ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - Generic Drug Details

What are the generic sources for elexacaftor, ivacaftor, tezacaftor; ivacaftor and what is the scope of patent protection?

Elexacaftor, ivacaftor, tezacaftor; ivacaftor is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in two NDAs. There are thirty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elexacaftor, ivacaftor, tezacaftor; ivacaftor has five hundred and nineteen patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

International Patents:	519
US Patents:	35
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	23
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
DailyMed Link:	ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR at DailyMed

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

Constraining patent/regulatory exclusivity:

11,453,655

Dosage:

TABLET, TABLET;ORAL

Constraining patent/regulatory exclusivity:

11,453,655

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.

Recent Clinical Trials for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

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

Sponsor	Phase
Vertex Pharmaceuticals Incorporated	PHASE3
University of Kansas Medical Center	PHASE2
University of North Carolina, Chapel Hill	Phase 4

See all ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR clinical trials

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

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

US Patents and Regulatory Information for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

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	GRANULE;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes	10,239,867		Y	Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No	11,639,347		Y	Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-001	Apr 26, 2023		RX	Yes	No	8,754,224		Y	Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No	11,564,916

Expired US Patents for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

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

International Patents for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

Country	Patent Number	Title	Estimated Expiration
Australia	2007235260
Brazil	PI0710965
Canada	2648719
Canada	2869945
China	101460489

Supplementary Protection Certificates for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	C 2015 027	Romania		PRODUCT NAME: IVACAFTOR SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIAN-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1H-CHINOLIN-3-CARBOXAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/12/782/001, EU/1/12/782/002; DATE OF NATIONAL AUTHORISATION: 20120723; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/782/001, EU/1/12/782/002; DATE OF FIRST AUTHORISATION IN EEA: 20120723
2826776	301105	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPAANCARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1306 20181106
2826776	2021C/517	Belgium		PRODUCT NAME: SYMKEVI - TEZACAFTOR/IVACAFTOR; EEN COMBINATIE VAN (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 OF EEN VANUIT FARMACEUTISCH OOGPUNT GESCHIKT ZOUT DAARVAN EN (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OF EEN VANUIT FARMACEUTISCH OOGPUNT GESCHIKT ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106
1773816	C201530042	Spain		PRODUCT NAME: N-(5-HIDROXI-2, 4-DI-TERC-BUTIL-FENIL)-4-OXO-1H-QUINOLIN-3-CARBOXAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/12/782; DATE OF AUTHORISATION: 20120723; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/782; DATE OF FIRST AUTHORISATION IN EEA: 20120723
2826776	C02826776/01	Switzerland		PRODUCT NAME: TEZACAFTOR UND IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66742 10.05.2019

Last updated: June 19, 2026

Elexacaftor, Ivacaftor, Tezacaftor + Ivacaftor (Trikafta and related regimens): market dynamics and financial trajectory for ivacaftor revenue

Executive summary: Ivacaftor-linked revenues are driven by uptake and continued persistence of combination CFTR modulator regimens, primarily TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) in patients with qualifying CF genotypes. Near-term financial trajectory reflects (1) continued share gains in eligible genotype segments, (2) pricing and contracting pressure in US commercial and international markets, and (3) competitive risk from other CFTR modulators and pipeline entrants. The “ivacaftor” revenue pool is concentrated in the bundled combination portfolio rather than stand-alone ivacaftor, with financial visibility tied to TRIKAFTA durability, payer coverage, and durability of clinical value leading to low discontinuation.

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How does ivacaftor revenue track TRIKAFTA uptake in cystic fibrosis?

Ivacaftor revenue in practice is inseparable from the sales of TRIKAFTA, because the clinical and commercial market is structured around CFTR modulator combination therapy. The ivacaftor component is delivered within combination products, and payer coverage typically maps to the combination’s labeled eligibility criteria.

What drives TRIKAFTA market adoption for ivacaftor-linked sales?

Key adoption drivers that translate into steady ivacaftor revenue allocation inside combination sales:

• Genotype eligibility expansion and patient base capture

  • Patients with at least one F508del allele are central to commercialization for elexacaftor/tezacaftor/ivacaftor.
  • The mix of “F508del” and “non-F508del” genotype responders shapes addressable demand and regional penetration.

• Real-world persistence

  • CFTR modulator therapies often show higher treatment persistence than older symptomatic regimens, which supports revenue durability.

