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Last Updated: March 23, 2025

TEMOVATE Drug Patent Profile


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When do Temovate patents expire, and when can generic versions of Temovate launch?

Temovate is a drug marketed by Fougera Pharms and is included in five NDAs.

The generic ingredient in TEMOVATE 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 Temovate

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

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Summary for TEMOVATE
US Patents:0
Applicants:1
NDAs:5
Raw Ingredient (Bulk) Api Vendors: 80
Clinical Trials: 2
Patent Applications: 4,356
Drug Prices: Drug price information for TEMOVATE
What excipients (inactive ingredients) are in TEMOVATE?TEMOVATE excipients list
DailyMed Link:TEMOVATE at DailyMed
Drug patent expirations by year for TEMOVATE
Drug Prices for TEMOVATE

See drug prices for TEMOVATE

Recent Clinical Trials for TEMOVATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
VA Office of Research and DevelopmentN/A
University Hospitals Cleveland Medical CenterN/A
GlaxoSmithKlinePhase 2

See all TEMOVATE clinical trials

US Patents and Regulatory Information for TEMOVATE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Fougera Pharms TEMOVATE clobetasol propionate CREAM;TOPICAL 019322-001 Dec 27, 1985 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fougera Pharms TEMOVATE clobetasol propionate OINTMENT;TOPICAL 019323-001 Dec 27, 1985 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fougera Pharms TEMOVATE clobetasol propionate SOLUTION;TOPICAL 019966-001 Feb 22, 1990 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fougera Pharms TEMOVATE clobetasol propionate GEL;TOPICAL 020337-001 Apr 29, 1994 DISCN Yes 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 4 of 4 entries

Expired US Patents for TEMOVATE

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Fougera Pharms TEMOVATE clobetasol propionate CREAM;TOPICAL 019322-001 Dec 27, 1985 3,721,687 ⤷  Try for Free
Fougera Pharms TEMOVATE clobetasol propionate OINTMENT;TOPICAL 019323-001 Dec 27, 1985 3,721,687 ⤷  Try for Free
Fougera Pharms TEMOVATE clobetasol propionate SOLUTION;TOPICAL 019966-001 Feb 22, 1990 3,721,687 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

International Patents for TEMOVATE

See the table below for patents covering TEMOVATE around the world.

CountryPatent NumberTitleEstimated Expiration
Canada 952900 ANTI-INFLAMMATORY STEROIDS OF THE PREGNANE SERIES AND PROCESSES FOR THEIR PREPARATION ⤷  Try for Free
Netherlands 7811738 ⤷  Try for Free
Netherlands 6900795 ⤷  Try for Free
Switzerland 564035 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Temovate (Clobetasol Propionate)

Introduction

Temovate, a brand name for the topical corticosteroid clobetasol propionate, is a widely used medication for treating various skin conditions, including psoriasis, eczema, and other steroid-responsive dermatoses. Understanding the market dynamics and financial trajectory of Temovate is crucial for stakeholders in the pharmaceutical industry.

Market Size and Growth

The global market for clobetasol propionate, including Temovate, is part of the broader topical drug delivery market. This market is projected to grow significantly, driven by increasing incidences of skin diseases and a preference for localized treatment options. The topical drug delivery market is expected to reach USD 177.97 billion by 2031, growing at a CAGR of 6.3% from 2024 to 2031[3].

Key Drivers

Increasing Incidences of Dermatological Conditions

The rise in dermatological conditions such as psoriasis, eczema, and skin infections is a major driver for the demand of topical corticosteroids like Temovate. These conditions affect millions globally, intensifying the need for targeted therapeutic solutions[3].

Technological Advancements in Drug Formulation

Continuous innovations in drug formulations and delivery technology are creating new opportunities for topical medications. These advancements improve the efficacy and convenience of drug delivery, making products like Temovate more appealing to patients and healthcare providers[3].

Preference for Non-Invasive Treatment Methods

Patients increasingly prefer drug delivery systems that avoid the complexities of injections or oral medications. Topical creams, gels, and foams, such as those under the Temovate brand, are gaining prominence due to their ease of use and localized action[3].

Competitive Landscape

The market for topical corticosteroids is competitive, with several players offering generic and branded products. Temovate, being a well-established brand, faces competition from generic versions of clobetasol propionate as well as other topical corticosteroids. However, its strong brand recognition and efficacy help it maintain a significant market share[4].

Regional Analysis

Geographical Dominance

North America is a leading region in the topical drug delivery market, driven by advanced healthcare infrastructure and substantial R&D investments. This region is expected to continue dominating the market for Temovate and other topical corticosteroids due to high demand and favorable regulatory environments[3].

