Last Updated: August 9, 2026

TEMOVATE E Drug Patent Profile


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

Temovate E is a drug marketed by Fougera Pharms and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Temovate E

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

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  • What is the 5 year forecast for TEMOVATE E?
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Summary for TEMOVATE E
Recent Clinical Trials for TEMOVATE E

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

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US Patents and Regulatory Information for TEMOVATE E

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms TEMOVATE E clobetasol propionate CREAM;TOPICAL 020340-001 Jun 17, 1994 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: June 17, 2026

TEMOVATE E market dynamics and financial trajectory: pricing, demand drivers, competitive pressure, exclusivity, and generic risk

Executive summary: TEMOVATE E (clobetasone butyrate propionate cream) competes in a topical corticosteroid segment that is highly price- and channel-driven, with demand tied to eczema/dermatitis prevalence, prescriber switching from higher- or lower-potency steroids, and payer formulary placement. Financial trajectory is typically characterized by steady volume under long-running supply, mid-cycle price erosion from wholesaler and payer contracting, and incremental displacement from generics and private label. For jurisdictions where TEMOVATE E is not protected by meaningful remaining patent life and where the brand is no longer first-line on typical formularies, revenue usually trends toward contraction unless manufacturers reinvest in channel programs or expand indications/dosage strengths via regulatory action.


What is TEMOVATE E and how does it perform in the topical corticosteroid market?

TEMOVATE E is a branded topical corticosteroid product containing clobetasone butyrate propionate (a steroid used for inflammatory skin conditions). The therapeutic use case is the dermatology “anti-inflammatory” bucket, centered on eczema and dermatitis.

Where does TEMOVATE E sit versus potency competitors?

Within topical corticosteroids, payer and prescriber decisioning often follows potency and duration-of-therapy rules:

  • Lower potency agents are preferred for mild disease and sensitive sites.
  • Medium-to-high potency agents capture moderate flares or refractory areas, often with quantity limits and step-therapy.
  • Potency tiering drives substitution behavior and affects brand retention, even when the active ingredient is the same across multiple manufacturers.

Key market dynamics for prescription topical steroids

  • Formulary steering: managed care plans and national formularies commonly steer to lower-cost equivalents or specific contracting tiers.
  • Channel concentration: national accounts, hospital formularies, and large wholesaler tenders shape price realizations.
  • Low single-patient economics: dermatology creams often see high Rx counts but relatively limited per-Rx revenue versus oral specialty.
  • Adherence and size tradeoffs: tube/pack size and prescriber instruction (thin layer frequency, duration) influence total unit consumption.

How do pricing and channel contracting typically shape TEMOVATE E revenues?

Branded topical corticosteroids tend to experience revenue dilution from three mechanisms:

1) Ex-manufacturer price pressure

  • Annual payer contracting resets.
  • Wholesale price benchmarking across interchangeable strengths pushes down net sales.
  • Brands that are no longer protected by strong exclusivity rely on rebate leverage to defend share.

2) Substitution to generics or therapeutically interchangeable products

Even when switching requires clinical justification, many topical steroid classes are viewed as interchangeable at the class level by formularies, creating a path for “same potency, cheaper product” substitution.

3) Private label and low-cost reallocation

Some markets see private label or widely distributed generic equivalents displace branded creams. Outcomes depend on local procurement rules.


What demand drivers support TEMOVATE E, and what weakens them?

Demand support

  • Chronic prevalence: atopic dermatitis and contact dermatitis keep baseline demand.
  • Flares create recurring prescriptions: episodic usage still produces repeated Rx demand.
  • Dermatology activity cycles: seasonal variation can increase overall corticosteroid utilization.

Revenue headwinds

  • Guideline-driven steroid stewardship: restrictions on potency duration can reduce total days of therapy, shifting volume away from stronger corticosteroids.
  • Brand-to-generic conversion: once equivalents are firmly established, new prescriptions often begin on the cheapest covered product.
  • Payer quantity limits: per-Rx or per-month limits constrain repeat purchasing.

When does TEMOVATE E lose exclusivity, and how does that change the generic launch timeline?

Actionable conclusion: TEMOVATE E’s financial trajectory is most sensitive to the interaction between:

  1. patent exclusivity status in each target jurisdiction, and
  2. regulatory entry readiness (manufacturing, bioequivalence where relevant, packaging, and labeling changes).

Where remaining exclusivity is limited, the brand typically shifts from “protection-driven revenue” to “price-defense revenue,” and the next generic launch often accelerates unit erosion.

Market pattern: topical corticosteroid brands usually show:

  • pre-entry plateau (contracting stabilizes net price),
  • entry shock (instant list-price-to-N1 tier replacement and stocking changes),
  • post-entry settling (share loss slows but net revenue continues to compress).

What patents protect TEMOVATE E, and how strong is the patent estate for the brand?

This section cannot be completed accurately. A complete patent landscape requires specific jurisdictional patent numbers, assignees, grant and expiration data, and Orange Book (or equivalent) listings tied to TEMOVATE E’s exact formulation, strength, and dosage form.

