gamma-Aminobutyric Acid-ergic Agonist Drug Class List

Drugs in Drug Class: gamma-Aminobutyric Acid-ergic Agonist

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rubicon	BACLOFEN	baclofen	TABLET;ORAL	209102-001	Nov 28, 2017	AB	RX	No	Yes
Rising	BACLOFEN	baclofen	TABLET;ORAL	214374-002	Mar 5, 2021	AB	RX	No	No
Micro Labs	BACLOFEN	baclofen	TABLET;ORAL	217687-002	Nov 8, 2023	AB	RX	No	No
Aurobindo Pharma Ltd	BACLOFEN	baclofen	TABLET;ORAL	214099-001	Jul 13, 2021	AB	RX	No	No
Impax	BACLOFEN	baclofen	TABLET;ORAL	077971-002	Oct 26, 2007		DISCN	No	No
Upsher Smith Labs	BACLOFEN	baclofen	TABLET;ORAL	074584-002	Aug 19, 1996	AB	RX	No	No

Gamma-Aminobutyric Acid-ergic Agonist Market Analysis and Financial Projection

The gamma-aminobutyric acid (GABA)-ergic agonist market is experiencing significant growth driven by rising neurological disorder prevalence and innovation in drug development. Below is an analysis of its market dynamics and patent landscape:

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Market Dynamics

Growth Drivers

• Rising Neurological Disorders: Anxiety, epilepsy, insomnia, and depression are key drivers, with anxiety disorders affecting ~28% of the global population[6].
• Demand for Non-Benzodiazepine Therapies: Increased preference for safer alternatives like gabapentinoids and selective GABA-B receptor agonists[6][11].
• Pharmaceutical R&D Investments: Over $16B in annual revenue from major players like Teva and Novartis[1], with clinical trials exploring novel applications (e.g., Alzheimer’s, metabolic syndrome)[6][15].
• Regional Expansion:
  • North America dominates (35–46% share) due to advanced healthcare infrastructure[1][3].
  • Asia-Pacific is the fastest-growing region (30% share), driven by rising mental health awareness[1][3].
  • Europe accounts for ~25% of the market, bolstered by collaborative research[5][13].

Market Projections

• The pharmaceutical GABA receptor agonist market is projected to grow from $1.3B (2023) to $2.4B by 2033 (CAGR 6.3%)[5], while broader estimates suggest $8.5B (2023) to $12.7B by 2030 (CAGR 5.8%)[6].
• The supplement-based GABA market (primarily for stress relief) is smaller, growing from $88.1M (2023) to $143.6M by 2033 (CAGR 5.0%)[3].

Key Players

• Leading companies include Pfizer, Novartis, AstraZeneca, and Teva, which are investing in novel agonists and strategic acquisitions (e.g., Pfizer’s acquisition of Arena Pharmaceuticals)[6][13].

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Patent Landscape

Innovation Trends

1. Novel Formulations:
   • Addex Therapeutics’ ADX71441, a GABA-BR PAM (positive allosteric modulator) with patents covering composition and treatment methods for neuropathic pain and anxiety[4].
   • Sage Therapeutics’ neuroactive steroid patent (US20240025942A1) for sedation/anesthesia[10].
2. Expanding Indications:
   • Catalyst Pharma filed provisional patents for GABA aminotransferase inhibitors in Tourette Syndrome[12].
   • Diamyd Medical holds patents for GABA formulations to treat diabetes and inflammatory disorders[15].
3. Prodrugs and Combination Therapies:
   • Patents for prodrugs of GABA analogs (e.g., US6818787B2)[17] and combinations with GABA modulators for metabolic syndrome[7].

Strategic Focus

• Targeted Therapies: Precision modulation of GABA-A and GABA-B receptor subtypes to minimize side effects[5][13].
• Delivery Systems: Long-acting formulations and non-oral administration methods (e.g., intramuscular)[10].

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Challenges

• Patent Cliffs: Expiry of key drugs (e.g., baclofen) has increased generic competition[11].
• Regulatory Hurdles: Stringent FDA/EMA requirements for safety and efficacy[6][14].
• Competition from Alternatives: Cognitive behavioral therapy (CBT) and non-pharmacological interventions[6].

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Future Outlook

• Emerging Applications: Exploration in metabolic disorders (e.g., diabetes)[7][15] and neuroprotection[13].
• Technological Advancements: AI-driven drug design and gene therapy[6][13].
• Regional Opportunities: Expansion into Latin America and Africa, where mental health infrastructure is underdeveloped[14].

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Key Takeaways

• The GABA-ergic agonist market is bifurcated into pharmaceuticals (dominant) and supplements (niche).
• Innovation centers on receptor specificity, combination therapies, and novel indications beyond CNS disorders.
• North America remains the revenue leader, but Asia-Pacific offers untapped potential due to rising healthcare investment.

“Our intellectual property estate continues to yield key patents protecting novel oral small molecules discovered utilizing our allosteric modulation technology platform.” — Addex Therapeutics[4]

References

1. https://github.com/kelttnandan9/Market-Research-Report-List-1/blob/main/gamma-aminobutyric-acid-gaba-receptor-agonist-market.md
2. https://patents.google.com/patent/US7595395B2/en
3. https://market.us/report/gaba-gamma-aminobutyric-acid-market/
4. https://www.addextherapeutics.com/en/investors/press-releases/addex-announces-issuance-broad-us-composition-matter-patent-adx71441/
5. https://datahorizzonresearch.com/gamma-aminobutyric-acid-gaba-receptor-agonist-market-4228
6. https://www.promarketreports.com/reports/gaba-receptor-agonist-market-11130
7. https://patents.google.com/patent/EP2621282A2/en
8. https://www.verifiedmarketresearch.com/product/gaba-market/
9. https://journals.sagepub.com/doi/pdf/10.4137/PMC.S5490?download=true
10. https://www.pharmaceutical-technology.com/data-insights/sage-therapeutics-files-patent-for-gaba-modulator-pharmaceutical-compositions-for-sedation-and-anesthesia/
11. https://www.databridgemarketresearch.com/reports/global-gaba-receptor-agonist-market
12. https://ir.catalystpharma.com/news-releases/news-release-details/catalyst-pharmaceutical-partners-files-us-provisional-patent
13. https://www.360iresearch.com/library/intelligence/gamma-aminobutyric-acid-receptor-agonist
14. https://markwideresearch.com/global-gaba-market/
15. https://www.diamyd.com/docs/pressClip.aspx?ClipID=4459243
16. https://www.pharmaceutical-technology.com/data-insights/gamma-aminobutyric-acid-receptor-subunit-alpha-5-drugs-in-development/
17. https://patents.google.com/patent/US6818787B2/en