Mechanism of Action: Dopamine Uptake Inhibitors

Drugs with Mechanism of Action: 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
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y

Dopamine Uptake Inhibitors Market Analysis and Financial Projection

The global market for dopamine uptake inhibitors (DUIs) and related therapies demonstrates robust growth driven by expanding therapeutic applications and strategic patent management, while facing challenges from generic competition and regulatory pressures.

Market Dynamics

• Market Size & Growth: The dopamine and norepinephrine reuptake inhibitor (NDRI) market reached $17.43 billion in 2022, projected to grow at 4.90% CAGR through 2032[7]. Antidepressants, including NDRI bupropion, form a $18.7 billion industry (2024), growing at 7.5% CAGR[16].
• Key Applications:
  • Mental Health: DUIs like bupropion address major depressive disorder (MDD), seasonal affective disorder, and smoking cessation, with emerging roles in treatment-resistant depression (TRD)[1][15].
  • Neurological Disorders: Safinamide (Xadago), a MAO-B inhibitor with DRI properties, targets Parkinson’s "OFF" episodes in a $694.3 million market by 2035[9][12].
  • Autoimmune & Others: Experimental DUIs show promise for lupus and multiple sclerosis[14].
• Drivers: Rising depression rates, COVID-19-related mental health strain[7], and advancements in early detection technologies (e.g., AI-driven diagnostics)[9].

Patent Landscape

• Innovative Formulations:
  • WO2006135715A1: Benztropinamine analogs for dopamine transporter inhibition[2].
  • US20050250739A1: Dopamine glycoconjugates enhancing blood-brain barrier penetration for Parkinson’s[10].
  • WO2005067931A2: DUIs repurposed for epilepsy and migraine prophylaxis[8].
• Therapeutic Expansions:
  • Safinamide: Protected by multiple patents for Parkinson’s[6].
  • Bupropion: Patent evergreen strategies aim to extend exclusivity beyond 2026 via TRD indications[15].
• Challenges: Generics dominate markets for drugs like levodopa[6][12], while litigation risks persist over "skinny labeling"[15].

Competitive Strategies

• R&D Focus: Companies like Bausch Health target niche applications (e.g., TRD) to bypass generic competition[15]. Novel delivery systems (e.g., transdermal patches) and combo therapies gain traction[16].
• Collaborations: Partnerships between pharma giants (e.g., GSK, Pfizer) and biotech firms accelerate precision medicine approaches[7][16].
• Regional Trends:
  • North America leads antidepressant sales ($6.8 billion in 2024)[16].
  • Asia-Pacific sees rapid growth due to untreated mental health populations[7].

Challenges and Future Outlook

• Generic Pressures: Bupropion faces looming patent cliffs, though NDRI demand persists for SSRI-resistant cases[1][15].
• Innovation Frontiers:
  • Digital Therapeutics: Wearable sensors and telemedicine platforms improve treatment monitoring[9][13].
  • Biomarker-Driven Development: Blood-based α-synuclein assays refine Parkinson’s diagnostics[9].
• Regulatory Pathways: Fast-track designations for TRD therapies could shorten approval timelines[15].

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"The COVID-19 outbreak has substantially increased demand for dopamine reuptake inhibitors to address pandemic-induced mental health crises."[7]

Key Takeaway: DUIs remain critical in neuropsychiatric care, with market resilience anchored in patent innovation and therapeutic diversification. Companies prioritizing targeted indications and advanced delivery systems are best positioned to thrive amid generic saturation.

References

1. https://americanaddictioncenters.org/antidepressants-guide/ndris
2. https://patents.google.com/patent/WO2006135715A1/ja
3. https://www.betterhelp.com/advice/medication/dopamine-reuptake-inhibitor-benefits-and-drawbacks/
4. https://en.wikipedia.org/wiki/Dopamine_reuptake_inhibitor
5. https://www.govinfo.gov/content/pkg/FR-1998-05-28/html/98-14139.htm
6. https://www.maxval.com/blog/pharma-patent-landscape-parkinsons-disease-uncovered/
7. https://www.einpresswire.com/article/590864051/dopamine-and-norepinephrine-reuptake-inhibitor-market-to-perceive-biggest-trend-and-trending-opportunity-by-2032-qmi
8. https://patents.google.com/patent/WO2005067931A2/en
9. https://www.biospace.com/press-releases/parkinsons-disease-psychosis-market-size-to-reach-usd-694-3-million-by-2035-impelled-by-advancements-in-personalized-medicine
10. https://patents.google.com/patent/US20050250739A1/en
11. https://pubs.acs.org/doi/10.1021/ml500113s
12. https://www.fiercepharma.com/pharma/through-2020-growth-parkinson-s-disease-drug-market-will-be-constrained-by-generic
13. https://www.biospace.com/press-releases/obstructive-sleep-apnea-market-expected-to-exhibit-a-cagr-of-16-2-during-2025-2035-impelled-by-advancements-in-early-detection
14. https://patents.google.com/patent/US8691853B2/en
15. https://www.investing.com/analysis/bausch-potential-breakthrough-in-depression-treatment-to-unlock-3b-opportunity-200658563
16. https://www.gminsights.com/industry-analysis/antidepressant-drugs-market