Drugs in MeSH Category Adrenergic Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Fl Inc	AMPHETAMINE	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	209253-006	Jun 22, 2023		DISCN	No	No
Rexar	METHAMPHETAMINE HYDROCHLORIDE	methamphetamine hydrochloride	TABLET;ORAL	084931-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-004	Jan 27, 2016		RX	Yes	No	9,839,619		Y

Adrenergic Agents Market Analysis and Financial Projection

The market for adrenergic agents is experiencing dynamic growth driven by therapeutic innovations and expanding applications, while the patent landscape reflects strategic R&D investments and evolving competitive pressures. Below is a detailed analysis of both domains:

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Market Dynamics

Growth Drivers

• Cardiovascular disease prevalence: Responsible for 17.9M global deaths annually, driving demand for β-blockers like metoprolol and carvedilol[2].
• Aging populations: 76% of seniors have ≥2 chronic conditions, increasing usage of adrenergic drugs for hypertension and mental health disorders[2].
• Expanding therapeutic applications: Emerging uses in anxiety, migraines, and cancer[3].

Market Size & Projections

• Overall adrenergic drug market: Valued at $3.18B in 2024, expected to grow at 6.1% CAGR to $6.87B by 2037[2].
• α2-adrenergic agonists: Projected to reach $2.35B by 2033, growing at 5.5% CAGR (from $1.45B in 2024)[7].

Regional Insights

• North America: Holds 35% market share due to high chronic disease burden and pharmaceutical spending[2].
• Asia-Pacific: Fastest growth, fueled by COPD prevalence (impacting 6.3% of the population) and rising cardiovascular awareness[2][3].

Key Trends

1. Personalized medicine: Genetic profiling to optimize drug efficacy (e.g., Adial Pharmaceuticals’ AD04 for opioid/alcohol use disorder)[10].
2. Innovative formulations: Extended-release β-blockers, transdermal patches, and stable liquid formulations (e.g., Novalar’s α-antagonist patent)[9].
3. Cost-effectiveness focus: Payers increasingly demand pharmacoeconomic data for formulary inclusion[5].

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Patent Landscape

Strategic Patent Holdings	Patent No.	Assignee	Key Innovation	Target Indication
8,247,415	Merck Sharp & Dohme	Hydroxymethyl pyrrolidines as β3 agonists	Metabolic disorders, obesity[1]
6,673,337	Allergan	α2-agonist compositions with carboxymethylcellulose	Glaucoma, anesthesia reversal[6]
6,730,792	Boehringer Ingelheim	β3 agonists for lipolysis enhancement	Obesity, type 2 diabetes[11]

Emerging Innovations

• Biotech mergers: Consolidation (e.g., Allergan’s acquisition activity) to pool R&D resources[3].
• Novel delivery systems: Inhalable β2-agonists for asthma/COPD and biodegradable implants (e.g., MedinCell’s BEPO® tech)[13].

Challenges

• Generic competition: 1984 Hatch-Waxman Act accelerates generics post-patent expiry, reducing branded drug revenues by 80% within 1–2 years[5].
• Regulatory pressures: Stricter safety protocols and off-label use reimbursement hurdles (e.g., Medicaid formulary delays)[5][14].

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Regulatory and Economic Factors

• Patent-term extensions: Up to 5 years granted under the Drug Price Competition Act to offset FDA approval delays[5].
• Global IP disparities: India’s denial of Novartis’ Gleevec patent (2015) underscores regional challenges in protecting incremental innovations[14].

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Key Takeaways

1. Adrenergic agents remain pivotal in treating cardiovascular/metabolic diseases, with R&D pivoting to novel mechanisms (e.g., β3 agonists for obesity).
2. Market expansion hinges on addressing geriatric needs and diversifying into neuropsychiatric indications.
3. Patent strategies increasingly prioritize formulation innovations and combinatory therapies to delay generic erosion.

FAQs
Q1 Which adrenergic drug class dominates current sales?
A1 β-blockers (e.g., atenolol) and α2-agonists (e.g., clonidine) lead due to cardiovascular applications[2][7].

Q2 How does personalized medicine impact adrenergic drug development?
A2 Genetic markers (e.g., SLC6A4 variants) enable targeted therapies like AD04 for addiction[10].

Q3 What risks do manufacturers face in emerging markets?
A3 Price controls and compulsory licensing (e.g., India’s patent laws) limit profitability[14].

Q4 Are biologics influencing this market?
A4 Limited penetration, though long-acting injectables (e.g., RPV-LAI for HIV) signal future trends[13].

Q5 How are payers shaping R&D priorities?
A5 Demands for cost-benefit analyses and comparative effectiveness data are redirecting investments[5].

References

1. https://www.drugpatentwatch.com/p/patent/8247415
2. https://www.researchnester.com/reports/adrenergic-drug-market/2541
3. https://www.einpresswire.com/article/664228199/adrenergic-drug-market-emerging-trends-and-growth-prospects-during-2023-2032
4. https://www.lb7.uscourts.gov/documents/16c651.pdf
5. https://www.ncbi.nlm.nih.gov/books/NBK234316/
6. https://www.drugpatentwatch.com/p/patent/6673337
7. https://www.verifiedmarketreports.com/product/alpha-2-adrenergic-agonist-market/
8. https://synapse.patsnap.com/blog/decoding-norepinephrine-bitartrate-a-comprehensive-study-of-its-randd-trends
9. https://pubchem.ncbi.nlm.nih.gov/patent/US-7569230-B2
10. https://www.psychiatrictimes.com/view/patent-issued-for-methods-of-identifying-patients-with-substance-use-associated-genetic-markers-treatment-with-ad04
11. https://patents.google.com/patent/US6730792B2/en
12. https://patents.google.com/patent/WO2003072572A1/en
13. https://medicinespatentpool.org/uploads/2020/04/MPP-Unitaid_Intellectual-property-report-on-long-acting-technologies.pdf
14. https://www.pharmacytimes.com/view/supp_2008-04_004

Last updated: 2025-03-23