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-four 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:	114
Clinical Trials:	9
Patent Applications:	783
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
Robert W. Baloh	Phase 2/Phase 3
Henry M. Jackson Foundation for the Advancement of Military Medicine	N/A
Beth Israel Deaconess Medical Center	Phase 4

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	020864-002	Jun 29, 1998
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-002	Jun 29, 1998
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-001	Jun 29, 1998

International Patents for MAXALT

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

Country	Patent Number	Title	Estimated Expiration
China	1157821
South Africa	9200703
China	1128617
Bulgaria	62024
Germany	19975007
China	1064485
Czechoslovakia	9200198

Supplementary Protection Certificates for MAXALT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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

MAXALT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MAXALT (Rizatriptan Benzoate)

Introduction to MAXALT (Rizatriptan Benzoate)

MAXALT, known generically as rizatriptan benzoate, is a triptan-class medication used for the acute treatment of migraine headaches. It works by increasing serotonin levels in the brain, reducing inflammation, and constricting blood vessels to alleviate migraine symptoms.

Market Growth Drivers

Increasing Prevalence of Migraines

The rising incidence of migraines among both children and adults is a significant driver for the growth of the rizatriptan benzoate market. With approximately 17.1% of women and 5.6% of men in the United States reporting migraine symptoms, the demand for effective treatments like MAXALT is on the rise[4].

Pressure and Lifestyle Factors

The modern lifestyle, characterized by increased stress and pressure, contributes to the higher incidence of headaches and migraines. This trend is expected to continue, driving the demand for quick and effective solutions like rizatriptan benzoate[1].

Advancements in Pharmaceutical Solutions

The development of new medication classes, such as triptans, and the improvement in existing ones have enhanced the efficacy of migraine treatments. Rizatriptan benzoate, being a part of the triptan class, benefits from these advancements, making it a preferred choice for many patients[3][4].

Market Trends

New Product Launches

Recent launches and approvals of new products in the triptan class have significantly impacted the market. For example, Teva Generics launched Maxalt-MLT, an oral tablet formulation of rizatriptan benzoate, which has helped in flourishing the market[1].

Patient Preference for Fast-Acting Solutions

There is a growing patient preference for rapid-acting acute migraine therapies with minimal adverse effects. This shift in consumer demand is driving pharmaceutical companies to develop more tailored therapies, which includes rizatriptan benzoate[3].

Regional Dominance

North America is expected to hold a significant share of the migraine therapeutics market, including the segment for rizatriptan benzoate, due to the high prevalence of migraines and the adoption of novel therapeutics in this region[4].

Financial Trajectory

Revenue and Market Size

The global acute migraine drugs market, which includes rizatriptan benzoate, is projected to grow at a CAGR of 8.58% from 2023 to 2030, reaching a value of USD 8.75 billion by the end of the forecast period. This growth is indicative of the increasing demand and financial potential of drugs like MAXALT[3].

Company Performance

Companies involved in the production and distribution of rizatriptan benzoate, such as Teva Generics, have seen positive financial outcomes. For instance, the launch of Maxalt-MLT has contributed to the revenue growth of these companies, reflecting the market's financial trajectory[1].

Challenges and Restraints

Side Effects and Safety Concerns

Despite its efficacy, rizatriptan benzoate is associated with side effects such as tightness in the chest and drowsiness. These adverse effects can hamper the growth of the market as they may deter patients and healthcare providers from using the drug[1].

High Cost of Advanced Therapies

The elevated costs of novel and sophisticated migraine treatments, including some formulations of rizatriptan benzoate, present a challenge. These high costs can restrict accessibility, particularly in economically disadvantaged areas, and may impede market acceptance[3].

Stringent Regulatory Approvals

The intricate regulatory clearance process can delay the launch of new pharmaceuticals, including new formulations or delivery methods of rizatriptan benzoate. This can slow down market expansion, especially in regions with stringent healthcare systems[3].

Competitive Landscape

The migraine therapeutics market is highly competitive, with several key players involved in the development and marketing of triptan-class drugs. Companies like Eli Lilly and Company, Lundbeck, and Biohaven Pharmaceutical Holding Company Ltd. are actively launching new products and seeking approvals, which drives competition and innovation in the market[4].

Key Insights and Opportunities

Emerging Therapies

The emergence of new medication classes, such as CGRP inhibitors and gepants, alongside advancements in biologics, offers more efficacious therapy alternatives with reduced adverse effects. These innovations provide patients with enhanced options and stimulate investment in pharmaceutical development, which can impact the market for rizatriptan benzoate[3].

Strategic Activities

Strategic activities such as product launches, approvals, and mergers and acquisitions by key market players are crucial for market growth. For example, the FDA approval of NURTEC ODT (rimegepant 75 mg) for the preventive treatment of migraine highlights the dynamic nature of the market and the opportunities for growth[4].

Regional Insights

North America

North America is expected to dominate the migraine therapeutics market due to the high prevalence of migraines and the adoption of novel therapeutics. The large target population in the United States and the strategic activities of key market players in this region contribute to its dominance[4].

Conclusion

The market dynamics for MAXALT (rizatriptan benzoate) are influenced by a combination of factors including the increasing prevalence of migraines, advancements in pharmaceutical solutions, and patient preference for fast-acting treatments. While the market faces challenges such as side effects and high costs, the overall financial trajectory is positive, driven by growing demand and strategic activities by key players.

Key Takeaways

• Increasing Demand: The rising incidence of migraines drives the demand for effective treatments like rizatriptan benzoate.
• Advancements in Pharmaceuticals: New medication classes and improvements in existing ones enhance the efficacy of migraine treatments.
• Patient Preference: Patients increasingly prefer rapid-acting therapies with minimal adverse effects.
• Regional Dominance: North America is expected to dominate the market due to high migraine prevalence and adoption of novel therapeutics.
• Challenges: Side effects, high costs, and stringent regulatory approvals pose challenges to market growth.

FAQs

What is MAXALT used for?

MAXALT (rizatriptan benzoate) is used for the acute treatment of migraine headaches with or without aura in adults.

What are the common side effects of MAXALT?

Common side effects include tightness in the chest and drowsiness.

How does MAXALT work?

MAXALT works by increasing serotonin levels in the brain, reducing inflammation, and constricting blood vessels to alleviate migraine symptoms.

What is the projected growth rate of the acute migraine drugs market?

The acute migraine drugs market is projected to grow at a CAGR of 8.58% from 2023 to 2030.

Which region is expected to dominate the migraine therapeutics market?

North America is expected to dominate the market due to the high prevalence of migraines and the adoption of novel therapeutics.

Sources

1. Allied Market Research: Rizatriptan Benzoate Market Statistics | Forecast 2030
2. Organon: Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2023
3. GlobeNewswire: Acute Migraine Drugs Market is expected to generate a revenue of USD 8.75 Billion by 2030 Globally at 8.58% CAGR
4. Mordor Intelligence: Global Migraine Therapeutics Market Trends - Mordor Intelligence
5. MaxCyte: MaxCyte Reports Second Quarter and Half-Year 2024 Financial Results