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Last Updated: December 22, 2024

ALA-CORT Drug Patent Profile


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Which patents cover Ala-cort, and when can generic versions of Ala-cort launch?

Ala-cort is a drug marketed by Crown Labs and is included in two NDAs.

The generic ingredient in ALA-CORT 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 Ala-cort

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

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Drug patent expirations by year for ALA-CORT
Drug Prices for ALA-CORT

See drug prices for ALA-CORT

Pharmacology for ALA-CORT

US Patents and Regulatory Information for ALA-CORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Crown Labs ALA-CORT hydrocortisone CREAM;TOPICAL 080706-007 Jan 5, 2016 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Crown Labs ALA-CORT hydrocortisone CREAM;TOPICAL 080706-006 Approved Prior to Jan 1, 1982 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Crown Labs ALA-CORT hydrocortisone LOTION;TOPICAL 083201-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ALA-CORT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing 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

ALA-CORT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ALA-CORT and Similar Topical Corticosteroids

Introduction

Topical corticosteroids, such as ALA-CORT, are widely used for their anti-inflammatory and immunosuppressive properties. Understanding the market dynamics and financial trajectory of these medications is crucial for both healthcare providers and pharmaceutical companies.

Market Overview of Topical Corticosteroids

Topical corticosteroids are a diverse group of drugs, including various strengths and formulations like creams, ointments, and lotions. The market for these drugs is influenced by several key factors:

Generic and Branded Products

The market includes numerous generic and branded products. Generics are generally more affordable and play a significant role in cost savings for patients. For instance, a study found that branded topical corticosteroids are 105% more expensive than their generic counterparts[1].

Pricing Trends

Over the past few years, the prices of topical corticosteroids have largely stabilized, except for branded ultrapotent corticosteroids, which saw a 63% increase in cash prices from 2017 to 2021[1].

Cost Savings

Significant cost savings can be achieved by switching from branded to generic products or between different generic products. The average savings per unit from brand-to-generic switching was $14.75, and from generic-to-generic switching was $6.82[1].

Formulation Impact

The formulation of the topical corticosteroid also affects its cost. Ointments are generally 19% less expensive than creams, making them a more cost-effective option for patients[1].

Financial Performance of Pharmaceutical Companies

Companies involved in the production and distribution of topical corticosteroids, such as Corcept Therapeutics, provide insights into the financial health and growth potential of this market segment.

Revenue Growth

Corcept Therapeutics, which focuses on medications related to endocrinologic, oncologic, metabolic, and neurologic disorders, reported a strong financial performance in 2023. The company saw a 31% increase in fourth-quarter revenue and a 20% increase in full-year revenue compared to 2022. This growth indicates a robust demand for their products, which could be indicative of the broader market for topical corticosteroids[5].

Revenue Guidance

Corcept Therapeutics reiterated its revenue guidance for 2024, projecting revenues between $600 and $630 million. This confidence in future growth suggests a stable and expanding market for related pharmaceutical products[5].

Research and Development

Investments in research and development (R&D) are crucial for pharmaceutical companies. Corcept Therapeutics increased its R&D expenses from $130.9 million in 2022 to $184.4 million in 2023, reflecting a commitment to innovation and expansion in the therapeutic areas they serve[5].

Competitive Landscape

The competitive landscape for topical corticosteroids is characterized by several factors:

Generic Competition

Generic competition is a significant driver in the market. Generic products offer substantial cost savings and are often preferred by patients and healthcare providers due to their affordability. However, the entry of generic products can be complex, especially for biologic drugs, which have higher development costs and longer development times compared to small-molecule drugs[3].

Brand Loyalty and Marketing

Branded products often maintain market share through strong brand loyalty and marketing efforts. Despite the availability of generics, branded ultrapotent corticosteroids continue to command higher prices and retain a significant market share[1].

Regulatory Environment

The regulatory environment plays a critical role in shaping the market. For biologic drugs, the lack of automatic substitution between a follow-on biologic (FOB) product and a pioneer biologic drug slows the rate at which FOB products can acquire market share. This contrasts with small-molecule generic drugs, where automatic substitution is common and leads to quicker market share erosion for branded products[3].

Impact of Coupons and Discounts

Coupons and discounts can significantly influence the cost of topical corticosteroids for patients.

Coupon Prices

Coupon prices for topical corticosteroids are consistently lower than cash prices, providing additional savings for patients. The correlation between coupon prices and cash prices is high, indicating that coupons mirror the hierarchy of cash prices and can help assess real-time costs[1].

Reimbursement Methodologies

Reimbursement methodologies used by healthcare providers, such as Medicare and Medicaid, can affect the market share of different products. These methodologies may not always favor lower-priced drugs, which can impact the adoption rate of generic or FOB products[3].

Key Takeaways

  • Pricing Stability: Topical corticosteroid prices have generally stabilized, except for branded ultrapotent products.
  • Cost Savings: Significant savings can be achieved through generic and generic-to-generic switching.
  • Formulation Impact: Ointments are often less expensive than creams.
  • Revenue Growth: Pharmaceutical companies like Corcept Therapeutics are experiencing robust revenue growth.
  • R&D Investments: Continuous investment in R&D is crucial for market expansion and innovation.
  • Competitive Landscape: Generic competition and brand loyalty are key factors in the market.
  • Regulatory Environment: Regulatory differences between small-molecule and biologic drugs affect market dynamics.
  • Coupons and Discounts: Coupons provide additional cost savings and mirror cash price hierarchies.

FAQs

What is the current trend in pricing for topical corticosteroids?

Topical corticosteroid prices have largely stabilized over the past five years, except for branded ultrapotent corticosteroids, which have seen a significant increase.

How do generic and branded products compare in terms of cost?

Branded topical corticosteroids are 105% more expensive than their generic counterparts, offering significant cost savings through generic switching.

What is the impact of formulation on the cost of topical corticosteroids?

Ointments are generally 19% less expensive than creams, making them a more cost-effective option.

How do coupons affect the cost of topical corticosteroids?

Coupons provide additional savings, with prices consistently lower than cash prices and mirroring the hierarchy of cash prices.

What are the regulatory challenges for follow-on biologic (FOB) products?

FOB products face challenges such as high development costs, lack of automatic substitution, and complex reimbursement methodologies, which slow their market share acquisition.

Sources

  1. Trends in price for topical corticosteroids from 2017 to 2021 and the potential for cost saving. PubMed.
  2. Alaunos Therapeutics Debt to Equity Ratio 2010-2024. Macrotrends.
  3. Emerging Health Care Issues: Follow-on Biologic Drug Competition. Federal Trade Commission.
  4. Ala-Cort - Drug Summary. PDR.net.
  5. Corcept Therapeutics Announces Fourth Quarter and Full-Year 2023 Audited Financial Results and Provides Corporate Update. Stock Titan.

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