Topiramate - Generic Drug Details

What are the generic drug sources for topiramate and what is the scope of freedom to operate?

Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Amta, Dr Reddys, Glenmark Pharms Ltd, Lupin Ltd, Ph Health, Xiamen Lp Pharm Co, Zydus, Zydus Pharms, Supernus Pharms, Janssen Pharms, Anda Repository, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Rubicon Research, Strides Pharma, Teva, Twi Pharms, Watson Labs, Zydus Pharms Usa Inc, Azurity, Accord Hlthcare, Actavis Totowa, Aiping Pharm Inc, Ascent Pharms Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Hikma Pharms, Invagen Pharms, Natco, Pharmaco, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, and Unichem Labs Ltd, and is included in fifty-four NDAs. There are twenty patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Topiramate has twenty-one patent family members in eleven countries.

There are twenty-six drug master file entries for topiramate. Forty-eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for topiramate

International Patents:	21
US Patents:	20
Tradenames:	6
Applicants:	42
NDAs:	54
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	293
Drug Prices:	Drug price trends for topiramate
Drug Sales Revenues:	Drug sales revenues for topiramate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for topiramate
What excipients (inactive ingredients) are in topiramate?	topiramate excipients list
DailyMed Link:	topiramate at DailyMed

See drug prices for topiramate

See drug sales revenues for topiramate

Recent Clinical Trials for topiramate

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

Sponsor	Phase
Shalamar Institute of Health Sciences	N/A
AbbVie	Phase 3
Henan Cancer Hospital	Phase 2

See all topiramate clinical trials

Generic filers with tentative approvals for TOPIRAMATE

Applicant	Application No.	Strength	Dosage Form
		200MG	TABLET;ORAL
		100MG	TABLET;ORAL
		50MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for topiramate

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

Anatomical Therapeutic Chemical (ATC) Classes for topiramate

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TOPIRAMATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPRONTIA	Oral Solution	topiramate	25 mg/mL	214679	1	2022-10-06
QUDEXY XR	Extended-release Capsules	topiramate	25 mg, 50 mg, 100 mg, 150 mg, and 200 mg	205122	1	2015-12-24
TROKENDI XR	Extended-release Capsules	topiramate	25 mg, 50 mg, and 100 mg	201635	1	2014-05-12
TROKENDI XR	Extended-release Capsules	topiramate	200 mg	201635	1	2014-04-03
TOPAMAX	Tablets	topiramate	50 mg	020505	1	2005-09-08
TOPAMAX SPRINKLE	Capsules	topiramate	15 mg and 25 mg	020844	1	2005-09-07
TOPAMAX	Tablets	topiramate	25 mg, 100 mg and 200 mg	020505		2001-12-26

US Patents and Regulatory Information for topiramate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus	TOPIRAMATE	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	208949-004	Nov 29, 2022	AB2	RX	No	No
Ajanta Pharma Ltd	TOPIRAMATE	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	219564-004	Sep 2, 2025	AB2	RX	No	No
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-004	Aug 16, 2013	AB1	RX	Yes	Yes			Y
Watson Labs	TOPIRAMATE	topiramate	TABLET;ORAL	077643-003	Mar 27, 2009		DISCN	No	No
Roxane	TOPIRAMATE	topiramate	TABLET;ORAL	076306-003	Mar 27, 2009		DISCN	No	No
Xiamen Lp Pharm Co	TOPIRAMATE	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	215638-001	Nov 5, 2024	AB2	RX	No	No
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-005	Mar 11, 2014	AB2	RX	Yes	Yes			Y

Expired US Patents for topiramate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-002	Oct 26, 1998
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-001	Dec 24, 1996
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-005	Dec 24, 1996
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-005	Dec 24, 1996
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-002	Dec 24, 1996
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-004	Dec 24, 1996
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-006	Dec 24, 1996

