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Last Updated: March 24, 2025

Drugs in MeSH Category Nootropic Agents


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ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Aurobindo Pharma GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 204895-001 Aug 5, 2016 AB RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Aurobindo Pharma Ltd GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 090957-001 Mar 29, 2011 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Barr GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077605-002 Aug 28, 2008 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Norvium Bioscience GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077603-003 Aug 28, 2008 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Nootropic Agents Market Analysis and Financial Projection

The global nootropics market is experiencing explosive growth, driven by increasing demand for cognitive enhancement across diverse demographics. Valued at $3.75 billion in 2022[2], projections estimate a 14.6% CAGR through 2030[2], with some analysts forecasting a $73 billion market by 2034[8]. This expansion is fueled by aging populations seeking dementia prevention, professionals optimizing productivity, and students pursuing academic performance advantages.

Market Dynamics

Key growth drivers include:

  • Wellness industry convergence: 42% of nootropic compounds originated as dementia treatments[13], now repurposed for mainstream cognitive enhancement
  • Formulation innovation: Capsules/tablets dominate (72% market share)[5], but novel delivery systems like gummies and functional beverages gain traction[11]
  • Regional dominance: North America holds 64% market share[8], driven by U.S. consumers spending $5.49 billion in 2024[8]
  • Personalization algorithms: AI-driven custom "stacks" combining 3-5 compounds now command premium pricing[9]
Market Segment 2024 Value 2030 Projection CAGR
Cognitive Enhancers $18.48B[8] $39.88B[9] 13.85%
Dementia Treatments $1.2B[5] $3.1B[6] 7.6%

Patent Landscape

The IP environment shows strategic fragmentation:

  • Citicoline wars: Kyowa Hakko's Cognizin® holds 4 patents covering brain protection to motor function enhancement[3], creating a $480M/year niche[3]
  • Memantine case study: Original patent extensions until 2015 created $1B/year sales[6], with generics now capturing 68% of dementia treatment scripts[4]
  • Formulation patents: 34% of recent filings focus on combination therapies (EP2705841A1)[15] and sustained-release systems[6]

Emerging trends:

  1. Natural compound patents increased 22% YoY (2021-2024)[11]
  2. 61% of European filings now claim non-therapeutic uses post-T 1916/19 ruling[11]
  3. FDA Orange Book listings for nootropics grew 40% since 2020[12]

Regulatory Challenges

The line between pharma and nutraceuticals creates IP complexities:

  • EPO restrictions: 78% of method patents rejected as therapeutic claims[11]
  • FDA pathway conflicts: Only 12% of cognitive claims meet 505(b) NDA requirements[12]
  • Generics impact: Donepezil prescriptions surged 300% post-patent expiry[4]

The market's trajectory suggests increasing stratification between clinically validated pharmaceuticals (memantine, citicoline) and consumer-focused nutraceuticals. As patent walls crumble for legacy drugs ($5.4M UK cost reduction for memantine[6]), innovators hedge through combination therapies and AI-personalized stacks[9]. This dual-track evolution positions nootropics as both medical necessity and lifestyle enhancement, with IP strategies adapting to bridge these paradigms.

References

  1. https://decs.bvsalud.org/en/ths/resource/?id=32110
  2. https://www.grandviewresearch.com/industry-analysis/nootropics-market
  3. https://blog.priceplow.com/industry-news/cognizin-patent-2024
  4. https://pubmed.ncbi.nlm.nih.gov/29843807/
  5. https://www.gminsights.com/industry-analysis/nootropic-supplements-market/market-analysis
  6. https://pmc.ncbi.nlm.nih.gov/articles/PMC6425228/
  7. https://pubmed.ncbi.nlm.nih.gov/24898652/
  8. https://www.precedenceresearch.com/nootropics-market
  9. https://www.databridgemarketresearch.com/reports/global-nootropics-market
  10. https://patents.google.com/patent/RU2045958C1/en
  11. https://www.mathys-squire.com/insights-and-events/news/nootropics-revolution-patentability-in-the-uk-and-eu/
  12. https://www.fda.gov/media/155200/download
  13. https://pmc.ncbi.nlm.nih.gov/articles/PMC7516264/
  14. https://patents.google.com/patent/WO2014037412A1/en
  15. https://patents.google.com/patent/EP2705841A1/en

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