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Last Updated: April 8, 2025

Prostacycline Vasodilator Drug Class List


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Drugs in Drug Class: Prostacycline Vasodilator

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Mylan EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 213913-002 Jun 12, 2024 AP2 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Mylan EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 213913-001 Jun 12, 2024 AP2 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 210473-001 Jan 15, 2021 AP2 RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 210473-002 Jan 15, 2021 AP2 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Prostacycline Vasodilator Market Analysis and Financial Projection

The prostacyclin vasodilator market is experiencing dynamic growth driven by therapeutic advancements and increasing prevalence of cardiovascular conditions, particularly pulmonary arterial hypertension (PAH). Below is an analysis of the market dynamics and patent landscape for this drug class:


Market Dynamics

Growth Drivers

  • Rising PAH Prevalence: Prostacyclin analogs (e.g., treprostinil, epoprostenol) dominate PAH treatment, accounting for 45% of the PAH drug class revenue in 2023[6][7]. Their role in vasodilation and platelet inhibition makes them critical for managing PAH, which affects ~1% of the global population[5][7].
  • Innovative Delivery Systems: Subcutaneous, inhaled, and oral formulations (e.g., Orenitram®) improve bioavailability and patient compliance, driving a 9.58% CAGR in the prostacyclin market (2024–2032)[1][5].
  • Telemedicine Integration: Remote monitoring and digital health tools enhance treatment adherence, particularly for chronic PAH management[1][5].

Market Segmentation

  • By Drug: Treprostinil leads due to its extended-release formulations, followed by epoprostenol and iloprost[1][5].
  • By Dosage: Parenteral administration remains dominant, but oral and inhaled routes are growing rapidly (CAGR >10%)[1][13].
  • By Region: Region Market Share (2024) Growth Driver
    North America 40% High healthcare spending, robust R&D[1][5]
    Asia-Pacific 25% (projected) Expanding healthcare infrastructure[5][13]
    Europe 20% Aging population and PAH awareness[5][13]

Competitive Landscape

  • Key Players: United Therapeutics (Orenitram®, Remodulin®), Actelion (Uptravi®), and GSK hold ~60% market share[4][13].
  • Revenue Trends: United Therapeutics reported $1.5B in 2022 revenue, while Johnson & Johnson’s PAH segment exceeds $3B annually[4].

Patent Landscape

Key Innovations and Litigations

  • Patent 7,417,070 (United Therapeutics): Covers treprostinil’s oral formulations, critical for Orenitram®'s market exclusivity until 2030[2].
  • Invalidated Patents: The USPTO canceled United Therapeutics’ ‘393 patent in 2017, enabling competitors like SteadyMed’s Trevyent® to enter the market[10].
  • Prostacyclin Derivatives: Early patents (e.g., US4539333A, CA1205467A) laid the foundation for vasodilation and anti-thrombotic applications[3][8].

Emerging Trends

  • Expanding Indications: Research into prostacyclin’s efficacy in COPD, heart failure, and vascular remodeling could unlock $650M+ in new applications by 2030[1][7].
  • Biocompatible Polymers: Patent filings for heat-resistant and recyclable prostacyclin delivery systems aim to reduce costs and environmental impact[9].

Challenges and Opportunities

  • Cost Barriers: Annual PAH therapy costs exceed $100K, limiting access in developing regions[5][13].
  • Pipeline Potential: Over 15 prostacyclin analogs are in Phase II/III trials, targeting improved stability and reduced dosing frequency[12][13].
  • Telehealth Synergy: Remote dosing adjustments and adherence tracking could reduce hospitalization rates by 20%[1][5].

Key Takeaways

  1. The prostacyclin market is projected to reach $2.06B by 2032, driven by PAH demand and drug delivery innovations[1][5].
  2. United Therapeutics dominates through strategic patents, though litigation risks persist[2][10].
  3. Asia-Pacific’s growth (25% CAGR) reflects untapped potential in emerging economies[5][13].

“The development of novel prostacyclin delivery systems is revolutionizing PAH treatment, offering hope for improved patient outcomes.” – Data Bridge Market Research[1]

FAQs
Q: How do prostacyclin analogs compare to SGC stimulators?
A: Prostacyclins show broader vasodilation effects, while SGC stimulators (e.g., Adempas®) target specific pathways, achieving 5% CAGR[6][7].

Q: What factors threaten United Therapeutics’ market dominance?
A: Patent expirations (e.g., ‘393 patent) and generic competition post-2030 could reduce its 40% market share[2][10].

References

  1. https://www.databridgemarketresearch.com/reports/global-prostacyclin-market
  2. https://www.drugpatentwatch.com/p/patent/7417070
  3. https://patents.google.com/patent/CA1205467A/en%E2%80%8B
  4. https://github.com/roffefaith6l/Market-Research-Report-List-1/blob/main/prostacyclin-market.md
  5. https://www.databridgemarketresearch.com/es/reports/global-prostacyclin-market/market-analysis
  6. https://www.precedenceresearch.com/pulmonary-arterial-hypertension-market
  7. https://www.maximizemarketresearch.com/market-report/pulmonary-arterial-hypertension-market/122335/
  8. https://patents.google.com/patent/US4539333A/en
  9. https://www.businesswire.com/news/home/20250110674650/en/Medical-PET-Patent-Landscape-Report-2025-Covering-1408-Patents-Filed-from-2010-to-2024---ResearchAndMarkets.com
  10. https://www.biospace.com/steadymed-receives-favorable-ruling-in-inter-partes-review-against-united-therapeutics-patent
  11. https://www.polarismarketresearch.com/industry-analysis/prostaglandin-analogs-market
  12. https://drughunter.com/articles/january-2025-patent-highlights-part-1
  13. https://www.verifiedmarketreports.com/product/prostacyclin-drug-market/

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