Drugs in MeSH Category Anti-Anxiety Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Inventia Hlthcare	BUSPIRONE HYDROCHLORIDE	buspirone hydrochloride	TABLET;ORAL	209696-003	May 3, 2018	AB	RX	No	No
Actavis Elizabeth	FLUVOXAMINE MALEATE	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	091482-002	Nov 18, 2013	AB	RX	No	Yes
Sun Pharm Industries	TEMAZEPAM	temazepam	CAPSULE;ORAL	078581-001	Sep 8, 2009	AB	RX	No	No
Adaptis	PREGABALIN	pregabalin	CAPSULE;ORAL	216197-006	Jul 18, 2022	AB	RX	No	No
Alembic	DIAZEPAM	diazepam	INJECTABLE;INJECTION	218450-001	Apr 25, 2024	AP	RX	No	No

Anti-Anxiety Agents Market Analysis and Financial Projection

The market for anti-anxiety drugs is undergoing significant growth and transformation, driven by increasing global mental health awareness and advancements in pharmacological research. Here's a detailed analysis of the current dynamics and patent landscape:

Market Dynamics

Growth Projections and Drivers

• The global anti-anxiety drugs market was valued at USD 8.1 billion in 2022 and is projected to reach USD 12.5 billion by 2030, growing at a CAGR of 6.0% [2][13]. Another report estimates the anxiolytic market at USD 13.95 billion in 2025, expanding at a CAGR of 3.19% through 2033 [3].
• Key growth drivers include:
  • Rising prevalence of anxiety disorders (affecting ~31.1% of U.S. adults) [13].
  • Shift toward non-benzodiazepine drugs (e.g., SSRIs, SNRIs) due to lower addiction risks [4][5].
  • Integration of digital health solutions (telemedicine, mental health apps) improving access [13].

Trends and Innovations

• Personalized medicine: Genetic profiling to tailor treatments for non-responders [2][3].
• Holistic approaches: Combining pharmacological therapies with behavioral interventions (e.g., CBT) [2].
• Emerging targets: Glutamate, neuropeptide Y (NPY), and endocannabinoid systems show promise for novel drug development [1][9][11]. For example, intranasal NPY reduced PTSD-like symptoms in preclinical studies [11].

Challenges

• Side effects: Dependency risks (benzodiazepines), sedation, and withdrawal complications [13].
• Regulatory hurdles: Prolonged approval processes (e.g., FDA clinical trials) delaying drug launches [13].
• Cost barriers: High prices of newer medications limiting accessibility [4].

Patent Landscape

Key Innovations and Filings

• Non-addictive formulations: Patents like US4994455A describe compounds with tranquilizing effects without sedation [15]. GABA Therapeutics is developing a modified Etifoxine to mimic Xanax’s efficacy with fewer side effects [14].
• Novel mechanisms: US9815827B2 covers imide derivatives for schizophrenia treatment, highlighting potential anxiolytic applications [10].
• Regional dominance: China leads in patent filings (1,758 applications), followed by the U.S. (291) and Japan (193), focused on antidepressants and anti-addictive therapies [8].

Emerging Targets

• NMDA/AMPA receptor modulators: Ketamine derivatives (e.g., KET01) are in Phase 3 trials for treatment-resistant depression and anxiety [17].
• Neuropeptide Y (NPY): Preclinical studies show NPY’s role in stress resilience; low CSF NPY levels correlate with PTSD severity [11].

Competitive Landscape

Key Players

• Major pharmaceutical companies include Pfizer, Novartis, Roche, and GlaxoSmithKline [3].
• Recent developments:
  • AbbVie’s supplemental FDA application for cariprazine (VRAYLAR) as an adjunct for major depressive disorder [17].
  • VistaGen’s Phase 3 trial of PH94B, a nasal spray for social anxiety disorder [17].

Future Outlook

• Non-pharmaceutical alternatives: Growing interest in herbal supplements (e.g., lavender, chamomile) and lifestyle interventions [13].
• Technological integration: AI-driven drug discovery and digital therapeutics to enhance treatment personalization [13].

“The recognition that antidepressants are effective in anxiety even in nondepressed patients has caused researchers to develop antianxiety agents that affect the serotonin and norepinephrine systems.” [5]

In conclusion, the anti-anxiety drug market is poised for growth, fueled by innovation in non-addictive therapies and personalized approaches. However, overcoming regulatory and cost barriers remains critical for translating research into accessible treatments.

References

1. https://pubmed.ncbi.nlm.nih.gov/26012843/
2. https://sites.google.com/view/spectrumadvisorygroup/top-industry-reports/anti-anxiety-drugs-market-by-application
3. https://www.promarketreports.com/reports/anxiolytic-market-11500
4. https://www.databridgemarketresearch.com/reports/global-anti-anxiety-drug-market/market-analysis
5. https://pubmed.ncbi.nlm.nih.gov/12662131/
6. https://aspe.hhs.gov/reports/market-barriers-development-pharmacotherapies-treatment-cocaine-abuse-addiction-final-report
7. https://www.drugwatch.com/drugs/ozempic/mounjaro/
8. https://www.neuroscigroup.us/articles/JAMTS-7-151.php
9. https://pmc.ncbi.nlm.nih.gov/articles/PMC4176700/
10. https://patents.google.com/patent/US9815827B2/en
11. https://pmc.ncbi.nlm.nih.gov/articles/PMC4869976/
12. https://meshb.nlm.nih.gov/record/ui?ui=D014151
13. https://www.verifiedmarketreports.com/product/anti-anxiety-drugs-market/
14. https://gabarx.com/2020/02/24/biotech-with-anxiety-drug-lands-funding/
15. https://patents.google.com/patent/US4994455A/en
16. https://www.businesswire.com/news/home/20220520005334/en/United-States-Anxiety-Drugs-Generic-and-Patent-Medicine-Market-Research-Report-2022-2027---ResearchAndMarkets.com
17. https://www.globenewswire.com/news-release/2024/08/02/2923706/0/en/Anxiety-Disorders-Treatment-Market-Size-to-Reach-USD-15-90-Bn-by-2032.html