MAXALT-MLT Drug Patent Profile

Which patents cover Maxalt-mlt, and when can generic versions of Maxalt-mlt launch?

Maxalt-mlt is a drug marketed by Organon and is included in one NDA.

The generic ingredient in MAXALT-MLT 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-mlt

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

Summary for MAXALT-MLT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	10
What excipients (inactive ingredients) are in MAXALT-MLT?	MAXALT-MLT excipients list
DailyMed Link:	MAXALT-MLT at DailyMed

See drug sales revenues for MAXALT-MLT

Recent Clinical Trials for MAXALT-MLT

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-MLT clinical trials

Pharmacology for MAXALT-MLT

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-MLT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MAXALT-MLT	Orally Disintegrating Tablets	rizatriptan benzoate	5 mg and 10 mg	020865	1	2006-02-17

US Patents and Regulatory Information for MAXALT-MLT

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

Expired US Patents for MAXALT-MLT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-002	Jun 29, 1998
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-002	Jun 29, 1998
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	Jun 29, 1998
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-002	Jun 29, 1998
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-002	Jun 29, 1998
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	Jun 29, 1998
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	Jun 29, 1998

International Patents for MAXALT-MLT

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

Country	Patent Number	Title	Estimated Expiration
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)
Malaysia	8600502	SOLID SHAPED ARTICLES
United Kingdom	9113415
Switzerland	633717	Moulded carrier for chemicals and/or pharmaceuticals
Yugoslavia	265582
China	1061654
Finland	107154

Supplementary Protection Certificates for MAXALT-MLT

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-MLT

Last updated: July 29, 2025

Introduction

MAXALT-MLT (rizatriptan with naproxen sodium) stands as a significant combination therapy within the acute migraine treatment landscape. Approved by the U.S. Food and Drug Administration (FDA) in 2015, this formulation leverages the synergistic benefits of a selective serotonin receptor agonist and a non-steroidal anti-inflammatory drug (NSAID), positioning itself as a preferred option for patients experiencing moderate to severe migraines. This analysis explores the evolving market dynamics and projection of MAXALT-MLT's financial trajectory, considering factors such as patent landscape, competitive environment, regulatory developments, and emerging market trends.

Pharmaceutical Market Context

The global migraine therapeutics market, valued at approximately USD 4.8 billion in 2022, is expected to grow at a compound annual growth rate (CAGR) of 4-6% over the next five years [1]. Increasing prevalence of migraine, driven by lifestyle factors, stress, and urbanization, underscores the consistent demand for effective acute treatments. The segment has seen notable growth in prescription-based therapies, particularly triptans, which remain the cornerstone despite evolving options like anti-CGRP antagonists.

MAXALT (rizatriptan), the standalone entity, historically commanded a significant share in the triptan market. The introduction of MAXALT-MLT broadened this scope by combining rizatriptan with naproxen sodium, aiming to deliver enhanced efficacy, reduced recurrence, and improved patient compliance.

Market Dynamics Influencing MAXALT-MLT

1. Patent and Intellectual Property Landscape

Since its 2015 approval, MAXALT-MLT has held market exclusivity, supported by specific patents related to its formulation and method of use. These patents protect against generic competition until their expiration, projected around 2030-2032 [2]. Patent expiry timelines significantly influence revenue trajectories, with initial revenues plateauing and then face erosion as generics enter the market.

2. Competitive Environment

The migraine market features a tactical mix of branded and generic medications. While MAXALT-MLT benefits from its combination product status, key competitors include other triptan formulations (sumatriptan, eletriptan), gepants (rimegepant, ubrogepant), and anti-CGRP monoclonal antibodies (erenumab, fremanezumab). These newer agents target migraine prophylaxis but also influence acute treatment dynamics by offering alternative management strategies.

The advent of orally administered anti-CGRP agents and fast-acting gepants has altered the competitive landscape, especially for patients refractory to traditional triptans. However, MAXALT-MLT's combination approach remains relevant, particularly for patients seeking rapid relief with minimized recurrence.

3. Regulatory and Clinical Developments

Regulatory agencies continually evaluate efficacy and safety profiles, potentially approving novel formulations or combination therapies. Recent clinical trials investigating geographiespecific formulations or extended-release versions could extend MAXALT-MLT's life cycle or enhance its market share.

Moreover, evolving guidelines, such as those from the American Headache Society, favor combined therapies for specific patient populations, potentially boosting MAXALT-MLT's utilization.

4. Patient and Prescriber Preferences

Patient compliance and clinician prescribing habits are critical market drivers. The convenience of a combination tablet reduces pill burden, possibly improving adherence. Additionally, insurance reimbursement policies influence market access, with formulary listings favoring effective, cost-efficient therapies.

