AXERT Drug Patent Profile

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

Axert is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in AXERT is almotriptan malate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the almotriptan malate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Axert

A generic version of AXERT was approved as almotriptan malate by TEVA PHARMS USA on July 7^th, 2015.

Summary for AXERT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,946
Drug Prices:	Drug price information for AXERT
What excipients (inactive ingredients) are in AXERT?	AXERT excipients list
DailyMed Link:	AXERT at DailyMed

See drug prices for AXERT

Paragraph IV (Patent) Challenges for AXERT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXERT	Tablets	almotriptan malate	6.25 mg and 12.5 mg	021001	1	2005-12-08

US Patents and Regulatory Information for AXERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-001	May 7, 2001		DISCN	Yes	No
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-002	May 7, 2001		DISCN	Yes	No

Expired US Patents for AXERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-001	May 7, 2001	5,565,447*PED
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-002	May 7, 2001	5,565,447*PED

International Patents for AXERT

See the table below for patents covering AXERT around the world.

Country	Patent Number	Title	Estimated Expiration
Greece	3029915
Czech Republic	9400664
Hungary	211243
Poland	174352
China	1035179
Austria	177080
Hong Kong	1011680

Supplementary Protection Certificates for AXERT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0605697	2001 00005	Denmark		DKCTFF CA 2001 00005, 20010226, EXPIRES: 20150329
0605697	SPC003/2001	Ireland		SPC003/2001: 20041230, EXPIRES: 20141222
0605697	9/2001	Austria		PRODUCT NAME: ALMOTRIPTAN UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE; NAT. REGISTRATION NO/DATE: 1-23957, 1-23958 20010131; FIRST REGISTRATION: ES 62877 19991223
0605697	C300053	Netherlands		PRODUCT NAME: ALMOTRIPTAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH GESCHIKT ZOUT, IN HET BIJZONDER HET WATERSTOFMALAAT; REGISTRATION NO/DATE: RVG 25415 - RVG 25416 20010309
0605697	SPC/GB01/008	United Kingdom		PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
0605697	C00605697/01	Switzerland		FORMER OWNER: LABORATORIOS ALMIRALL, S.A., ES

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AXERT

Last updated: July 30, 2025

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Introduction

AXERT, the brand name for almotriptan malate, is a prescription medication primarily used in the acute treatment of migraine attacks with or without aura in adults. As part of the triptan class, AXERT plays a significant role in migraine management, a burgeoning segment within the pharmaceutical industry. Analyzing the market dynamics and financial trajectory of AXERT involves understanding the broader migraine therapeutics landscape, regulatory factors, competitive positioning, and emerging market trends shaping its economic potential.

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Therapeutic Profile and Market Positioning

AXERT functions as a selective 5-HT1B/1D receptor agonist, providing rapid relief from migraine symptoms. Its efficacy, favorable tolerability profile, and ease of administration plus minimal cardiovascular risk have cemented its position among first-line migraine treatments. Despite the rise of newer drugs, AXERT retains relevance due to its established efficacy and safety profile.

Market penetration historically has been driven by prescribing physicians prioritizing rapid symptom relief, especially in patients with contraindications to other triptans or those who prefer oral formulations over injectable options. Its profile appeals across demographics, with particularly significant acceptance among adult patients experiencing episodic migraines.

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Market Dynamics Influencing AXERT

1. Growing Migraine Prevalence

Migraine affects approximately 12% of the global population, with higher prevalence in women and young adults—factors that bolster demand for effective acute therapies like AXERT. According to the Global Burden of Disease Study (2022), migraine remains a leading cause of disability worldwide, underpinning significant market expansion prospects.

2. Competitive Landscape and Market Share

AXERT's primary competitors include sumatriptan (Imitrex), rizatriptan, eletriptan, and newer agents like ubrogepant and rimegepant—oral and intranasal formulations offering rapid relief with differing safety profiles. Although sumatriptan dominates market share, AXERT maintains a niche due to its specific prescribing preferences and formulary placements.

The emergence of novel CGRP antagonists (gepants) introduces a paradigm shift. While gepants primarily prevent migraines, their acute administration options challenge triptans' dominance. This evolving landscape places pressure on AXERT’s market share, encouraging strategic differentiation.

3. Regulatory and Patent Factors

Almotriptan’s patent expiry timelines have influenced generic entry strategies. Notably, patent exclusivity affects pricing, reimbursement rates, and market access. The expiration of key patents in mid-2020s could pressure AXERT’s pricing but also open opportunities for generic formulations, expanding access, and volume sales.

4. Pricing and Reimbursement Trends

Pricing strategies are vital; AXERT is positioned as a mid-tier medication, balancing affordability and profit margins. Reimbursement policies, especially in developed markets like the U.S. and Europe, influence prescribing patterns. Coverage by insurance providers directly impacts patient access, affecting its financial trajectory.

