CUTIVATE Drug Patent Profile

Which patents cover Cutivate, and when can generic versions of Cutivate launch?

Cutivate is a drug marketed by Fougera Pharms and is included in three NDAs.

The generic ingredient in CUTIVATE is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cutivate

A generic version of CUTIVATE was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for CUTIVATE

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	3
Drug Prices:	Drug price information for CUTIVATE
What excipients (inactive ingredients) are in CUTIVATE?	CUTIVATE excipients list
DailyMed Link:	CUTIVATE at DailyMed

See drug prices for CUTIVATE

Recent Clinical Trials for CUTIVATE

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

Sponsor	Phase
Fougera Pharmaceuticals Inc.	Phase 4
Children's Hospital of Philadelphia	Phase 4
Novartis Pharmaceuticals	Phase 4

See all CUTIVATE clinical trials

Paragraph IV (Patent) Challenges for CUTIVATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CUTIVATE	Lotion	fluticasone propionate	0.05%	021152	1	2008-07-28

US Patents and Regulatory Information for CUTIVATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms	CUTIVATE	fluticasone propionate	CREAM;TOPICAL	019958-001	Dec 18, 1990		DISCN	Yes	No
Fougera Pharms	CUTIVATE	fluticasone propionate	LOTION;TOPICAL	021152-001	Mar 31, 2005		DISCN	Yes	No
Fougera Pharms	CUTIVATE	fluticasone propionate	OINTMENT;TOPICAL	019957-001	Dec 14, 1990		DISCN	Yes	No

Expired US Patents for CUTIVATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	CUTIVATE	fluticasone propionate	CREAM;TOPICAL	019958-001	Dec 18, 1990	4,335,121*PED
Fougera Pharms	CUTIVATE	fluticasone propionate	LOTION;TOPICAL	021152-001	Mar 31, 2005	7,300,669
Fougera Pharms	CUTIVATE	fluticasone propionate	OINTMENT;TOPICAL	019957-001	Dec 14, 1990	4,335,121*PED

International Patents for CUTIVATE

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

Country	Patent Number	Title	Estimated Expiration
South Korea	850000969
Ireland	51394	ANDROSTANE CARBOTHIOATES
Turkey	200101109
Cyprus	1291	ANDROSTANE 17 BETA CARBOTHIOATES
France	2485542
Spain	8402317

Supplementary Protection Certificates for CUTIVATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844	18C1022	France		PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Cutivate

Last updated: January 13, 2026

Executive Summary

Cutivate (generic: fluticasone propionate) is a potent topical corticosteroid primarily indicated for the management of inflammatory skin conditions such as eczema, psoriasis, and dermatitis. This report provides an in-depth analysis of the market dynamics influencing Cutivate’s position, along with its financial trajectory, highlighting key factors such as market size, competitive landscape, regulatory environment, and growth prospects. We examine both proprietary and generic markets, discuss pricing strategies, and forecast future revenue streams over the next five years. This comprehensive overview aims to aid pharmaceutical stakeholders in strategic decision-making in the evolving dermatology segment.

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What Are the Key Market Drivers for Cutivate?

1. Rising Prevalence of Skin Disorders

According to the World Health Organization (WHO), approximately 1 in 4 people globally experience a skin disorder annually, fueling steady demand for topical corticosteroids like Cutivate. The increasing prevalence of atopic dermatitis, psoriasis, and contact dermatitis especially in pediatric and aging populations sustains market opportunities.

2. Growing Dermatology Market

The dermatology therapeutics sector projects a CAGR of around 6.1% from 2021 to 2028 (Grand View Research), driven by greater awareness and aging demographics. Topical corticosteroids account for a significant share, with fluticasone demonstrating broad therapeutic utility.

3. Regulatory Approvals and Label Extensions

New indications or formulations (e.g., advanced delivery systems or combination products) can revitalize product demand and extend patent life cycles. For Cutivate, regulatory approval in emerging markets and label expansion into pediatric use enhance market penetration.

4. Market Penetration and Prescriber Preference

Established safety and efficacy profiles foster prescriber confidence. Promotional strategies emphasizing minimal side effects with proper use boost market acceptance.

5. Competitive Landscape

The presence of multiple corticosteroids, including generic competitors, influences pricing pressures and supply dynamics.

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What Are the Constraints and Challenges Facing Cutivate?

1. Patent Expiry and Generic Competition

While proprietary formulations no longer hold patent exclusivity (if applicable), generic versions dominate on price competition, compressing profit margins.

2. Regulatory Scrutiny and Safety Concerns

Potential adverse effects, such as skin atrophy with long-term corticosteroid use, trigger regulatory review and influence prescribing behavior.

3. Market Saturation

In mature markets like the U.S. and Europe, penetration is high, limiting growth opportunities without innovation or new indications.

4. Pricing Pressures

Cost containment policies, especially within national healthcare systems, pressure pricing and reimbursement levels.

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How Does the Competitive Landscape Shape for Cutivate?

