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-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-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:	9
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
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-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	020865-002	Jun 29, 1998	5,298,520*PED
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	Jun 29, 1998	5,457,895*PED
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-002	Jun 29, 1998	4,758,598
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	Jun 29, 1998	4,305,502
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-002	Jun 29, 1998	4,305,502

International Patents for MAXALT-MLT

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

Country	Patent Number	Title	Estimated Expiration
China	1064485
Norway	920424
New Zealand	202482	MOULDING PILLS BY SOLVENT SUBLIMATION
Japan	H0149242
Egypt	15502	SOLID SHAPED ARTICLES

Supplementary Protection Certificates for MAXALT-MLT

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

MAXALT-MLT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MAXALT-MLT

Introduction to MAXALT-MLT

MAXALT-MLT, known generically as rizatriptan benzoate, is a prescription drug used for the treatment of migraine headaches. It is available in various forms, including oral tablets and orally disintegrating tablets, making it a convenient option for patients seeking quick relief from migraine symptoms.

Market Growth Drivers

The market for MAXALT-MLT is driven by several key factors:

Increasing Incidence of Migraines

The rising incidence of migraines among both children and adults significantly boosts the demand for rizatriptan benzoate. In the United States, for example, 17.1% of women and 5.6% of men report having migraine symptoms, contributing to a large target population[4].

Pressure and Stress in Daily Life

The modern fast-paced lifestyle often leads to increased stress, anxiety, and headaches, further driving the demand for migraine treatments like MAXALT-MLT[1].

New Product Launches

Recent launches of generic and branded versions of rizatriptan benzoate, such as Teva Generics' Maxalt-MLT in 2020, have expanded market options and attracted more consumers[1].

Market Restraints

Despite the growth drivers, there are several factors that could hamper the market growth of MAXALT-MLT:

Side Effects

The drug is associated with several side effects, including dizziness, fatigue, pressure or pain in the chest, throat, neck, or jaw, and sleepiness. These side effects, although often mild and temporary, can deter some patients from using the medication[2].

High Blood Pressure Concerns

MAXALT-MLT can rarely cause high blood pressure, which is a significant concern for patients with uncontrolled hypertension. This can lead to serious health issues such as stroke if not managed properly[2].

Market Trends

Generic Competition

The entry of generic versions of rizatriptan benzoate into the market has increased competition, which can impact the sales of branded products like MAXALT-MLT. However, this also provides more affordable options for patients, potentially expanding the market reach[1].

Innovative Formulations

The development of orally disintegrating tablets, such as MAXALT-MLT, offers convenience and quick relief, appealing to patients seeking instant solutions for their migraine symptoms[5].

Regional Market Analysis

North America

North America is expected to hold a significant share of the migraine therapeutics market, driven by the high prevalence of migraines in the United States and the adoption of novel therapeutics. The region's large target population and strategic activities by key market players, such as product launches and approvals, contribute to its dominance[4].

Asia Pacific

The Asia Pacific region is projected to be the fastest-growing market for migraine therapeutics, including MAXALT-MLT, due to increasing healthcare expenditure and a growing awareness of migraine treatments[4].

Financial Trajectory

Historical Sales

In 2012, sales of MAXALT, the branded version of rizatriptan benzoate, were $638 million, indicating a substantial market presence[5].

Current and Future Market Size

The global migraine therapeutics market, which includes MAXALT-MLT, is expected to reach USD 6.16 billion in 2024 and grow at a CAGR of 6.84% to reach USD 8.58 billion by 2029. This growth trajectory suggests a robust financial outlook for MAXALT-MLT and similar migraine treatments[4].

Key Players and Strategic Activities

Major players in the migraine therapeutics market, including Amgen, Teva Pharmaceutical Industries Ltd, GlaxoSmithKline, Eli Lilly and Company, and Bausch Health, are actively involved in product launches, approvals, and mergers and acquisitions. For instance, the FDA approval of VYEPTI (eptinezumab-jjmr) and NURTEC ODT (rimegepant 75 mg) in recent years has propelled market growth[4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry. While it has presented challenges in terms of supply chain disruptions, it has also accelerated the development and demand for various medications, including those for migraine treatment. The increased stress and pressure during the pandemic have likely contributed to a higher incidence of migraines, thereby boosting the demand for MAXALT-MLT and similar drugs[1].

Consumer Preferences and Market Adaptation

Consumers are increasingly seeking convenient and effective treatments for migraines. The orally disintegrating tablets of MAXALT-MLT cater to this demand by providing quick relief without the need for water. This adaptation to consumer preferences is crucial for maintaining market competitiveness.

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of MAXALT-MLT. FDA approvals and stringent safety regulations ensure that the drug meets high standards of efficacy and safety. Compliance with these regulations is essential for market success.

Key Takeaways

• The market for MAXALT-MLT is driven by the increasing incidence of migraines and the need for quick, effective treatments.
• Side effects and high blood pressure concerns are significant restraints.
• North America dominates the market, while the Asia Pacific region is the fastest-growing.
• The global migraine therapeutics market is expected to grow significantly by 2029.
• Key players are actively involved in strategic activities to boost market growth.

Frequently Asked Questions (FAQs)

What is MAXALT-MLT used for?

MAXALT-MLT is used for the treatment of migraine headaches, providing quick relief from symptoms.

What are the common side effects of MAXALT-MLT?

Common side effects include dizziness, fatigue, pressure or pain in the chest, throat, neck, or jaw, and sleepiness.

How big is the global migraine therapeutics market?

The global migraine therapeutics market is expected to reach USD 6.16 billion in 2024 and grow to USD 8.58 billion by 2029.

Which region is expected to dominate the migraine therapeutics market?

North America is expected to hold the largest share of the migraine therapeutics market.

What is the impact of COVID-19 on the market for MAXALT-MLT?

The COVID-19 pandemic has increased the demand for migraine treatments due to heightened stress and pressure, but it has also presented supply chain challenges.

Sources:

1. Allied Market Research - Rizatriptan Benzoate Market Statistics | Forecast 2030
2. Medical News Today - Maxalt and Maxalt-MLT: Side effects, dosage, uses, and more
3. River Country News Channel Nebraska - Migraine Drugs Market 2024 Research Report
4. Mordor Intelligence - Migraine Therapeutics Market Size & Share Analysis
5. IntelGenx - IntelGenx Reports Q1, 2013 Results and Provides Operational Update