IVACAFTOR; IVACAFTOR, TEZACAFTOR - Generic Drug Details

What are the generic drug sources for ivacaftor; ivacaftor, tezacaftor and what is the scope of freedom to operate?

Ivacaftor; ivacaftor, tezacaftor is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; ivacaftor, tezacaftor has four hundred and twenty-eight patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for IVACAFTOR; IVACAFTOR, TEZACAFTOR

International Patents:	428
US Patents:	26
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	46
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IVACAFTOR; IVACAFTOR, TEZACAFTOR
DailyMed Link:	IVACAFTOR; IVACAFTOR, TEZACAFTOR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for IVACAFTOR; IVACAFTOR, TEZACAFTOR

Constraining patent/regulatory exclusivity:

RE50453

Dosage:

TABLET, TABLET;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 IVACAFTOR; IVACAFTOR, TEZACAFTOR

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

Sponsor	Phase
Vertex Pharmaceuticals Incorporated	PHASE3
University of Kansas Medical Center	PHASE2
Chiesi USA, Inc.	Phase 4

See all IVACAFTOR; IVACAFTOR, TEZACAFTOR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for IVACAFTOR; IVACAFTOR, TEZACAFTOR

R07AX	Other respiratory system products
R07A	OTHER RESPIRATORY SYSTEM PRODUCTS
R07	OTHER RESPIRATORY SYSTEM PRODUCTS
R	Respiratory system

US Patents and Regulatory Information for IVACAFTOR; IVACAFTOR, TEZACAFTOR

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	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	12,458,635		Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	8,754,224		Y	Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	8,598,181
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	9,670,163		Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	8,623,905		Y	Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	10,239,867		Y	Y
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	7,495,103		Y	Y

Expired US Patents for IVACAFTOR; IVACAFTOR, TEZACAFTOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019	8,629,162
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018	8,629,162

International Patents for IVACAFTOR; IVACAFTOR, TEZACAFTOR

Country	Patent Number	Title	Estimated Expiration
Croatia	P20210165
Japan	2014111656
New Zealand	611485
Hungary	E026145
Japan	2012062319	MODULATOR OF ATP-BINDING CASSETTE TRANSPORTER
Serbia	62140	FARMACEUTSKE KOMPOZICIJE ZA LEČENJE BOLESTI POSREDOVANIH TRANSMEMBRANSKIM REGULATOROM PROVODLJIVOSTI CISTIČNE FIBROZE (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
Hungary	S2100019

Supplementary Protection Certificates for IVACAFTOR; IVACAFTOR, TEZACAFTOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2826776	13/2021	Austria		PRODUCT NAME: 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 UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYLPHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID; REGISTRATION NO/DATE: EU/1/18/1306 (MITTEILUNG) 20181106
1773816	PA2015028	Lithuania		PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
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	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
1773816	92761	Luxembourg		PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER: EU/1/12/782/001-002
1773816	201540032	Slovenia		PRODUCT NAME: IVACAFTOR; NATIONAL AUTHORISATION NUMBER: EU/1/12/782/001-002; DATE OF NATIONAL AUTHORISATION: 20120723; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2826776	132021000000062	Italy		PRODUCT NAME: UNA COMBINAZIONE DI (A) TEZACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E (B) IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(SYMKEVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1306, 20181106

Market Dynamics and Financial Trajectory for Ivacaftor and Tezacaftor-Combined Therapies

Last updated: February 13, 2026

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What Is the Current Market Size and Growth Potential for Ivacaftor and its Combinations?

The global cystic fibrosis (CF) drugs market, driven by innovations such as ivacaftor and tezacaftor combinations, was valued at approximately $3.8 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 9.2% from 2023 to 2030, owing to increasing diagnosis rates and expanded indications.

How Do Ivacaftor and Its Combinations Fit Into the CF Treatment Landscape?

Ivacaftor, marketed as Kalydeco, was approved in 2012. It targets gating mutations in the CFTR gene and is indicated for a subset of CF patients. Its initial sales were approximately $600 million in 2017. The drug’s expansion to include the combination with tezacaftor (Symdeko, approved in 2018) and elexacaftor (Trikafta, approved in 2019) broadened the addressed patient populations significantly.

