ALYFTREK Drug Patent Profile

When do Alyftrek patents expire, and what generic alternatives are available?

Alyftrek is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are thirty-four patents protecting this drug.

This drug has five hundred and forty-eight patent family members in fifty-two countries.

The generic ingredient in ALYFTREK is deutivacaftor; tezacaftor; vanzacaftor calcium. One supplier is listed for this compound. Additional details are available on the deutivacaftor; tezacaftor; vanzacaftor calcium profile page.

DrugPatentWatch^® Generic Entry Outlook for Alyftrek

Alyftrek will be eligible for patent challenges on December 20, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2035. This may change due to patent challenges or generic licensing.

There have been nineteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ALYFTREK

International Patents:	548
US Patents:	34
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALYFTREK
What excipients (inactive ingredients) are in ALYFTREK?	ALYFTREK excipients list
DailyMed Link:	ALYFTREK at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALYFTREK

NDA:

218730

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 ALYFTREK

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

US Patents and Regulatory Information for ALYFTREK

ALYFTREK is protected by thirty-four US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	218730-002	Dec 20, 2024		RX	Yes	Yes			Y
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	218730-002	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
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes			Y	Y

Expired US Patents for ALYFTREK

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 ALYFTREK

When does loss-of-exclusivity occur for ALYFTREK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

Morocco

New Zealand

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Turkey

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ALYFTREK around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2010251787
Denmark	2674428
Montenegro	02970
Israel	288388
European Patent Office	3705477	MODULATEURS DE TRANSPORTEURS DE CASSETTE À LIAISON ATP (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS)
Israel	213158	תהליכים להכנת מאפנני הובלת קסטות מקושרות atp (Processes for the preparation of modulators of atp-binding cassette transporters)
Chile	2020002055

Supplementary Protection Certificates for ALYFTREK

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
2826776	LUC00207	Luxembourg		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; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106
2826776	122021000025	Germany		PRODUCT NAME: EINE 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 ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1306 20181031
3752510	CR 2025 00041	Denmark		PRODUCT NAME: VANZACAFTOR ELLER ET FARMACEUTISK ACCEPTABLELT SALT DERAF, FORTRINSVIS ET CALCIUM-SALT DERAF; REG. 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	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	300748	Netherlands		PRODUCT NAME: IVACAFTOR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725

Market Dynamics and Financial Trajectory for ALYFTREK

Last updated: July 28, 2025

Introduction

ALYFTREK, a novel pharmaceutical agent, is rapidly attracting industry attention due to its innovative mechanism of action and promising therapeutic profile. As the pharmaceutical landscape evolves, understanding ALYFTREK's market potential, competitive positioning, and financial trajectory is essential for stakeholders aiming to capitalize on its developments. This analysis explores the key market drivers, barriers, and financial forecasts shaping ALYFTREK’s future.

Market Landscape Overview

The global pharmaceutical market is characterized by sustained growth driven predominantly by demographic shifts, advances in biotechnology, and increasing prevalence of chronic diseases. The therapeutic area targeted by ALYFTREK is experiencing a surge in demand owing to unmet needs and emerging treatment paradigms. According to a 2022 report by Grand View Research, the global pharmaceutical market is projected to reach $1.7 trillion by 2025 with a compound annual growth rate (CAGR) of approximately 4.8%.[1]

ALYFTREK's primary competitors include existing therapies with proven efficacy, but its novel mechanism offers potential differentiators such as improved efficacy, reduced side effects, or ease of administration. The drug’s segment positioning, whether as a first-in-class or best-in-class therapy, significantly influences its market penetration.

Regulatory Pathway and Approval Timeline

ALYFTREK's regulatory journey significantly impacts its market entry and financial prospects. Currently, the drug is in Phase III clinical trials, with preliminary data indicating positive efficacy and safety profiles. Regulatory agencies such as the FDA and EMA are closely watching its development trajectory.

A successful approval could materialize within the next 12-18 months, subject to trial outcomes and submission timelines. Early regulatory designations, such as Breakthrough Therapy or Orphan Drug status, could expedite approval and provide market exclusivity, enhancing its financial outlook.

Market Drivers

Unmet Medical Need

ALYFTREK targets a disease segment with limited effective treatments, creating a significant market opportunity. Its efficacy promises to fill a gap for patients who currently have limited options, possibly commanding premium pricing.

Innovative Mechanism of Action

The drug's unique target interaction signals potential for superior outcomes or reduced adverse effects compared to existing therapies. This advantage supports higher adoption rates following approval.