Because the prompt does not provide TEMOVATE E’s jurisdiction(s), product strength, manufacturer/marketing authorization holder, or its regulatory identifiers, a patent-strength assessment would be speculative.


What is the Orange Book status of TEMOVATE E and what does it imply for generic entry risk?

This section cannot be completed accurately without the FDA NDA/BLA number or an exact mapping from “TEMOVATE E” to the corresponding US application and Orange Book listing.

Without that mapping, a valid Orange Book exclusivity and patent-expiration read is not possible.


How many patents cover TEMOVATE E formulations, and what formulation barriers exist?

This section cannot be completed accurately. Formulation protection depends on:

  • exact base (cream composition),
  • excipient system and concentration,
  • manufacturing process and impurity specifications,
  • any combination with other active ingredients (if applicable).

Without the product’s exact composition listing and regulatory identifiers, the formulation patent count and barriers cannot be quantified.


Which companies are positioned to compete with TEMOVATE E, including generics and private label?

This section cannot be completed accurately. Competitive identification requires:

  • the active ingredient’s approved manufacturers for the same strength/dosage form in each jurisdiction,
  • tender/contract lists for payer markets,
  • and post-approval generic labeling.

Without those inputs, naming competitors would risk inaccuracy.


What patent litigation affects TEMOVATE E, and what settlement outcomes change entry timing?

This section cannot be completed accurately. Patent litigation and Paragraph IV (or national equivalents) outcomes must be tied to specific docket numbers, asserted patents, and settlement agreements. The prompt provides no litigation identifiers.


How does TEMOVATE E compare with other topical corticosteroids in commercial resilience?

Even without product-specific exclusivity data, commercial resilience in topical steroids usually correlates with:

  • formulary tier placement (preferred vs non-preferred),
  • reimbursement stability (less frequent benefit removals),
  • perceived equivalence (same potency active ingredient tolerance),
  • supply chain reliability (fewer shortages protect continued demand).

Under standard market behavior, a brand with dwindling exclusivity shows weaker pricing power, and share depends more on payer relationships and dermatologist familiarity than on patent-driven differentiation.


What is TEMOVATE E’s financial trajectory: revenue curve shape, gross margin pressure, and unit trends?

Generic topical steroid reality: revenue curves typically mirror a “mature brand” profile.

  • Net sales: compress as rebates increase to defend share and as contracting shifts to lower-cost covered products.
  • Gross margin: declines as the manufacturer’s net price falls and channel incentives rise.
  • Units: can remain stable for a period if the brand keeps “first Rx” behavior via formulary status, then declines when switching reaches a tipping point.

Financial bottom line (typical pattern for older topical steroid brands):

  • steady-to-declining net sales over time,
  • margin compression due to rebate growth and competitive pricing,
  • reduced ability to fund growth unless new strengths or labeling expansions exist.

This trajectory differs by region depending on:

  • remaining regulatory protection,
  • payer substitution rules,
  • the depth of generic penetration,
  • and presence of combination products or new vehicles (lotion/ointment vs cream) that can restart demand.

Revenue exposure: which countries drive upside or downside for TEMOVATE E?

This section cannot be completed accurately without:

  • the key commercialization territories,
  • local marketing authorization status,
  • and region-specific competitive entry timing.

Key Takeaways

  • TEMOVATE E’s commercial performance is governed by topical steroid formulary dynamics, rebate pressure, and generic/therapeutic substitution behavior.
  • The revenue curve for mature topical corticosteroid brands is typically contractionary post-exclusivity as payer contracting shifts to lower-cost equivalents.
  • A precise exclusivity, patent strength, and generic entry-risk profile requires jurisdiction-specific regulatory identifiers and patent/Orange Book mappings tied to TEMOVATE E’s exact strength and dosage form.
  • Practical financial forecasting should focus on net pricing (rebates and tender outcomes), share under managed care tiers, and the timing of substitution cycles in major markets.

FAQs

1) Why do topical steroid brands like TEMOVATE E lose net price even if list price stays stable?

Rebates, wholesaler incentives, and payer contracting can reduce realized net price while list price remains controlled.

2) What does formulary tier status do to TEMOVATE E prescriptions during generic entry?

Preferred tier placement sustains initial Rx behavior; tier downgrades accelerate substitution as pharmacists and prescribers seek covered alternatives.

3) Do cream and ointment versions of the same steroid behave differently in market share?

Yes. Vehicle preferences, patient adherence, and eczema site suitability can shift utilization and protect demand even when active ingredient is shared.

4) What role do quantity limits play in the revenue trajectory of topical corticosteroids?

Quantity limits cap total units per member per month, often forcing earlier refills to switch to alternative products that are not limited.

5) How do shortages or supply disruptions affect financial performance in mature topical brands?

Shortages can temporarily protect share for remaining stock but often trigger longer-term switching to alternative covered products, raising permanent erosion risk.


References

No sources cited.

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