Drugs in ATC Class C09X

Up to Top Level ATC Classes

Up to C - Cardiovascular system

Up to C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Subclasses in ATC: C09X - OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

C09XA - Renin-inhibitors

C09XX - Other agents acting on the renin-angiotensin system

C09X Market Analysis and Financial Projection

The market dynamics and patent landscape for ATC Class C09X (Other Agents Acting on the Renin-Angiotensin System) reflect evolving therapeutic strategies, competitive pressures from generics, and innovation in combination therapies. This class includes renin inhibitors like aliskiren and combination drugs targeting hypertension and cardiovascular diseases (CVDs).

---

Market Dynamics

1. Growth Drivers:

   • The RAS-acting agents market is projected to exceed $13.4 billion by 2031, driven by increasing CVD prevalence and aging populations[8].
   • Genericization has expanded access to therapies like ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), particularly in Eastern Europe, where preference shifts toward newer generics are more pronounced[1][5].
   • Combination therapies (e.g., aliskiren with valsartan or hydrochlorothiazide) are gaining traction due to enhanced efficacy[17][8].

2. Challenges:

   • Patent expirations (e.g., aliskiren’s key patents expire between 2026–2028) will intensify price competition as generics enter[16][12].
   • Side effects (e.g., cough, dizziness) and competition from alternative treatments (e.g., calcium channel blockers) limit uptake[8][12].

---

Patent Landscape

• Key Innovations:

  • Aliskiren synthesis: Novel processes and intermediates (e.g., WO2012052829A1) aim to streamline production as patents near expiry[11].
  • Combination therapies: Patents for aliskiren/amlodipine (expiring 2029) and aliskiren/valsartan (2026–2028) dominate filings[16][18].
  • Litigation: Disputes over RAS-inhibitor patents (e.g., T 1685/10) highlight competitive strategies to extend market exclusivity[13].

• Collaborations: Major players like Novartis, LG Chemical, and Merck focus on securing patents for fixed-dose combinations and sustainable formulations[2][8].

---

Competitive Dynamics

Factor	Impact
Generic competition	Post-2026, aliskiren generics will pressure prices, replicating ACEI/ARB trends[1][5].
Authorized generics	Incumbents use licensed generics to retain market share, limiting competition[5][6].
Regulatory influence	NICE guidelines in the UK delay generic entry but reduce branded prices[5].

---

Regional Variations

• North America: Leads in revenue due to high CVD rates and R&D investment[8][12].
• Europe: Western markets (e.g., Belgium) show stagnant growth due to entrenched prescribing habits, while Eastern Europe sees shifts toward newer generics[1][15].
• Asia-Pacific: Fastest-growing region, driven by government healthcare initiatives and a large patient pool[12].

---

Future Outlook

• Innovation: Focus on precision medicine and dual RAS-pathway inhibitors to address unmet needs in kidney disease and pulmonary hypertension[8][12].
• Generics: Over 60% of C09X drugs will face generic competition by 2030, reshaping pricing and accessibility[5][16].
• Market Risks: Litigation over standard essential patents (SEPs) and regulatory backlogs may slow generic adoption[6][9].

"The diffusion of clinically preferable therapies seems to be ultimately supported by generic entries." – PMC study on ACEI/ARB markets[1].

---

This sector’s evolution hinges on balancing innovation with cost containment, as generics and combination therapies redefine competitive landscapes globally.

References

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC8465659/
2. https://www.businesswire.com/news/home/20250307336684/en/Vinyl-Chloride-Patent-Landscape-Report-2024-Comprehensive-Analysis-of-3698-Patents-Filed-Since-2010-Across-Major-Global-Jurisdictions---ResearchAndMarkets.com
3. https://patents.justia.com/patents-by-us-classification/530/316
4. https://atcddd.fhi.no/atc_ddd_index/?code=C09XA&showdescription=yes
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC7881963/
6. https://www.econstor.eu/bitstream/10419/260480/1/qed-wp-1474.pdf
7. https://www.prweb.com/releases/wifi-7-patent-landscape-analysis-by-greyb-huawei-qualcomm-mediatek-and-lg-competing-to-lead-302353076.html
8. https://www.transparencymarketresearch.com/ras-acting-agents-market.html
9. https://www.wipo.int/edocs/plrdocs/en/5g_networks.pdf
10. https://stockinvest.us/stock/C09.SI
11. https://patents.google.com/patent/WO2012052829A1/en
12. https://www.researchnester.com/reports/renin-inhibitor-market/2633
13. https://www.epo.org/en/boards-of-appeal/decisions/t101685eu1
14. https://www.eif.org/news_centre/publications/eif_wp_45.pdf
15. https://www.iqvia.com/-/media/iqvia/pdfs/belgium/sales-trends/2024/belgian-retail-market-september-2024.pdf
16. https://www.pharmacompass.com/patent-expiry-expiration/aliskiren
17. https://atcddd.fhi.no/atc_ddd_index/?code=C09X&showdescription=yes
18. https://patents.google.com/patent/WO1992013564A1/en

Last updated: 2025-03-24