Drugs in ATC Class S01FB

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Drugs in ATC Class: S01FB - Sympathomimetics excl. antiglaucoma preparations

Tradename	Generic Name
ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride
ADVIL MULTI-SYMPTOM COLD & FLU	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride
PHENERGAN VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride
PHERAZINE VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride
PROMETH VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride

S01FB Market Analysis and Financial Projection

The market for ATC Class S01FB (Sympathomimetics excluding antiglaucoma preparations) is shaped by increasing diagnostic needs and surgical advancements, while its patent landscape reflects both innovation and competitive pressures. Below is a detailed analysis:

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Market Dynamics

Current Valuation and Growth Projections

• The global sympathomimetic agents market was valued at $5.2 billion in 2024, with a projected CAGR of 6.0% (2026–2033), reaching $8.7 billion by 2033[14].
• The mydriasis market (closely linked to S01FB drugs) reached $641.5 million in 2024 and is expected to grow to $1.23 billion by 2035 (CAGR: 6.10%)[13].

Key Growth Drivers

1. Rising Demand for Ophthalmic Diagnostics

   • Increased prevalence of retinal disorders, cataracts, and diabetic retinopathy drives the need for pupil-dilating agents like phenylephrine and ephedrine[13].
   • Over 30% of adults over 40 require regular eye exams, amplifying demand for mydriatics[13].

2. Surgical and Therapeutic Applications

   • Sympathomimetics are critical in pre-operative settings (e.g., intraocular surgeries) and post-surgical hypotonia treatment[15][16].
   • Drugs like ibopamine are used for post-surgical ocular hypotonia, while phenylephrine aids in retinal imaging[12][16].

3. Innovation in Drug Delivery

   • Microdose formulations (e.g., Eyenovia’s MydCombi™) reduce systemic side effects and improve patient compliance[13].
   • Combination therapies, such as phenylephrine with ketorolac, enhance efficacy and streamline administration[12].

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Patent Landscape

Key Patents and Innovations

• AU617479B2: Covers combinations of sympathomimetics (e.g., epinephrine) with beta-blockers for intraocular pressure control, though excluded from S01FB’s antiglaucoma scope[10].
• Phenylephrine Patents: Multiple patents focus on formulations and delivery systems (e.g., US8173707, US9855246), addressing stability and bioavailability challenges[6].
• Ephedrine Sulfate: Projected 6.1% CAGR (2024–2031) driven by generics and demand in emerging markets[8].

Strategic Trends

• Combination Therapies: Fixed-dose combinations (e.g., phenylephrine + ketorolac) are patented to reduce procedural steps[12].
• Non-Glaucoma Applications: Recent patents emphasize diagnostic and surgical uses, avoiding overlap with antiglaucoma agents like prostaglandin analogs[10][15].

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Regional Insights

• North America: Dominates with >40% market share due to high healthcare spending and advanced diagnostic adoption[11][13].
• Asia-Pacific: Fastest-growing region (CAGR: 8%), fueled by aging populations and rising cataract surgeries[11][14].
• Europe: Steady growth from ophthalmic infrastructure upgrades and regulatory support for novel formulations[14].

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Challenges and Constraints

• Regulatory Scrutiny: Potential misuse of sympathomimetics (e.g., systemic absorption risks) prompts stricter oversight[14].
• Generic Competition: Expiry of patents (e.g., phenylephrine) has intensified price pressures, though branded combinations retain market share[6][8].

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Future Outlook

1. Targeted Drug Development: Emphasis on alpha-1 antagonists like phentolamine for rapid reversal of pharmacologically induced mydriasis[13].
2. Expansion in Emerging Markets: Companies like Santen Pharmaceutical are launching cost-effective formulations in Asia and Latin America[4][14].
3. Integration with AI Diagnostics: Partnerships to align sympathomimetic use with AI-driven imaging tools for precision ophthalmology[13].

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“Innovations in drug delivery and combination therapies are reshaping the S01FB market, balancing diagnostic efficacy with patient safety.” – IndustryARC Report, 2025[11].

This sector’s growth hinges on balancing innovation with regulatory compliance, particularly as generic entrants and regional healthcare disparities shape accessibility.

References

1. https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/drug-shortages-impact.html
2. https://go.drugbank.com/drugs/DB01364
3. https://www.pharmacompass.com/chemistry-chemical-name/efedrin
4. https://www.thebusinessresearchcompany.com/report/antiglaucoma-drugs-global-market-report
5. https://pharmacy.moh.gov.my/sites/default/files/document-upload/malaysian-statistics-medicines-2011-2014.pdf
6. https://pubchem.ncbi.nlm.nih.gov/compound/Phenylephrine
7. https://www.researchandmarkets.com/reports/5734950/antiglaucoma-drugs-global-market-report
8. https://www.drugpatentwatch.com/p/generic/ephedrine+sulfate
9. https://simplywall.st/stocks/it/media/bit-1fb/meta-platforms-shares
10. https://patents.google.com/patent/AU617479B2/en
11. https://www.industryarc.com/Research/Eye-Drop-And-Lubricants-Market-Research-502244
12. https://atcddd.fhi.no/atc_ddd_index/?code=S01FB&showdescription=yes
13. https://www.biospace.com/press-releases/mydriasis-market-size-to-reach-usd-1-230-5-million-by-2035-impelled-by-increasing-prevalence-of-eye-diseases
14. https://www.verifiedmarketreports.com/product/global-sympathomimetic-agents-market-growth-status-and-outlook-2019-2024/
15. https://globalrph.com/drugs/ophthalmic-mydriatics-cycloplegics/
16. https://go.drugbank.com/drugs/DB13316
17. https://prediction.charite.de/subpages/tree.php