TOPAMAX Drug Patent Profile

Which patents cover Topamax, and what generic alternatives are available?

Topamax is a drug marketed by Janssen Pharms and is included in two NDAs.

The generic ingredient in TOPAMAX is topiramate. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Topamax

A generic version of TOPAMAX was approved as topiramate by ACCORD HLTHCARE on March 27^th, 2009.

Summary for TOPAMAX

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	86
Patent Applications:	5,077
Drug Prices:	Drug price information for TOPAMAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TOPAMAX
What excipients (inactive ingredients) are in TOPAMAX?	TOPAMAX excipients list
DailyMed Link:	TOPAMAX at DailyMed

See drug prices for TOPAMAX

See drug sales revenues for TOPAMAX

Recent Clinical Trials for TOPAMAX

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

Sponsor	Phase
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Stanford University	Early Phase 1
Université de Sherbrooke	Phase 4

See all TOPAMAX clinical trials

Pharmacology for TOPAMAX

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for TOPAMAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TOPAMAX	Tablets	topiramate	50 mg	020505	1	2005-09-08
TOPAMAX	Tablets	topiramate	25 mg, 100 mg and 200 mg	020505		2001-12-26

US Patents and Regulatory Information for TOPAMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-001	Oct 26, 1998	AB	RX	Yes	No
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-003	Dec 24, 1996		DISCN	No	No
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-005	Dec 24, 1996	AB	RX	Yes	No
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-006	Dec 24, 1996		DISCN	No	No
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-002	Oct 26, 1998	AB	RX	Yes	Yes
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-004	Dec 24, 1996	AB	RX	Yes	No

Expired US Patents for TOPAMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-001	Dec 24, 1996
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-002	Oct 26, 1998
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-004	Dec 24, 1996
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-003	Dec 24, 1996
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-003	Dec 24, 1996
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-005	Dec 24, 1996

International Patents for TOPAMAX

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

Country	Patent Number	Title	Estimated Expiration
Denmark	457784
Ukraine	65607	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ ЕЕ ПРИГОТОВЛЕНИЯ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ (ВАРІАНТИ) ТА СПОСІБ ЇЇ ПРИГОТУВАННЯ (PHARMACEUTICAL COMPOSITION (VARIANTS) AND PROCESS FOR ITS PREPARATION)
Croatia	P20000563	FARMACEUTSI SASTAV TOPIRAMATA (PHARMACEUTICAL COMPOSITION OF TOPIRAMATE)
Estonia	04175	Meetod topiramaadi farmatseutilise kompositsioonivalmistamiseks, farmatseutiline kompositsioon ning topiramaadi kasutamine diabeedi raviks ette nähtud ravimi valmistamiseks
Spain	2204109
Canada	1241951	DERIVES DE SULFAMATE ANTICONVULSIVANTS (ANTICONVULSANT SULFAMATE DERIVATIVES)

Supplementary Protection Certificates for TOPAMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0138441	SPC/GB95/028	United Kingdom		PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
0138441	97C0097	Belgium		PRODUCT NAME: TOPIRAMAAT; NAT. REGISTRATION NO/DATE: 1028 IS 71 F 3 19970616; FIRST REGISTRATION: GB PL/0242/0301 19950718

TOPAMAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Topamax

Introduction to Topamax

Topamax, also known as topiramate, is a widely used antiepileptic drug and migraine preventive therapy. It has been a significant player in the pharmaceutical market, particularly in the treatment of neurological and psychiatric disorders.

Market Size and Growth

The global Topamax market was valued at approximately USD 2.5 billion in 2020 and is projected to grow at a CAGR of around 4% during the forecast period of 2021 to 2026[1].

Key Market Drivers

• Continued Demand for Antiepileptic and Migraine Therapies: The ongoing need for effective treatments for epilepsy and migraines drives the demand for Topamax. Its broad-spectrum antiepileptic properties and efficacy in migraine prevention make it a crucial therapeutic option[1].
• Expanding Use in Neurological and Psychiatric Disorders: Topamax is increasingly used in managing various neurological and psychiatric conditions, further boosting its market demand[1].
• Availability of Generic Formulations: The expiration of Topamax's patent and the subsequent availability of generic topiramate formulations have made the drug more accessible, although this has also introduced pricing pressures and competition[1].

Regional Market Dynamics

• Dominant Regions: North America and Europe are the dominant regional markets for Topamax. These regions have well-established healthcare systems and a high prevalence of neurological conditions[1].
• Emerging Markets: The Asia-Pacific region is expected to witness the fastest growth during the forecast period, driven by the rising prevalence of epilepsy and migraines, expansion of healthcare infrastructure, and increasing focus on addressing unmet needs in neurological and psychiatric conditions. Countries like China, Japan, and South Korea are key contributors to this growth[1].

