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, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Natco Pharma Ltd, Norvium Bioscience, Panacea, Sandoz, Unichem, Organon Llc, Alkem Labs Ltd, Avet Lifesciences, Chartwell Rx, Creekwood Pharms, Invagen Pharms, Mylan Pharms Inc, 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-four suppliers are listed for this compound.

Summary for rizatriptan benzoate

International Patents:	20
US Patents:	1
Tradenames:	4
Applicants:	20
NDAs:	28
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	5
Patent Applications:	1,161
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
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
Jubilant Generics	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	203334-001	Oct 16, 2015		DISCN	No	No
Natco Pharma Ltd	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET;ORAL	200482-002	Dec 31, 2012		DISCN	No	No
Alkem Labs Ltd	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET;ORAL	203269-001	Feb 18, 2016	AB	RX	No	No

Expired US Patents for rizatriptan benzoate

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
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-002	Jun 29, 1998
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	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	20160089335	계면활성제 또는 폴리알콜을 포함하지 않은 즉각적 습윤성의 경구용 필름 제형 (INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL)
Canada	2919442	FORME POSOLOGIQUE ORALE EN FILM INSTANTANEMENT MOUILLABLE SANS TENSIOACTIF NI POLYOL (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	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	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	99C0011	Belgium		PRODUCT NAME: RIZATRIPTAN BENZOAS EQ. RIZATRIPTAN; REGISTRATION NO/DATE: 922 IS 181 F 3 19981130; FIRST REGISTRATION: NL RVG 21815 19980211

Rizatriptan benzoate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rizatriptan Benzoate

Introduction to Rizatriptan Benzoate

Rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist, is widely used for the acute treatment of migraine headaches in adults. It is marketed under the trade names Maxalt and Maxalt-MLT by Merck & Co.[2].

Market Size and Growth Projections

The rizatriptan benzoate market has been experiencing steady growth, driven by several key factors. As of 2023, the market size was valued at USD 120 million and is projected to reach USD 200 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.7% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Incidence of Migraine Disorders

The rising incidence of migraine disorders globally is a significant driver of the rizatriptan benzoate market. Migraines affect a substantial portion of the population, and the need for effective treatments is on the rise[1][4].

Improvements in Medication Delivery and Formulation

Advancements in drug delivery and formulation technologies have enhanced the efficacy and patient compliance of rizatriptan benzoate. The availability of orally disintegrating tablets (ODTs) and other formulations has improved patient outcomes and adherence to treatment[1][2].

Generic Versions and Market Expansion

The introduction of generic versions of rizatriptan benzoate has increased accessibility and affordability, contributing to market expansion. Generic substitutes promote price competition, which accelerates market growth[1][4].

Increased Awareness and Continuous Research

Growing awareness about migraine management and continuous research aimed at extending indications and optimizing dose regimens further support the market's growth. This increased knowledge and ongoing research ensure sustained demand for rizatriptan benzoate[1][4].

Market Segmentation

The rizatriptan benzoate market is segmented based on several criteria:

Application

• Tablets
• Oral dissolvable tablets
• Powder for solution[1]

Product

• Migraine relief
• Cluster headache treatment
• Acute headache management
• Clinical trials[1]

Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1]

Competitive Landscape

The market for rizatriptan benzoate is competitive, with several major pharmaceutical companies involved. Key players include Merck & Co., Pfizer, Johnson & Johnson, Novartis, Teva Pharmaceuticals, GlaxoSmithKline, Allergan, Sanofi, Eli Lilly, and Mylan N.V.[1].

Economic and Cost-Effectiveness

Rizatriptan benzoate has been shown to be cost-effective in the treatment of migraines. Cost-utility analyses indicate that rizatriptan 10 mg is dominant over other treatments such as ergotamine/caffeine, sumatriptan, naratriptan, and zolmitriptan in terms of reducing migraine-related productivity losses and healthcare resource use[3].

Productivity and Healthcare Resource Use

The use of rizatriptan instead of usual care can result in significant cost offsets due to reduced productivity losses. For example, a study indicated that this could result in annual cost offsets of approximately $84-118 per employee in lost productivity avoided[3].

Challenges and Restraints

Side Effects

Despite its effectiveness, rizatriptan benzoate is associated with side effects such as tightness in the chest and drowsiness, which can hamper market growth[4].

Regulatory and Safety Considerations

The safety profile of rizatriptan benzoate is closely monitored. Clinical reviews and postmarketing surveillance ensure that the risk-benefit ratio remains favorable, especially in adolescent populations[2].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry, including the rizatriptan benzoate market. While the pandemic has led to increased demand for certain drugs, it has also presented challenges in supply chain management. However, the overall impact on the rizatriptan benzoate market has been relatively minimal compared to other sectors[4].

Market Trends and Future Projections

New Product Launches

Recent launches, such as Teva Generics' Maxalt-MLT in 2020, are expected to flourish the market by providing more accessible and affordable treatment options[4].

Research and Development

Continuous research into better treatment approaches and the extension of indications for rizatriptan benzoate are expected to drive future market growth. This includes optimizing dose regimens and exploring new formulations[1][4].

Key Takeaways

• The rizatriptan benzoate market is projected to grow from USD 120 million in 2023 to USD 200 million by 2031, with a CAGR of 6.7%.
• Key drivers include the rising incidence of migraines, improvements in medication delivery, generic versions, and increased awareness.
• The market is segmented by application, product, and geography.
• Rizatriptan benzoate is cost-effective in reducing migraine-related productivity losses and healthcare resource use.
• Side effects and regulatory considerations are potential restraints.
• The COVID-19 pandemic has had a minimal impact on the market.

FAQs

What is rizatriptan benzoate used for?

Rizatriptan benzoate is used for the acute treatment of migraine headaches in adults, providing relief from symptoms such as pain, headache, nausea, vomiting, and sensitivity to light and sound[2][4].

What are the key drivers of the rizatriptan benzoate market?

Key drivers include the rising incidence of migraines, improvements in medication delivery and formulation, the introduction of generic versions, and increased awareness about migraine management[1][4].

Which companies are major players in the rizatriptan benzoate market?

Major players include Merck & Co., Pfizer, Johnson & Johnson, Novartis, Teva Pharmaceuticals, GlaxoSmithKline, Allergan, Sanofi, Eli Lilly, and Mylan N.V.[1].

Is rizatriptan benzoate cost-effective?

Yes, rizatriptan benzoate has been shown to be cost-effective in reducing migraine-related productivity losses and healthcare resource use compared to other treatments[3].

What are the potential side effects of rizatriptan benzoate?

Potential side effects include tightness in the chest and drowsiness[4].

How has the COVID-19 pandemic impacted the rizatriptan benzoate market?

The COVID-19 pandemic has had a relatively minimal impact on the rizatriptan benzoate market, with the pharmaceutical industry facing supply chain challenges but overall demand remaining stable[4].

Sources

1. Market Research Intellect, "Rizatriptan Benzoate Market Size, Share and Forecast to 2031"
2. FDA, "20864 & 20865 Rizatriptan Clinical BPCA"
3. PubMed, "Rizatriptan: a pharmacoeconomic review of its use in the acute treatment of migraine"
4. Allied Market Research, "Rizatriptan Benzoate Market Statistics | Forecast 2030"