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 fifty-seven 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 May 17, 2032. This may change due to patent challenges or generic licensing.

There have been twenty-two 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:	557
US Patents:	33
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALYFTREK

US Patents and Regulatory Information for ALYFTREK

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

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

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Malaysia

Mexico

Montenegro

Poland

Portugal

San Marino

Serbia

Slovenia

Spain

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	2007235260
Brazil	PI0710965
Canada	2648719
Canada	2869945
China	101460489
China	103254177

Supplementary Protection Certificates for ALYFTREK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	617	Finland
1773816	2015/036	Ireland		PRODUCT NAME: N-(5-HYDROXYL-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE (IVACAFTOR) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
1773816	C201530042	Spain		PRODUCT NAME: N-(5-HIDROXI-2, 4-DI-TERC-BUTIL-FENIL)-4-OXO-1H-QUINOLIN-3-CARBOXAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/12/782; DATE OF AUTHORISATION: 20120723; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/782; DATE OF FIRST AUTHORISATION IN EEA: 20120723
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	C20253011	Finland
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

ALYFTREK (Fezolinetant) Investment Analysis

Last updated: February 19, 2026

This report analyzes the investment landscape for ALYFTREK (fezolinetant), a novel neurokinin-3 receptor antagonist developed by Astellas Pharma for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. The analysis covers market opportunity, competitive landscape, intellectual property, regulatory status, and key financial considerations.

What is the Market Opportunity for ALYFTREK?

The market for menopausal symptom management is substantial and growing, driven by an aging global population and increased awareness of the impact of menopausal symptoms on quality of life. ALYFTREK targets VMS, a prevalent and often debilitating symptom.

• Target Patient Population: The U.S. Food and Drug Administration (FDA) approved ALYFTREK in May 2023 for the treatment of moderate to severe VMS associated with menopause. The target population includes millions of women experiencing hot flashes and night sweats.
• Prevalence of Menopausal Symptoms:
  • An estimated 1 million women in the U.S. experience menopause annually.
  • Approximately 75% of perimenopausal and postmenopausal women in the U.S. experience VMS.
  • A significant portion of these women experience moderate to severe symptoms requiring treatment.
• Unmet Need: While hormone replacement therapy (HRT) has been a traditional treatment, concerns regarding its long-term risks (e.g., cardiovascular disease, certain cancers) have led to a demand for non-hormonal alternatives. ALYFTREK offers a non-hormonal mechanism of action.
• Market Size Projections: While specific figures for the fezolinetant market are proprietary, the broader menopausal symptom management market is projected to grow. A market research report from Grand View Research projected the global menopause market size to be valued at USD 22.4 billion in 2022 and expects it to grow at a compound annual growth rate (CAGR) of 5.3% from 2023 to 2030.

What is the Competitive Landscape for ALYFTREK?

The competitive landscape for menopausal symptom management includes existing therapies and emerging treatments. ALYFTREK's primary differentiator is its novel, non-hormonal mechanism targeting the KNDy neurons.

Existing Therapies

• Hormone Replacement Therapy (HRT):
  • Estrogen Therapy: The most effective treatment for VMS, but carries risks like increased risk of blood clots, stroke, breast cancer, and endometrial cancer.
  • Progestin Therapy: Often used in combination with estrogen to protect the endometrium, but also carries risks.
  • Tibolone: A synthetic steroid with tissue-selective estrogenic, progestogenic, and androgenic activity.
• Non-Hormonal Therapies (Prescription):
  • SSRIs/SNRIs: Certain selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), such as paroxetine, escitalopram, and venlafaxine, are approved and used off-label for VMS. Their efficacy is generally considered less potent than HRT.
  • Gabapentin: An anticonvulsant used off-label for VMS, particularly effective for night sweats.
  • Clonidine: An alpha-2 adrenergic agonist used off-label.
• Non-Hormonal Therapies (Over-the-Counter/Dietary Supplements):
  • Phytoestrogens (e.g., soy isoflavones), black cohosh, red clover. Efficacy is often variable and not supported by robust clinical data for severe symptoms.

Emerging Treatments and Competitors

The development of non-hormonal therapies is a key area of innovation.

