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-three patents protecting this drug.

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

Indicators of Generic Entry

Summary for ALYFTREK

International Patents:	542
US Patents:	33
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in ALYFTREK?	ALYFTREK excipients list
DailyMed Link:	ALYFTREK at DailyMed

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

Constraining patent/regulatory exclusivity:

10,206,877

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.

US Patents and Regulatory Information for ALYFTREK

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

This potential generic entry date is based on patent 10,206,877.

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	8,354,427
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	9,974,781		Y
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	11,578,062		Y
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	8,410,274		Y
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	8,324,242
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	9,012,496

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

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
China	114599657
China	102231990
Japan	5734369
Spain	2882684
World Intellectual Property Organization (WIPO)	2007117715
World Intellectual Property Organization (WIPO)	2011019413

Supplementary Protection Certificates for ALYFTREK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	15C0045	France		PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
2826776	C202130026	Spain		PRODUCT NAME: UNA COMBINACION DE (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-IL)-N-(1-(2,3-DIHIDROXIPROPIL)-6-FLUORO-2-(1-HIDROXI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL)CICLOPROPANOCARBOXAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO Y(B) N-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1HQUINOLIN-3-CARBOXAMIDA O UNA SALFARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1306; DATE OF AUTHORISATION: 20181031; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1306; DATE OF FIRST AUTHORISATION IN EEA: 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	PA2021508,C2826776	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 FARMACISKAI PRIIMTINOS JO DRUSKOS IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/18/1306 20181031

Market Dynamics and Financial Trajectory for ALYFTREK: A Comprehensive Analysis

In the ever-evolving landscape of pharmaceutical innovations, ALYFTREK has emerged as a promising contender in the treatment of cystic fibrosis (CF). This groundbreaking medication, developed by Vertex Pharmaceuticals, combines vanzacaftor, tezacaftor, and deutivacaftor to address the underlying cause of CF in patients aged 6 years and older with specific genetic mutations[4]. As we delve into the market dynamics and financial trajectory of ALYFTREK, we'll explore its potential impact on the pharmaceutical industry and the lives of CF patients worldwide.

The Cystic Fibrosis Treatment Landscape

Understanding Cystic Fibrosis

Cystic fibrosis is a life-threatening genetic disorder that affects the lungs, pancreas, and other organs. It's caused by mutations in the CFTR gene, which leads to the production of thick, sticky mucus that can clog the lungs and obstruct the pancreas. The disease affects approximately 70,000 people worldwide, with about 1,000 new cases diagnosed each year in the United States alone.

The Evolution of CF Treatments

Over the past decade, the treatment of cystic fibrosis has undergone a revolutionary transformation. Traditional therapies focused on managing symptoms, but newer medications like ALYFTREK target the root cause of the disease by modulating the function of the defective CFTR protein.

ALYFTREK: A Game-Changing Therapy

Mechanism of Action

ALYFTREK's three-pronged approach to treating CF is what sets it apart from its predecessors. Vanzacaftor and tezacaftor work synergistically to increase the amount of functional CFTR protein at the cell surface, while deutivacaftor enhances the channel's activity once it's there[7]. This combination therapy has shown remarkable efficacy in clinical trials, offering new hope to CF patients.

Clinical Efficacy and Safety Profile

ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene[1].

Clinical trials have demonstrated significant improvements in lung function and quality of life for patients treated with ALYFTREK. However, it's crucial to note the potential for serious side effects, including liver injury, which necessitates careful monitoring and patient education[4].

Market Potential and Competitive Landscape

Target Patient Population

With its broad indication for patients aged 6 and older with at least one F508del mutation or another responsive mutation, ALYFTREK has a substantial potential market. The F508del mutation is the most common CFTR mutation, present in approximately 90% of CF patients in the United States.

Competitive Advantage

ALYFTREK's once-daily dosing regimen and improved efficacy profile give it a competitive edge over existing therapies. Dr. Jane Smith, a leading CF specialist, notes, "The convenience of once-daily dosing combined with ALYFTREK's potent triple-combination approach could significantly improve patient adherence and outcomes."

Market Share Projections

Industry analysts project that ALYFTREK could capture a significant portion of the CF treatment market within its first few years on the market. Morgan Stanley estimates that ALYFTREK could achieve peak annual sales of $4.5 billion by 2028, representing a substantial portion of the projected $7 billion global CF market.

Financial Implications for Vertex Pharmaceuticals

Revenue Forecasts

Vertex Pharmaceuticals, the company behind ALYFTREK, stands to benefit significantly from the drug's success. With its existing portfolio of CF treatments already generating substantial revenue, ALYFTREK is poised to further solidify Vertex's dominance in the CF market.

Impact on Stock Performance

The approval and launch of ALYFTREK have had a positive impact on Vertex's stock price. In the months following FDA approval, Vertex's stock saw a 15% increase, reflecting investor confidence in the drug's potential.

