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-two 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	020864-001	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

International Patents for MAXALT

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

Country	Patent Number	Title	Estimated Expiration
Hungary	9200299
Germany	19975007
Norway	180447
Israel	100756	Imidazole triazole and tetrazole derivatives their preparation and pharmaceutical compositions containing them
China	1161967
Greece	3036864

Supplementary Protection Certificates for MAXALT

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

Market Dynamics and Financial Trajectory for Maxalt

Last updated: February 20, 2026

What is Maxalt and its market positioning?

Maxalt (rizatriptan) is a selective serotonin receptor agonist indicated for the acute treatment of migraines. It is a branded medication with multiple formulations, including tablets and orally disintegrating tablets. Introduced in 1997 by Merck, Maxalt is part of the triptan class known for fast onset and efficacy.

Its market position relies heavily on its efficacy, safety profile, and patent status. Although patent exclusivity has expired in some jurisdictions, the original formulation remains a preferred choice for certain providers.

How has the market for migraine treatments evolved with Maxalt?

Prevalence and Diagnosis:
Migraine affects about 15% of the global population, estimated at over 1.2 billion people worldwide [1]. Diagnosis and treatment optimization have driven demand for effective acute therapies like Maxalt.

Competitive Landscape:
Maxalt faces competition from generics and newer biphasic formulations. Major competitors include:

• Sumatriptan (and other triptans, available generically)
• One-off drugs like gepants (e.g., ubrogepant)
• Ditans (e.g., lasmiditan)

Market penetration:
Maxalt has a significant share in developed markets, especially among patients preferring oral formulations. However, market penetration in emerging economies is limited by availability and reimbursement hurdles.

Regulatory environment:
Regulatory approvals for generics and new formulations influence Maxalt's market dynamics. Patent expirations in 2007 for the original formulation opened market share to generics.

What are the key factors impacting Maxalt's sales?

Patent and patent expirations

• Original patent expiry: 2007 in the US, leading to increased generic competition.
• Current exclusivity: Some formulations and trademarks are still protected until they face generic competition or patent law expiration.

Formulation innovations

• Oral disintegrating tablets launched after original release.
• No significant new patents for reformulations, limiting innovative growth.

Reimbursement and pricing policies

• Insurance coverage impacts prescribing practices.
• Generics have driven down prices, affecting profit margins of branded Maxalt.

Off-label and alternative therapies

• Increased adoption of CGRP antagonists and gepants provide alternatives.
• Preference for newer options with fewer contraindications influences Maxalt's market share.

How does Maxalt’s financial trajectory look?

Revenue trends

• Peak sales near $300 million globally in late 2000s.
• Post-generic entry, US sales declined sharply, reaching approximately $50 million in 2015.
• Recent global sales stabilize around $100 million annually, primarily in Europe and Asia.

Market share

Year	Maxalt US Market Share	Generics Market Share	Growth Drivers
2010	60%	40%	Branding strength, physician preference
2015	20%	80%	Generic competition, price sensitivity
2022	25%	75%	Limited reformulation development, new therapies uptake

Research and Development (R&D) impact

• Limited investment post-patent expiry.
• Focus shifted to formulations with improved delivery but no major breakthroughs.

Future revenue outlook

• Patent cliff mostly passed.
• Market is transitioning toward newer therapies.
• Limited pipeline reduces potential for significant revenue growth.

Which regulatory and market trends influence Maxalt's future?

• Increased approval of gepants and ditans reduces reliance on triptans.
• Growing preference for personalized medicine affects prescribing.
• Reimbursement policies favor generics, putting sustainable price pressure on branded products.
• The potential introduction of combination therapies could limit Maxalt’s market share.

What strategic options exist for Maxalt?

• Development of new formulations or delivery mechanisms.
• Expansion into emerging markets where migraine treatment access improves.
• Strategic licensing or partnership to extend patent protections or develop biosimilars.

Key Takeaways

• Maxalt's market dominance declined sharply post-2007 patent expiry.
• Generic competition accounts for most of its revenue decline.
• The shift toward newer migraine therapies limits growth prospects.
• Future revenue relies on niche markets, formulary retention, and potential reformulation efforts.

FAQs

1. Will Maxalt regain market share with new formulations?

Unlikely. The absence of significant innovation and the dominance of generics and newer therapies make a substantial rebound improbable.

2. How does Maxalt compare price-wise with its competitors?

Branded Maxalt traditionally commands higher prices than generics. The introduction of generics and newer therapies has driven prices downward, reducing profit margins.

3. What is the outlook for Maxalt in emerging markets?

Growth depends on regulatory approvals, local reimbursement policies, and healthcare infrastructure. Currently, market penetration is limited but may improve as migraine diagnosis and treatment access expand.

4. Are new triptan formulations in development for Maxalt?

No. Merck has not announced significant investment in new Maxalt formulations. Focus has shifted to emerging drug classes.

5. How does Maxalt's safety profile impact its market?

Maxalt maintains a favorable safety profile, but newer options with fewer contraindications are preferred for certain patient populations.

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References

[1] World Health Organization. (2022). Headache disorders. WHO. https://www.who.int/news-room/fact-sheets/detail/headache-disorders

[2] IQVIA. (2023). Global Prescription Data. IQVIA Institute.

[3] U.S. Food and Drug Administration. (2022). Rizatriptan Tablets. FDA Drug Approvals.