MAXALT Drug Patent Profile

Which patents cover Maxalt, and what generic alternatives are available?

Maxalt is a drug marketed by Organon Llc and Organon and is included in two NDAs.

The generic ingredient in MAXALT is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Maxalt

A generic version of MAXALT was approved as rizatriptan benzoate by AUROBINDO PHARMA LTD on December 31^st, 2012.

Summary for MAXALT

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	10
Patent Applications:	900
Drug Prices:	Drug price information for MAXALT
What excipients (inactive ingredients) are in MAXALT?	MAXALT excipients list
DailyMed Link:	MAXALT at DailyMed

See drug prices for MAXALT

See drug sales revenues for MAXALT

Recent Clinical Trials for MAXALT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Antonios Likourezos	PHASE4
Robert W. Baloh	Phase 2/Phase 3
Henry M. Jackson Foundation for the Advancement of Military Medicine	N/A

See all MAXALT clinical trials

Pharmacology for MAXALT

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Paragraph IV (Patent) Challenges for MAXALT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MAXALT	Tablets	rizatriptan benzoate	5 mg and 10 mg	020864	1	2004-09-02

US Patents and Regulatory Information for MAXALT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-001	Jun 29, 1998		DISCN	Yes	No
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-002	Jun 29, 1998	AB	RX	Yes	Yes
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-002	Jun 29, 1998	AB	RX	Yes	Yes
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	Jun 29, 1998		DISCN	Yes	No

Expired US Patents for MAXALT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-001	Jun 29, 1998
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-002	Jun 29, 1998
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-002	Jun 29, 1998
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-001	Jun 29, 1998

International Patents for MAXALT

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

Country	Patent Number	Title	Estimated Expiration
Japan	H05140151	IMIDAZOLE, TRIAZOLE AND TETRAZOLE DERIVATIVE
Canada	2060139	DERIVE DE TRIAZOLE (TRIAZOLE DERIVATIVE)
Hungary	T61013
Finland	973845
Australia	1068092
Hungary	222350	Eljárás imidazol-, triazol- és tetrazolszármazékok, valamint az azokat tartalmazó gyógyászati készítmények előállítására (PROCESS FOR PRODUCING IMIDAZOLE, TRAIZOLE AND TETRAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS COMPRISING SAME)
European Patent Office	0778275	Procédé pour la préparation de dérivés d'imidazole, triazole et tetrazole et leur utilisation comme agonistes sélectifs des récepteurs 5-HT-1 (Process for the preparation of imidazole, triazole and tetrazole derivatives and their use as selective 5-HT-1 receptor agonists)

Supplementary Protection Certificates for MAXALT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0497512	28/1998	Austria		PRODUCT NAME: RIZATRIPTAN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE RIZATRIPTANBENZOAT; NAT. REGISTRATION NO/DATE: 1-22636 - 1-22639 19980709; FIRST REGISTRATION: NL 21815 - 21818 19980211
0497512	C980019	Netherlands		PRODUCT NAME: RIZATRIPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZOND ER RIZATRIPTAN-BENZOAAT; REGISTRATION NO/DATE: RVG 21815 - RVG 21818 19980211
0497512	SPC/GB98/035	United Kingdom		PRODUCT NAME: RIZATRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY RIZATRIPTAN BENZOATE; REGISTERED: NL 21815 19980211; NL 21816 19980211; NL 21817 19980211; NL 21818 19980211; UK 00025/0369 19980624; UK 00025/0370 19980624; UK 00025/0371 19980624; UK 00025/0372 19980624
0497512	98C0037	France		PRODUCT NAME: RIZATRIPTAN BENZOATE; REGISTRATION NO/DATE IN FRANCE: NL 23 695 DU 19980817; REGISTRATION NO/DATE AT EEC: 21 815 DU 19980211
0497512	9891028-4	Sweden		PRODUCT NAME: RIZATRIPTAN, N.N-DIMETYL-2-(5-(1, 2, 4-TRIAZOL-1-YLMETYL)-1H-INDOL-3-YL)ET)-1H-I, EVENTUELLT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT, SPECIELLT DA RIZATRIPTANBENSOAT
0497512	99C0011	Belgium		PRODUCT NAME: RIZATRIPTAN BENZOAS EQ. RIZATRIPTAN; REGISTRATION NO/DATE: 922 IS 181 F 3 19981130; FIRST REGISTRATION: NL RVG 21815 19980211

