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:	928
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

International Patents for MAXALT

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

Country	Patent Number	Title	Estimated Expiration
Austria	158582
Australia	1068092
Australia	644939
Bulgaria	62024
Brazil	1100797
Canada	2060139	DERIVE DE TRIAZOLE (TRIAZOLE DERIVATIVE)
Canada	2238140	DERIVES DE L'IMIDAZOLE, DU TRIAZOLE ET DU TETRAZOLE (IMIDAZOLE, TRIAZOLE AND TETRAZOLE DERIVATIVES)

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	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	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
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

Last updated: July 29, 2026

Maxalt (rizatriptan): Market Dynamics and Financial Trajectory, Patent/Generic Threat Timeline, and Revenue Exposure

Maxalt (rizatriptan) is a long-established oral migraine product whose market is shaped by (1) post-patent generic pressure in the US and (2) periodic substitution with other triptans and CGRP-directed acute therapies. The financial trajectory is dominated by loss of exclusivity-led erosion after generic entry, persistent use of rizatriptan in treatment algorithms for acute migraine, and continued demand for fast-onset oral dosing forms.

This analysis focuses on drug-level market drivers and the patent and regulatory path that determines US competitive entry timing and revenue exposure.

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How big is the Maxalt (rizatriptan) market and what drives demand?

Featured snippet answer: Maxalt demand is driven by acute migraine frequency in diagnosed patient populations, clinical guideline placement of triptans as first-line options for many patients, and substitution effects from multiple available branded and generic migraine agents.

Key demand drivers

• Migraine prevalence and diagnosis rates: Market growth tracks treated migraine populations rather than incident migraine incidence.
• Acute therapy switching dynamics: Patients and payers frequently switch among triptans based on formulary tiering, tolerability, onset, and cost.
• Coverage and copay design: Commercial penetration is sensitive to pharmacy benefit manager (PBM) formulary decisions and generic substitution incentives.
• Competitive class pressure: Even where triptans remain standard of care, CGRP antagonists and ditans can shift share at the margin for patients who fail triptans.

Formulation and use pattern matter

Maxalt is commercially associated with rapid-acting oral rizatriptan presentations. In practice, uptake depends on:

• time-to-treatment after attack onset
• patient adherence to dosing instructions
• tolerance profile (trip tan adverse effects and contraindication patterns)

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When did Maxalt lose exclusivity and when could generics enter?

Featured snippet answer: Maxalt’s US brand exclusivity ended prior to the modern CGRP acute launch era; generic rizatriptan tablets and orally disintegrating tablets entered after brand patent coverage and regulatory exclusivity barriers were cleared, driving structural revenue erosion.

US exclusivity and patent reality for established triptans

For legacy small-molecule migraine brands, generic entry is typically enabled by the expiration of:

• composition-of-matter patents (core active ingredient protection)
• branded-manufacturing or formulation patents (if still active)
• regulatory exclusivities (if applicable, usually limited for small molecules)

Generic entry effects on revenue

Once generics entered:

• Brand price compression became immediate through payer step edits and dispensing channel behavior.
• Market share of the brand typically stabilizes at a smaller base if differentiation persists (speed perception, prescriber inertia, or payer restrictions), but volume tends to move to lower net cost equivalents.

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What is the Orange Book status of Maxalt and what does it imply for generic competition risk?

Featured snippet answer: Maxalt’s Orange Book listing for rizatriptan-related products indicates that the major listed patent protections have expired, which reduces remaining generic-avoidance leverage for additional brand exclusivity.

What “Orange Book status” means operationally

• Active patents listed for a specific NDA can delay generic approval via the “patent-by-patent” framework.
• With most key protections expired for legacy rizatriptan products, the dominant issue becomes standard generic substitution and payer contracting rather than ongoing Paragraph IV outcomes.

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How many patents protect rizatriptan (Maxalt) and which types of patents matter most?

Featured snippet answer: For an established active ingredient like rizatriptan, most enforceable value historically centered on composition-of-matter and key formulations, with method-of-use and secondary formulation patents becoming the residual barrier only if still active.

Patent categories that influence launch timing

1. Composition of matter: protects the active ingredient itself; once expired, it removes the primary barrier.
2. Formulations and delivery systems: tablets, orally disintegrating tablets, and excipient-specific IP can delay generics if still in-force.
3. Methods of use: acute dosing regimens or patient sub-populations can theoretically sustain competition head-to-head, but enforcement is narrow for branded triptans once generics are approved.

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What generic entry risks exist for Maxalt (rizatriptan) and how do they play out?

Featured snippet answer: The generic risk for Maxalt is primarily already realized through approved generic rizatriptan products; remaining risks are more about incremental formulation or device-like differences and launch timing disputes rather than “new-to-market” active ingredient barriers.

Typical post-expiry competitive pattern

• Multiple ANDA entrants after patent expiry lead to price convergence.
• Brand differentiation shifts from IP protection to contracting and access, not patent defensibility.
• Litigation activity, if any, tends to be concentrated near the expiry window, not years later.

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How does Maxalt compare with other acute migraine products in market dynamics?

Featured snippet answer: Maxalt competes in the acute migraine space with other triptans (oral and specialty forms) and increasingly with non-triptan acute options, with share effects driven by formulary preference and patient response.

Competitive axes

• Speed and tolerability: Differentiates within triptans.
• Mechanism diversification: CGRP antagonists and ditans can reallocate some patient demand away from triptans.
• Payer economics: generics compress the triptan segment price floor; branded non-triptans may win coverage with clinical or economic contracting.

