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Last Updated: April 18, 2025

Drugs in MeSH Category Glucocorticoids


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ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Alembic BETAMETHASONE VALERATE betamethasone valerate AEROSOL, FOAM;TOPICAL 215832-001 Aug 22, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Cosette BETA-VAL betamethasone valerate OINTMENT;TOPICAL 070069-001 Dec 19, 1985 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lupin Ltd CLOBETASOL PROPIONATE clobetasol propionate LOTION;TOPICAL 209147-001 Sep 22, 2017 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novitium Pharma PREDNISONE prednisone TABLET;ORAL 215246-001 Jul 6, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pharm Assoc PREDNISOLONE prednisolone SYRUP;ORAL 040570-001 Aug 25, 2005 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Savage Labs BETATREX betamethasone valerate LOTION;TOPICAL 018867-001 Aug 31, 1983 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa EOHILIA budesonide SUSPENSION;ORAL 213976-001 Feb 9, 2024 RX Yes Yes 11,260,064 ⤷  Try for Free Y ⤷  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 7 of 7 entries

Glucocorticoids Market Analysis and Financial Projection

The glucocorticoids market is experiencing significant growth driven by rising demand for anti-inflammatory and immunosuppressive therapies, while the patent landscape reflects ongoing innovation in drug delivery systems and targeted therapies. Here's a breakdown of key dynamics:

Market Dynamics

North America dominates with a $10 billion valuation in 2022, projected to reach $15 billion by 2030 (5.5% CAGR) due to strong R&D investment and advanced healthcare infrastructure[1]. Globally, corticosteroids (including glucocorticoids) grew from $4.47B in 2020 to $5.33B in 2025, driven by COVID-19 applications[6]. The glucocorticoid segment alone is expected to reach $8.9B by 2032[11].

Key growth drivers include:

  • 40% increase in cancer-related glucocorticoid use since 2020 for chemotherapy support[6][11]
  • 25% rise in biologic-glucocorticoid combination therapies for autoimmune diseases[1]
  • Emergence of topical delivery systems (e.g., mucoadhesive patches) reducing systemic side effects[11]

Patent Landscape

Recent innovations focus on overcoming traditional limitations:

Patent Focus Example Innovations Key Players
Targeted Delivery Antibody-drug conjugates (US10772970B2) Pfizer, Novartis
Stability Improvements Aqueous dexamethasone formulations (WO2020102474A1) GSK, AstraZeneca
Combination Therapies Anti-CD3/glucocorticoid bispecific antibodies (US10071158B2) AbbVie, Roche
Diagnostic Methods MetAP-2 biomarkers for treatment efficacy (US20070254303A1) Medical Diagnostics Co

Notable Trends:

  • 71% increase in PCT filings for glucocorticoid repurposing since 2020, particularly for COVID-19[2][16]
  • 34 active tradenames for dexamethasone alone, with 15 US patents expiring between 2025-2030[8]
  • Selective glucocorticoid receptor modulators (SGRMs) represent <5% of recent patents, suggesting untapped potential[10]

Regulatory & Research Impact

The NIH's $10M funding boost generates 2.3 new pharmaceutical patents on average[5], though recent legislative proposals (e.g., Affordable Prescriptions Act) could limit biologics to 20 post-approval patents[17]. Analytical advances in 19F-NMR screening enable better detection of illicit corticosteroid formulations[9], while chronopharmacology research reveals time-dependent metabolic effects influencing patent strategies[14].

Key Challenges:

  • 30% of glucocorticoid patents face challenges from generics within 2 years of expiration[17]
  • Only 2% of NIH-funded research translates to Phase III clinical candidates[5]
  • Split 19F-NMR signals in topical formulations complicate quality control[9]

The intersection of market needs and patent innovation continues to drive glucocorticoid development, though balancing therapeutic efficacy with patent viability remains critical. As biologic combinations and personalized delivery systems advance, stakeholders must navigate evolving regulatory landscapes and verification technologies to maintain competitive advantage.

References

  1. https://sites.google.com/view/peakperformance-insights/insight/north-america-glucocorticoids-market-by-application-market-insights-tre
  2. https://drugrepocentral.scienceopen.com/hosted-document?doi=10.58647%2FDRUGREPO.24.2.0017
  3. https://patents.google.com/patent/US10772970B2/en
  4. https://pmc.ncbi.nlm.nih.gov/articles/PMC6744986/
  5. https://gps.ucsd.edu/_files/faculty/graff-zivin/graff-zivin_research_012017.pdf
  6. https://markets.businessinsider.com/news/stocks/global-corticosteroids-markets-report-2021-2030-glucocorticoids-mineralocorticoids-market-is-expected-to-reach-5-33-billion-in-2025-1030436297
  7. https://patents.google.com/patent/WO2020102474A1/en
  8. https://www.drugpatentwatch.com/p/generic-api/dexamethasone
  9. https://www.diva-portal.org/smash/get/diva2:442696/FULLTEXT01.pdf
  10. https://pubmed.ncbi.nlm.nih.gov/32148111/
  11. https://www.gminsights.com/industry-analysis/corticosteroids-market
  12. https://www.conceptfoundation.org/wp-content/uploads/2022/01/AIM-pipeline-FINAL-021221.pdf
  13. https://www.qualityhealth.org/bree/wp-content/uploads/sites/8/2018/12/SpineSurgery_EvidenceTable_20181210.xlsx
  14. https://pmc.ncbi.nlm.nih.gov/articles/PMC11601906/
  15. https://patents.google.com/patent/US20070254303A1/en
  16. https://pmc.ncbi.nlm.nih.gov/articles/PMC2709006/
  17. https://www.lifescienceleader.com/doc/trends-in-proposed-laws-aimed-at-drug-patents-0001
  18. https://patents.google.com/patent/US10071158B2/en

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