You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 9, 2025

EPICORT Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Epicort is a drug marketed by Bluline and is included in one NDA.

The generic ingredient in EPICORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Epicort

A generic version of EPICORT was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.

  Try for Free

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for EPICORT?
  • What are the global sales for EPICORT?
  • What is Average Wholesale Price for EPICORT?
Summary for EPICORT
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 109
Patent Applications: 2,869
DailyMed Link:EPICORT at DailyMed
Drug patent expirations by year for EPICORT

US Patents and Regulatory Information for EPICORT

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bluline EPICORT hydrocortisone LOTION;TOPICAL 083219-002 Approved Prior to Jan 1, 1982 DISCN 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 1 of 1 entries

EU/EMA Drug Approvals for EPICORT

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Plenadren hydrocortisone EMEA/H/C/002185
Treatment of adrenal insufficiency in adults.
Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Authorised no no no 2018-02-09
Diurnal Europe B.V. Efmody hydrocortisone EMEA/H/C/005105
Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
Authorised no no no 2021-05-27
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Innovative Drugs: A Case Study on EPICORT and Similar Therapies

Introduction

The pharmaceutical industry is a dynamic and highly innovative sector, driven by continuous research, regulatory changes, and evolving market demands. This article will delve into the market dynamics and financial trajectory of innovative drugs, using examples like EPICORT and other recent therapeutic advancements.

Market Drivers in the Pharmaceutical Industry

The pharmaceutical market is driven by several key factors, including the launch of innovative new products, changes in regulatory environments, and shifting patient needs.

Innovative New Products

The launch of novel therapies is a significant driver of market growth. For instance, drugs like Mounjaro (tirzepatide), a GIP and GLP-1 agonist, have shown remarkable growth since their introduction. Mounjaro, launched in June 2022, generated over $2 billion in sales for the remainder of 2022, making it a major driver in the diabetes market[1].

Regulatory Environments

Regulatory changes and healthcare reforms play a crucial role in shaping the market. For example, the potential passage of the Value in Health Care Act of 2023 could shift financial incentives towards value-based care, impacting payment models and risk management in healthcare[5].

Financial KPIs for Pharmaceutical Companies

To understand the financial trajectory of innovative drugs, it is essential to monitor key financial KPIs.

Operating Cash Flow

Operating cash flow is a critical metric that indicates the financial health of a pharmaceutical company. A positive operating cash flow suggests proper business handling, while a negative flow signals financial issues[2].

Gross Profit Margin

Gross profit margin measures the profitability of a pharmacy or pharmaceutical company. It is calculated as the difference between net sales and the cost of goods sold, divided by net sales. This KPI is vital for understanding the financial sustainability of new drug launches[2].

Operating Expenses (OPEX)

Operating expenses include costs such as equipment, inventory, payroll, and insurance. Managing OPEX is crucial for maintaining a competitive edge without compromising service quality[2].

Average Revenue per Customer

This metric helps in predicting revenue growth by measuring the average revenue generated per customer. It is particularly useful for assessing the market potential of new drugs[2].

Market Performance of Recent Therapies

Diabetes Market

The diabetes market has seen significant growth driven by SGLT2 inhibitors like Jardiance (empagliflozin) and Forxiga (dapagliflozin). Jardiance has shown a CAGR of 50% from 2017 to 2022, while Forxiga saw a 52% year-over-year growth rate from 2021 to 2022. Mounjaro, with its unique dual mechanism, has also become a major growth driver in this market[1].

Cardiovascular Market

The cardiovascular market, particularly the heart failure segment, has grown rapidly. Entresto (sacubitril/valsartan) dominates this market with a 39% year-over-year growth rate. Additionally, diabetes drugs like Forxiga and Jardiance have entered the heart failure market, showing rapid growth despite lower sales compared to Entresto[1].

