TOPAMAX SPRINKLE Drug Patent Profile

Which patents cover Topamax Sprinkle, and when can generic versions of Topamax Sprinkle launch?

Topamax Sprinkle is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in TOPAMAX SPRINKLE 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 Sprinkle

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

Summary for TOPAMAX SPRINKLE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	4
Patent Applications:	5,077
Drug Prices:	Drug price information for TOPAMAX SPRINKLE
DailyMed Link:	TOPAMAX SPRINKLE at DailyMed

See drug prices for TOPAMAX SPRINKLE

Recent Clinical Trials for TOPAMAX SPRINKLE

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1
Teva Pharmaceuticals USA	Phase 1

See all TOPAMAX SPRINKLE clinical trials

Pharmacology for TOPAMAX SPRINKLE

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 SPRINKLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TOPAMAX SPRINKLE	Capsules	topiramate	15 mg and 25 mg	020844	1	2005-09-07

US Patents and Regulatory Information for TOPAMAX SPRINKLE

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 SPRINKLE	topiramate	CAPSULE;ORAL	020844-003	Oct 26, 1998		DISCN	Yes	No

Expired US Patents for TOPAMAX SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	TOPAMAX SPRINKLE	topiramate	CAPSULE;ORAL	020844-003	Oct 26, 1998
Janssen Pharms	TOPAMAX SPRINKLE	topiramate	CAPSULE;ORAL	020844-003	Oct 26, 1998
Janssen Pharms	TOPAMAX SPRINKLE	topiramate	CAPSULE;ORAL	020844-003	Oct 26, 1998
Janssen Pharms	TOPAMAX SPRINKLE	topiramate	CAPSULE;ORAL	020844-003	Oct 26, 1998

International Patents for TOPAMAX SPRINKLE

See the table below for patents covering TOPAMAX SPRINKLE 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

Supplementary Protection Certificates for TOPAMAX SPRINKLE

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 SPRINKLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Topamax (Topiramate) Sprinkle

Market Overview

Topamax, or topiramate, is a versatile antiepileptic drug used in the treatment of various conditions including epilepsy, migraine, weight loss, bipolar disorder, and alcohol dependence. The market for topiramate, including its sprinkle capsule form, is experiencing significant growth and is poised for continued expansion.

Market Size and Growth Forecast

The global topiramate market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from 2023 to 2031. This growth is driven by increasing demand for effective treatments for neurological disorders and other conditions where topiramate is prescribed[1].

Product Segmentation

The topiramate market is segmented based on product forms, which include tablets, capsules, sprinkle capsules, and extended-release capsules. The sprinkle capsule form, in particular, offers convenience and ease of administration, especially for pediatric patients or those who have difficulty swallowing tablets[1][4].

Application Segmentation

Topiramate is used across various therapeutic applications:

• Epilepsy: As monotherapy or adjunctive therapy for adults and children.
• Migraine: For the prophylaxis of migraine headaches.
• Weight Loss: Often used off-label for weight reduction.
• Bipolar Disorder: As part of the treatment regimen.
• Alcohol Dependence: To support alcohol cessation.

Each application segment contributes to the overall market growth, with epilepsy and migraine being the primary drivers[1][4].

Geographical Segmentation

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America and Europe are significant markets due to high healthcare spending and a large patient base. However, the Asia-Pacific region is expected to show substantial growth due to increasing healthcare infrastructure and awareness[1].

Market Drivers

Several factors drive the growth of the topiramate market:

• Increasing Prevalence of Neurological Disorders: Rising cases of epilepsy, migraine, and other neurological conditions drive the demand for effective treatments.
• Advancements in Healthcare Infrastructure: Improving healthcare facilities and access to medications in emerging markets.
• Generic Entry: While generic entry can increase competition, it also expands market reach by making the drug more affordable[1][3].

Market Restraints

Despite the growth, there are several restraints:

• Side Effects and Safety Concerns: Topiramate is associated with side effects such as oral clefts in newborns when taken during pregnancy, which necessitates a Risk Evaluation and Mitigation Strategy (REMS)[5].
• Regulatory Challenges: Strict regulatory environments and the need for continuous monitoring and assessment of the drug's safety profile.
• Generic Competition: The entry of generic versions can reduce the market share of branded products[1][3][5].

Financial Trajectory

Revenue Projections

The topiramate market, including the sprinkle capsule form, is projected to see significant revenue growth. The market size is expected to increase from its current valuation to a substantial figure by 2031, driven by the factors mentioned above[1].

