Drugs in MeSH Category Anesthetics, Dissociative

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	KETALAR	ketamine hydrochloride	INJECTABLE;INJECTION	016812-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	No
Gland	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	216809-002	Jan 24, 2023	AP	RX	No	No
Fresenius Kabi Usa	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	215808-001	Jan 13, 2023	AP	RX	No	No
Eugia Pharma	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	076092-002	Dec 28, 2001	AP	RX	No	No
Eugia Pharma	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	076092-003	Oct 25, 2002	AP	RX	No	No
Endo Operations	KETALAR	ketamine hydrochloride	INJECTABLE;INJECTION	016812-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

Anesthetics, Dissociative Market Analysis and Financial Projection

Last updated: March 24, 2025

The market dynamics for dissociative anesthetics like ketamine and esketamine are marked by rapid growth driven by expanding therapeutic applications, while the patent landscape faces challenges over monopolization and ethical concerns regarding biopiracy.

Market Dynamics

• Projected Growth:

  • The global anesthesia drugs market is expected to grow at a 3.3% CAGR, reaching $9.4 billion by 2033 [15]. Dissociative anesthetics contribute significantly, with ketamine leading due to its dual use in anesthesia and mental health.
  • The ketamine treatment market is growing exponentially at a 42.35% CAGR, projected to reach $5.18 billion by 2030, fueled by its off-label use for treatment-resistant depression (TRD), PTSD, and chronic pain [17].
  • Esketamine (a ketamine derivative) is a key driver, with its market forecasted to hit $2.2 billion by 2030 due to FDA approval for TRD and nasal spray formulations [16].

• Therapeutic Expansion:

  • Ketamine’s mechanism—NMDA receptor antagonism—has spurred research into glutamate modulation for depression, with studies showing dissociation and analgesia can be separated, enabling targeted therapies [5][12].
  • 65% of sales for dissociative anesthetics target non-retail settings (e.g., hospitals), while 17% are retail prescriptions, reflecting increased accessibility for mental health applications [9][15].

Patent Landscape and Challenges

• Monopolization Risks:

  • Companies like Compass Pathfinder and Janssen Biotech (maker of Spravato®) use patent thickets to dominate markets, filing overlapping patents on formulations (e.g., crystalline psilocybin) or administration methods (e.g., therapy settings) [2][10].
  • Ketamine’s generic status has led to "supergeneric" innovations like Abraxane® (nanoparticle albumin-bound paclitaxel) to extend patent life [3][12].

• Ethical and Legal Issues:

  • Biopiracy concerns arise when patents fail to acknowledge Indigenous knowledge, such as traditional uses of psychedelics in healing practices [2][10].
  • The U.S. Patent Office’s lack of expertise in psychedelic history has led to controversial patents, including methods for “muted room settings” during therapy, which critics argue lack novelty [2][10].

• Innovation vs. Access:

  • Patent pledges and prior art repositories are proposed to prevent unwarranted patents, but adoption remains limited [2][10].
  • Esketamine’s FDA breakthrough designation accelerated approval but raised costs, with treatment courses exceeding $6,000, limiting accessibility despite efficacy [12][16].

Future Outlook

• Regulatory and Research Trends:
  • Psychedelic therapy startups are bypassing patents via telehealth models and derivative drugs (e.g., arketamine) to avoid litigation [12].
  • NMDA-targeting peptides (e.g., ProTx-II) and glutamatergic drugs are under development to improve specificity and reduce side effects [6].

Factor	Impact
Generic Competition	Reduces prices but incentivizes supergenerics (e.g., nasal sprays) [3][12]
FDA Designations	Accelerate approvals but prioritize branded drugs over generics [12][16]
Patent Litigation Risks	Deter small firms from entering the market [2][10]

"The dissociative properties of ketamine have opened new pathways in mental health treatment, yet patent strategies risk stifling the very innovation they aim to protect." [10][12]

This landscape highlights a tension between therapeutic potential and intellectual property challenges, requiring balanced policies to ensure equitable access and continued innovation.

References

1. https://adf.org.au/drug-facts/dissociatives/
2. https://harvardlawreview.org/forum/no-volume/patents-on-psychedelics-the-next-legal-battlefront-of-drug-development/
3. https://www.ufrgs.br/imunovet/molecular_immunology/anticancer.html
4. https://www.lahacienda.com/dissociative-anesthetics
5. https://journals.lww.com/painrpts/fulltext/2021/07000/dissociative_and_analgesic_properties_of_ketamine.7.aspx
6. https://elifesciences.org/reviewed-preprints/81727
7. https://jamanetwork.com/journals/jama/fullarticle/360140
8. https://patents.google.com/patent/WO2004103260A2/en
9. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM628319.pdf
10. https://ir.law.fsu.edu/cgi/viewcontent.cgi?article=1738&context=articles
11. https://www.bjmp.org/category/content/review-article?if=1
12. https://btlj.org/wp-content/uploads/2024/05/0004_39-LSI_Joralemon.pdf
13. https://nida.nih.gov/research-topics/psychedelic-dissociative-drugs-medicines
14. https://meshb-prev.nlm.nih.gov/record/ui?ui=D000778
15. https://media.market.us/ketamine-statistics/
16. https://www.globenewswire.com/news-release/2023/09/21/2747317/0/en/Latest-Esketamine-Market-Analysis-Consumption-Patterns-Trends-Growth-Opportunities-Forecast-2023-2030.html
17. https://www.maximizemarketresearch.com/market-report/ketamine-treatment-market/216827/