• Neurokinin Receptor Antagonists: Other companies are exploring NK3 antagonists, positioning fezolinetant as a first-mover in this class for VMS.
  • Belapectrum (Fezolinetant): The trade name for fezolinetant in the U.S. market.
  • Veozah (Fezolinetant): The trade name for fezolinetant in Japan.
  • Other NK3 Antagonists in Development: Various other companies have NK3 antagonist candidates in earlier stages of development, but none have reached market approval for VMS to date.
• Other Novel Mechanisms: Research is ongoing into other pathways for VMS treatment, but NK3 antagonism currently represents the most advanced novel non-hormonal approach to market.

What is ALYFTREK's Intellectual Property Position?

A robust intellectual property portfolio is critical for protecting market exclusivity and justifying R&D investment. Astellas Pharma holds key patents for fezolinetant.

• Composition of Matter Patents: These are typically the strongest patents, covering the molecule itself. Specific patent numbers and expiry dates are critical for assessing long-term protection.
• Method of Use Patents: These patents cover specific indications (e.g., treatment of VMS), formulations, or dosing regimens.
• Formulation Patents: Patents on specific drug delivery systems or formulations can extend exclusivity.
• Patent Expiry: The expiry dates of core patents are essential for estimating the period of market exclusivity. While precise details are often found in patent databases, key patents protecting fezolinetant are expected to provide protection through the mid-to-late 2030s, with potential for extensions through the U.S. Hatch-Waxman Act. For example, US Patent No. 8,975,257, covering certain crystalline forms of fezolinetant, was granted in 2015 and has an expiry date in 2031. Additional patents related to its synthesis and use are also in force.
• Orphan Drug Exclusivity (ODE): Not applicable for fezolinetant as VMS is not a rare disease.
• New Chemical Entity (NCE) Exclusivity: In the U.S., NCE exclusivity is typically 5 years from approval, during which the FDA cannot accept an ANDA (Abbreviated New Drug Application) for a generic version of the same molecule. ALYFTREK received NCE exclusivity upon its FDA approval in May 2023.

What is the Regulatory Status of ALYFTREK?

Regulatory approvals are the gateway to market access. ALYFTREK has secured key approvals.

• United States:
  • FDA Approval: May 2023.
  • Indication: Treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause.
  • FDA Label: The prescribing information includes a boxed warning regarding the potential for liver enzyme elevations. Patients are advised to undergo liver enzyme monitoring.
• Japan:
  • PMDA Approval: January 2024 (under the brand name Veozah).
  • Indication: Treatment of VMS associated with menopause.
• European Union:
  • EMA Submission: Astellas submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in December 2022. The review process is ongoing.
• Other Regions: Filings in other major pharmaceutical markets are anticipated.

Post-Market Surveillance and Potential Labeling Changes

• Liver Enzyme Monitoring: The requirement for liver enzyme monitoring is a significant aspect of the prescribing information and may influence patient and physician uptake. Post-market studies will be crucial for further characterizing liver safety.
• Risk Evaluation and Mitigation Strategies (REMS): Currently, no REMS program is mandated for ALYFTREK, but this can evolve based on post-market data.

What are the Key Financial and Commercial Considerations?

Investment decisions require an understanding of market dynamics, pricing, sales forecasts, and the financial health of the parent company.

• Pricing Strategy: The price of ALYFTREK will be a critical determinant of market penetration and revenue generation. Pricing will be benchmarked against existing HRT and non-hormonal prescription therapies.
  • Estimated Launch Price: While specific pricing is not publicly disclosed, estimates for novel non-hormonal menopausal therapies can range from $150-$400 per month, depending on formulary access and copay assistance programs.
• Sales Forecasts: Analysts' consensus sales forecasts for ALYFTREK are essential for valuation. These forecasts will consider:
  • Market Penetration: The rate at which ALYFTREK captures market share from existing treatments.
  • Physician Adoption: The willingness of healthcare providers to prescribe the drug.
  • Patient Adherence: The ability of patients to remain on therapy.
  • Reimbursement Landscape: The extent to which ALYFTREK is covered by insurance plans.
• Astellas Pharma's Financial Strength: As a subsidiary of Astellas Pharma, ALYFTREK's performance is integrated into the parent company's overall financial results. Astellas Pharma's R&D pipeline, existing revenue streams, and financial stability are relevant.
  • Astellas Pharma Revenue (FY2022): ¥1,343.9 billion (approximately $9.9 billion USD at an exchange rate of 136 JPY/USD).
  • Astellas Pharma Net Income (FY2022): ¥123.8 billion (approximately $0.91 billion USD).
  • R&D Investment: Astellas Pharma’s continued investment in women's health and other therapeutic areas indicates a commitment to growth.
• Commercialization Strategy: Astellas' marketing and sales efforts will be crucial for driving awareness and adoption. This includes physician education, direct-to-consumer advertising (where permitted), and patient support programs.

