Topiramate - Generic Drug Details

What are the generic 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, Dr Reddys, Endo Operations, Glenmark Pharms Ltd, Lupin Ltd, Xiamen Lp Pharm Co, Zydus, Zydus Pharms, Supernus Pharms, Janssen Pharms, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Senores Pharms, 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, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Viwit Pharm, and Wockhardt, and is included in fifty-one NDAs. There are nineteen 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. Fifty-two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for topiramate

International Patents:	21
US Patents:	19
Tradenames:	6
Applicants:	41
NDAs:	51
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	52
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	293
Patent Applications:	7,416
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
		25MG	TABLET;ORAL
		200MG	TABLET;ORAL
		100MG	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
Unichem Labs Ltd	TOPIRAMATE	topiramate	TABLET;ORAL	090162-003	Mar 27, 2009	AB	RX	No	No
Alkem Labs Ltd	TOPIRAMATE	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	217248-001	Jun 20, 2023	AB1	RX	No	No
Aiping Pharm Inc	TOPIRAMATE	topiramate	TABLET;ORAL	078499-001	Jan 7, 2010		DISCN	No	No

Expired US Patents for topiramate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-002	Dec 24, 1996	4,513,006*PED
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-005	Dec 24, 1996	7,018,983*PED
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-002	Oct 26, 1998	4,513,006*PED

International Patents for topiramate

Country	Patent Number	Title	Estimated Expiration
Spain	2555066
World Intellectual Property Organization (WIPO)	2014143380
Germany	07870164

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

Topiramate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Topiramate

Introduction

Topiramate, a versatile antiepileptic drug, has been widely used for various medical conditions including epilepsy, migraine, weight loss, bipolar disorder, and alcohol dependence. This article delves into the market dynamics and financial trajectory of topiramate, highlighting its current market size, growth prospects, and economic implications.

Market Size and Growth Prospects

The global topiramate market is anticipated to experience significant growth over the forecast period from 2023 to 2031. The market size is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent, reaching an estimated valuation of several million USD by 2031[1][4].

Market Segmentation

The topiramate market is segmented based on product forms such as tablets, capsules, sprinkle capsules, and extended-release capsules. Additionally, it is categorized by application areas including epilepsy, migraine, weight loss, bipolar disorder, and alcohol dependence. Geographically, the market is divided into regions like North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1][4].

Drivers of Market Growth

Several factors drive the growth of the topiramate market:

• Increasing Prevalence of Epilepsy and Other Conditions: The rising incidence of epilepsy and other conditions for which topiramate is prescribed contributes to the market's expansion.
• Diverse Applications: Topiramate's efficacy in treating multiple conditions broadens its market reach.
• Advancements in Healthcare: Improvements in healthcare infrastructure and access to medications in various regions also boost market growth[1][4].

Restraints and Challenges

Despite the positive outlook, there are several challenges:

• Generic Entry: The introduction of generic versions of topiramate can lead to increased competition and potentially higher healthcare costs in some regions. For instance, studies have shown that generic entry in European countries resulted in higher health costs due to increased pharmacy dispensings and hospitalizations[3].
• Regulatory and Economic Factors: Economic evaluations and regulatory approvals can impact the cost-effectiveness and adoption of topiramate, especially in the context of obesity treatment where long-term clinical trials are necessary to fully evaluate outcomes[2].

Cost-Effectiveness and Economic Impact

The cost-effectiveness of topiramate, particularly when combined with other medications like phentermine, is a critical aspect of its market dynamics. A study on the treatment of obesity in adolescents found that top-dose phentermine and topiramate was cost-effective after 5 years, with an incremental cost-effectiveness ratio of $56,876 per quality-adjusted life year (QALY) gained[2].

Financial Trajectory

The financial trajectory of the topiramate market is influenced by several factors:

• Revenue Growth: The market is expected to see revenue growth at the global, regional, and country levels. This growth is driven by increasing demand and the expansion of end-use industries[1][4].
• Competitor Analysis: Key companies such as Chemwerth Inc. and Levachem are focusing on strategy building and product portfolio expansion to strengthen their market position[4].
• Pricing and Savings Programs: Programs like the TOPAMAX® Savings Program, which offers significant discounts to eligible patients, can affect the financial dynamics by reducing out-of-pocket costs and increasing patient adherence[5].

Regional Analysis

The topiramate market varies significantly across different regions:

• North America and Europe: These regions are expected to dominate the market due to advanced healthcare systems and higher adoption rates of topiramate.
• Asia-Pacific: This region is anticipated to show significant growth due to increasing healthcare expenditure and a large patient population[1][4].

Technological and Regulatory Trends

Technological advancements and regulatory changes play a crucial role in shaping the market:

• Patent Analysis: The expiration of patents can lead to the entry of generic versions, affecting market dynamics.
• ESG and PESTEL Analysis: Environmental, social, and governance (ESG) factors, along with political, economic, social, technological, legal, and environmental (PESTEL) analysis, provide a comprehensive view of the market's sustainability and future prospects[4].

Consumer Behavior and Healthcare Utilization

Consumer behavior and healthcare utilization patterns are vital in understanding the market's trajectory:

• Patient Adherence: Savings programs and cost-effective treatment options can improve patient adherence, thereby influencing market growth.
• Healthcare Utilization: Studies have shown that generic use of topiramate can lead to increased healthcare utilization, including more pharmacy dispensings and hospitalizations[3].

Key Takeaways

• The global topiramate market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
• The market is driven by increasing prevalence of epilepsy and other conditions, diverse applications, and advancements in healthcare.
• Generic entry and regulatory factors can impact the market's financial trajectory.
• Topiramate, especially when combined with phentermine, shows cost-effectiveness in long-term obesity treatment.
• Regional variations and technological trends are crucial in understanding the market's dynamics.

FAQs

Q: What is the expected CAGR of the global topiramate market from 2023 to 2031? A: The global topiramate market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031[1][4].

Q: What are the primary applications of topiramate? A: Topiramate is used for treating epilepsy, migraine, weight loss, bipolar disorder, and alcohol dependence[1][4].

Q: How does generic entry affect the topiramate market? A: Generic entry can lead to increased competition and higher healthcare costs due to increased pharmacy dispensings and hospitalizations[3].

Q: Is topiramate cost-effective for obesity treatment? A: Yes, top-dose phentermine and topiramate is projected to be cost-effective after 5 years, with an incremental cost-effectiveness ratio of $56,876 per QALY gained[2].

Q: What regions are expected to dominate the topiramate market? A: North America and Europe are expected to dominate the market, with the Asia-Pacific region showing significant growth potential[1][4].

Sources

1. Market Research Intellect - Global Topiramate Market Size Forecast 2
2. JAMA Network - Cost-Effectiveness of Pharmacotherapy for the Treatment of Obesity
3. PubMed - Projected economic impact of clinical findings of generic entry of topiramate
4. Cognitive Market Research - Global Topiramate Market Report 2024 Edition
5. Topamax - TOPAMAX® Savings Program