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Last Updated: March 25, 2025

EMBELINE E Drug Patent Profile


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When do Embeline E patents expire, and what generic alternatives are available?

Embeline E is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in EMBELINE E is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Embeline E

A generic version of EMBELINE E was approved as clobetasol propionate by COSETTE on February 16th, 1994.

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Summary for EMBELINE E
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 80
Patent Applications: 4,356
DailyMed Link:EMBELINE E at DailyMed
Drug patent expirations by year for EMBELINE E

US Patents and Regulatory Information for EMBELINE E

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hikma EMBELINE E clobetasol propionate CREAM;TOPICAL 075325-001 Dec 24, 1998 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

Market Dynamics and Financial Trajectory for Embeline (Clobetasol)

Introduction to Embeline (Clobetasol)

Embeline, also known as clobetasol, is a potent topical corticosteroid used to treat various skin conditions, including psoriasis, dermatitis, and rashes. It reduces swelling, itching, and redness associated with these conditions[2][5].

Global Dermatological Drugs Market Overview

The global dermatological drugs market, within which Embeline operates, is experiencing significant growth. In 2024, the market size was valued at USD 23.9 billion and is anticipated to grow at a CAGR of 10.1% from 2025 to 2030. This growth is driven by increasing awareness of skin diseases, improvements in the life science industry, and rising incomes and purchasing power in countries like China and India[4].

Segmentation and Market Share

Drug Class

The dermatological drugs market is segmented into various drug classes, including corticosteroids, biologics, and others. Clobetasol, being a corticosteroid, falls under the non-biologics segment. This segment is expected to grow significantly during the forecast period due to its widespread use and effectiveness in treating skin conditions[1].

Route of Administration

Embeline is administered topically, which is one of the segments in the route of administration category. While the parenteral/systemic segment dominates the market due to the increasing adoption of biologics, the topical segment remains crucial for treating skin conditions like psoriasis. The oral segment is also expected to witness lucrative growth, but topical treatments like Embeline will continue to be vital for localized skin issues[1].

Regional Market Dynamics

North America

North America holds a significant share of the dermatological drugs market, driven by the rising burden of skin diseases and increasing initiatives to raise awareness. The region is expected to witness substantial growth due to higher adoption of advanced treatment therapies and increasing research and development spending on clinical trials[1].

Europe

Europe is the second-largest market, with a significant prevalence of skin disorders. The region's growth is supported by large investments in the healthcare sector, greater prevalence of healthcare insurance, and supportive regulatory frameworks[4].

Asia Pacific

The Asia Pacific region is anticipated to record the highest growth rate due to government initiatives to raise awareness about skin diseases and promote clinical research and studies. Countries like India and China, with large populations, are key drivers of this growth[1][4].

Financial Trajectory

Market Size and Growth

The global psoriasis treatment market, a subset of the dermatological drugs market, is projected to grow from USD 27.20 billion in 2024 to USD 57.68 billion by 2032, exhibiting a CAGR of 9.9% during the forecast period. This growth is driven by the increasing prevalence of moderate-to-severe plaque psoriasis, strategic collaborations among key players, and the high demand for safe and effective therapies[1].

Impact of Drug Price Dynamics

The financial trajectory of Embeline and similar drugs can be influenced by drug price dynamics. For instance, the loss of exclusivity for branded products can lead to a decline in prices due to the entry of biosimilar versions. This can impact the cost-effectiveness of treatments, as seen in studies evaluating the influence of US drug price dynamics on cost-effectiveness analyses[3].

Distribution Channels

Retail Pharmacies

Retail pharmacies dominate the distribution channel for dermatological drugs, including Embeline. The increasing number of independent retail pharmacies, especially in emerging nations, provides easy access to patients and contributes to market growth[1].

Competitive Landscape

The market for dermatological drugs is competitive, with key players such as AbbVie Inc., Novartis AG, Johnson & Johnson Services, Inc., and Pfizer Inc. dominating the landscape. These companies invest heavily in research and development, which drives innovation and growth in the market[1].

Challenges and Opportunities

Side Effects and Safety Concerns

Embeline, like other potent corticosteroids, comes with potential side effects such as skin changes, irritation, thinning of the skin, and other systemic effects. Managing these side effects while maintaining efficacy is a challenge that manufacturers and healthcare providers must address[2][5].

Innovations and New Treatments

The increasing number of clinical trials and the development of new drugs offer opportunities for growth. For example, the rise of interleukin inhibitors and other biologics is expected to gain traction due to their effectiveness in treating psoriasis and other skin conditions[1].

Key Takeaways

  • The global dermatological drugs market, including Embeline, is expected to grow significantly due to increasing awareness and improvements in healthcare.
  • The topical segment, though not the largest, remains crucial for treating localized skin conditions.
  • Regional growth is driven by different factors, including government initiatives, healthcare investments, and population demographics.
  • Drug price dynamics can significantly impact the financial trajectory of treatments like Embeline.
  • Retail pharmacies play a dominant role in the distribution of these drugs.

FAQs

1. What is Embeline used for? Embeline, or clobetasol, is used to treat skin conditions such as psoriasis, dermatitis, and rashes by reducing swelling, itching, and redness[2][5].

2. How does the global dermatological drugs market grow? The market grows at a CAGR of 10.1% from 2025 to 2030, driven by increasing awareness of skin diseases, improvements in the life science industry, and rising incomes and purchasing power[4].

3. What are the key regions driving the market growth? North America, Europe, and the Asia Pacific are the key regions driving market growth, each with unique factors such as healthcare investments, government initiatives, and population demographics[1][4].

4. How do drug price dynamics affect the market? Drug price dynamics, including price increases during exclusivity periods and decreases after the loss of exclusivity, can impact the cost-effectiveness and financial trajectory of treatments like Embeline[3].

5. What are the potential side effects of using Embeline? Potential side effects include skin changes, irritation, thinning of the skin, and other systemic effects such as signs of a weak adrenal gland and changes in eyesight[2][5].

Cited Sources

  1. Fortune Business Insights: Psoriasis Treatment Market Size, Share & Global Report [2032]
  2. Drugs.com: Embeline (Clobetasol Cream, Gel, and Ointment)
  3. PubMed: The Influence of US Drug Price Dynamics on Cost-Effectiveness
  4. Grand View Research: Dermatological Drugs Market Size | Industry Report, 2030
  5. WebMD: Embeline For The Scalp: Uses, Side Effects, Interactions

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