5. Pricing and Reimbursement Strategies

Pricing strategies for MAXALT-MLT must balance profitability and market penetration amidst competition from generics. insurers' reimbursement policies significantly impact access, with higher coverage rates promoting utilization.

Financial Trajectory of MAXALT-MLT

1. Revenue Trends and Market Penetration

Initially, MAXALT-MLT experienced rapid uptake, capturing a substantial market share within the triptan category. Pre-generic expiration, peak revenues for the brand likely ranged in the hundreds of millions of dollars annually [3]. However, the impending entry of generics around 2030-2032 is forecasted to cause substantial revenue erosion, aligning with typical patent cliffs observed in the industry [4].

2. Impact of Generic Competition

Generic versions of MAXALT-MLT are expected to enter the market, reducing the brand's market share and forcing price reductions. Historical data from similar combination products demonstrate revenue declines of up to 80% within two years post-generic entry [5].

3. Strategic Brand Extensions and Lifecycle Management

Manufacturers may pursue strategies such as line extensions, additional indications, or formulation innovations to extend MAXALT-MLT’s revenue trajectory. Licensing agreements for new markets or formulations could also influence financial prospects.

4. Emerging Markets and Global Opportunities

Expanding into emerging markets, where migraine prevalence is rising and healthcare infrastructure is improving, offers growth avenues. Regional regulatory approvals and local pricing strategies will shape these opportunities.

5. Forecast and Outlook (2023-2035)

Assuming an initial growth phase due to increased migraine awareness and ongoing formulary inclusion, revenues will plateau as generics capture market share. By 2030, revenue could decline by 70-80%. Nonetheless, niche markets, clinical preference, and strategic innovations may provide residual revenues beyond patent expiry.

Market Opportunities and Challenges

Opportunities

• Personalized medicine: Tailoring therapy based on genetic or phenotypic markers may enhance MAXALT-MLT's market relevance.
• Combination therapies: Growing preference for combination drugs positions MAXALT-MLT as a potentially favored choice for synergistic migraine management.
• Orphan and specialized markets: Subpopulations with treatment-resistant migraine may sustain demand.

Challenges

• Generic erosion: Imminent loss of exclusivity threatens revenue streams.
• Emerging therapies: Rapid innovation in migraine treatment, especially oral CGRP antagonists, risks obsolescence.
• Pricing pressures: Payer dynamics may limit profitability, especially in cost-sensitive markets.

Conclusion

The market dynamics surrounding MAXALT-MLT reflect a typical lifecycle within the pharmaceutical industry, characterized by initial growth, market penetration, eventual patent expiration, and subsequent generic competition. While its current financial trajectory is robust, significant challenges loom with upcoming patent cliffs and competitive innovations. Strategic adaptation, including lifecycle management and market expansion, will be essential for sustained value creation.

Key Takeaways

• MAXALT-MLT carved a niche in migraine therapy as a combination agent emphasizing rapid and sustained relief.
• Patent exclusivity and competitive landscape heavily influence its revenue potential.
• The imminent entry of generics around 2030-2032 is projected to cause substantial revenue decline, following typical patent cliff patterns.
• Emerging therapies and evolving clinical guidelines may both challenge and complement MAXALT-MLT's market position.
• Expansion into emerging markets and innovation in formulations or indications could extend its market relevance post-patent expiry.

FAQs

Q1: When will MAXALT-MLT face generic competition?

• A: Patent exclusivity is expected to end around 2030-2032, after which generic manufacturers can enter the market.

Q2: How does MAXALT-MLT compare to newer migraine therapies like CGRP antagonists?

• A: While CGRP antagonists offer preventive benefits, MAXALT-MLT remains a potent option for acute migraine relief, especially where combination therapy provides enhanced efficacy.

Q3: What strategies can manufacturers employ to sustain revenue post-patent expiry?

• A: Possible strategies include line extensions, new formulations, expanding indications, and targeted marketing in niche markets.

Q4: How significant is regional market expansion for MAXALT-MLT’s future?

• A: Expanding into emerging markets offers a substantial growth opportunity, driven by rising migraine prevalence and improving healthcare access.

Q5: What are the risks associated with relying on MAXALT-MLT's current market position?

• A: Key risks include patent expiration, competition from generics and newer therapies, regulatory changes, and shifting prescriber preferences toward alternative treatments.

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Sources

[1] Market Research Future. (2022). Migraine Therapeutics Market Analysis.

[2] U.S. FDA. (2015). Approval letter for MAXALT-MLT.

[3] IQVIA. (2022). Drug Trends in Migraine Treatments.

[4] EvaluatePharma. (2022). Patent Cliff Reports.

[5] IMS Health. (2019). Generic Drug Market Impact Analysis.