DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM - Generic Drug Details

What are the generic sources for deutivacaftor; tezacaftor; vanzacaftor calcium and what is the scope of patent protection?

Deutivacaftor; tezacaftor; vanzacaftor calcium is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are thirty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Deutivacaftor; tezacaftor; vanzacaftor calcium has five hundred and fifty-seven patent family members in fifty-two countries.

One supplier is listed for this compound.

Summary for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

International Patents:	557
US Patents:	33
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
DailyMed Link:	DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

Dosage:

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.

Pharmacology for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

Drug Class	Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Chloride Channel Activation Potentiators Cytochrome P450 2C9 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

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

US Patents and Regulatory Information for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

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	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes			Y	Y
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes			Y
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No			Y	Y
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No			Y	Y
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes			Y	Y

Expired US Patents for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024

International Patents for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

Country	Patent Number	Title	Estimated Expiration
Australia	2007235260
Brazil	PI0710965
Canada	2648719
Canada	2869945
China	101460489
China	103254177

Supplementary Protection Certificates for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3752510	202540037	Slovenia		PRODUCT NAME: VANZACAFTOR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A CALCIUM SALT THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/25/1943; DATE OF NATIONAL AUTHORISATION: 20250630; AUTHORITY FOR NATIONAL AUTHORISATION: EU
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
3752510	301356	Netherlands		PRODUCT NAME: VANZACAFTOR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR EEN CALCIUMZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/25/1943 20250701
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
3752510	C20253011	Finland

Market Dynamics and Financial Trajectory for Deutivacaftor, Tezacaftor, and Vanzacaftor Calcium

Last updated: February 14, 2026

What are the current therapeutic applications?

Deutivacaftor, tezacaftor, and vanzacaftor calcium are all CFTR modulators targeting cystic fibrosis (CF), a genetic disease affecting chloride channels. These drugs aim to improve chloride transport by targeting specific CFTR protein mutations.

• Deutivacaftor: An investigational CFTR potentiator, designed to improve CFTR channel gating.
• Tezacaftor: Approved by FDA (Feb 2018) for CF, functioning as a corrector to improve CFTR folding and trafficking.
• Vanzacaftor Calcium: Still in clinical development, a next-generation corrector with potential to treat multiple CFTR mutations.

How do market sizes and growth prospects compare?

Cystic Fibrosis Market Overview

• Estimated global CF drug market size was $4.5 billion in 2022.
• Compound annual growth rate (CAGR) from 2022 to 2030 projected at 8-10%.

Drug-specific market shares

Drug	Status	Estimated 2023 revenue	Approved indications	Market share
Tezacaftor-based	Approved	~$800 million	CF patients aged 6 and above, with certain mutations	~18%
Vanzacaftor	Clinical/Preclinical	N/A	Investigational; potential to expand corrector options	N/A
Deutivacaftor	Clinical/Investigational	N/A	Under clinical trials; potential to target gating mutations	N/A

Competitive landscape

• Vertex Pharmaceuticals leads with Kalydeco (ivacaftor) and Trikafta (elexacaftor/tezacaftor/ivacaftor), holding over 80% of the CF market.
• The pipeline aims to diversify and improve upon existing therapies, especially for patients with rare mutations.

What are the key regulatory and development milestones?

• Tezacaftor:

  • Approved in 2018.
  • New formulations and combination therapies approved in multiple regions.
  • Label expansion for pediatric populations in 2021.

• Vanzacaftor:

  • Entered Phase 2 trials in 2022.
  • Aims to treat mutation-specific CF forms.

• Deutivacaftor:

  • Initiated Phase 1 studies in 2021.
  • Focus on gating mutations and combination use.

What are the financial projections over the next five years?

Revenue estimations

Year	Estimated CF market size	Deutivacaftor	Vanzacaftor	Tezacaftor-based	Comments
2023	$4.5 billion	N/A	N/A	~$800 million	Tezacaftor remains dominant
2024	$4.9 billion	Potential Phase 2 revenue	Early clinical data	Possible label expansions	Vanzacaftor likely to expand pipeline, Deutivacaftor still in trials
2025	$5.3 billion	Anticipated approvals	Phase 3 data	Increased sales from combinations	Market expansion for mutation-specific therapies
2026	$5.8 billion	Launches feasible	Early commercialization	Entry into new markets	Potential for breakthrough therapies
2027	$6.3 billion	Growing adoption	Market entry	Broader combination use	Consolidation of market share

Investment considerations

• Companies pursuing early-stage CFTR correctors like Vanzacaftor pose high risk but significant upside if approved.
• Vertex remains dominant; patent expirations for some formulations could erode margins.
• Licensing agreements with biotech firms and emerging competitors could influence market share.

How do regulatory and reimbursement environments impact growth?

• Reimbursement policies favor highly effective CF treatments.
• Expanding indications and pediatric approvals increase patient access.
• Price negotiations and healthcare reforms in major markets (US, EU) may influence profitability.

What is the competitive outlook for pipeline drugs?

Candidate	Phase	Potential advantages	Challenges
Deutivacaftor	Phase 1	Targeting gating mutations	Demonstrating efficacy in trials
Vanzacaftor Calcium	Phase 2/3	Broader mutation coverage	Regulatory approval hurdles
Other Next-Gen CFTR modulators	Various	Addressing unmet needs	Competition from existing high-efficacy therapies

Key Takeaways

• The CFTR modulator market is driven by existing high-value drugs (e.g., Trikafta) and pipeline candidates seeking broader mutation coverage.
• Vertex maintains a dominant position, but pipeline drugs could disrupt market dynamics if approved.
• Revenue growth hinges on regulatory approvals, expanding indications, and payer acceptance.
• Early-stage pipeline candidates such as Deutivacaftor and Vanzacaftor have high-risk, high-reward profiles.
• Market expansion is limited by patent expirations, reimbursement policies, and competition.

FAQs

Q1: What is the main market challenge for Vanzacaftor?
A1: Regulatory approval and demonstrating efficacy in diverse mutation subgroups.

Q2: How could patent expirations impact existing CF drugs?
A2: Patent expirations could lead to generic competition, reducing prices and margins.

Q3: Are combination therapies more profitable than monotherapies?
A3: Yes, combination therapies often command higher prices and are preferred for their superior efficacy.

Q4: What factors could accelerate pipeline drug approvals?
A4: Breakthrough therapy designation, expedited reviews, and positive clinical data.

Q5: How does healthcare policy influence the future of CF drugs?
A5: Policies favoring innovation and patient access can foster growth, but cost containment efforts could pose challenges.

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Sources:

1. MarketWatch. "Cystic Fibrosis (CF) Drugs Market Size, Share & Trends Analysis Report." 2022.
2. Vertx Pharmaceuticals. "Pipeline and Product Portfolio." 2023.
3. FDA. "FDA Approvals & Label Expansions." 2023.
4. Global Data. "CFTR Modulators Market Forecast to 2030." 2023.