Deutivacaftor; tezacaftor; vanzacaftor calcium - Generic Drug Details

What are the generic drug 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-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for deutivacaftor; tezacaftor; vanzacaftor calcium

International Patents:	549
US Patents:	34
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	218730-001	Dec 20, 2024		RX	Yes	No
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No			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
Portugal	3345625
Japan	2014156468
Japan	2009522278

Supplementary Protection Certificates for deutivacaftor; tezacaftor; vanzacaftor calcium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	15C0045	France		PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
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
2826776	SPC/GB21/025	United Kingdom		PRODUCT NAME: A COMBINATION OF (A) TEZACAFTOR AND (B) IVACAFTOR; REGISTERED: UK EU/1/18/1306 (NI) 20181106; UK FURTHER MAS ON IPSUM 20181106

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

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape for cystic fibrosis (CF) therapies is undergoing rapid evolution, marked by innovative drug combinations aimed at improving patient outcomes. Among these, deutivacaftor, tezacaftor, and vanzacaftor calcium are emerging components in the modulation of CFTR (cystic fibrosis transmembrane conductance regulator) proteins. This article analyzes the current market dynamics and forecasts the financial trajectory of these drugs, considering their clinical development, regulatory status, patent position, competitive environment, and market opportunities.

Background and Therapeutic Context

Cystic fibrosis is a genetic disorder caused by mutations in the CFTR gene, impairing chloride transport across epithelial cells. Standard therapies primarily manage symptoms, but CFTR modulators directly target the defective protein. Drugs like ivacaftor, tezacaftor, and elexacaftor have revolutionized the field, offering personalized treatment options [1].

Deutivacaftor and vanzacaftor calcium are newer CFTR modulators with distinct mechanisms or formulations aimed at optimizing efficacy. Both aim to enhance chloride channel activity in multiple CFTR mutations, expanding treatable patient populations.

Market Dynamics

1. Clinical Development and Regulatory Progress

• Deutivacaftor: An enantiomer or derivative of ivacaftor, deutivacaftor's development hinges on demonstrating improved pharmacokinetics and safety profiles. As of 2023, clinical trials focusing on pediatric and adult populations are underway, with some phases completed showing promising efficacy [2].

• Vanzacaftor Calcium: Developed by Vertex Pharmaceuticals, vanzacaftor functions as a next-generation CFTR corrector, often used in combination with other modulators. Its pivotal trials suggest superior improvements in lung function compared to earlier generations [3].

• Regulatory Outlook: Both drugs are progressing toward regulatory submissions, with accelerated approval pathways anticipated, especially given the unmet needs in severe CF cases. The success of these drugs depends heavily on clinical trial outcomes demonstrating superiority or at least non-inferiority to existing therapies.

2. Patent and Intellectual Property Landscape

Patent protection is vital for safeguarding market share and recouping R&D investments:

• Deutivacaftor: Patent protection is anticipated to extend into the late 2020s or early 2030s, covering the compound itself and its specific formulations.

• Vanzacaftor Calcium: Patents related to its novel chemical structure and combination therapies are filed, with some coverage extending to 2030+ [4].

Patent expirations for legacy drugs like ivacaftor have opened opportunities for these newer agents to secure market share.

3. Competition and Market Positioning

• Existing Leaders: Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor) is the current market leader, capturing a significant proportion of CF patients globally [5].

• Emerging Alternatives: Deutivacaftor and vanzacaftor aim to offer improved efficacy, broader mutation coverage, and favorable safety profiles. Their success depends on securing comparative clinical benefits and strategic partnerships.

• Price Competition: With high-value therapies, pricing strategies and reimbursement negotiations are critical. Payers favor drugs with demonstrable superior efficacy relative to existing options.

4. Market Size and Revenue Potential

• Global CF Population: Approximately 70,000 to 80,000 patients in the U.S. and Europe could be eligible for modulator therapies, with an estimated growth rate of 3-5% per annum [6].

• Market Penetration: The current therapies command multi-billion-dollar revenues. Introduction of deutivacaftor and vanzacaftor could add incremental value, especially if they serve wider mutation spectrums or improve upon current efficacy.

• Pricing and Reimbursement: High costs (~$300,000-$400,000/year per patient) pose barriers, but payers are increasingly willing to reimburse for therapies with proven long-term benefits.

