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Last Updated: April 28, 2025

Drugs in MeSH Category Anti-Dyskinesia Agents


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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Group HALOPERIDOL haloperidol TABLET;ORAL 200854-005 Jul 1, 2022 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx HALOPERIDOL haloperidol TABLET;ORAL 071209-003 Nov 17, 1986 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Duramed Pharms Barr HALOPERIDOL haloperidol TABLET;ORAL 071220-001 Jul 7, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Mankind Pharma HALOPERIDOL haloperidol TABLET;ORAL 216918-005 Apr 11, 2024 AB RX 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

Anti-Dyskinesia Agents Market Analysis and Financial Projection

The market for anti-dyskinesia agents is experiencing significant growth driven by rising prevalence of drug-induced movement disorders and expanding therapeutic pipelines. Here's an analysis of key dynamics:

Market Growth and Drivers

The global tardive dyskinesia (TD) therapeutics market is projected to reach $5.88 billion by 2035, growing at 4.8% CAGR from $3.51 billion in 2024[14]. Key factors include:

  • 20-30% of long-term antipsychotic users developing TD[6][16]
  • Expanding use of neuroleptics for schizophrenia, bipolar disorder, and gastrointestinal conditions[6][8]
  • Dominance of VMAT2 inhibitors (valbenazine and deutetrabenazine) capturing $1.6 billion in 2023[6]

Neurocrine Biosciences leads with INGREZZA® (valbenazine), achieving 96.13% U.S. market share in 2022 through strong sales and strategic approvals[1]. Teva Pharmaceuticals follows with Austedo® (deutetrabenazine), growing steadily since its 2017 FDA approval[1].

Patent Landscape and Innovation

Recent developments highlight competitive IP strategies:

  • Vistagen secured Canadian (2034 expiry) and U.S. patents for AV-101, an NMDAR antagonist showing 64% dyskinesia reduction in trials[4][12]
  • Amarantus extended protection for eltoprazine (5HT1A/1B agonist) through 2027 via continuation patents[2]
  • Riluzole patents cover both Parkinson's LID and antipsychotic-induced TD[7]
  • Reformulation patents like ADS-5102 (extended-release amantadine) address dosing challenges in LID[13]

Emerging pipeline candidates include:

  • DYSVAL® (Mitsubishi Tanabe Pharma) targeting Asian markets[1]
  • SOM Biotech and Luye Pharma developing novel VMAT2 inhibitors[1]
  • mGluR5 NAMs (e.g., AFQ056) showing 40% LID reduction in trials[12]

Regional Dynamics

North America dominates (44.2% share) due to:

  • High antipsychotic prescription rates affecting 600,000+ Americans[6][10]
  • Advanced diagnostics and insurance coverage for TD therapies[14]

Europe and Asia-Pacific show growth potential through:

  • Germany's projected 7.4% CAGR in hospital pharmacy distribution[6]
  • Mitsubishi Tanabe's planned DYSVAL® approvals in Japan/Korea[1]

Challenges and Opportunities

Key barriers include:

  • 30% remission rates after neuroleptic discontinuation[10]
  • Limited awareness in developing regions[1][6]

Growth frontiers involve:

  • Digital health platforms improving medication adherence[14]
  • Combination therapies targeting serotonin and glutamate pathways[5][12]
  • Orphan drug designations accelerating development timelines[2][4]

"The pipeline candidates of these companies will occupy a significant proportion of the market in the future" [1], highlighting the sector's innovation trajectory.

This evolving landscape combines established VMAT2 inhibitors with novel mechanisms (NMDAR/glycine site antagonism, 5HT modulation) to address unmet needs in both TD and LID markets.

References

  1. https://www.fortunebusinessinsights.com/tardive-dyskinesia-therapeutics-market-107532
  2. https://parkinsonsnewstoday.com/news/amarantus-gets-us-patent-covering-method-of-treating-parkinsons-disease-levodopa-induced-dyskinesia/
  3. https://pmc.ncbi.nlm.nih.gov/articles/PMC6491120/
  4. https://www.businesswire.com/news/home/20230713041093/en/Vistagen-Receives-Notice-of-Allowance-for-AV-101-Canadian-Patent-for-Treatment-of-Dyskinesia-Related-to-Levodopa-Therapy-for-Parkinsons-Disease
  5. https://pubmed.ncbi.nlm.nih.gov/31694421/
  6. https://www.gminsights.com/industry-analysis/tardive-dyskinesia-therapeutics-market
  7. https://patents.google.com/patent/AU1780699A/en
  8. https://www.drugwatch.com/reglan/
  9. https://pubmed.ncbi.nlm.nih.gov/24310603/
  10. https://www.coherentmarketinsights.com/market-insight/tardive-dyskinesia-drugs-market-218/market-size-and-trends
  11. https://meshb-prev.nlm.nih.gov/record/ui?ui=D018726
  12. https://pmc.ncbi.nlm.nih.gov/articles/PMC4540734/
  13. https://www.openaccessjournals.com/articles/amantadine-and-phenytoin-patent-protected-cases-of-drug-repositioning.html
  14. https://www.metatechinsights.com/industry-insights/tardive-dyskinesia-therapeutics-market-2026
  15. https://www.maxval.com/blog/pharma-patent-landscape-parkinsons-disease-uncovered/
  16. https://www.mordorintelligence.com/industry-reports/tardive-dyskinesia-treatment-market

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