Potential Challenges

• Liver Safety Monitoring: The boxed warning and requirement for liver monitoring may deter some patients and prescribers, creating a barrier to widespread adoption compared to therapies without such requirements.
• Competition: While a first-in-class NK3 antagonist, ALYFTREK will face competition from established HRT and other non-hormonal options, including generic SSRIs/SNRIs.
• Reimbursement Hurdles: Securing favorable formulary placement and reimbursement from payers is critical. Payers may scrutinize the efficacy and safety profile against existing lower-cost options.

Key Takeaways

• ALYFTREK (fezolinetant) addresses a significant unmet need in the large and growing menopausal symptom management market with a novel, non-hormonal mechanism.
• Astellas Pharma holds a strong intellectual property position, with core patents expected to provide exclusivity through the mid-to-late 2030s.
• The drug has received FDA approval in the U.S. and PMDA approval in Japan, with EMA review ongoing.
• The primary commercial challenge is the boxed warning regarding liver enzyme elevations, necessitating patient monitoring and potentially impacting uptake.
• Investment valuation hinges on realistic sales forecasts considering market penetration, physician adoption, reimbursement, and the competitive landscape.

Frequently Asked Questions

1. What is the primary mechanism of action for ALYFTREK? ALYFTREK is a selective neurokinin-3 (NK3) receptor antagonist. It works by targeting the KNDy (kisspeptin/neurokinin B/dynorphin) neurons in the hypothalamus, which are believed to play a role in thermoregulation and the generation of hot flashes and night sweats during menopause.
2. What are the key safety concerns highlighted in ALYFTREK's prescribing information? The U.S. prescribing information for ALYFTREK includes a boxed warning for potential elevations in liver enzymes (transaminases). Patients are advised to undergo liver enzyme monitoring.
3. What is the expected duration of market exclusivity for ALYFTREK? Based on Astellas Pharma's patent portfolio, ALYFTREK is expected to have market exclusivity through the mid-to-late 2030s, with potential for extensions. The U.S. also provides 5 years of New Chemical Entity (NCE) exclusivity from the date of its May 2023 approval.
4. How does ALYFTREK compare to existing non-hormonal treatments for VMS? While SSRIs/SNRIs and gabapentin are established non-hormonal options, ALYFTREK represents a novel mechanism of action specifically targeting the neurobiological pathways underlying VMS. Clinical trials have demonstrated its efficacy in reducing the frequency and severity of hot flashes. However, the safety profile, including the need for liver monitoring, differentiates it from many existing non-hormonal agents.
5. What is the estimated annual revenue potential for ALYFTREK? Specific revenue forecasts are proprietary and subject to analyst projections. Key drivers for revenue include pricing, market penetration rates, physician and patient adoption, and the reimbursement landscape. Analysts' consensus reports and financial disclosures from Astellas Pharma provide the most current estimates.

Citations

[1] Grand View Research. (2023). Menopause Market Size, Share & Trends Analysis Report By Phase Of Menopause, By Treatment, By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/menopause-market [2] Astellas Pharma Inc. (2023, May 9). Astellas Announces U.S. FDA Approval of Veozah™ (fezolinetant) for Moderate to Severe Vasomotor Symptoms Due to Menopause. [Press Release]. [3] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-Approved Drugs. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ [4] U.S. Patent and Trademark Office. (n.d.). Patent Public Search. Retrieved from https://ppubs.uspto.gov/pubwebapp/static/pages/landing.html [5] Astellas Pharma Inc. (2023, April 28). Consolidated Financial Results for the Fiscal Year Ended March 31, 2023. [Financial Report].