International Patents for topiramate

Country	Patent Number	Title	Estimated Expiration
Canada	2905011	CAPSULE DE TOPIRAMATE A LIBERATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES)
South Korea	101674509
European Patent Office	2968177	CAPSULE DE TOPIRAMATE À LIBÉRATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES)
Mexico	2009001711	FORMULACIONES DE LIBERACION SOSTENIDA DE TOPIRAMATO. (SUSTAINED-RELEASE FORMULATIONS OF TOPIRAMATE.)
Brazil	112015022434	cápsulas de topiramato de liberação estendida
South Korea	20200010608	서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES)
European Patent Office	1973528

Supplementary Protection Certificates for topiramate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC/GB95/028	United Kingdom		PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718

Market Dynamics and Financial Trajectory for Topiramate

Last updated: July 27, 2025

Introduction

Topiramate, a versatile anticonvulsant and migraine prophylactic, has established itself as a significant player within the pharmaceutical landscape. Originally approved by the FDA in 1996 for epilepsy, its off-label uses and evolving therapeutic profile have propelled its market presence, impacting revenue streams and competitive strategies globally. This analysis delineates the current market dynamics and forecasts the financial trajectory of Topiramate, considering macroeconomic factors, patent landscape, regulatory environment, competitive pressures, and emerging opportunities.

Market Overview and Therapeutic Indications

Topiramate's primary approvals target epilepsy and migraine prevention, with additional off-label uses including weight management and bipolar disorder. The global prevalence of epilepsy stands at approximately 50 million, with migraine affecting over 1 billion individuals [1]. The expanding patient population fuels demand, particularly in regions with burgeoning healthcare access.

However, the therapeutic profile of Topiramate faces scrutiny due to adverse effects, notably cognitive impairment and metabolic concerns, influencing prescribing patterns. Despite this, its broad efficacy sustains its market relevance.

Market Dynamics

1. Patent Expiry and Generic Competition

The expiration of patent protection significantly influences Topiramate's market dynamics. Since the initial patent expiry around 2008-2010 in various jurisdictions, multiple generic manufacturers have entered the market, intensifying price competition [2]. Generics constitute the majority of prescriptions, leading to substantial declines in branded sales and downward pressure on prices.

For example, in the United States, the branded version of Topiramate, originally marketed by Merck, lost patent exclusivity, prompting a surge in generic options. According to IQVIA data, generic formulations dominate prescriptions, comprising over 80% of the market share by volume [3].

2. Regulatory and Off-Label Use Impact

Regulatory bodies have issued warnings regarding Topiramate's adverse profile, impacting prescribing behavior. Nonetheless, clinicians continue to favor the drug due to efficacy and cost-effectiveness, especially where generics are dominant. Off-label indications, particularly weight loss prescriptions, have contributed to market fluctuations. The FDA's concerns over off-label promotion and safety issues, such as teratogenic risks, impose constraints that influence market evolution.

3. Geographic Market Variation

Market dynamics vary regionally. North America and Europe dominate sales, bolstered by established healthcare infrastructure, regulatory approvals, and high disease prevalence. Conversely, emerging markets like Asia-Pacific display growing adoption driven by increasing healthcare expenditure, although regulatory variability and cost sensitivities affect penetration.

4. Competitive Landscape

Several pharmacological alternatives challenge Topiramate, including newer migraine preventatives like CGRP inhibitors and other anticonvulsants with more favorable side-effect profiles. The competitive pressure compels continual price erosion and marketing strategies focused on differentiation and formulary positioning.

5. Socioeconomic Factors and Reimbursement Policies

Insurance coverage and reimbursement policies heavily influence prescription dynamics. In markets with comprehensive coverage, branded revenue retains some resilience; otherwise, generics dominate, further compressing profit margins.

Financial Trajectory and Revenue Forecasts

1. Historical Financial Performance

Historically, Topiramate generated peak revenues prior to patent expiry. For instance, Merck's branded Topiramate achieved approximately USD 1.2 billion annually in the late 2000s [4]. Post-patent expiry, revenues declined sharply with the proliferation of generics, with US sales dropping to below USD 200 million within a few years [5].

