Drugs in MeSH Category GABA Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DEPAKENE	valproic acid	CAPSULE;ORAL	018081-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hikma	VIGABATRIN	vigabatrin	TABLET;ORAL	213104-001	Aug 29, 2022	AB	RX	No	No
Accord Hlthcare	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	214425-001	Nov 13, 2020		DISCN	No	No

GABA Agents Market Analysis and Financial Projection

Last updated: March 25, 2025

The GABA (gamma-aminobutyric acid) agents market is experiencing significant growth, driven by rising neurological disorder prevalence and innovations in therapeutic targeting. Here’s a breakdown of key dynamics and patent trends:

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Market Dynamics

Growth Projections

• The GABA market is projected to grow from $88.1 million (2023) to $143.6 million by 2033, with a 5.0% CAGR[1][6]. Alternative estimates suggest a 5.32% CAGR, reaching $129.4 million by 2031[6].
• The GABA receptor agonist market is expanding even faster, with a 12.5% CAGR, driven by demand for anxiety, epilepsy, and insomnia treatments[18].

Key Drivers

1. Neurological Disorders: Over 264 million people globally suffer from anxiety disorders, fueling demand for GABA-based therapies[20].
2. Aging Populations: Age-related cognitive decline increases reliance on GABA agents for neuroprotection[20].
3. Regional Trends:
   • North America dominates (46.4% market share in 2024) due to healthcare infrastructure and stress management needs[1].
   • Asia-Pacific is emerging as a growth hub, driven by rising mental health awareness[20].

Segment Dominance

• Production: Chemical synthesis commands 66.1% market share (2024) for scalable production, while biological fermentation grows for sustainability[1].
• Applications: Pharmaceuticals lead (38.2% share), followed by functional foods and dietary supplements[1][18].

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Patent Landscape

Recent Filings and Innovations

1. Gabather AB:
   • Filed two U.S. provisional patents for GT-002, a selective GABA-A receptor modulator targeting psychiatric disorders. These patents aim to strengthen IP around EEG/fMRI-based clinical findings[2][4].
2. Sage Therapeutics:
   • Patented neuroactive steroids targeting GABA receptors for sedation/anesthesia, with potential applications in CNS disorders[7].
3. Marinus Pharmaceuticals:
   • Advanced ganaxolone, a GABA-A receptor modulator, to Phase III trials for CDKL5 deficiency disorder[15].

Pipeline Developments

• Over 25 companies are developing GABA receptor agonists, with 25+ pipeline drugs in various stages[15]. Notable candidates:
  • GRX-917 (GABA Therapeutics): A deuterated anxiolytic in Phase 2/3 trials for generalized anxiety disorder (GAD), projected for 2028 approval[17].
  • EMB-001 (Embera NeuroTherapeutics): A Phase II/III combination therapy (metyrapone + oxazepam) for smoking cessation[15].

Patent Expirations

• Horizant (gabapentin enacarbil) faces generic competition by 2029, with 4 active patents expiring between 2025–2029[16].
• Strategies to extend IP include novel formulations (e.g., sustained-release prodrugs) and combination therapies[16][7].

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Therapeutic Trends

1. Anxioselective Agents: Development focuses on reducing anxiety without sedation (e.g., ocinaplon), though challenges like hepatotoxicity persist[13].
2. Non-Monoamine Strategies: Targeting glutamate-GABA balance for rapid-acting antidepressants, inspired by ketamine and brexanolone[10].
3. Diverse Receptor Targets:
   • GABA-A: Dominates drug development, with modulators like propofol and neuroactive steroids[3][12].
   • GABA-B: Emerging interest in antagonists (e.g., CGP36742) for depression and cognitive enhancement[8][19].

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Competitive Outlook

• Top Players: Teva, Novartis, and Pfizer lead in revenue, investing in novel GABA agonists and delivery systems[18].
• Innovation Areas:
  • Allosteric Modulation: Enhancing receptor specificity to reduce side effects[3][7].
  • Combination Therapies: Pairing GABA agents with other neuroactive compounds (e.g., cortisol inhibitors)[15][10].

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Challenges and Opportunities

• Regulatory Hurdles: Safety concerns (e.g., liver toxicity) delay approvals[13][17].
• Generics Threat: Patent expirations (e.g., Horizant) will increase affordability but reduce brand revenue[16].
• Untapped Markets: Expanding into obesity, pain, and neuroinflammation could diversify applications[17][19].

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Key Takeaways

• The GABA agents market is poised for sustained growth, driven by neurological disorder prevalence and therapeutic innovation.
• Patent activity focuses on novel modulators and extended IP strategies, while generics loom post-2025.
• Future success hinges on overcoming safety challenges and diversifying into new indications like obesity and neuroinflammation.

References

1. https://market.us/report/gaba-gamma-aminobutyric-acid-market/
2. https://www.biospace.com/gabather-files-two-new-patent-applications-to-secure-novel-findings-on-the-effects-of-gt-002-for-the-treatment-of-psychiatric-disorders
3. https://pubmed.ncbi.nlm.nih.gov/30337372/
4. https://news.cision.com/gabather-ab/r/gabather-files-two-new-patent-applications-to-secure-novel-findings-on-the-effects-of-gt-002-for-the,c3946912
5. https://aem-prod.oklahoma.gov/content/dam/ok/en/okhca/docs/about/boards-and-committees/dur/2024/june/06122024%20DUR%20Packet.pdf
6. https://www.verifiedmarketresearch.com/product/gaba-market/
7. https://www.pharmaceutical-technology.com/data-insights/sage-therapeutics-files-patent-for-gaba-modulator-pharmaceutical-compositions-for-sedation-and-anesthesia/
8. https://pubmed.ncbi.nlm.nih.gov/15039762/
9. https://pubmed.ncbi.nlm.nih.gov/11475940/
10. https://pubmed.ncbi.nlm.nih.gov/31991195/
11. https://patents.google.com/patent/EP2621282A2/en
12. https://meshb.nlm.nih.gov/record/ui?ui=D018757
13. https://pubmed.ncbi.nlm.nih.gov/22981367/
14. https://patents.justia.com/patent/20200138830
15. https://www.businesswire.com/news/home/20220210005812/en/GABA-Receptor-Agonists-Drug-Market-Research-Report-2022-Comprehensive-Insights-About-25-Companies-and-25-Pipeline-Drugs---ResearchAndMarkets.com
16. https://pharsight.greyb.com/drug/horizant-patent-expiration
17. https://gabarx.com/wp-content/uploads/2025/02/GABA-Therapeutics-Presentation-20250211.pdf
18. https://github.com/kelttnandan9/Market-Research-Report-List-1/blob/main/gamma-aminobutyric-acid-gaba-receptor-agonist-market.md
19. https://www.pharmaceutical-technology.com/data-insights/gamma-aminobutyric-acid-type-b-receptor-subunit-drugs-in-development/
20. https://pmarketresearch.com/product/worldwide-gamma-aminobutyric-acid-gaba-receptor-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030/