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-two 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
Novartis Pharmaceuticals	Phase 4
Children's Hospital of Philadelphia	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 Africa	8100976
Spain	499394
Ireland	862287

Supplementary Protection Certificates for CUTIVATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CUTIVATE

Last updated: July 30, 2025

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Introduction

CUTIVATE, known generically as fluocinolone acetonide, is a corticosteroid utilized in dermatology to manage inflammatory and pruritic skin conditions, including eczema, psoriasis, and dermatitis. Its market landscape is shaped by evolving regulatory standards, competitive shifts, and patent statuses, influencing its sales trajectory and overall financial prospects. This analysis explores the current market dynamics, growth drivers, challenges, and forward-looking financial projections for CUTIVATE within the global pharmaceutical arena.

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Market Overview and Therapeutic Significance

CUTIVATE competes in a niche but sizable market for topical corticosteroids, a class with a well-established role in dermatological care. The global dermatology market is projected to reach USD 23 billion by 2027, growing at a CAGR of approximately 4.4% from 2020 to 2027, driven by increasing prevalence of skin disorders, rising awareness, and expanding healthcare access [1].

Within this segment, corticosteroids account for a significant share, with drugs like CUTIVATE serving as frontline therapies due to their efficacy and safety profiles. The increasing prevalence of eczema and psoriasis, especially in aging populations and urbanized regions, sustains demand. However, the market faces saturation and rising competition from alternative therapies, including biologics and non-steroidal topical agents.

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Regulatory and Patent Landscape

Historically, patent protections for topical corticosteroids like CUTIVATE contributed to premium pricing and market exclusivity. However, patent expirations and the entry of generics significantly impact revenue streams. For instance, the patent for fluocinolone acetonide ointments has faced expiration in key markets, reducing barriers for generic competitors.

Regulatory frameworks vary globally; while approvals facilitate market entry, differences in safety and efficacy indications influence sales. In some regions, stricter regulation of corticosteroids’ long-term safety has led to restricted use, curbing growth prospects.

Manufacturers now focus on reformulations and combination therapies to extend lifecycle and differentiation. The development of low-dose, non-steroidal alternatives may further challenge CUTIVATE’s market dominance.

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Market Dynamics and Competitive Landscape

1. Competition from Generic and Branded Products

Generic fluocinolone acetonide formulations have penetrated markets post-patent expiry, exerting downward pressure on prices. Major pharmaceutical players, including Sun Pharma and Perrigo, produce affordable generics, leading to commoditization in certain geographies.

2. Development of Novel Therapies

Biologic therapies targeted at severe dermatologic conditions, such as dupilumab for eczema, are gaining prominence. While biologics are reserved for refractory cases due to cost and administration routes, their rising popularity may influence corticosteroid market share indirectly.

3. Increasing Focus on Safety and Compliance

Growing awareness of corticosteroids’ potential adverse effects has prompted the development of safer formulations, topical non-steroid agents, and combination products. These innovations aim to capture prescriber confidence but may threaten traditional corticosteroid sales if substitution occurs.

4. Regional Variations

Emerging markets, particularly Asia-Pacific, exhibit rapid dermatology market growth driven by rising disposable incomes and urbanization. However, inconsistent regulatory environments and consumer awareness levels create variability in product penetration.

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Market Drivers

• Prevalence of Skin Disorders: Rising incidence of eczema, psoriasis, and dermatitis globally sustains demand.
• Aging Population: Elderly demographics experience higher skin condition rates, expanding market potential.
• Increasing Awareness: Patient and physician education enhances diagnosis and treatment adherence.
• Healthcare Expansion: Growing access to dermatological healthcare services supports sales.

Market Challenges

• Patent Expirations: Erode premium pricing and profit margins.
• commoditization: Heightened competition from generics leads to price erosion.
• Safety Concerns: Long-term corticosteroid use associated with adverse effects limits prescribing.
• Alternatives: Non-steroidal treatments and biologics encroach on corticosteroid spaces.

