Drugs in MeSH Category Dopamine Uptake Inhibitors

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferndale Labs	FERNDEX	dextroamphetamine sulfate	TABLET;ORAL	084001-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Mylan Tech Viatris	METHYLPHENIDATE	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	206497-003	Mar 14, 2022	AB	RX	No	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-003	Feb 23, 2007	AB	RX	Yes	Yes
Prinston Inc	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	216266-004	Aug 25, 2023	AB	RX	No	No
Oxford Pharms	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	040706-001	Feb 14, 2008		DISCN	No	No
Tris Pharma Inc	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	TABLET;ORAL	207901-002	Aug 26, 2016	AB	RX	No	No
Ascent Pharms Inc	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	215523-002	Dec 8, 2021	AB	RX	No	No

Dopamine Uptake Inhibitors Market Analysis and Financial Projection

The market for dopamine uptake inhibitors (DUIs) is shaped by evolving therapeutic applications, patent strategies, and competitive dynamics across neurological and psychiatric disorders. Here's a detailed analysis:

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Market Dynamics

Growth Drivers

• Expanding Mental Health Needs: The global antidepressant market, valued at $20.11B in 2025, is projected to grow at a 7.4% CAGR through 2032[4]. While SSRIs dominate this space (48.1% market share)[4], DUIs like bupropion (an NDRI) are gaining traction for treatment-resistant depression (TRD) and smoking cessation[17].
• Emergence of Atypical DUIs: Compounds such as modafinil and JHW007 show promise due to lower abuse potential compared to traditional psychostimulants. These are being explored for ADHD, cocaine addiction, and Parkinson’s disease[13][16].
• Technological Advancements: AI-driven drug discovery (e.g., Exscientia’s DSP-1181) accelerates DUI development, though structural similarities to older drugs like haloperidol raise questions about novelty[2][3].

Key Therapeutic Segments

1. Depression: SNRIs and SSRIs lead the market, but DUIs like bupropion address TRD. Aplenzin (bupropion HBr) could capture a $3B+ opportunity if approved for TRD by 2026[17].
2. ADHD: Methylphenidate, a DUI, remains a cornerstone treatment with a multimodal mechanism[11].
3. Neurodegenerative Diseases: DUIs like mito-apocynin are studied for Parkinson’s disease due to neuroprotective effects against oxidative stress[10].

Challenges

• Safety Concerns: Side effects (e.g., dry mouth, agitation) limit long-term adherence[11].
• Complex CNS Drug Development: High attrition rates persist due to blood-brain barrier challenges and target specificity[3].

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Patent Landscape

Key Patents and Players

Drug/Patent	Assignee	Expiry	Innovation
Bupropion (Aplenzin)	Bausch Health	~2026+	Extended use patents for TRD; potential for 20-year evergreen status[17].
CDTP-32476	Undisclosed	Pending	Slow-onset DUI with reduced abuse potential; enantiomer separation achieved[16].
Benztropinamine Analogs	Undisclosed	Pending	Novel DUIs targeting dopamine transporters for addiction treatment[14].
DSP-1181	Exscientia/Sumitomo	Post-2030	AI-designed 5-HT1a agonist (structurally similar to haloperidol)[2].

Strategies

• Patent Extensions: Companies like Bausch leverage new indications (e.g., TRD) to prolong exclusivity[17].
• Structural Modifications: Slow-onset DUIs (e.g., CDTP-32476) aim to reduce abuse liability while maintaining efficacy[16].
• AI/ML Integration: Firms use machine learning to optimize BBB permeability and target engagement for CNS drugs[3][10].

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Regional and Competitive Insights

• North America: Holds 42.3% market share in antidepressants (2023), driven by high mental disorder prevalence[1].
• Asia-Pacific: Emerging growth due to rising awareness and AI adoption in drug discovery[3][15].
• Key Players: Novo Nordisk (semaglutide patents)[5], Bausch Health (bupropion), and Exscientia (AI-driven candidates)[2][17].

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Opportunities and Trends

1. Combination Therapies: DUIs paired with antioxidants (e.g., mito-apocynin) for neurodegenerative diseases[10].
2. Abuse-Resistant Formulations: Atypical DUIs like JHW007 may disrupt stimulant addiction markets[13].
3. Digital Health Integration: EEG-based screening tools accelerate DUI development by predicting neuroactivity[13].

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Key Takeaways

• Market Growth: Antidepressant and DUI markets are projected to exceed $30B by 2033, with SNRIs/SSRIs leading but DUIs gaining ground[1][7][15].
• Innovation Focus: AI and structural modifications drive patent filings, while safety and efficacy remain critical.
• Unmet Needs: TRD and neuroprotection in Parkinson’s present significant commercial opportunities[10][17].

By addressing niche indications and leveraging novel technologies, DUIs are poised to expand their role in neurology and psychiatry despite developmental hurdles.

References

1. https://market.us/report/antidepressants-drugs-market/
2. https://www.cas.org/resources/cas-insights/ai-drug-discovery-assessing-the-first-ai-designed-drug-candidates-to-go-into-human-clinical-trials
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC8043990/
4. https://www.coherentmarketinsights.com/industry-reports/antidepressant-market
5. https://www.keionline.org/wp-content/uploads/KEI-BN-2024-1.pdf
6. https://en.wikipedia.org/wiki/Antipsychotic
7. https://www.imarcgroup.com/depression-drugs-market
8. https://patents.google.com/patent/WO2005067931A2/en
9. https://meshb.nlm.nih.gov/record/ui?ui=D018765
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC4995106/
11. https://pmc.ncbi.nlm.nih.gov/articles/PMC8455398/
12. https://pmc.ncbi.nlm.nih.gov/articles/PMC3758386/
13. https://pmc.ncbi.nlm.nih.gov/articles/PMC8369976/
14. https://patents.google.com/patent/WO2006135715A1/ja
15. https://www.einpresswire.com/article/590864051/dopamine-and-norepinephrine-reuptake-inhibitor-market-to-perceive-biggest-trend-and-trending-opportunity-by-2032-qmi
16. https://pubs.acs.org/doi/10.1021/acsomega.3c02997
17. https://www.investing.com/analysis/bausch-potential-breakthrough-in-depression-treatment-to-unlock-3b-opportunity-200658563
18. https://www.maxval.com/blog/pharma-patent-landscape-parkinsons-disease-uncovered/
19. https://www.psychiatrictimes.com/view/new-hope-depression-horizon

Last updated: 2025-03-24