Competitive Landscape

The Topamax market is highly competitive, with several factors influencing its dynamics:

• Generic Competition: The availability of generic topiramate formulations has increased accessibility but also introduced significant competition, impacting the revenue generated from branded Topamax. This competition has forced companies to differentiate their products and maintain a competitive edge[1].
• Off-Label Promotion Challenges: Topamax manufacturers have faced legal issues due to off-label promotion for unapproved uses such as bipolar disorder, drug and alcohol dependency, and other psychiatric conditions. This has resulted in substantial fines, including an $81 million fine in 2010[2].
• New Therapeutic Applications: The exploration of Topamax's therapeutic applications in additional neurological or psychiatric conditions presents opportunities for market growth. Demonstrating efficacy in new target conditions could help maintain or expand its market position[1].

Financial Impact of Generic Entry

The entry of generic topiramate formulations has had a mixed financial impact:

• Increased Accessibility: Generic versions have made the drug more affordable, increasing its accessibility to a broader patient population[3].
• Reduced Revenue: However, the generic competition has reduced the revenue generated from branded Topamax, potentially limiting resources for further research and development[1].
• Higher Health Costs: Studies have shown that the generic entry of topiramate can lead to higher health costs in some regions due to increased pharmacy dispensings, hospitalizations, and lengths of hospital stays[4].

Market Opportunities

Several opportunities exist for the growth and expansion of the Topamax market:

• Targeted Marketing Strategies: Developing targeted marketing strategies, particularly for weight management solutions, can tap into new market segments[3].
• Demographic Trends: Analyzing demographic trends to predict future demand among aging populations can help in strategic planning[3].
• Combination Therapies: Exploring topiramate's potential in combination therapies for a wider range of health conditions offers significant growth opportunities[3].

Market Challenges

Despite the opportunities, the Topamax market faces several challenges:

• Intellectual Property Challenges: Competitors may try to access formulations or production methods, posing intellectual property challenges[3].
• Economic and Regulatory Hurdles: Economic and regulatory barriers can restrict the widespread adoption of topiramate medications globally[3].
• Clinical and Technological Challenges: Assessing and overcoming clinical and technological challenges that impede topiramate drug development and innovation is crucial[3].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the Topamax market:

• Increased Focus on Chronic Conditions: The pandemic has increased the focus on managing chronic neurological conditions, potentially driving demand for Topamax[1].
• Disruptions in Healthcare Access: However, disruptions in healthcare access, clinical trials, and supply chain logistics have posed challenges for the market's growth in certain regions[1].

Legal and Regulatory Issues

Topamax manufacturers have faced significant legal and regulatory issues:

• Lawsuits and Settlements: The company has settled numerous lawsuits related to birth defects and off-label promotion, including a notable $81 million fine for misbranding and illegal marketing[2].
• Regulatory Compliance: Ensuring compliance with regulatory standards and avoiding off-label promotion are critical to maintaining market integrity and avoiding legal repercussions[2].

Key Takeaways

• The Topamax market is driven by the demand for effective antiepileptic and migraine prevention therapies.
• Generic competition has increased accessibility but reduced revenue from branded Topamax.
• Emerging markets, particularly in the Asia-Pacific region, offer significant growth opportunities.
• The market faces challenges from intellectual property issues, economic and regulatory hurdles, and clinical and technological challenges.
• The COVID-19 pandemic has had a mixed impact on the market, with increased focus on chronic conditions but disruptions in healthcare access.

Frequently Asked Questions (FAQs)

1. What are the primary uses of Topamax? Topamax is primarily used in the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, Lennox-Gastaut syndrome, and the preventive treatment of migraines in adult populations[1].

2. How has the generic entry of topiramate affected the market? The generic entry of topiramate has made the drug more affordable and accessible but has also reduced the revenue generated from branded Topamax and introduced pricing pressures and competition[1].

3. What are the key growth drivers for the Topamax market? The key growth drivers include the continued demand for effective antiepileptic and migraine prevention therapies, the expanding use of Topamax in various neurological and psychiatric disorders, and the availability of generic topiramate formulations[1].

4. Which regions are expected to witness the fastest growth in the Topamax market? The Asia-Pacific region is expected to witness the fastest growth, driven by the rising prevalence of epilepsy and migraines, expansion of healthcare infrastructure, and increasing focus on addressing unmet needs in neurological and psychiatric conditions[1].

5. What legal issues have Topamax manufacturers faced? Topamax manufacturers have faced legal issues related to off-label promotion and have paid significant fines, including an $81 million fine in 2010. They have also settled lawsuits related to birth defects associated with the drug[2].

Cited Sources:

1. DataHorizon Research - Topamax Market Size, Share, Growth, Statistics Report 2033
2. DrugWatch - Topamax Lawsuit – FDA Warnings, Verdicts and Settlements
3. 360iResearch - Topiramate Drugs Market Size & Share 2025-2030
4. PubMed - Projected economic impact of clinical findings of generic entry of topiramate[1][2][3][4]