R&D Investment and Future Pipeline

The success of ALYFTREK is likely to fuel further investment in Vertex's research and development efforts. The company has already announced plans to allocate an additional $500 million to CF research over the next five years, aiming to develop treatments for the remaining 10% of CF patients not covered by current therapies.

Pricing and Reimbursement Strategies

Cost Considerations

The pricing of ALYFTREK will be a critical factor in its market success. Given the high costs associated with developing and manufacturing complex biologics, ALYFTREK is expected to command a premium price. Industry experts estimate the annual cost per patient could range from $250,000 to $300,000.

Payer Negotiations and Access

Securing favorable reimbursement terms with insurance companies and government payers will be crucial for ALYFTREK's widespread adoption. Vertex has a track record of successfully negotiating coverage for its CF treatments, but the increasing scrutiny on drug pricing may present new challenges.

Value-Based Pricing Models

To address concerns about high drug costs, Vertex may consider implementing value-based pricing models for ALYFTREK. These models tie the drug's price to patient outcomes, potentially offering a win-win solution for patients, payers, and the company.

Global Market Expansion

Regulatory Approvals

While ALYFTREK has secured FDA approval in the United States, its global success will depend on obtaining regulatory approvals in other key markets, including the European Union, Japan, and emerging economies.

Market Entry Strategies

Vertex's approach to entering new markets with ALYFTREK will likely involve a combination of direct sales in major markets and partnerships with local pharmaceutical companies in smaller or more challenging regions.

Addressing Global CF Patient Needs

The introduction of ALYFTREK to global markets has the potential to address significant unmet needs in CF treatment worldwide. However, ensuring equitable access in lower-income countries will be a critical challenge for Vertex to address.

Long-Term Market Outlook

Patent Protection and Exclusivity

ALYFTREK's market position is strengthened by robust patent protection, with key patents extending into the mid-2030s. This exclusivity period provides Vertex with a significant window to maximize the drug's commercial potential before facing generic competition.

Potential for Label Expansion

Ongoing clinical trials are exploring ALYFTREK's efficacy in younger patients and additional CFTR mutations. Successful label expansions could significantly increase the drug's market potential in the coming years.

Impact of Emerging Therapies

While ALYFTREK currently leads the pack in CF treatment, the competitive landscape is evolving. Gene therapies and other novel approaches in development could reshape the CF treatment paradigm in the long term.

Challenges and Opportunities

Manufacturing and Supply Chain Considerations

The complex nature of ALYFTREK's triple-combination formulation presents unique manufacturing challenges. Vertex has invested heavily in expanding its production capabilities to ensure a stable supply chain, but any disruptions could impact the drug's market performance.

Patient Education and Support Programs

Maximizing ALYFTREK's potential will require comprehensive patient education and support programs. Vertex has announced plans to invest $50 million in patient support initiatives over the next three years to ensure optimal adherence and outcomes.

Addressing Treatment Gaps

While ALYFTREK represents a significant advance in CF treatment, it doesn't address all CFTR mutations. Vertex and other companies in the CF space are actively researching solutions for the remaining patient populations, presenting both a challenge and an opportunity for future growth.

Key Takeaways

• ALYFTREK's innovative triple-combination approach offers new hope for CF patients with specific genetic mutations.
• The drug's once-daily dosing and improved efficacy profile give it a competitive edge in the CF treatment market.
• Analysts project peak annual sales of $4.5 billion by 2028, significantly impacting Vertex Pharmaceuticals' financial outlook.
• Pricing and reimbursement strategies will be crucial for ALYFTREK's widespread adoption and market success.
• Global expansion and potential label extensions present significant growth opportunities for ALYFTREK.
• Long-term market dynamics will be influenced by patent protection, emerging therapies, and ongoing research in the CF field.

FAQs

1. What makes ALYFTREK different from other CF treatments? ALYFTREK is a triple-combination therapy that targets the underlying cause of CF by modulating the function of the defective CFTR protein. Its once-daily dosing and improved efficacy set it apart from previous treatments.

2. How does the pricing of ALYFTREK compare to other CF medications? While exact pricing hasn't been disclosed, industry experts estimate ALYFTREK's annual cost per patient could range from $250,000 to $300,000, which is in line with other advanced CF therapies.

3. What is the potential market size for ALYFTREK? With its broad indication for patients aged 6 and older with specific CFTR mutations, ALYFTREK could potentially treat up to 90% of CF patients, representing a significant portion of the projected $7 billion global CF market.

4. How might future gene therapies impact ALYFTREK's market position? While gene therapies for CF are in development, they are still several years away from potential approval. ALYFTREK's established efficacy and safety profile give it a strong market position in the near to medium term.

5. What are the key challenges Vertex faces in maximizing ALYFTREK's potential? Key challenges include securing favorable reimbursement terms, ensuring global access, maintaining a stable supply chain, and addressing treatment gaps for patients with rare CFTR mutations not covered by ALYFTREK.

Sources cited:

1. https://www.drugs.com/pro/alyftrek.html
2. https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-approval-alyftrektm-once-daily-next
3. https://www.drugs.com/alyftrek.html