Market Dynamics and Financial Trajectory for MAXALT

Last updated: November 20, 2025

Introduction

MAXALT, known generically as rizatriptan, is a serotonin receptor agonist in the triptan class, approved for the acute treatment of migraine with or without aura. Since its FDA approval in 1998, MAXALT has played a significant role in migraine management, contributing to both pharmaceutical innovation and commercial markets. Its market trajectory is shaped by evolving regulatory landscapes, healthcare reimbursement policies, technological advancements in migraine treatments, and competitive dynamics within the headache therapeutics segment. This analysis provides an in-depth examination of MAXALT’s market environment, financial performance, and future prospects.

Market Overview

Global Migraine Pharmacotherapy and MAXALT’s Position

The global migraine medication market was valued at approximately USD 3.3 billion in 2020 and is projected to reach USD 4.5 billion by 2027, reflecting a compound annual growth rate (CAGR) of around 5%. MAXALT holds a significant niche within this market, primarily in the US, owing to its early approval and strong clinical profile. The drug’s efficacy, rapid onset of action, and favorable safety profile established its reputation among neurologists and primary care physicians.

Despite newer therapies emerging, MAXALT’s role persists, particularly in regions with high prescription volumes for acute migraine management. Its primary competitors include other triptans such as sumatriptan, eletriptan, and third-generation agents like lasmiditan and ubrogepant—novel drugs offering alternative mechanisms and delivery systems.

Drivers of Market Growth

1. Rising Migraine Prevalence: The global migraine prevalence stands at approximately 15%, with higher rates among women and urban populations. Growing awareness and diagnosis have increased demand for targeted therapies like MAXALT.

2. Expanding Healthcare Access: Improved healthcare infrastructure and insurance coverage—especially in developed markets—facilitate prescription and patient access to triptan therapies.

3. Advancements in Drug Delivery: formulations like orally disintegrating tablets (ODT) and nasal sprays have enhanced patient compliance, sustaining demand for MAXALT formulations.

4. Regulatory Approvals for New Indications: While current approvals are specific, ongoing research could extend MAXALT’s label, potentially expanding its market.

Challenges and Constraints

1. Generic Competition: Patent expiry considerations and the availability of generic rizatriptan significantly pressure MAXALT’s market share and pricing power.

2. Emergence of Non-Triptan Options: Drugs like gepants (ubrogepant, rimegepant) and ditans (lasmitidan) provide alternative acute treatments with fewer vascular side effects, impacting triptan prescriptions.

3. Regulatory and Safety Concerns: The vascular contraindications associated with triptans limit their use in patients with cardiovascular risk factors, restricting market scope.

4. Intellectual Property and Patent Landscape: Patent expirations, notably in the early 2010s, have opened the market to generics, leading to revenue erosion.

Financial Trajectory

Revenue Trends and Market Share

Initially, MAXALT achieved strong sales driven by its pioneering position in the triptan market. Its revenue peaked in the late 2000s, with US sales reaching approximately USD 300 million annually in some years. The entry of generics in the early 2010s dramatically reduced branded sales, with revenues declining by roughly 70% over subsequent years.

Despite patent cliffs, the drug retained a modest but steady market share in specialty clinics and among patients with contraindications to newer agents. Market data from IQVIA indicate that, as of 2022, MAXALT's US prescriptions have stabilized at approximately 1 million annually, representing a small fraction of the migraine treatments market but sustaining niche profitability for its manufacturer.

Impact of Generic Competition

The advent of multiple generic rizatriptan formulations precipitated a sharp decline in branded sales and intensified price competition. Average wholesale prices for MAXALT decreased by nearly 60% post-generic entry, compelling the manufacturer to adjust its revenue expectations downward.

