Last Updated: May 2, 2026

PARACORT Drug Patent Profile


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Which patents cover Paracort, and what generic alternatives are available?

Paracort is a drug marketed by Parke Davis and is included in one NDA.

The generic ingredient in PARACORT is prednisone. There are sixteen drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the prednisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Paracort

A generic version of PARACORT was approved as prednisone by WATSON LABS on December 31st, 1969.

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Summary for PARACORT
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for PARACORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis PARACORT prednisone TABLET;ORAL 010962-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario and Fundamentals Analysis for PARACORT (Hydrocortisone)

Last updated: February 22, 2026

What Is PARACORT and Its Market Position?

PARACORT is a corticosteroid medication primarily used to treat inflammatory and autoimmune conditions such as allergic reactions, skin diseases, and adrenal insufficiency. Its active ingredient, hydrocortisone, is a generic compound with established therapeutic uses.

The drug exists mainly as a topical formulation, but systemic forms are also available. It operates in a highly competitive market with several established brands and generics. The global corticosteroids market was valued at approximately USD 7.8 billion in 2021 and is expected to grow at a CAGR of 4.2% through 2028.

What Are Key Drivers and Opportunities?

  • Growing prevalence of autoimmune and inflammatory diseases: An aging population and rising chronic disease rates increase demand.
  • Generic and biosimilar market expansion: Patent expirations favor generic sales and formulations.
  • Regulatory pathways: Well-understood approval processes for generic corticosteroids reduce development risk.
  • Emerging markets: Increased healthcare access drives growth in developing economies.

What Risks and Challenges exist?

  • Market saturation: Numerous generics lead to intense price competition.
  • Pricing pressure: Governments and payers enforce formulary restrictions, limiting price increases.
  • Regulatory hurdles: Strict adherence to quality standards is necessary, especially in launch markets.
  • Patent and exclusivity status: If the formulation or delivery system is patented, it could delay or block generic entry.

What Are the Financial Fundamentals?

Parameter Data/Estimate
Market Size (2022) USD 7.8 billion (globally)
CAGR (2023–2028) 4.2%
Estimated Market Share (Generic) 80% (by volume), 60% (by value)
Current Price Range USD 10–50 per unit (depending on formulation and region)
Cost of Goods Sold (COGS) Approx. 20-30% of sales
Estimated R&D Cost for New Formulation USD 2–5 million over 2–3 years
Regulatory Approval Timeline 1–2 years in developed markets

How Do Competitive Dynamics Influence Investment?

  • Leading generic manufacturers such as Teva, Sandoz, and Mylan dominate the market.
  • Brand-name prescribers are gradually shifting toward generics due to cost savings.
  • Entry barriers for new formulations are relatively low, given the mature patent landscape.
  • Price erosion is a primary concern; profit margins for generics decline as competition intensifies.

What Is the Patent and Regulatory Landscape?

  • The patent for original hydrocortisone formulations expired in most markets by 2012.
  • New formulations or delivery methods may hold secondary patents, creating potential exclusivity.
  • Regulatory approval typically requires bioequivalence data and good manufacturing practices (GMP) compliance.
  • Countries such as the U.S., EU, and Japan have streamlined generic approval pathways, reducing time-to-market.

Investment Considerations

  • Market Entry: Low-cost entry with existing formulations in mature markets offers limited upside. Focus on emerging markets and niche indications.
  • Product Differentiation: Innovation in delivery systems (e.g., sustained-release patches) could create competitive advantages.
  • Pricing Strategy: Aggressive cost management allows for better margins amid price compression.
  • Partnerships: Licensing arrangements with regional manufacturers facilitate market penetration.

Conclusion

Investing in PARACORT, primarily a generic hydrocortisone product, entails exposure to a mature, highly competitive market characterized by steady growth driven by demographic trends and expanding indications. Risks stem from intensified price competition and regulatory complexities. Profitability hinges on strategic market entry, cost control, and potential product differentiation.

Key Takeaways

  • PARACORT operates within a USD 7.8 billion global corticosteroid market, expected to grow at 4.2% CAGR.
  • The market is saturated with generics, leading to significant price competition.
  • Barriers to entry are moderate; regulatory pathways are well-established.
  • Growth opportunities exist in emerging markets and novel formulations.
  • Profitability depends on managing manufacturing costs and securing regional licensing.

FAQs

1. What growth factors could positively impact PARACORT?
Increasing prevalence of autoimmune conditions in aging populations and expanding healthcare access in developing regions support growth.

2. How does patent status influence PARACORT’s competitiveness?
Expired patents on hydrocortisone formulations enable generic entry, intensifying price competition but reducing regulatory barriers.

3. What are the main cost considerations for investing in PARACORT?
Manufacturing costs, regulatory compliance expenses, and marketing costs in target regions.

4. Are there opportunities for innovation within the PARACORT product line?
Yes, formulations such as sustained-release patches or combination therapies could provide differentiation.

5. Which regions present the highest growth potential?
Emerging markets in Asia, Latin America, and Africa, where healthcare infrastructure improves.


References

[1] MarketsandMarkets. (2022). Corticosteroids Market. Retrieved from https://www.marketsandmarkets.com/Market-Reports/corticosteroids-market-751.html

[2] U.S. Food and Drug Administration. (2021). Bioequivalence Guidance. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/bioequivalence-guidance

[3] IMS Health. (2022). Global Pharmaceutical Market Analysis. Retrieved from https://www.imshealth.com

[4] European Medicines Agency. (2022). Generic Medicines. https://www.ema.europa.eu/en/human-regulatory/overview/generic-medicines

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