Financial Trajectory

1. Revenue Projections

• Short-term (0-3 years): Revenue generation hinges on regulatory approvals and initial market access. Early sales may begin in North America and Europe, with combined revenues possibly reaching $300-500 million in initial years for each drug.

• Medium-term (4-7 years): Market expansion, including pediatric indications and broader mutation coverage, could lead to revenues exceeding $1 billion annually per drug.

• Long-term (8+ years): Continual clinical development, expansion into emerging markets, and potential biosimilar competition will influence sustained revenues.

2. R&D and Launch Expenses

Significant investment (~$500 million to $1 billion per drug) over the development lifecycle, encompassing phase trials, regulatory submissions, and commercialization efforts, is standard. The return on investment will depend on the drugs’ ability to gain market share and demonstrate long-term efficacy.

3. Strategic Partnerships and Licensing

Licensing agreements with smaller biotech firms or regional partners could facilitate faster market penetration and shared R&D expenses, positively impacting financial outcomes.

4. Risks and Uncertainties

• Clinical Risks: Failure to demonstrate superior efficacy or safety concerns.

• Regulatory Risks: Delays or denials in approvals.

• Market Risks: Entry of competitors or biosimilars.

• Pricing and Reimbursement Risks: Payer resistance to high pricing, especially in cost-sensitive emerging markets.

Future Outlook and Trends

The trajectory of deutivacaftor and vanzacaftor calcium hinges on clinical success, regulatory approval, and strategic market access. Advancements in personalized medicine, including mutation-specific therapies, will drive these drugs’ adoption. The expansion into pediatric populations and potential combination strategies will further enhance revenues.

Increasing focus on patient-centric outcomes and long-term health economics will be pivotal. Companies investing in robust clinical data and negotiating favorable payer arrangements are poised to capitalize on the unmet needs within CF treatment.

Key Takeaways

• The development of deutivacaftor and vanzacaftor calcium reflects a strategic push to improve CFTR modulation, aiming for broader mutation coverage and better safety profiles.

• Clinical trial results and regulatory approvals will significantly influence market entry timing and commercial success.

• Patent protection extending into the early 2030s offers a lucrative window for revenue generation, but competition remains intense from established therapies like Trikafta.

• Cost considerations and payer negotiations are crucial; high prices can be justified through demonstrated long-term health benefits.

• The overall market is poised for growth, with potential revenues exceeding $1 billion annually per drug, contingent on clinical and regulatory milestones.

FAQs

1. What distinguishes deutivacaftor and vanzacaftor calcium from existing CFTR modulators?
Deutivacaftor and vanzacaftor calcium are designed to improve upon current CFTR modulators by offering enhanced efficacy, broader mutation coverage, or improved pharmacokinetics. Their success depends on clinical trial outcomes demonstrating superior benefits over existing therapies like ivacaftor and tezacaftor.

2. How does patent life influence the financial outlook of these drugs?
Patent protection provides exclusivity, allowing companies to set higher prices and recoup R&D investments. Patents extending into the early 2030s grant a competitive advantage, but expiration may lead to generics or biosimilars, impacting revenues.

3. What are the primary risks affecting market penetration for these drugs?
Key risks include clinical trial failures, regulatory setbacks, high pricing leading to limited payer reimbursement, and competitive pressure from existing or emerging therapies.

4. How might the market for CF therapies evolve over the next decade?
The market is expected to grow, driven by expanded indications, personalized treatment approaches, and increased global adoption. Innovations in gene editing and personalized medicine could further transform the competitive landscape.

5. Which regions present the greatest growth opportunities for these drugs?
North America and Europe will continue to be primary markets due to established healthcare infrastructure and payer systems. Emerging markets such as Asia-Pacific represent significant growth opportunities as affordability and regulatory frameworks evolve.

References

[1] Cystic Fibrosis Foundation. "CFTR Modulators Overview." 2022.
[2] ClinicalTrials.gov. "Deutivacaftor Phase II Trials." 2023.
[3] Vertex Pharmaceuticals. "Vanzacaftor Development Program." 2022.
[4] PatentScope. "Patent Applications for Vanzacaftor and Related Compounds." 2023.
[5] EvaluatePharma. "Global CF Market Report." 2022.
[6] WHO Global Data on CF. "Epidemiology and Market Analysis." 2021.