Drugs in MeSH Category Anticonvulsants

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adaptis	PREGABALIN	pregabalin	CAPSULE;ORAL	216197-006	Jul 18, 2022	AB	RX	No	No
Adaptis	PREGABALIN	pregabalin	CAPSULE;ORAL	216197-007	Jul 18, 2022	AB	RX	No	No
Chartwell Rx	CLONAZEPAM	clonazepam	TABLET;ORAL	074925-001	Sep 30, 1997		DISCN	No	No
Cipla	PREGABALIN	pregabalin	CAPSULE;ORAL	212280-002	Jan 10, 2020		DISCN	No	No
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	Dec 30, 2004	AB	RX	Yes	No
Watson Labs	DIAZEPAM	diazepam	INJECTABLE;INJECTION	070296-001	Feb 12, 1986		DISCN	No	No

Anticonvulsants Market Analysis and Financial Projection

The anticonvulsants market is experiencing steady growth driven by rising epilepsy prevalence, expanded therapeutic applications, and advancements in drug development. Below is a detailed analysis of its market dynamics and patent landscape:

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Market Dynamics

Growth Projections

• The global anticonvulsants market is projected to grow from $18.85 billion in 2024 to $22.72 billion by 2029, at a 4.0% CAGR [1]. A separate report estimates the antiepileptic drugs market will reach $27.5 billion by 2033 (5.1% CAGR) [5].
• Key growth drivers include:
  • Increasing epilepsy prevalence: Over 5 million new cases annually worldwide, with higher incidence in low- and middle-income countries [1].
  • Expanding indications: Use in neuropathic pain, migraines, bipolar disorder, and anxiety [6][11].
  • Innovations in drug formulations: Extended-release options and digital health integrations (e.g., seizure-tracking apps) [1][6].

Regional Trends

• North America dominates due to advanced healthcare infrastructure and high R&D investments [15].
• Asia-Pacific and Africa show growth potential due to rising epilepsy awareness and improving healthcare access [6][7].

Competitive Landscape

• Leading companies include Johnson & Johnson, Pfizer, UCB, and GlaxoSmithKline [5][11].
• Recent developments:
  • FDA approval of Epidiolex (cannabis-derived drug) for pediatric epilepsy [5].
  • SK Biopharmaceuticals' expansion of Cenobamate in Canada [5].
  • Collaborations for novel drug candidates targeting rare epilepsy syndromes [5].

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Patent Landscape

Key Drug Patents

• Vimpat (lacosamide) by UCB:
  • Protected by patents expiring in 2026 [4].
  • Critical patents (e.g., USRE38551) cover enantiomeric amino acid derivatives and expired in 2022 [4][12].
  • Generics expected post-2026, with a projected $1.26–$15.43 price disparity between generic and brand formulations [10].
• Valproic Acid:
  • Off-patent but faces competition from newer agents with fewer side effects [8].
• Methylphenidate-based antiepileptics:
  • A 2014 patent (WO2014203696A1) highlights innovations targeting SCN1A gene mutations linked to epilepsy [9].

Challenges in Drug Development

• Plant-derived anticonvulsants:
  • Face hurdles like patenting difficulties for natural compounds and lengthy clinical trials [7].
  • Deforestation and variable active ingredient concentrations further complicate scalability [7].
• Generics Paradox:
  • Post-patent expiration, brand-name drug prices often rise (e.g., +24.4% during COVID-19) despite generic competition [10].
  • Each additional generic manufacturer reduces generic prices by 5.45% but increases brand prices by 2.46% [10].

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Pricing and Accessibility

• Cost Trends:
  • Median U.S. anticonvulsant prices doubled from 2006–2021 [10].
  • Generic immediate-release formulations are 7,751% cheaper than extended-release versions [10].
• Regulatory Impact:
  • Stringent FDA requirements for adjunctive therapy approval before monotherapy use delay market entry [13].

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Future Outlook

1. Innovation Trends:
   • Focus on neuroprotective effects and pediatric-friendly formulations [1][6].
   • AI-driven drug discovery to address drug-resistant epilepsy cases [11].
2. Market Risks:
   • Supply chain disruptions and inflation post-COVID-19 [10].
   • High R&D costs for novel mechanisms (e.g., glutamate modulation) [6][14].

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"The rise in epilepsy cases and advancements in personalized medicine are reshaping the anticonvulsants market, but pricing disparities and patent cliffs remain critical challenges." [1][10]

References

1. https://www.thebusinessresearchcompany.com/report/anticonvulsants-global-market-report
2. https://www.ninds.nih.gov/about-ninds/what-we-do/strategic-plans-evaluations/program-evaluations/anticonvulsant-screening-program-report-february-27-2012
3. https://meshb.nlm.nih.gov/record/ui?ui=D000927
4. https://pharsight.greyb.com/drug/vimpat-patent-expiration
5. https://www.alliedmarketresearch.com/antiepileptic-drugs-market
6. https://www.marketresearch.com/VPA-Research-v4245/Anticonvulsants-Size-Share-Outlook-Drug-40314773/
7. https://www.medrxiv.org/content/10.1101/2024.11.13.24317300v1.full.pdf
8. https://www.ncbi.nlm.nih.gov/sites/entrez?Db=mesh&Cmd=DetailsSearch&Term=%22Valproic+Acid%22%5BMeSH+Terms%5D
9. https://patents.google.com/patent/WO2014203696A1/en
10. https://pubmed.ncbi.nlm.nih.gov/39306895/
11. https://www.giiresearch.com/report/ires1602822-anticonvulsants-market-by-drug-types-ampa.html
12. https://ipwatchdog.com/2018/06/05/federal-circuit-confirms-validity-patent-ucb-vimpat/id=98022/
13. https://www.neurology.org/doi/10.1212/WNL.0000000000005756
14. https://pubmed.ncbi.nlm.nih.gov/11994018/
15. https://www.thebrainyinsights.com/report/anticonvulsants-market-12920