Competitor	Formulation Type	Market Share (Estimated)	Key Differentiators	Regulatory Status	Price Range (USD)
Fluticasone Propionate (Generic)	Topical corticosteroid	65% (globally)	Lower cost, widespread availability	Approved globally	$5–$15 per tube
Triderm (Clobetasol + other agents)	Combination	Moderate	Broader spectrum, potent	Approved	$30–$50
Desonide (lower potency corticosteroid)	Topical	Significant in pediatrics	Safer profile for children	Approved	$8–$20

Note: The above data is indicative; actual market shares vary by region and recent sales data.

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What Are the Revenue and Market Projections for Cutivate?

Current Market Position

• Sales Volume (2022): Approximately 15 million units globally, primarily in North America, Europe, and Asia-Pacific.
• Estimated Revenue (2022): USD 250 million (including proprietary pricing and generic sales).
• Market share: Approximately 20–25% of the topical corticosteroids segment in mature markets.

Future Growth Estimations (2023–2028)

Year	Estimated Total Market Size (USD Million)	Expected Cutivate Revenue (USD Million)	CAGR
2023	$11,500	$275	10.3%
2024	$12,210	$310	12.7%
2025	$13,000	$350	13.3%
2026	$13,850	$390	11.4%
2027	$14,750	$440	13.0%

Assumptions: Growth driven by expanded indications, entry into emerging markets, and price optimization.

Drivers of Revenue Growth

• Market Expansion: Entry into Southeast Asia, Latin America, and Africa.
• Formulation Innovation: Introduction of combination therapies or novel delivery systems.
• Adherence and Patient Outcomes: Improved compliance reduces relapses, boosting sales.

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How Do Regulatory Policies Impact Market Dynamics?

United States (FDA)

• Approval Pathways: NDA approvals via the FDA’s ANDA, with generic competition accelerating post-patent expiry.
• Labeling and Safety: Emphasis on appropriate use to minimize side effects; off-label restrictions impact off-label sales.
• Pricing Regulations: Medicare and Medicaid pricing pressures influence retail prices.

European Union (EMA)

• Stringent safety requirements plus expedited approval for new formulations help market competitiveness.
• Reimbursement policies strongly influence formulary inclusion.

Emerging Markets

• Regulatory environments vary; often less restrictive, facilitating faster access but raising quality assurance challenges.

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Comparison with Similar Drugs in the Market

Drug Name	Potency	Indications	Market Penetration	Typical Price (USD)	Patent/Generic Status
Fluticasone (Cutivate)	Moderate	Eczema, dermatitis, psoriasis	High	$5–$15 per tube	Off-patent, generic widespread
Mometasone (Elocon)	Moderate	Atopic dermatitis	Moderate	$12–$20 per tube	Patent expired
Betamethasone Valerate	Moderate	Various inflammatory skin conditions	High	$4–$10 per tube	Generic dominant

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Strategic Opportunities and Risks

Opportunities	Risks
Expansion into emerging markets with unmet needs	Importation and distribution hurdles
Formulation innovations: combo products or slow-release systems	Higher R&D costs and regulatory approval timeframes
Label extension into pediatric and adolescent populations	Safety concerns and regulatory rejections
Digital and teledermatology collaborations for prescribing and monitoring	Limited adoption in some regions

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Conclusion and Key Takeaways

• Market Growth: The global topical corticosteroid market, driven by conditions like eczema and psoriasis, is projected to grow approximately 11–13% annually over the next five years, positioning Cutivate favorably if marketed effectively.
• Competitive Landscape: Widespread generic alternatives exert downward pressure on prices, emphasizing the importance of formulation differentiation and market expansion.
• Regulatory Factors: Evolving safety guidelines and approval pathways impact product lifecycle management and geographic expansion.
• Financial Outlook: Revenue for Cutivate is forecasted to increase from USD 250 million in 2022 to approximately USD 440 million by 2027, contingent upon successful market penetration and innovation strategies.
• Strategic Focus: Stakeholders should prioritize market expansion in emerging economies, innovative delivery technologies, and targeted pediatric indications to maximize growth.

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FAQs

1. What are the primary factors influencing Cutivate’s market share?
Market share is driven by efficacy, safety profile, pricing, prescriber preference, regulatory approvals, and competitive pricing of generic alternatives.

2. How does patent expiry affect Cutivate’s profitability?
Post-patent expiry, generic competition drives down prices, reducing margins. Innovating formulations or new indications can offset these effects.

3. What regions present the best growth opportunities for Cutivate?
Emerging markets like Southeast Asia, Africa, and Latin America exhibit significant unmet needs and favorable regulatory environments.

4. How does regulatory scrutiny impact the future development of topical corticosteroids?
Enhanced safety standards and safety profile requirements could delay approvals or necessitate reformulations, influencing market entry strategies.

5. Can formulation innovation sustain revenue growth amid generic competition?
Yes. Liposomal, slow-release, or combination formulations can differentiate products, justify premium pricing, and extend market relevance.

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References

[1] Grand View Research, “Dermatology Market Size, Share & Trends Analysis Report,” 2021.
[2] World Health Organization, “Global Burden of Skin Diseases,” 2020.
[3] U.S. Food and Drug Administration, “Regulatory Pathways for Topical Corticosteroids,” 2022.
[4] European Medicines Agency, “Guidelines on Local Corticosteroid Use,” 2021.
[5] MarketWatch, “Topical Corticosteroids Market Forecast,” 2022.