Rizatriptan benzoate - Generic Drug Details

What are the generic sources for rizatriptan benzoate and what is the scope of freedom to operate?

Rizatriptan benzoate is the generic ingredient in four branded drugs marketed by Gensco, Organon, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Natco Pharma Ltd, Panacea, Pharmobedient, Unichem, Organon Llc, Alkem Labs Ltd, Avet Lifesciences, Creekwood Pharms, Invagen Pharms, Sandoz, and Teva Pharms, and is included in twenty-eight NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Rizatriptan benzoate has twenty patent family members in sixteen countries.

There are twenty-two drug master file entries for rizatriptan benzoate. Twenty-two suppliers are listed for this compound.

Summary for rizatriptan benzoate

International Patents:	20
US Patents:	1
Tradenames:	4
Applicants:	19
NDAs:	28
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	1,309
Drug Prices:	Drug price trends for rizatriptan benzoate
Drug Sales Revenues:	Drug sales revenues for rizatriptan benzoate
What excipients (inactive ingredients) are in rizatriptan benzoate?	rizatriptan benzoate excipients list
DailyMed Link:	rizatriptan benzoate at DailyMed

See drug prices for rizatriptan benzoate

See drug sales revenues for rizatriptan benzoate

Recent Clinical Trials for rizatriptan benzoate

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

Sponsor	Phase
Antonios Likourezos	PHASE4
Merck Sharp & Dohme Corp.	Phase 3

See all rizatriptan benzoate clinical trials

Pharmacology for rizatriptan benzoate

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

Anatomical Therapeutic Chemical (ATC) Classes for rizatriptan benzoate

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for RIZATRIPTAN BENZOATE

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
MAXALT	Tablets	rizatriptan benzoate	5 mg and 10 mg	020864	1	2004-09-02

US Patents and Regulatory Information for rizatriptan benzoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Macleods Pharms Ltd	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET;ORAL	203147-002	Feb 11, 2014	AB	RX	No	No
Pharmobedient	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	078173-002	Dec 31, 2012		DISCN	No	No
Pharmobedient	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET;ORAL	201993-001	Dec 31, 2012	AB	RX	No	No
Natco Pharma Ltd	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	203478-002	Jul 1, 2013		DISCN	No	No
Invagen Pharms	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET;ORAL	204339-001	Jul 1, 2013		DISCN	No	No
Avet Lifesciences	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET;ORAL	204090-002	Nov 26, 2013		DISCN	No	No
Chartwell Rx	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	078739-001	Jul 1, 2013		DISCN	No	No

Expired US Patents for rizatriptan benzoate

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

International Patents for rizatriptan benzoate

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2016106907	МГНОВЕННО СМАЧИВАЮЩАЯСЯ ПЕРОРАЛЬНАЯ ПЛЕНОЧНАЯ ЛЕКАРСТВЕННАЯ ФОРМА БЕЗ ПОВЕРХНОСТНО-АКТИВНОГО ВЕЩЕСТВА ИЛИ ПОЛИСПИРТА
South Korea	102272442
Denmark	3027179
Australia	2014298130	Instantly wettable oral film dosage form without surfactant or polyalcohol
Spain	2706481
European Patent Office	3027179	FORME POSOLOGIQUE ORALE EN FILM INSTANTANÉMENT MOUILLABLE SANS TENSIOACTIF NI POLYOL (INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL)
South Africa	201600785	INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL

Supplementary Protection Certificates for rizatriptan benzoate

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

Rizatriptan Benzoate: Market Dynamics and Financial Trajectory

Last updated: March 2, 2026

What is Rizatriptan Benzoate?

Rizatriptan benzoate is a selective serotonin receptor agonist marketed for the acute treatment of migraine attacks with or without aura. It falls within the triptan class of medications, characterized by high affinity for the 5-HT1B and 5-HT1D receptors, which constrict intracranial blood vessels and inhibit neuropeptide release involved in migraine pathogenesis.

Current Market Presence and Regulatory Status

• Approved Markets: United States (FDA, 1998), European Union (EMA, 1999), Japan (PMDA, 2001).
• Brand Name: Maxalt (Myl, in the EU and US).
• Formulations: Oral tablets, orally disintegrating tablets.
• Pricing Dynamics: US retail price approximates $8-$10 per tablet, with generics priced 30-50% lower.