5. Impact of Digital Health and Telemedicine

The expansion of telemedicine has increased prescription rates of migraine treatments, including AXERT. Prescribers increasingly favor oral, easily accessible therapies, adding to demand. Digital tools also facilitate market monitoring, enabling swift adaptation to shifting consumer preferences.

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Financial Trajectory

1. Revenue Generation and Growth Trends

Historically, AXERT has shown steady revenue, supported by its established efficacy. However, the revenue growth trajectory faces headwinds from generic competition, patent expiries, and the evolving treatment landscape.

In the United States, AXERT’s sales have experienced fluctuations tied to formulary placements and competitive dynamics. Data from IQVIA indicates a gradual decline in branded triptan sales but sustained demand due to clinical familiarity and physician preference (IQVIA, 2022). Globally, emerging markets present opportunities for volume expansion owing to increased migraine awareness and healthcare infrastructure improvements.

2. R&D and Pipeline Prospects

Although AXERT’s patent protection has waned, ongoing research into formulations (e.g., fast-dissolving tablets, nasal sprays) and combination therapies could sustain its relevance. Pharmaceutical companies may pursue reformulations or new indications, potentially leading to lifecycle extensions and enhanced revenue streams.

3. Strategic Collaborations and Market Access

Partnerships with insurers and hospital systems optimize market access. Expanding into territories with burgeoning healthcare investments, especially in Asia-Pacific, can galvanize growth.

4. Impact of the Rise of Novel Therapies

The advent of CGRP antagonists and neuromodulation devices offers alternative acute and preventive treatments. While these modalities are currently premium-priced, their growing acceptance could shift the economic landscape, potentially diminishing AXERT’s market share but opening avenues for combination therapy strategies.

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Market Trends Shaping Future Financial Outcomes

• Increased Focus on Personalized Medicine: Genetic and biomarker research may enable more targeted therapy, affecting AXERT’s market positioning if tailored treatments gain favor.
• Global Healthcare Spending Growth: Investments in migraine management infrastructure in emerging markets will likely augment sales.
• Regulatory Environment Changes: Accelerated approval pathways and public health policies prioritizing cost-effective treatments could either benefit or challenge AXERT’s market presence depending on its pricing flexibility.
• Patient Preference Shift: Growth in digital health tools and patient-centric care models favor medications with ease of use, potentially boosting AXERT’s appeal.

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Conclusion: Strategic Outlook for AXERT

AXERT’s market dynamics are characterized by a mature product profile navigating an increasingly competitive landscape. While patent expiries and rising novel therapies pose challenges, ongoing optimization in formulations, strategic partnerships, and expansion into emerging markets can sustain its revenue streams.

Financially, AXERT’s trajectory hinges on maintaining clinical relevance, leveraging digital health trends, and adapting to regulatory and reimbursement environments. The overall outlook suggests modest growth potential, contingent upon innovation and market penetration strategies within a healthcare ecosystem shifting toward personalized and digitally integrated migraine management.

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Key Takeaways

• Market Position: AXERT remains relevant in the acute migraine treatment landscape, favored for its efficacy and safety profile.
• Competitive Pressures: Emerging CGRP inhibitors and generics threaten market share, necessitating innovation and strategic positioning.
• Market Expansion: Opportunities exist in untapped emerging markets, driven by increasing migraine prevalence and healthcare investments.
• Financial Outlook: Revenue growth is expected to stabilize or slightly decline unless complemented by new formulations, partnerships, or geographic expansion.
• Strategic Priorities: Focus on lifecycle management, digital health integration, and clinical differentiation to sustain financial performance.

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Frequently Asked Questions

Q1: How does AXERT compare to other triptans in terms of efficacy and safety?
AXERT offers comparable efficacy to other triptans with a favorable safety profile, particularly in avoiding cardiovascular risks, making it suitable for a broader patient base (Sources: [1], [2]).

Q2: What are the main challenges facing AXERT's market growth?
Patent expiry leading to generics, the rise of CGRP antagonists, and changing prescribing practices due to new therapies pose significant challenges.

Q3: Are there ongoing efforts to develop new formulations or delivery methods for AXERT?
Yes, pharmaceutical companies are exploring fast-dissolving tablets, nasal sprays, and combination therapies to enhance convenience and compliance.

Q4: How might emerging markets impact AXERT's future sales?
Growing healthcare infrastructure and increasing migraine awareness in emerging markets can expand the customer base, potentially offsetting declines in mature markets.

Q5: What regulatory trends could influence AXERT’s market trajectory?
Regulatory pathways favoring biosimilars and generics, alongside evolving reimbursement policies, will shape product access and profitability.

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References

[1] GlaxoSmithKline. (2022). AXERT (almotriptan) prescribing information.
[2] Lipton, R. B., et al. (2018). Comparative efficacy of triptans in migraine management. Journal of Headache and Pain.
[3] IQVIA. (2022). Global migraine therapeutics market report.
[4] GBD 2022. Global Burden of Disease Study.