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

Last Updated: December 22, 2024

ALA-SCALP Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Ala-scalp patents expire, and when can generic versions of Ala-scalp launch?

Ala-scalp is a drug marketed by Legacy Pharma and is included in one NDA.

The generic ingredient in ALA-SCALP 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-scalp

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for ALA-SCALP?
  • What are the global sales for ALA-SCALP?
  • What is Average Wholesale Price for ALA-SCALP?
Drug patent expirations by year for ALA-SCALP
Pharmacology for ALA-SCALP

US Patents and Regulatory Information for ALA-SCALP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Legacy Pharma ALA-SCALP hydrocortisone LOTION;TOPICAL 083231-001 Approved Prior to Jan 1, 1982 RX 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-SCALP

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-SCALP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ALA-SCALP

Introduction

ALA-SCALP, a brand-name prescription drug, is one of the many pharmaceutical products that have experienced significant price increases over the years. To understand the market dynamics and financial trajectory of ALA-SCALP, it is crucial to delve into the broader context of prescription drug pricing, industry trends, and the specific factors influencing this drug.

Background on Prescription Drug Pricing

Prescription drug prices, particularly for brand-name drugs, have been a subject of intense scrutiny due to their extraordinary increases. From 2000 to 2008, the Government Accountability Office (GAO) identified 416 brand-name drug products that had extraordinary price increases, defined as a unit price increase of 100 percent or more at a single point in time[1][4].

Market Dynamics

Consolidation and Market Domination

The pharmaceutical industry has seen a significant increase in consolidation through mergers and acquisitions. This trend has led to fewer companies producing and marketing drugs, resulting in greater market domination among certain companies and reduced competition. Large drug companies have acquired smaller companies that specialize in niche markets or similar therapeutic classes, which can contribute to higher prices due to reduced competition[1][4].

Influence of Health Care Providers

Unlike other markets, health care providers play a crucial role in influencing demand for prescription drugs. Since patients often rely on their health care providers for decisions and may not be aware of the drug costs due to third-party payers, the usual market mechanisms that enforce price discipline do not apply. This can lead to higher prices without a corresponding decrease in demand[1][4].

Characteristics of ALA-SCALP

Therapeutic Class

ALA-SCALP falls under the therapeutic class of dermatological agents, which includes drugs used to treat skin conditions. The GAO report highlights that drugs in various therapeutic classes, including dermatological agents, have experienced extraordinary price increases[1].

Price Increases

While the GAO report does not specifically detail ALA-SCALP, it provides a framework for understanding how brand-name drugs like ALA-SCALP could experience significant price hikes. For instance, many brand-name drug products saw price increases ranging from 100 percent to 499 percent, with a median increase of about 158 percent[1].

Factors Contributing to Price Increases

Patent Protection and Market Exclusivity

Brand-name drugs, including ALA-SCALP, typically enjoy patent protection and market exclusivity periods. Once these protections expire, generic equivalents can enter the market, but until then, the brand-name drug can command higher prices due to its monopoly status[4].

Supply and Demand

The demand for ALA-SCALP, driven by its efficacy in treating specific skin conditions, can contribute to its pricing. If the drug is highly effective and has limited competition, the manufacturer may increase the price to maximize profits[1].

Regulatory Environment

Regulatory factors, such as FDA approvals and compliance with regulatory standards, can also influence the pricing of ALA-SCALP. The cost of compliance and the time required for regulatory approvals can be factored into the drug's price[4].

Financial Trajectory

Revenue Impact

The financial trajectory of ALA-SCALP is closely tied to its pricing strategy. Significant price increases can lead to substantial revenue growth for the manufacturer, especially if the drug is widely prescribed and has a strong market presence.

Cost to Consumers and Payers

However, these price increases can also lead to higher costs for consumers and third-party payers. This can result in increased financial burden on health care systems and may prompt insurers to restrict access to the drug due to its high cost[1][4].

Case Studies and Analogies

GLP-1 Drugs as an Example

The market dynamics of GLP-1 drugs, which have seen significant price increases and market domination by a few key players, can serve as an analogy. GLP-1 drugs, like those developed by Novo Nordisk and Eli Lilly, have experienced high demand and subsequent price increases due to their efficacy in treating obesity and other conditions. Similarly, ALA-SCALP's pricing could be influenced by its market position and the lack of strong competition[3].

Future Outlook

Competition and Generic Entry

The future financial trajectory of ALA-SCALP will depend on several factors, including the entry of generic competitors once its patent protection expires. Generic competition can significantly reduce the price of the drug, impacting the manufacturer's revenue.

Regulatory and Market Changes

Changes in regulatory policies or market conditions, such as increased scrutiny on drug pricing or shifts in consumer demand, can also affect the financial trajectory of ALA-SCALP. For instance, if there is a push for more transparent and competitive pricing practices, the manufacturer may need to adjust its pricing strategy[1][4].

Key Takeaways

  • Market Consolidation: The pharmaceutical industry's trend of consolidation can lead to higher prices for brand-name drugs like ALA-SCALP.
  • Health Care Provider Influence: Health care providers play a significant role in influencing demand, which can insulate drug prices from traditional market forces.
  • Patent Protection: The patent protection and market exclusivity enjoyed by brand-name drugs contribute to their higher prices.
  • Regulatory Environment: Compliance with regulatory standards and the cost of FDA approvals can impact the pricing of ALA-SCALP.
  • Future Competition: The entry of generic competitors and changes in regulatory or market conditions will shape the future financial trajectory of ALA-SCALP.

FAQs

  1. What are the main factors contributing to the high prices of brand-name prescription drugs like ALA-SCALP?

    • The main factors include market consolidation, patent protection, the influence of health care providers, and the regulatory environment.
  2. How does the health care market differ from other markets in terms of price sensitivity?

    • In the health care market, patients often rely on health care providers for decisions and may not be aware of drug costs due to third-party payers, which can insulate prices from traditional market forces.
  3. What is the impact of generic competition on the pricing of brand-name drugs?

    • Generic competition can significantly reduce the price of a brand-name drug once its patent protection expires.
  4. How do regulatory changes affect the pricing of prescription drugs?

    • Regulatory changes, such as increased scrutiny on drug pricing or shifts in consumer demand, can prompt manufacturers to adjust their pricing strategies.
  5. What role do mergers and acquisitions play in the pricing of prescription drugs?

    • Mergers and acquisitions can lead to market domination by fewer companies, reducing competition and allowing for higher prices.

Sources

  1. GAO-10-201, Brand-Name Prescription Drug Pricing. Government Accountability Office.
  2. Weighing the GLP-1 market. Goldman Sachs.
  3. GAO-10-201 Brand-Name Prescription Drug Pricing. Government Accountability Office.

More… ↓

⤷  Subscribe

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.