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Last Updated: December 25, 2024

Topiramate - Generic Drug Details


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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, 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.

Drug Prices for topiramate

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Drug Sales Revenue Trends for topiramate

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Recent Clinical Trials for topiramate

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

SponsorPhase
Shalamar Institute of Health SciencesN/A
AbbViePhase 3
Henan Cancer HospitalPhase 2

See all topiramate clinical trials

Generic filers with tentative approvals for TOPIRAMATE
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe200MGTABLET;ORAL
⤷  Subscribe⤷  Subscribe100MGTABLET;ORAL
⤷  Subscribe⤷  Subscribe50MGTABLET;ORAL

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

Anatomical Therapeutic Chemical (ATC) Classes for topiramate
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alkem Labs Ltd TOPIRAMATE topiramate CAPSULE, EXTENDED RELEASE;ORAL 217248-001 Jun 20, 2023 AB1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aiping Pharm Inc TOPIRAMATE topiramate TABLET;ORAL 078499-001 Jan 7, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-002 Aug 16, 2013 AB1 RX Yes No 8,298,576 ⤷  Subscribe Y ⤷  Subscribe
Aiping Pharm Inc TOPIRAMATE topiramate TABLET;ORAL 078499-003 Jan 7, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Subscribe
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-005 Dec 24, 1996 7,018,983*PED ⤷  Subscribe
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 4,513,006*PED ⤷  Subscribe
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 7,498,311*PED ⤷  Subscribe
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 Dec 24, 1996 7,018,983*PED ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for topiramate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2317997 2190050-1 Sweden ⤷  Subscribe 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 ⤷  Subscribe PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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