Relative structural headwinds

• Generic-led price pressure in triptans reduces brand profitability even if volumes remain stable.
• Therapeutic substitution pulls share to newer mechanisms for patients who avoid triptans.

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What patent litigation affects Maxalt and generic rizatriptan launches?

Featured snippet answer: For an established product like Maxalt, patent litigation that affects entry is concentrated around the expiry of enforceable patents listed in the Orange Book; subsequent litigation generally reflects discrete formulation or procedural disputes rather than renewed active ingredient protection.

Litigation patterns observed in legacy migraine brands

• Court filings or settlement agreements typically align with the ANDA approval window.
• Post-launch litigation reduces incremental damages claims because generic competition already sets new pricing baselines.

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What settlement agreements and Paragraph IV outcomes matter for Maxalt?

Featured snippet answer: Paragraph IV outcomes matter most when timed close to major patent expiry; for legacy rizatriptan brands, the primary settlement effects are already reflected in the realized generic market structure.

Why settlement terms drive financial trajectory

• “Carve-out” or agreed launch dates can cap early competition temporarily.
• If settlement is late or margins are already compressed by generic presence, incremental financial uplift is limited.

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How does the payer and formulary environment shape Maxalt’s financial trajectory?

Featured snippet answer: Maxalt’s financial trajectory tracks formulary tiering and substitution rules in commercial and managed care plans, with greatest volatility occurring around generic availability and periodic PBM contract renegotiations.

Commercial model dynamics

• Net sales vs gross: Branded net revenue falls steeply when generics are preferred by PBMs.
• Rebates and rebates pressure: Brand manufacturers respond with rebates to defend formulary position.
• Switching elasticity: Patient switching from branded to generic accelerates with lower copays and physician willingness.

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What is Maxalt’s manufacturing and IP barrier profile after generic entry?

Featured snippet answer: After the principal IP barriers expire, the manufacturing/IP barrier for rizatriptan becomes compliance and process consistency, not enforceable exclusionary rights.

Residual barriers that can still matter

• Specific solid-state formulation know-how (if still protected, which is time-limited)
• Regulatory process and bioequivalence constraints (standard ANDA pathways still require BE evidence)
• Supply stability (ability of generics to meet demand without shortages)

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How do FDA pathway considerations influence the Maxalt competitive landscape?

Featured snippet answer: Generic rizatriptan products enter through the ANDA pathway once patents and regulatory barriers clear; brand-to-generic competition then becomes the main financial driver.

ANDA implications

• Multiple approved ANDAs lead to competitive redundancy and fast pricing convergence.
• Post-approval changes to formulation require CBE-30 or PAS supplements, but these rarely restore brand economics.

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What does the Maxalt revenue exposure look like across regions?

Featured snippet answer: The revenue exposure is highest where branded reimbursement sustains differentiation; globally, the economics trend toward generic substitution with regulatory timelines and patent status differences by jurisdiction.

Regional pattern

• US: Dominated by generic rizatriptan availability and formulary substitution.
• EU and other markets: Similar trajectory with local patent expiry timing and national reimbursement rules.
• Emerging markets: Often faster generic adoption but constrained by enforcement and supply chain maturity.

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Key market scenario outcomes: what happens to Maxalt financials under different competitive speeds?

Featured snippet answer: Faster generic entry or deeper payer preference for lowest-cost equivalents drives steeper brand revenue decline; slower entry or temporary exclusivity keeps brand net sales higher for longer.

Scenario table: competitive speed vs likely revenue impact

Scenario	Competitive event timing	Expected brand net sales trajectory	Primary driver
Slow erosion	Later generic substitution and higher copays for generics	Higher retention for a longer window	PBM tiering and patient inertia
Base case	Standard generic uptake	Gradual but sustained decline	Generic price convergence and rebates
Fast erosion	Aggressive formulary placement for generics	Steep drop post-entry	Lowest net cost contracting

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Maxalt key takeaways for R&D, licensing, and investment decisions

• Maxalt’s financial trajectory is structurally tied to post-exclusivity generic substitution and payer formulary economics, not to active ongoing IP barriers typical of new molecular entities.
• The competitive landscape in acute migraine means Maxalt faces class substitution pressure from newer mechanisms, but the dominant revenue risk remains trip tan generic commoditization.
• Patent leverage for the brand is primarily relevant around historic exclusivity windows; after that, competition is driven by contracting and net pricing.

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FAQs

1) What is the main competitive threat to Maxalt (rizatriptan) today?
Generic rizatriptan substitution and payer preference for lowest-cost acute migraine options within and across triptan class and non-triptan mechanisms.

2) Do formulation differences between Maxalt and generic rizatriptan affect prescribing?
Yes, to the extent they influence time-to-effect perception and tolerability, but those effects typically do not overcome low-cost formulary incentives once generics are established.

3) Can patents still delay generic rizatriptan versions years after launch?
Only if specific formulation, method-of-use, or manufacturing patents remain in force for that exact product presentation; for legacy active ingredients, most core barriers are already expired.

4) How do Paragraph IV challenges typically influence pricing for legacy migraine brands?
They can delay launch in the short term near expiry, but the longer-term revenue structure is still dominated by post-entry generic price convergence.

5) What product format decisions matter most for acute migraine revenue?
Oral versus orally disintegrating formats, dosing convenience, and payer coverage tied to net pricing and perceived speed of relief.

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. (n.d.). ANDA approval process and regulatory framework. U.S. Food and Drug Administration.
3. IQVIA. (n.d.). U.S. and global pharmaceutical market measures (subscription-based).

DrugChatter Q&A for MAXALT

Generic maxalt for migraines?
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