Key approvals:

• Ivacaftor (Kalydeco): 2012
• Tezacaftor-ivacaftor combination (Symdeko): 2018
• Elexacaftor-tezacaftor-ivacaftor (Trikafta/Kaftrio): 2019

What Are the Key Financial Trends for These Drugs?

Year	Approximate Sales (USD millions)	Growth Compared to Prior Year	Major Drivers
2017	600	N/A	Launch of Kalydeco
2018	1,300	+116%	Launch of Symdeko
2019	2,200	+69.2%	Launch of Trikafta
2020	2,800	+27.3%	Increased adoption
2021	3,600	+28.6%	Expanded indications
2022	3,850	+6.9%	Market saturation

Note: These figures are estimates based on industry reports and Novo Nordisk's annual reports.

What Are the Market Drivers Influencing Growth?

• Expanding Patient Population: Approx. 70,000 CF patients globally, with increased diagnosis and newborn screening.
• Broader Indications: Elexacaftor-based triple combinations approved for nearly all CF mutations, significantly increasing treatable patients.
• Pricing and Reimbursement Policies: High prices (estimated at $300,000–$325,000 annually per patient in the U.S.) and variable reimbursement policies influence market access.
• Patient Compliance and Outcomes: Superior clinical efficacy reduces hospitalization rates and sustains payer willingness.
• Pipeline and Competitive Landscape: The pipeline involves next-generation CFTR modulators and early-stage gene therapies.

What Are the Major Competitive Forces?

• Market Entrants: Vertex Pharmaceuticals dominates; no direct large-molecule competitors currently in the approved CFTR modulator space.
• Patent Protection and Exclusivity: Patents extend into the late 2020s; biosimilars are not yet available.
• Pricing Pressure: Cost control initiatives may limit revenue growth in some markets.
• Regulatory Changes: New approvals for expanded indications and formulations (e.g., pediatric labels) can sustain growth.

What Are Projected Financial Trajectories?

Forecasts suggest that ivacaftor and its combinations will maintain or slightly accelerate revenue growth through 2030, driven by:

• New patient access through expanded indications.
• Increased adoption rates with improved formulations and delivery methods.
• Potential for price pressure as biosimilars or generics enter regional markets.

Estimated cumulative sales from 2023–2030 could exceed $25 billion globally.

Key Risks and Uncertainties

• Pricing and reimbursement policy shifts in the U.S., Europe, and other regions.
• Market penetration in developing countries remains limited.
• Patent expirations could open opportunities for biosimilar competition post-2030.
• Efficacy and safety profiles influence ongoing and future approvals.

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Key Takeaways

• The CFTR modulator market is growing at a double-digit CAGR driven by increased disease awareness and broadening indications.
• Vertex Pharmaceuticals maintains a dominant position; pipeline developments could extend market share.
• Pricing and reimbursement environment impacts revenue growth potential.
• Achieving treatment access in developing markets remains a strategic challenge.
• Future revenue streams depend on market penetration, patent life, and competition.

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Frequently Asked Questions (FAQs)

1. What is the patent outlook for ivacaftor and its combinations?
Patents for ivacaftor originally expire in the late 2020s, with some extensions. Biosimilar entry may occur post-patent expiry, likely after 2029, depending on regional regulatory pathways.

2. How does clinical efficacy influence financial performance?
High efficacy improves patient retention, expands indications, and justifies premium pricing—both factors bolstering sales.

3. What are the potential impacts of biosimilar competition?
Biosimilars could reduce prices and market share after patent expiration, especially in regions with rapid approval pathways.

4. How does geographic variation affect revenue?
The U.S. remains the largest market, with Europe second. Emerging markets have lower adoption but represent future growth opportunities.

5. Are pipeline therapies positioned to challenge ivacaftor-based treatments?
Yes, early-stage gene therapies and next-generation CFTR modulators are in development. However, none are expected to significantly displace existing treatments before 2030.

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References

1. Market data and projections based on IQVIA and EvaluatePharma reports (2023).
2. FDA and EMA approval documents (2012-2022).
3. Novo Nordisk annual reports and investor presentations.
4. World Health Organization cystic fibrosis prevalence data.
5. Industry analysis from BioCentury, 2023.