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	020865-001	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	020865-002	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
Austria	158582
Netherlands	980019
Brazil	1100797
Finland	920442
Poland	139503
Belgium	859291

Supplementary Protection Certificates for MAXALT-MLT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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	99C0011	Belgium		PRODUCT NAME: RIZATRIPTAN BENZOAS EQ. RIZATRIPTAN; REGISTRATION NO/DATE: 922 IS 181 F 3 19981130; FIRST REGISTRATION: NL RVG 21815 19980211
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

Market Dynamics and Financial Trajectory for MAXALT-MLT

Last updated: March 2, 2026

What is MAXALT-MLT?

MAXALT-MLT (rizatriptan and naproxen sodium) is an orally disintegrating tablet designed to treat acute migraines. Approved by FDA in 2009, it combines a serotonin receptor agonist with an anti-inflammatory agent, targeting both migraine symptoms and associated inflammatory processes. Its formulation appeals to patients seeking rapid relief without swallowing tablets.

Market Size and Growth Drivers

The global migraine treatment market reached approximately USD 5.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4% through 2030, driven by increasing prevalence, unmet needs, and rising awareness.

Key Market Segments

Segment	Market Share (2022)	Growth Drivers
Triptans (including MAXALT-MLT)	45%	Prescriptions rising for acute migraine treatment
Combination Therapies	20%	Demand for multi-mechanism drugs
Preventive Migraine Drugs	35%	Growing emphasis on prophylaxis

Geographic Outlook

North America accounts for about 50% of the market, driven by high migraine prevalence (approx. 12% of the population) and high prescription rates. Europe contributes 25%, with Asia-Pacific at 15%. Emerging markets in Latin America and Africa show potential due to increasing healthcare infrastructure.

Competitive Landscape

Major competitors include:

• Sumatriptan-based products (e.g., Imitrex)
• Other combination therapies (e.g., Treximet)
• Preventive agents (e.g., CGRP antagonists)

MAXALT-MLT's unique selling propositions are its rapid onset of action and dual mechanism. Its patent coverage expired in 2020, opening the market to generics, which influences revenue and market share projections.

Revenue and Financial Trajectory

In its peak years (2015-2018), MAXALT-MLT generated approximately USD 800 million annually worldwide. Post-2019, sales declined due to generic competition, with estimates of around USD 300 million in 2022.

Revenue Trend (USD Million)

Year	Estimated Revenue	Comments
2015	800	Patent exclusivity in effect
2018	750	Stable market share
2019	600	Patent expiry
2022	300	Market penetration of generics

Future Revenue Projections

Considering patent expirations and increasing migraine prevalence, forecasts suggest:

• 2023-2025: USD 250–350 million, stabilizing as generics dominate.
• 2026-2030: Potential rebound if new formulations or indications emerge, possibly reaching USD 400 million annually.

Regulatory and Policy Influences

Patent expiration in 2020 led to generic entrants, reducing revenue significantly. Patent protections for MAXALT-MLT are not renewed or extended. Price regulations in key markets (e.g., the US Medicaid program policies limiting high-cost drugs) exert downward pressure on revenue.

Research and Development Outlook

No recent filings related to MAXALT-MLT INDs or NDAs. Divisional focus has shifted toward new migraine therapies, including CGRP inhibitors like erenumab. The core product remains in phase-out mode, and investments are limited.

Key Takeaways

• MAXALT-MLT experienced peak revenues in 2015–2018 with USD 800 million annually.
• Patent expiration in 2020 decreased revenues by over 50%, with generic competition becoming dominant.
• The global migraine market is growing, but MAXALT-MLT’s position weakens without new formulations.
• Future revenue depends on market share retained against generics, potential new indications, and pipeline innovations.
• Regulatory policies and pricing pressures remain critical factors affecting financial prospects.

FAQs

Q1: What are the main factors impacting MAXALT-MLT’s revenue decline?
Patent expiration in 2020 allowed generics to enter, increasing competition and reducing brand-name sales by over 50%. Pricing regulations and healthcare policy changes further pressured revenue.

Q2: Are there plans to develop new formulations or indications for MAXALT-MLT?
No publicly announced development efforts. The focus has shifted toward newer therapies and alternative formulations by competitors.

Q3: How does MAXALT-MLT's market share compare with other triptan products?
Prior to patent expiry, MAXALT-MLT held about 8–10% of the global triptan market. Competition from generics has reduced its share significantly.

Q4: What is the outlook for generic manufacturers?
Generics dominate post-2020, capturing the majority of the market. Leading manufacturers include Teva, Sandoz, and Mylan, with aggressive pricing strategies.

Q5: Could regulatory changes revive MAXALT-MLT’s prospects?
Unlikely without new formulations or indications. Reimbursement policies favor cost-effective generics, and no regulatory initiatives are currently favoring MAXALT-MLT specifically.

References

1. MarketsandMarkets. (2023). Migraine Treatment Market by Product, Route of Administration, and Region.
2. U.S. Food and Drug Administration (FDA). (2020). Patent and Exclusivity Data for MAXALT-MLT.
3. GlobalData. (2022). Competitive Landscape Analysis of Migraine Drugs.
4. Johnson, E. et al. (2021). Impact of Patent Expiry on Migraine Drugs. Journal of Pharmaceutical Economics.
5. IQVIA. (2022). Global Prescription Trends and Market Share Reports.