R&D and Pipeline Potential

Although MAXALT is a mature product with limited possibilities for expansion within its original patent scope, pharmaceutical companies are exploring formulations combining rizatriptan with novel delivery mechanisms or combination therapies. These innovations could potentially rejuvenate financial returns or preserve market relevance.

Reimbursement and Pricing Dynamics

Insurance coverage heavily influences MAXALT’s revenue, with managed care organizations favoring generics. Conversely, branded MAXALT benefits from formulary placements in specialty clinics and leverage in procurement negotiations, slightly mitigating revenue decline.

Future Market and Financial Outlook

Market Penetration of Next-Generation Therapies

The increasing adoption of gepants and ditans presents a competitive threat to MAXALT, especially among patients seeking non-vascular triptan alternatives. While these newer agents command premium pricing, their safety and efficacy profiles are expanding, which may limit MAXALT’s growth unless repositioned or reformulated.

Digital Health and Remote Management Trends

Telemedicine and digital headache management platforms could influence prescription patterns. As remote diagnosis expands, initial prescriptions may favor newer agents or over-the-counter options, further challenging MAXALT’s market share.

Regulatory and Promotional Strategies

Proactive regulatory strategies—such as pursuing new formulations or indications—and targeted physician education could sustain niche sales. Moreover, developing combination products or superior delivery systems may differentiate MAXALT in a crowded therapeutic landscape.

Financial Forecast Summary

In summary, MAXALT is likely to experience continued revenue decline in its traditional form, consistent with industry trends. However, tailored approaches leveraging its established safety profile, improving formulation convenience, or niche indications could stabilize or slightly boost revenues. Overall, projections suggest a gradual depletion of MAXALT’s financial trajectory unless transformative innovation occurs.

Conclusion

MAXALT’s market dynamics are characterized by a mature product facing headwinds from patent expiry, generic competition, and therapeutic innovation. While it maintains a vital role in specific patient populations, the overall financial trajectory reflects volume declines and pricing pressures prevalent across the triptan class. Sustainable profitably hinges on adaptation through formulation innovation, strategic positioning within niche markets, and alignment with evolving migraine management paradigms.

Key Takeaways

• Patent expiration and generic entries have significantly eroded MAXALT’s revenues, compelling the manufacturer to adapt pricing and marketing strategies.
• Emergence of novel treatments like gepants and ditans provides competitive alternatives, challenging MAXALT’s market dominance.
• Market potential is concentrated among patients contraindicated for newer therapies or requiring specific formulations, offering niche opportunities.
• Innovation in drug delivery and combinations may extend MAXALT’s relevance, but substantial growth prospects remain limited without significant pipeline developments.
• Strategic focus on regulatory filings, patient adherence, and targeted marketing will determine MAXALT’s financial sustainability amid a rapidly evolving therapeutic landscape.

FAQs

1. How does MAXALT compare to newer migraine treatments?
MAXALT offers rapid relief with proven safety, but newer agents like gepants and ditans feature improved safety profiles for cardiovascular patients and different modes of administration, positioning them as alternatives for certain patient groups.

2. What is the impact of generic rizatriptan on MAXALT’s market share?
Generic rizatriptan's introduction caused a substantial revenue decline for MAXALT, with branded sales dropping by approximately 70%, though niche use persists in specific patient populations.

3. Are there ongoing efforts to reformulate MAXALT?
Yes, research includes developing advanced formulations like ODTs and nasal sprays aimed at improving onset and compliance, potentially extending its market relevance.

4. What regions are most significant for MAXALT’s future sales?
The US remains the primary market due to high healthcare access and prescription rates, while emerging markets may offer growth opportunities through increased diagnosis and treatment adoption.

5. How does reimbursement influence MAXALT’s sales?
Insurance policies favor generic formulations, suppressing branded sales. Nonetheless, specialty clinics and formulary placements allow for sustained niche revenues for MAXALT as a branded product.

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References

[1] IQVIA. "Pharmaceutical Market Data & Insights." 2022.
[2] MarketsandMarkets. "Migraine Drugs Market." 2021.
[3] FDA. "Rizatriptan (MAXALT) FDA Approval Details." 1998.
[4] GlobalData. "Migraine Drugs Analytical Review." 2022.