• Payer contracting and formulary placement

  • Commercial pricing is influenced by rebate structures and contracting intensity, which can stabilize net sales while affecting growth rates.

• Care pathway shift

  • Once CF centers adopt TRIKAFTA as first-line modulator therapy for eligible patients, switching costs and clinical familiarity support continued share.

What limits ivacaftor growth in TRIKAFTA’s market?

• Penetration ceilings
  • When the eligible population saturates, volume growth slows and net sales growth becomes more reliant on pricing, mix, and adherence.
• Net price compression
  • Broader competition and payer negotiations reduce effective price.
• Discontinuation risk in special populations
  • Individual intolerance, adherence issues, or lab-monitoring constraints can reduce persistence for a subset.

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What market dynamics affect TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) pricing and share over time?

The ivacaftor revenue trajectory tracks how TRIKAFTA performs against competing CFTR modulators and how payers respond to cost.

Competitive and contracting dynamics

• Portfolio competition inside CFTR modulation
  • Other approved CFTR modulators can substitute for parts of the eligible landscape based on genotype and payer preferences.
• Rebate and outcomes-based pressure
  • With mature adoption, payers push harder on net pricing through rebates and utilization management.
• International reimbursement variability
  • Effective revenue trajectory is highly sensitive to country-level pricing approvals, reimbursement lists, and tender outcomes.

US-specific commercial levers

• 340B, PBM and payer contracting
  • Net sales can swing based on channel mix and rebate intensity.
• Formulary tier placement
  • Continued “preferred” status supports volume stability; tier downgrades slow adoption.

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When does ivacaftor face exclusivity erosion for TRIKAFTA and how does that change financial trajectory?

Financial trajectory risk is tied to patent and exclusivity expiry for TRIKAFTA and adjacent CFTR modulator filings. For an ivacaftor-based combination, the risk is largely about combination product exclusivity rather than the ivacaftor API itself.

Exclusivity and patent landscape impact (commercially relevant timing)

• If combination product exclusivity sunsets, the market can transition into:
  • Generic competition for covered strengths/forms and label coverage, or
  • Authorized generics where settlement agreements allow earlier supply.
• Revenue effects typically show as:
  • Volume share loss shortly after entry,
  • Net price decline due to payer switching, and
  • Margin compression and increased contracting.

Biosimilar risk?

• Not applicable in the strict biosimilar sense because TRIKAFTA/elexacaftor/tezacaftor/ivacaftor is a small molecule combination, not a biologic.

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What patent and litigation factors most influence ivacaftor revenue protection?

Ivacaftor revenue protection is primarily a function of combination patents, including:

• composition-of-matter and combination claims (elexacaftor/tezacaftor/ivacaftor),
• dosing regimen claims,
• formulation and manufacturing method claims (where they restrict generic entry).

Paragraph IV challenge and settlement scenarios that affect net sales

Revenue-sensitive litigation patterns in small-molecule branded drugs include:

• Paragraph IV filings that lead to automatic stay periods,
• subsequent 27-month litigation risk windows,
• settlements that shift entry dates and preserve market share until the agreed supply launch window.

Business impact

• If entry is delayed, ivacaftor-linked revenues continue to follow the maturity curve rather than the cliff.
• If entry is permitted earlier, the revenue trajectory breaks into a sharper decline period.

(Proper identification of specific patents, Orange Book listings, and litigation outcomes requires drug-specific Orange Book and docket data and is not included here.)

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What is the Orange Book status and how does it map to generic entry risk for ivacaftor combinations?

Ivacaftor combinations are regulated under CDER small molecule exclusivity rules with an Orange Book listing that typically contains:

• active ingredient and strength,
• dosage form,
• listed patents by claim type.

Generic entry risk mapping (how the market calculates it)

Generic entry risk is strongest when:

• listed patents are expir­ing soon,
• patents are narrow to specific manufacturing processes or formulation approaches,
• the label is easier to match for genotype eligibility.

Risk is weaker when:

• multiple listed patents remain unexpired,
• key patents cover broad claims that restrict design-around.

(Orange Book status and specific patent numbers are not provided here.)

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How does ivacaftor’s financial trajectory compare with stand-alone ivacaftor (KALYDECO)?

Even though the user question references elexacaftor/tezacaftor/ivacaftor and ivacaftor, the commercial reality is that:

• TRIKAFTA captures the largest eligible population segments.
• KALYDECO (ivacaftor) retains a role in genotype segments not captured by TRIKAFTA eligibility.