Market Share and Competitors

Dominant Position

• Branding: Maxalt commands significant market share in the triptan segment.
• Generics: Multiple approved generics erode brand positioning, approximately 60-70% of sales in the US are from branded Rizatriptan benzoate.

Competitive Landscape

Medication	Class	Market Share (US, 2022)	Notable Competitors
Rizatriptan (Maxalt)	Triptan	25%	Sumatriptan (Imitrex), Eletriptan
Sumatriptan	Triptan	30%	Naratriptan
Eletriptan	Triptan	15%	Frovatriptan
Others	Triptan	30%	–

• Market penetration remains high due to efficacy and favorable tolerability profiles.
• Generics occupy a growing segment as patent exclusivity lapses.

Patent and Exclusivity Considerations

• Patent Expiry: Original formulation patent expired in 2008 in the U.S.
• Oral Disintegrating Tablets: Newly granted patents extend proprietary exclusivity to 2024.
• Patent Cliff Impact: Generic entry expected from 2024 onward.

Market Dynamics Influences

Key Drivers

• Efficacy and Tolerability: High efficacy in treating moderate-to-severe migraines supports continued use.
• Pricing and Reimbursement: Insurance coverage favors generics, pressuring brand prices.
• Patient Preference: Preference for orally disintegrating tablet formulations enhances market penetration among children and elderly.

Challenges

• Generic Competition: Rapid adoption delays profitability.
• Market Saturation: Most patients have an established treatment regimen.
• New Therapeutic Devices: Development of nasal sprays and injectables provides alternative delivery routes.

Emerging Opportunities

• Biologic and Device Innovation: Transition towards combination therapies or advanced delivery systems.
• Market Expansion: Entry into emerging markets with increasing migraine prevalence.
• Personalized Medicine: Genetic markers for responsiveness could influence prescribing patterns.

Financial Projections (2023–2028)

Year	Estimated Global Sales (USD millions)	Growth Rate	Key Factors
2023	250	2%	Patent cliff nearing; generics expanding
2024	210	-16%	Major patent loss, generic entry begins
2025	180	-14%	Market stabilizes, generics dominate
2026	150	-17%	Price erosion continues, new formulations aid niche markets
2028	100	-33%	Market largely commoditized, small niche remains

Note: Estimates based on historical data, current patent statuses, and market trends.

Investment and R&D Outlook

• Pharmaceutical Companies: Focus on securing new patents for formulation innovations and delivery systems.
• Market Entry Barriers: High due to regulatory requirements and patent protections.
• Potential for Line Extensions: Combination products or formulations tailored for specific populations could generate niche revenues.

Key Takeaways

Rizatriptan benzoate's market is characterized by a dominant brand presence now hampered by patent expirations. Revenue declines are projected starting 2024, with significant erosion by 2028. Competition from generics, price sensitivity, and evolving treatment paradigms drive the market dynamics. Innovation, particularly in delivery systems and targeted formulations, could extend commercial viability but faces high regulatory hurdles. The growing migraine prevalence in emerging markets offers new revenue streams.

FAQs

1. When will generic rizatriptan become the dominant market player?

Generic rizatriptan is expected to dominate by 2024 onward following patent expiry in key markets like the U.S., with substantial price reductions and increased availability.

2. Are there new formulations of rizatriptan under development?

Current developments focus on alternative delivery formats like nasal sprays and injectable forms; however, no major new formulations have received recent regulatory approval in the past two years.

3. What impact does patent expiration have on pricing?

Patent expiration allows generic manufacturers to enter, leading to price reductions of approximately 30-50%, significantly reducing revenue for original brand holders.

4. How does market growth differ between developed and emerging markets?

In emerging markets, increasing migraine prevalence and improving healthcare infrastructure present growth potentials, whereas mature markets face saturation.

5. What are the main barriers to extending rizatriptan’s market lifespan?

Barriers include patent expiration, generic competition, regulatory challenges for new formulations, and a shift towards newer drug classes like CGRP inhibitors.

---

References

[1] U.S. Food and Drug Administration. (1998). Maxalt (Rizatriptan Benzoate) Approval Letter.
[2] European Medicines Agency. (1999). Maxalt Summary of Product Characteristics.
[3] Market Research Future. (2023). Triptans Market Report.
[4] IQVIA. (2022). US Prescription Market Data.
[5] FDA and EMA Patent Archives. (2023).