2. Market Size and Revenue Projections

Current global sales are largely driven by generics. Projections suggest the global Topiramate market will stabilize at USD 300-500 million annually over the next five years, influenced by generics' penetration and off-label use patterns [6].

Emerging markets are expected to demonstrate compounded annual growth rates (CAGRs) of 4-6%, mainly due to increasing epilepsy and migraine prevalence, improved healthcare access, and rising healthcare spending.

3. Impact of Patent Litigations and New Formulations

Patent litigations and the development of fixed-dose combinations or extended-release formulations could temporarily buoy revenues. However, such innovations face challenges due to existing generics and regulatory hurdles. A flagship example is the development of novel formulations aimed at improving tolerability, which could command premium pricing and expand market share.

4. Regulatory and Safety Developments

Ongoing safety concerns, including teratogenicity and neuropsychiatric side effects, influence regulatory decisions and consequently, market size. Stricter prescribing guidelines and contraindications may restrict use, thereby limiting revenue expansion.

5. Strategic Business Insights

Manufacturers aiming to sustain revenue streams are focusing on niche indications, exploring new formulations, and leveraging biosimilar or brand revitalization strategies. Venturing into combination therapies or adjunct indications remains a key strategy.

Future Outlook and Key Trends

The future of Topiramate’s market growth hinges on several variables:

• Innovation in Formulations: Extended-release and combination formulations could command better market positioning.
• Regulatory Landscape: Ongoing safety assessments and potential label updates may affect prescribing, thus influencing revenue.
• Generic Market Dynamics: Price competition will prevail unless new formulations or indications emerge.
• Emerging Therapeutics: Adoption of novel migraine preventives and seizure medications could reduce Topiramate’s market share.

Forecasts indicate that unless integrated with innovative strategies, Topiramate’s revenue trajectory will gradually decline, stabilizing at a relatively modest level, aligning with generic drug markets resilient to decline due to continual demand and labeling.

Key Takeaways

• Patent expirations have transformed Topiramate’s revenue landscape, shifting dominance to generics and prompting intense price competition.
• Despite safety concerns and regulatory challenges, demand persists in established markets driven by cost-effectiveness and broad therapeutic applications.
• Emerging markets present revenue growth opportunities owing to rising disease prevalence and expanding healthcare infrastructure.
• Continuous innovation, such as advanced formulations and combination therapies, is critical for manufacturers seeking to sustain or boost revenues.
• Regulatory and safety developments will heavily dictate future market size, emphasizing the need for adaptive strategies and vigilance.

FAQs

1. How has patent expiry affected Topiramate's market revenue?
Patent expiry led to an influx of generic competitors, sharply reducing the branded drug's revenue. Today, the market is dominated by generics, resulting in significantly lower sales compared to peak years.

2. What are the main therapeutic indications influencing Topiramate's market?
Epilepsy and migraine prevention remain primary indications. Off-label uses like weight management have contributed to demand but are limited by safety concerns.

3. Are there upcoming innovations that could revive Topiramate’s market?
Yes, formulations like extended-release versions, combination therapies, and new indication explorations could potentially revitalize market interest, provided they meet regulatory approval and demonstrate clinical benefits.

4. How do safety concerns impact the financial outlook for Topiramate?
Safety issues, especially teratogenicity and cognitive effects, lead to regulatory restrictions and cautious prescribing, which may constrain market growth and reduce revenue potential.

5. What regions offer the most growth potential for Topiramate?
Emerging markets in Asia-Pacific and Latin America offer promising growth due to expanding healthcare access, rising disease prevalence, and increasing adoption of generics.

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Sources:

1. WHO. Epilepsy. World Health Organization; 2019.
2. U.S. Patent and Trademark Office. Patent Expiry Date Records.
3. IQVIA. Pharmaceutical Market Data, 2022.
4. Merck Annual Reports, 2008-2010.
5. EvaluatePharma. Market Intelligence, 2021.
6. MarketsandMarkets. Antiepileptic Drugs Market Forecast, 2022-2027.