Relative drivers

• TRIKAFTA-linked ivacaftor revenue
  • tied to broad genotype coverage for elexacaftor/tezacaftor/ivacaftor.
• KALYDECO-linked ivacaftor revenue
  • tied to smaller genotype pools and potential replacement by broader combination therapy as eligibility criteria and physician preference evolve.

Net effect

As TRIKAFTA adoption increases, ivacaftor’s commercial “addressable” base shifts from stand-alone ivacaftor to combination-driven utilization.

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What formulations and dosage forms affect market access and sales velocity for ivacaftor combination regimens?

Market dynamics depend on how quickly prescribers can treat eligible patients with available dosage forms.

Dose form constraints that matter commercially

• pediatric and adult dosing availability supports broader uptake across age cohorts
• stability and dispensing convenience support persistence and refill rates
• patient assistance programs and insurance coverage depend on pack sizes and billing codes

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How does FDA regulatory status influence ivacaftor combination sales growth?

Regulatory status affects sales through:

• label eligibility and genotype matching,
• post-marketing requirements that shape prescribing behavior,
• potential safety signals affecting persistence.

Key sales impact pathways

• broader label eligibility expands the eligible population for TRIKAFTA
• stable safety profile supports continued prescribing and reduces discontinuation
• post-marketing communications can shift center-of-mass risk tolerance

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Where are revenue exposures concentrated for ivacaftor combination products by geography and payer segment?

Ivacaftor combination revenues typically concentrate in:

• US commercial (largest volume and best visibility on net pricing),
• major European reimbursement systems (where approvals and tenders affect uptake speed),
• other international markets where pricing approvals and payer access lag.

Channel mix sensitivity

• In the US, Medicare and Medicaid mix and PBM contracting can drive net price variance.
• Outside the US, reimbursement delays can create step-function growth patterns.

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What generic launch scenarios could disrupt ivacaftor combination revenues?

Commercial disruption scenarios usually depend on:

• entry of a combination generic versus individual components,
• timing relative to label coverages,
• payer willingness to switch.

Most disruptive entry pattern

• a generic with broad label coverage and immediate formulary placement generates the sharpest revenue drop.

Less disruptive patterns

• narrow label coverage due to genotype constraints
• limited dosage form availability for certain pediatric/age cohorts
• delayed channel switching due to contracts

(Specific launch scenarios require Orange Book patent claims and timeline mapping, which are not enumerated here.)

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How strong is the competitive moat for ivacaftor combination therapy?

Moat strength in CFTR modulators is a function of:

• breadth of genotype coverage and clinical outcomes positioning,
• physician familiarity and persistence,
• payer access stability,
• patent estate density and enforceability against generic design-around.

Commercial moat components

• Label breadth and switching costs
  • When combinations cover the largest genotype segments, switching away requires genotype mismatch or payer-driven substitution.
• Persistence and adherence
  • Sustained therapy improves longitudinal revenue reliability.
• Manufacturing scale and supply reliability
  • Supply stability reduces discontinuation risk and payer coverage uncertainty.

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Key Takeaways

• Ivacaftor revenue is primarily monetized through TRIKAFTA, so financial trajectory follows combination uptake, persistence, and payer net pricing rather than stand-alone ivacaftor utilization.
• Market growth is shaped by genotype eligibility capture, contracting and rebate intensity, and international reimbursement speed.
• The largest long-run revenue risks are combination exclusivity and patent expiration, with potential step-downs driven by generic entry timing and label coverage breadth.
• Competitive pressure is managed through label coverage dominance and treatment persistence, which support revenue durability until exclusivity erosion accelerates switching.

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FAQs

1. How does genotype distribution in cystic fibrosis affect TRIKAFTA (ivacaftor-based) net sales?
2. What is the biggest payer lever that changes net revenue for ivacaftor combinations in the US?
3. Do formulation or dosage form patents materially increase generic entry barriers for ivacaftor combination products?
4. How do settlement agreements typically change the timing of generic entry for small-molecule CFTR modulators?
5. What differentiates stand-alone KALYDECO (ivacaftor) revenue trends from TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) over a product life cycle?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. FDA. Drug Labels and Prescribing Information for TRIKAFTA and KALYDECO. (Accessed 2026).