Atrial Fibrillation Market

In the atrial fibrillation market, Direct Oral Anticoagulants (DOACs) like Eliquis (apixaban) and Xarelto (rivaroxaban) are leading the way. Eliquis has become the market leader with a 14% year-over-year growth rate, while Xarelto has a single-digit growth rate[1].

Global Pharmaceutical Market Outlook

Forecasted Growth

The global pharmaceutical market, excluding vaccines, is expected to reach $2,030 billion by 2027 at a CAGR of approximately 7%. Developed markets, including the EU4+UK, Japan, the US, and Canada, will contribute significantly to this growth[4].

Regional Contributions

Germany is expected to be a major contributor to growth in the EU4+UK region, while the US will post a CAGR of 7-8% over the 2022-2027 period. However, major patent expiries and generic/biosimilar competition will impact growth in these regions[4].

Impact of Regulatory Changes

Value-Based Care

The shift towards value-based care, as proposed by the Value in Health Care Act of 2023, will significantly impact financial incentives, payment models, and risk management in healthcare. This change will require healthcare providers to be more data-driven and analytical in their financial forecasting[5].

Compliance and Reimbursements

Regulatory changes will also affect compliance costs and reimbursement rates. Healthcare providers need to be prepared for decreased reimbursements and increased compliance costs, which can be managed through robust data analytics and scenario planning[5].

Financial Forecasting in Healthcare

Data-Driven Decision Making

Healthcare providers must collect and analyze data to inform process improvements. This includes quantifying lengths-of-stay and other relevant metrics to make strategic decisions[5].

Regulatory Uncertainty

Healthcare is highly regulated, and ongoing regulatory changes pose significant challenges for financial forecasting. Scenario planning for regulatory changes is essential to anticipate and prepare for potential financial impacts[5].

Key Takeaways

  • Innovative Products: New therapies like Mounjaro and SGLT2 inhibitors are driving significant growth in various therapeutic areas.
  • Financial KPIs: Monitoring operating cash flow, gross profit margin, OPEX, and average revenue per customer is crucial for understanding the financial health and potential of new drug launches.
  • Market Outlook: The global pharmaceutical market is expected to grow at a CAGR of approximately 7% by 2027, driven by innovative products and regulatory changes.
  • Regulatory Impact: Shifts towards value-based care and other regulatory changes will significantly impact financial incentives and operational strategies in healthcare.

FAQs

Q: What are the key drivers of growth in the diabetes market? A: The diabetes market is driven by innovative drugs such as SGLT2 inhibitors (e.g., Jardiance and Forxiga) and newer therapies like Mounjaro (tirzepatide)[1].

Q: How do regulatory changes impact financial forecasting in healthcare? A: Regulatory changes, such as the shift towards value-based care, can significantly impact financial incentives, payment models, and risk management, requiring healthcare providers to be more data-driven and analytical[5].

Q: What is the significance of operating cash flow in the pharmaceutical industry? A: Operating cash flow is a critical metric that indicates the financial health of a pharmaceutical company, signaling whether the business is generating enough cash from its daily operations[2].

Q: How does the global pharmaceutical market outlook look for the next few years? A: The global pharmaceutical market is expected to reach $2,030 billion by 2027 at a CAGR of approximately 7%, driven by innovative products and growth in developed markets[4].

Q: What role does data play in financial forecasting for healthcare providers? A: Data is crucial for informing process improvements and making strategic decisions. Healthcare providers need to collect and analyze data to anticipate and prepare for financial impacts of regulatory changes[5].

Sources

  1. IQVIA: Finding the growth engines of the endocrine & metabolic ... - IQVIA
  2. InsightSoftware: 15 Best Pharma KPIs and Metric Examples for 2024 Reporting
  3. IQVIA: Understanding the Dynamics of Drug Expenditure - IQVIA
  4. IQVIA: IQVIA Quarterly Pharmaceutical Market Outlook - November 2023
  5. NetSuite: Healthcare Forecasting in 2024: An Overview & Key Strategies

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.