacaftor alone) or Orkambi (lumacaftor/ivacaftor), especially given its efficacy across a broader mutation spectrum.

Competitive Products

While Vertex’s TRIKAFTA holds a strong position, competitors like Moderna (mRNA-based therapies), Miron (novel CFTR modulators), and emerging gene-editing technologies threaten to reshape the landscape. However, as of 2023, few alternatives match TRIKAFTA’s broad mutation coverage and clinical efficacy.

Pricing and Reimbursement Strategies

TRIKAFTA’s pricing is premium—list prices exceed USD 300,000 annually per patient—reflecting the high R&D investments and clinical value. Reimbursement dependence on PBMs and health insurers poses some access barriers but remains stable due to demonstrated outcomes and cost offsets from reduced hospitalizations.

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Financial Trajectory Analysis

Sales Performance

Vertex’s financial reports reveal rapid growth for TRIKAFTA. In 2022, global sales revenues for the drug surpassed USD 2 billion, representing approximately 60% of Vertex’s total revenues. Annual sales have exhibited a CAGR of roughly 40% since launch, driven by increased patient enrollment and expanded indications.

Pricing Trends and Revenue Forecasts

Following initial high pricing, payers have negotiated discounts and managed access agreements, balancing profitability with market access. Current forecasts project USD 4–5 billion in annual sales for TRIKAFTA globally by 2030 if market penetration continues unabated, contingent on regulatory and clinical expansion strategies.

Pipeline and Long-term Outlook

Vertex’s pipeline, including next-generation CFTR modulators and gene therapy approaches, could influence TRIKAFTA’s dominance over the next decade. However, given its established efficacy, TRIKAFTA is expected to maintain a significant market share, with revenues sustaining at high levels, driven by further indication approvals and global expansion.

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Challenges and Risks

• Pricing and reimbursement pressures may limit growth in more cost-sensitive markets.
• Emergence of biosimilar or gene editing therapies could threaten market share.
• Patient access disparities persist in underdiagnosed regions, impacting global revenue potential.
• Regulatory hurdles for new indications or formulations could delay commercialization.

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Regulatory and Policy Impacts

Regulatory agencies prioritize personalized medicine, likely facilitating incremental approvals for new indications. Government policies emphasizing value-based care and drug affordability could influence pricing strategies, potentially constraining profit margins but also fostering sustainable access.

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Conclusion and Strategic Insights

TRIKAFTA’s market position continues to strengthen, grounded in its clinical efficacy and broad mutation coverage. The drug’s financial trajectory indicates robust growth, driven by expanding indications and global adoption. However, sustained success requires vigilant navigation of reimbursement landscapes, competitive innovations, and regulatory environments. Companies invested in CF therapies should pursue strategic collaborations, innovative pricing models, and market diversification to maximize long-term value.

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Key Takeaways

• TRIKAFTA has established a dominant position in the CF market, with sales trajectory expected to reach USD 4–5 billion annually by 2030.
• Ongoing regulatory approvals and expanded indications will be pivotal in fueling future growth.
• Competition from emerging genetic and gene-editing therapies presents potential threats but currently has limited market impact.
• Pricing strategies and reimbursement negotiations are critical levers influencing access and profitability.
• The evolving regulatory landscape and healthcare policies necessitate adaptive strategies to sustain market leadership.

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FAQs

1. What clinical advantages does TRIKAFTA offer over earlier CF therapies?
TRIKAFTA demonstrates superior efficacy in improving lung function, reducing pulmonary exacerbations, and widening the mutation coverage, benefiting a larger patient population compared to earlier CFTR modulators.

2. How does pricing impact TRIKAFTA’s market penetration globally?
High list prices enable robust revenue streams but may restrict access in cost-sensitive markets. Reimbursement negotiations and government policies substantially influence patient affordability and uptake.

3. What are the primary growth drivers for TRIKAFTA in the coming years?
Key drivers include regulatory approval extensions for new age groups and mutations, increased diagnosis, product awareness, and global market expansion, especially in emerging economies.

4. How might competition from gene therapies affect TRIKAFTA’s future?
While gene editing and regenerative therapies are promising, they remain in experimental stages. If proven safe and cost-effective, these modalities could redefine CF treatment paradigms and challenge TRIKAFTA’s dominance.

5. What strategies should stakeholders adopt to maximize TRIKAFTA’s market share?
Prioritizing geographic expansion, fostering payer partnerships, investing in patient access programs, and supporting ongoing clinical research will be essential to sustain growth and market leadership.

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References

[1] Grand View Research. "Cystic Fibrosis Market Size, Share & Trends Analysis Report," 2022.