Regulatory Landscape

Regulatory Trends

The development and commercialization of topical medications like Temovate are heavily influenced by regulatory trends. Stringent rules concerning the safety and efficacy of novel topical formulations can sometimes delay commercialization, posing a challenge for market participants. However, established products like Temovate benefit from existing regulatory approvals and a proven safety profile[3].

Financial Performance

Revenue and Market Share

The financial performance of Temovate is closely tied to the overall growth of the topical drug delivery market. As the market expands, driven by increasing demand for localized treatment options, Temovate is expected to maintain a significant share. The revenue growth for clobetasol propionate products, including Temovate, is projected to be substantial over the forecast period from 2025 to 2031[1].

Cost and Pricing Dynamics

The pharmaceutical industry, including the segment for topical corticosteroids, has faced pricing pressures in recent years. However, the demand for effective treatments like Temovate helps mitigate some of these pressures. The cost of production and pricing strategies are critical factors in maintaining profitability, especially in a competitive market with generic alternatives[2].

Consumer Behavior and Usage

Treatment Guidelines and Usage Limits

Temovate and other clobetasol propionate products are subject to specific treatment guidelines and usage limits. For example, treatment with Temovate cream or ointment is typically limited to 2 consecutive weeks, and usage beyond this period is not recommended without medical supervision[4].

Technological Innovations

Advancements in Formulations

The market for Temovate benefits from continuous technological innovations in drug formulations. New delivery systems, such as foams and emollient foams (e.g., Olux and Olux-E), enhance patient compliance and treatment outcomes. These innovations are crucial for maintaining market competitiveness and driving growth[4].

Challenges and Restraints

Competitive Pressure from Alternative Drug Delivery Systems

The topical drug delivery market faces competition from alternative drug delivery systems, including oral, injectable, and transdermal systems. In some cases, these alternatives may offer more dependable or effective outcomes, which can restrict the demand for topical treatments like Temovate[3].

Regulatory Obstacles

Stringent regulatory requirements can impede the commercialization of new topical formulations and limit innovation, particularly for companies with constrained resources. This can slow market progress and affect the financial trajectory of products like Temovate[3].

Future Outlook

Market Projections

The future outlook for Temovate is positive, driven by the growing demand for topical drug delivery systems. The market is expected to continue expanding, with significant revenue growth projected over the next decade. However, the market will need to navigate regulatory challenges and competitive pressures to maintain its growth trajectory[3].

Strategic Insights

For healthcare industry leaders, aligning business strategies with the latest market trends and regulatory shifts is essential. Investing in R&D to improve efficacy and convenience in delivery mechanisms will be crucial for maintaining market dominance. Here is a key insight from industry experts:

"Patients prefer drug delivery systems that circumvent the intricacies of injections or oral medications, prompting innovation in creams, gels, and patches. This trend is anticipated to propel market growth, as pharmaceutical companies invest significantly in research to improve efficacy and convenience in delivery mechanisms."[3]

Key Takeaways

  • The global topical drug delivery market, including Temovate, is projected to grow at a CAGR of 6.3% from 2024 to 2031.
  • Increasing incidences of dermatological conditions and technological advancements in drug formulations are key drivers.
  • North America dominates the market due to advanced healthcare infrastructure and significant R&D investments.
  • Regulatory trends and competitive pressures from alternative drug delivery systems are significant challenges.
  • Continuous innovation in formulations and delivery systems is crucial for maintaining market competitiveness.

FAQs

What is the projected growth rate of the topical drug delivery market?

The topical drug delivery market is expected to grow at a CAGR of 6.3% from 2024 to 2031[3].

What are the main drivers for the demand of Temovate?

The main drivers include increasing incidences of dermatological conditions and technological advancements in drug formulations[3].

Which region dominates the market for Temovate?

North America dominates the market due to its advanced healthcare infrastructure and substantial R&D investments[3].

What are the key challenges faced by Temovate in the market?

Key challenges include competitive pressure from alternative drug delivery systems and regulatory obstacles[3].

How does Temovate benefit from technological innovations?

Temovate benefits from innovations in formulations such as foams and emollient foams, which enhance patient compliance and treatment outcomes[4].

Sources

  1. Cognitivemarketresearch.com: Clobetasol Propionate Market Report 2024 (Global Edition)
  2. Dsij.in: Annual Report - Edelweiss Securities Limited
  3. Globenewswire.com: Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031 Globally at 6.3% CAGR
  4. Cigna.com: Clobetasol Drug Quantity Management Policy – Per Days

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