Angiotensin 2 Receptor Blocker Drug Class List

Drugs in Drug Class: Angiotensin 2 Receptor Blocker

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	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209042-001	Aug 14, 2017	AB	RX	No	No
Hetero Labs Ltd V	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209591-002	Feb 14, 2025	AB	RX	No	No
Macleods Pharms Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	206884-004	Oct 26, 2016	AB	RX	No	No

Angiotensin 2 Receptor Blocker Market Analysis and Financial Projection

The Angiotensin II Receptor Blockers (ARBs) market is evolving amid shifting patent dynamics and growing demand driven by global health trends. Here's an in-depth analysis:

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Market Dynamics

Growth Projections

• The ARBs market is projected to grow from $8.87 billion in 2025 to $10.76 billion by 2029 at a 5% CAGR [1][7]. Non-peptide ARBs show even stronger growth, with their market expected to reach $325.99 billion by 2030 (9.1% CAGR) due to rising hypertension and cardiovascular disease prevalence [6][16].

Key Drivers

1. Chronic Disease Burden:
   • Hypertension affects ~45% of U.S. adults, driving ARB demand as first-line therapy [16].
   • Chronic kidney disease (CKD) prevalence is rising, with ARBs critical for renal protection. CKD cases in the UK are projected to grow 4% (8.27M to 8.61M) by 2032 [1].
2. Aging Populations:
   • Elderly populations require long-term cardiovascular management, sustaining ARB demand [6].
3. Precision Medicine:
   • Biomarker-driven therapies and tailored dosing are enhancing treatment outcomes [1].

Emerging Trends

• Combination Therapies: Fixed-dose drugs pairing ARBs with statins or diuretics (e.g., CardioPharma’s patented anti-hypertensive/cholesterol combination [11]) improve adherence and efficacy.
• Telemedicine: Remote monitoring and digital adherence tools are reducing treatment gaps [1].
• Generic Dominance: Generics captured ~70% of the U.S. ARB market by 2021, lowering costs but intensifying competition [5][12].

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Patent Landscape

Key Patents and Innovations

Patent/Patent Family	Assignee	Scope	Status
US-11655220-B2 [3]	Hetero Labs	Process to produce sartan drugs without nitrosoamine impurities	Active (2023–2043)
US5656650A [9][14]	GlaxoSmithKline	Compositions combining ARBs with diuretics/ACE inhibitors	Expired (1995–2015)
WO2002080910A1 [13]	Multiple	Cyclodextrin-based formulations enhancing ARB bioavailability	Active in multiple regions
US 11,737,988 B2 [11]	CardioPharma	Fixed-dose ARB/cholesterol-lowering combo	Active until 2039

Challenges and Shifts

1. Patent Expirations:
   • Losartan (2012), valsartan (2011), and candesartan (2011) patent expirations led to rapid generic entry. For example, losartan generics captured 50% market share within two months [12].
2. Efficacy Debates:
   • Studies suggest branded candesartan may reduce mortality vs. generic losartan, complicating cost-effectiveness analyses [10].
3. Biosimilar Competition:
   • Post-2025, biosimilars targeting niche ARB indications (e.g., diabetic nephropathy) are expected to pressure branded drugs [1][7].

Regional Dynamics

• North America: Holds ~40% market share due to high healthcare spending and major players like Novartis and Pfizer [6][7].
• Asia-Pacific: Fastest-growing region (9.1% CAGR) driven by India’s 137% healthcare budget increase and expanding access [6][16].

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Strategic Insights

• R&D Focus: Investment in novel formulations (e.g., impurity-free processes [3]) and combination therapies dominates innovation.
• Market Risks: Price erosion from generics and regulatory scrutiny on bioequivalence standards [5][12].
• Opportunities: Emerging markets and precision medicine approaches leveraging genetic biomarkers [1][6].

“The ARB market’s future hinges on balancing affordability through generics with innovation in targeted therapies.” [1][11].

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This landscape underscores a sector in transition, where cost-effective generics and cutting-edge R&D coexist to address global cardiovascular and renal health challenges.

References

1. https://www.researchandmarkets.com/reports/5790618/angiotensin-receptor-blockers-arbs-market-report
2. https://www.stout.com/en/insights/commentary/5g-iot-standard-essential-patents
3. https://pubchem.ncbi.nlm.nih.gov/patent/US-11655220-B2
4. https://app.orioleinsights.io/price-predictions/arbitrum
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC8465659/
6. https://www.databridgemarketresearch.com/reports/global-non-peptide-drugs-of-angiotensin-ii-receptor-antagonist-market
7. https://www.verifiedmarketresearch.com/product/angiotensin-receptor-blockers-arbs-market/
8. https://wysebridge.com/assignment-recordation-branch-arb-intellectual-property-terminology-explained
9. https://www.drugpatentwatch.com/p/patent/5656650
10. https://news.ki.se/better-result-with-patent-drug-in-heart-failure
11. https://synapse.patsnap.com/article/cardiopharma-granted-global-patent-to-combat-leading-cause-of-death
12. https://www.ahajournals.org/doi/10.1161/circoutcomes.117.003891
13. https://patents.google.com/patent/WO2002080910A1/en
14. https://patents.google.com/patent/US5656650A/en
15. https://www.verifiedmarketreports.com/product/global-angiotensin-receptor-blockers-arbs-market-report-history-and-forecast-2014-2025-breakdown-data-by-manufacturers-key-regions-types-and-application/
16. https://www.verifiedmarketreports.com/product/angiotensin-ii-receptor-blockers-market/
17. https://www.mondaq.com/uk/patents/122902/generic-opportunities-arising-for-the-blockbuster-antihypertensive-diovan%C2%AE-valsartan