Financial Trajectory and Revenue Forecasts

Given the patent expiry timeline and market saturation, the revenue for premium branded versions of CUTIVATE is expected to decline marginally over the next 3-5 years. However, revenues from generic formulations are anticipated to grow, compensating for this decline initially. Over the longer term, the overall market for fluocinolone acetonide products may stabilize with narrow margins.

Assumptions influencing financial trajectories:

• Patent cliff impact: A significant revenue decline is projected post-expiry, estimated at 30-50% in mature markets within 2 years.
• Market Penetration of Generics: Increased availability could reduce brand-based revenue shares by 20-30% over the next 3 years.
• Regulatory Restrictions: Stricter guidelines may limit prescribing, particularly for long-term therapy.
• Innovation Initiatives: Introduction of combination therapies or reformulations may mitigate declines.

Projected revenue estimates:

Year	Estimated Revenue (USD Million)	Drivers/Notes
2023	150 – 180	Pre-patent expiry, strong demand in emerging markets
2024	120 – 140	Patent expiration, entry of generics begins
2025	80 – 100	Market saturation with generics, price competition intensifies
2026	60 – 80	Stabilization of generic market, reformulation adoption
2027	50 – 70	Market maturation, minimal growth

Note: These are indicative figures based on industry trends and may vary by region.

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Strategic Approaches to Sustain Financial Performance

• Differentiation through Formulation Innovations: Reformulating the drug with improved safety profiles or lower dosing to prolong market relevance.
• Expansion into Emerging Markets: Capitalizing on higher growth rates and unmet needs in Asian, African, and Latin American regions.
• Combination Therapies: Developing adjunct products, such as corticosteroid-calcipotriol formulations, to rejuvenate demand.
• Brand Reinforcement and Patient Engagement: Enhancing physician and patient education to promote brand loyalty amidst generic competition.
• Regulatory Navigation: Seeking new indications or approved formulations to extend lifecycle.

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Conclusion

The market dynamics surrounding CUTIVATE are characterized by a typical lifecycle pattern, with initial growth driven by high-quality formulations and expanding demand. Patent expiries and the rise of generics impose pricing pressures, while competition from biologics and alternative therapies further challenge its market share.

Financial trajectories indicate an expected decline in premium brand revenues, offset by increased generic sales, particularly in emerging markets. To sustain profitability, industry players must innovate, diversify, and strategically target growth geographies.

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Key Takeaways

• Patent expiration and generic competition are primary factors influencing revenue decay for CUTIVATE.
• Emerging markets offer substantial growth opportunities despite regulatory variations.
• Innovation in formulations and combination therapies can extend life cycles and mitigate revenue decline.
• Safety considerations influence prescribing patterns, impacting long-term market dynamics.
• Strategic diversification into biologics and non-steroidal agents is crucial for maintaining a competitive edge.

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Frequently Asked Questions

1. What factors primarily affect the market share of CUTIVATE in the next five years?
Patent expirations, introduction of generics, safety concerns, and the emergence of biologic alternatives are the main determinants. Market penetration strategies and regional regulations will also significantly influence share dynamics.

2. How does the patent lifecycle impact CUTIVATE’s revenue trajectory?
Patent protection fosters premium pricing and exclusivity; expiration leads to generic competition and significant revenue declines unless countered by formulation innovations or new indications.

3. What regions provide the most growth opportunities for CUTIVATE?
Emerging markets in Asia-Pacific, Latin America, and Africa show high growth potential due to rising dermatology awareness, expanding healthcare infrastructure, and increasing skin disorder prevalence.

4. Can reformulation or combination therapies prolong CUTIVATE’s market relevance?
Yes. Reformulations with improved safety profiles or novel combination products can differentiate offerings, extend patent life, and sustain patient adherence.

5. How do safety concerns influence future prescribing patterns of topical corticosteroids like CUTIVATE?
Increased awareness of corticosteroid side effects leads to cautious prescribing, favoring shorter courses, lower doses, or alternative therapies, thereby influencing overall demand.

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References

[1] Grand View Research. "Dermatology Market Size, Share & Trends Analysis Report." 2021.