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 forty-eight patent family members in fifty-two countries.

One supplier is listed for this compound.

Summary for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

International Patents:	548
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
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
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	218730-001	Dec 20, 2024		RX	Yes	No			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
Portugal	2674428
Japan	2008504291
European Patent Office	3219705
Cyprus	1121572
Israel	213158	תהליכים להכנת מאפנני הובלת קסטות מקושרות atp (Processes for the preparation of modulators of atp-binding cassette transporters)

Supplementary Protection Certificates for DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2826776	PA2021508	Lithuania		PRODUCT NAME: (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOKSOL-5-IL)-N-(1-(2,3-DIHIDROKSIPROPIL)-6-FLUOR-2-(1-HIDROKSI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL) CIKLOPROPANKARBOKSAMIDO ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/18/1306 20181031
1773816	132016000022519	Italy		PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 20120725
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	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; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/18/1306, 2018-11-06; DEN 19 JUNI 2025 MEDDELADE PRV BESLUT OM RAETTAD SKYDDSTID FOER FOELJANDE TILLAEGGSSKYDD. 1790034-1 1490061-7 1790019-2 2090047-8 2390009-5 2390012-9 2090033-8 1790016-8 2190015-4 1990020-8 1090038-9 1190029-7
1773816	237 5014-2015	Slovakia		PRODUCT NAME: N-(5-HYDROXY-2,4-DITERC-BUTYL-FENYL)-4-OXO- -1H-CHINOLIN-3-KARBOXAMID (IVACAFTOR); REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120725

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.

---

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.