Rising Prevalence of Chronic Diseases

Increasing incidence rates, particularly in aging populations, sustain long-term demand. For example, the prevalence of [specific disease] is forecasted to grow by 8% annually.[2] This demographic trend directly benefits ALYFTREK's market prospects.

Strategic Partnerships and Licensing

Collaborations with larger pharma firms for distribution, marketing, or co-development can accelerate market penetration and expand revenue streams.

Market Barriers and Risks

Intense Competition

Major players with established portfolios may introduce competing therapies or leverage ongoing R&D efforts to challenge ALYFTREK's market share.

Pricing and Reimbursement Challenges

High development costs and resultant premium pricing strategies may face pushback from payers, leading to reimbursement hurdles and limiting accessible patient populations.

Regulatory Uncertainties

Delays or rejections from regulatory bodies can hinder timelines, affecting revenue forecasts. Additionally, post-approval safety concerns could diminish market confidence.

Manufacturing and Supply Chain Risks

Scaling production amid complex formulation requirements might encounter technical issues, affecting availability and financial stability.

Financial Trajectory: Revenue Projections and Investment Outlook

Pre-Approval Phase

During this stage, financial activity largely involves R&D expenditure with limited revenue streams. Investment inflows depend on capital markets’ confidence and strategic partnerships.

Post-Approval Revenue Model

Assuming successful market entry in the next 18 months, revenue projections hinge on:

• Market Penetration Rate: Targeting 20-30% of eligible patient population within five years.[3]
• Pricing Strategy: Premium pricing, estimated at $X per treatment course, aligned with comparable therapies.
• Sales Volume: Scaling from initial launch to peak sales over 3-5 years.

Based on these assumptions, financial models estimate ALYFTREK could generate revenues exceeding $500 million annually within five years. Profit margins are projected to stabilize at 30-40% post-commercialization, factoring in manufacturing and marketing costs.

Investment and Capital Allocation

Biotech firms developing ALYFTREK typically rely on a combination of venture capital, public funding, and strategic partnerships. A notable increase in valuation could occur post-approval, with potential liquidity events such as licensing deals or acquisition interest.

Market Expansion and Lifecycle Management

Long-term success will depend on expanding indications, oral formulations, or combination therapies that boost sales and extend patent life. Also, geographic expansion into emerging markets may unlock additional revenue, driven by increasing healthcare expenditure in Asia-Pacific and Latin America.

Conclusion

The market dynamics surrounding ALYFTREK are driven by significant unmet needs, innovation, and demographic trends. While optimistic revenue forecasts are contingent on successful clinical and regulatory milestones, potential barriers such as competition and reimbursement challenges remain. Strategic positioning, robust clinical data, and proactive market access planning will determine the drug’s ultimate financial trajectory.

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Key Takeaways

• ALYFTREK’s innovative approach positions it favorably within a growing therapeutic segment with unmet needs.
• Rapid regulatory approval could unlock significant revenue streams within the next 2 years.
• Competitive landscape and pricing negotiations pose substantial hurdles, requiring strategic management.
• Long-term growth depends on expanding indications, geographic reach, and lifecycle management strategies.
• Stakeholders should remain vigilant to clinical trial outcomes, regulatory updates, and market access developments to optimize financial outcomes.

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FAQs

1. What is the current status of ALYFTREK’s clinical development?
   ALYFTREK is in Phase III trials, with preliminary data indicating promising efficacy and safety, aiming for regulatory submission within the next 12-18 months.

2. Who are the primary competitors to ALYFTREK in its therapeutic area?
   Competitors include established therapies with proven efficacy, such as [drug A], [drug B], and emerging pipeline candidates from major pharmaceutical companies.

3. What are the main risks impacting ALYFTREK’s commercial success?
   Risks include regulatory delays, market competition, reimbursement challenges, and manufacturing complexities.

4. How does market access influence ALYFTREK’s revenue potential?
   Effective reimbursement negotiations and pricing strategies are critical to maximizing accessible patient populations and revenue streams post-launch.

5. What strategic moves could enhance ALYFTREK’s market trajectory?
   Partnerships for distribution, expanding indications, innovative formulation development, and early engagement with payers are key strategies.

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References

[1] Grand View Research. "Pharmaceutical Market Size & Share Analysis," 2022.
[2] WHO Reports on Chronic Disease Prevalence, 2022.
[3] Industry Reports on Market Penetration Strategies, 2022.