Key Players

Several pharmaceutical companies are key players in the topiramate market:

• Janssen Pharmaceuticals, Inc.
• Teva Pharmaceuticals
• Actavis
• Sandoz
• Mylan Pharmaceuticals
• Apotex Corp.
• Zydus Pharmaceuticals
• Aurobindo Pharma
• Torrent Pharmaceuticals
• Hikma Pharmaceuticals
• Sun Pharmaceutical Industries Ltd.
• Lannett Company, Inc.
• Glenmark Pharmaceuticals
• Lupin Limited

These companies contribute to the market's financial trajectory through their product offerings, pricing strategies, and market penetration[1].

Economic Impact of Generic Entry

The entry of generic topiramate has a mixed economic impact. While it increases affordability and accessibility, it can also lead to higher overall healthcare costs due to increased pharmacy dispensings, hospitalizations, and lengths of hospital stays. A study based on Canadian data projected higher health costs in European countries following the generic entry of topiramate[3].

Pricing Analysis

The pricing of topiramate, including the sprinkle capsule form, is influenced by several factors:

• Product Pricing: The cost of the drug varies based on the form and dosage.
• National and Regional Penetration: Prices differ across regions due to local healthcare policies and market dynamics.
• Competition: The presence of generic versions affects the pricing strategy of branded products[1].

Market Outlook

The market outlook for topiramate is positive, with sustained growth expected from 2023 to 2031. This growth is supported by:

• Porter's 5 Forces Framework: Analyzing the competitive landscape, bargaining power of suppliers and buyers, threat of new entrants, and substitute products.
• Macroeconomic Assessments: Considering national GDP, healthcare spending, and economic stability.
• Value Chain Analysis: Examining the entire supply chain from production to distribution.
• Pricing Analysis: Evaluating the impact of pricing strategies on market dynamics[1].

Corporate Profiles and Market Strategies

Key players in the market are focusing on various strategies to maintain and expand their market share:

• Product Diversification: Offering different forms of topiramate, such as sprinkle capsules.
• Market Expansion: Entering new geographical markets.
• Research and Development: Continuously monitoring and improving the safety and efficacy of the drug.
• Regulatory Compliance: Ensuring adherence to REMS and other regulatory requirements[1].

Consumer Behavior and Economic Landscape

Consumer behavior and the economic landscape play crucial roles in shaping the market:

• Consumer Awareness: Increasing awareness about neurological disorders and available treatments.
• Economic Stability: The financial stability of countries influences healthcare spending and access to medications.
• Healthcare Policies: Government policies and reimbursement schemes affect the affordability and accessibility of topiramate[1].

Key Takeaways

• The topiramate market, including the sprinkle capsule form, is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
• The market is driven by increasing demand for neurological disorder treatments and expanding healthcare infrastructure.
• Key players are focusing on product diversification, market expansion, and regulatory compliance.
• Generic entry has a mixed economic impact, increasing affordability but potentially leading to higher overall healthcare costs.
• The market outlook is positive, supported by favorable market dynamics and macroeconomic factors.

FAQs

What are the primary applications of Topamax (topiramate)?

Topamax is primarily used for the treatment of epilepsy, migraine prophylaxis, weight loss, bipolar disorder, and alcohol dependence.

How does the generic entry of topiramate affect the market?

Generic entry increases competition, reduces prices, and expands market reach but can also lead to higher overall healthcare costs due to increased pharmacy dispensings and hospitalizations.

What are the key factors driving the growth of the topiramate market?

The growth is driven by increasing prevalence of neurological disorders, advancements in healthcare infrastructure, and the convenience of different product forms like sprinkle capsules.

Which regions are expected to show significant growth in the topiramate market?

North America and Europe are significant markets, but the Asia-Pacific region is expected to show substantial growth due to increasing healthcare infrastructure and awareness.

What are the potential side effects and safety concerns associated with topiramate?

Topiramate is associated with side effects such as oral clefts in newborns when taken during pregnancy, necessitating a Risk Evaluation and Mitigation Strategy (REMS).

Sources

1. Market Research Intellect: Global Topiramate Market Size Forecast 2.
2. Supernus Pharmaceuticals, Inc.: Financial Performance and Regulatory Filings.
3. PubMed: Projected economic impact of clinical findings of generic entry of topiramate.
4. Health Canada: Product Monograph Including Patient Medication Information for Topamax.
5. FDA: Topamax (topiramate) Tablets - Supplement Approval and REMS Requirements.