Physiological Effect: Arteriolar Vasodilation

Drugs with Physiological Effect: Arteriolar Vasodilation

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	200737-002	Dec 7, 2012	AA	RX	No	No
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	AB	RX	Yes	Yes
Heritage Pharms Inc	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	040858-004	Feb 26, 2010	AA	RX	No	No
Hetero Labs Ltd Iii	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	040901-004	Sep 12, 2008	AA	RX	No	No
Hikma	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	INJECTABLE;INJECTION	213667-001	Dec 18, 2020	AP	RX	No	No
Pliva	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	088468-001	May 1, 1984	AA	RX	Yes	Yes
Strides Pharma	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	200770-004	Jun 25, 2019		DISCN	No	No

Arteriolar Vasodilation Market Analysis and Financial Projection

The global market for drugs inducing arteriolar vasodilation is experiencing sustained growth, driven by rising cardiovascular disease burdens and innovation in therapeutic approaches. Below is an analysis of market dynamics and patent trends shaping this sector.

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Market Dynamics

Growth Projections

• The global vasodilators market is projected to grow from $6.3B in 2022 to $10.04B by 2030 (CAGR 6%)[5], while peripheral vasodilator drugs alone are expected to reach $7.97B by 2028 (CAGR 6.2%)[13].
• Pulmonary arterial hypertension (PAH) drugs represent a high-growth niche, with the market anticipated to expand from $7.7B in 2023 to $11.6B by 2032 (CAGR 4.6%)[6].

Key Drivers

1. Disease Prevalence: Over 45% of U.S. adults have hypertension[12], and cardiovascular diseases account for 32% of global deaths[12], fueling demand for vasodilators like calcium channel blockers and nitrates.
2. Aging Populations: By 2030, 20% of Americans will be over 65[12], a demographic disproportionately affected by hypertension and peripheral artery disease.
3. Technological Advancements: Nitric oxide-based formulations[1] and prostacyclin analogs (e.g., treprostinil)[6] offer improved efficacy, while triple-drug combinations like Met XL AMT (telmisartan + amlodipine + metoprolol) target refractory hypertension[11][13].

Regional Insights

• North America: Dominates due to advanced healthcare infrastructure and high hypertension rates (accounting for ~40% of PAH drug revenue)[6][12].
• Asia-Pacific: Fastest-growing region, driven by improving healthcare access in India and China and a surge in lifestyle-related diseases[1][5].

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Patent Landscape

Innovation Trends

1. Drug Repurposing:

   • Muscular Dystrophy: Bosentan (pulmonary hypertension) repurposed for Duchenne muscular dystrophy[2].
   • Lysosomal Storage Disorders: Flutamide (prostate cancer) claimed for Fabry disease[2].
   • Over 30% of rare-disease repurposing patents originate from EU/U.S. entities[2].

2. Novel Molecules & Delivery Systems:

   • TRC 266: Torrent Pharmaceuticals’ selective coronary vasodilator with reduced hypotensive side effects[4].
   • Adenosine Infusion: Continuous IV methods to avoid heart block while achieving vasodilation (US5731296A)[14].
   • Carbon Monoxide-Releasing Compounds: Attached to anti-inflammatory drugs for atherosclerosis/stroke (US9023402)[3].

3. Combination Therapies:

   • OPSYNVI®: First single-tablet PAH therapy combining macitentan + tadalafil[6].
   • Hydralazine Hydrochloride: Used in 28 branded products, often paired with nitrates for heart failure[15].

Key Patent Holders

Patent Focus	Examples	Assignees
Mechanical Vasodilation	High-frequency wave devices for cerebral vasospasm (US6106546A, US6033371A)[8][9]	Midwestern University, Dartmouth College
Nitric Oxide Delivery	Thermography-based monitoring systems (US6762202)[3]	NitroMed, ALFAMA
Receptor-Targeting	Fenoterol analogs for heart failure (US9908841)[3]	U.S. Department of Health

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Competitive Strategies

• Mergers & Acquisitions: Advent International’s acquisition of Perrigo’s LATAM pharma assets to strengthen vasodilator portfolios[11].
• Orphan Drug Designations: Johns Hopkins University’s pioglitazone patent for Duchenne muscular dystrophy[2].
• Regional Expansion: Asia-Pacific-focused R&D by firms like Ajanta Pharma and Torrent[4][13].

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Challenges & Opportunities

• Restraints: Side effects (e.g., headaches with nitrates)[12] and stringent regulatory hurdles delaying approvals[5].
• Opportunities: Gene therapy advancements[10] and AI-driven drug discovery[10] to address unmet needs in resistant hypertension.

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"The future of vasodilators lies in precision delivery systems and multi-pathway targeting to minimize side effects while maximizing efficacy." – Summary of patent trends[1][3][14].

This landscape underscores a sector balancing established therapies with innovative biologics and repurposing strategies, positioning arteriolar vasodilators as critical tools in combating cardiovascular morbidity worldwide.

References

1. https://www.transparencymarketresearch.com/peripheral-vasodilator-drugs-market.html
2. https://drugrepocentral.scienceopen.com/hosted-document?doi=10.58647%2FDRUGREPO.24.1.0012
3. https://patents.justia.com/patents-by-us-classification/514/929
4. https://www.business-standard.com/article/specials/torrent-out-to-patent-new-coronary-vasodilator-198101401023_1.html
5. https://www.databridgemarketresearch.com/reports/global-vasodilators-market
6. https://www.biospace.com/pulmonary-arterial-hypertension-drugs-market-size-to-reach-usd-11-6-billion-by-2032-impelled-by-increasing-pulmonary-disorders
7. https://www.insights10.com/report/us-pulmonary-arterial-hypertension-drugs-market-analysis/
8. https://patents.google.com/patent/US6106546A/en
9. https://patents.google.com/patent/US6033371
10. https://www.researchandmarkets.com/report/global-vasodilator-market
11. https://www.thebusinessresearchcompany.com/report/peripheral-vasodilator-drugs-global-market-report
12. https://www.verifiedmarketreports.com/product/global-vasodilators-market-report-history-and-forecast-2014-2025-breakdown-data-by-manufacturers-key-regions-types-and-application/
13. https://www.researchandmarkets.com/reports/5990967/peripheral-vasodilator-drugs-global-market-report
14. https://patents.google.com/patent/US5731296A/en
15. https://www.drugpatentwatch.com/p/generic/hydralazine+hydrochloride