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 FOUGERA PHARMS 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	OINTMENT;TOPICAL	019957-001	Dec 14, 1990	4,335,121*PED
Fougera Pharms	CUTIVATE	fluticasone propionate	LOTION;TOPICAL	021152-001	Mar 31, 2005	7,300,669

International Patents for CUTIVATE

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	644615	ANDROSTAN-CARBOTHIOATE, VERFAHREN ZU DEREN HERSTELLUNG UND DIESE ENTHALTENDE PHARMAZEUTISCHE ZUSAMMENSETZUNGEN.
Norway	20011911
Netherlands	8100707
Philippines	24267	ANDROSTANE CARBOTHIOATES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME
Canada	1205464	CARBOTHIOATES D'ANDROSTANE (ANDROSTANE CARBOTHIOATES)
Austria	401521

Supplementary Protection Certificates for CUTIVATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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
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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

CUTIVATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CUTIVATE

Introduction

CUTIVATE, a topical corticosteroid cream containing fluticasone propionate, is a widely used treatment for various skin conditions such as psoriasis and eczema. To understand the market dynamics and financial trajectory of CUTIVATE, it is essential to delve into its pharmacological properties, market performance, and the broader pharmaceutical industry context.

Pharmacological Properties of CUTIVATE

CUTIVATE Cream, with its active ingredient fluticasone propionate, is classified as a medium-potency topical corticosteroid. The therapeutic potency of fluticasone propionate is linked to the half-life of the glucocorticoid-receptor complex, which is approximately 10 hours[1].

Market Position and Competition

CUTIVATE operates in a competitive market dominated by various topical corticosteroids. The market dynamics are influenced by factors such as the availability of therapeutically equivalent drugs, patent protection, and market exclusivity. For instance, the lack of generic or therapeutically equivalent drugs can lead to higher prices and reduced competition, allowing companies to recoup their research and development costs[4].

Financial Performance of the Manufacturer

CUTIVATE is manufactured by GlaxoSmithKline (GSK), a major pharmaceutical company. While specific financial data for CUTIVATE alone is not readily available, GSK's overall financial performance provides insight into the broader context.

In 2023, GSK reported strong financial results, with sales excluding COVID-19 solutions growing at double-digit levels. The company's total and adjusted operating profit also reflected strong growth. However, the performance of individual products like CUTIVATE would be a fraction of these overall figures[3].

Impact of Regulatory and Safety Studies

The financial trajectory of CUTIVATE can be influenced by regulatory and safety studies. For example, studies on CUTIVATE have shown that it can cause HPA axis suppression in some patients, particularly when used over large body surface areas. These findings can impact prescribing habits and, consequently, sales[1].

Pricing Dynamics

The pricing of CUTIVATE, like other prescription drugs, is influenced by several factors including patent protection, market exclusivity, and competition. The absence of generic alternatives and limited competition can result in higher prices. Additionally, corporate consolidations and the transfer of drug rights can further affect pricing and market dynamics[4].

Market Trends and Consumer Behavior

Consumer behavior and market trends play a significant role in the financial trajectory of CUTIVATE. The demand for topical corticosteroids is driven by the prevalence of skin conditions such as psoriasis and eczema. Any changes in healthcare policies, insurance coverage, or patient awareness can impact the sales of CUTIVATE.

Comparison with Other Pharmaceutical Products

GSK's portfolio includes other successful products like Arexvy, the RSV vaccine, and Shingrix, the shingles vaccine. These products have contributed significantly to GSK's revenue, with Arexvy generating £1.2 billion in its first year and Shingrix delivering £3.4 billion in sales in 2023. While CUTIVATE may not achieve the same level of revenue as these vaccines, it remains a valuable asset in GSK's dermatology segment[3].

Financial Outlook and Projections

The financial outlook for CUTIVATE is tied to GSK's overall financial health and the performance of its dermatology segment. Given GSK's strong financial performance in recent years, it is likely that CUTIVATE will continue to contribute to the company's revenue, although specific projections for CUTIVATE are not available.

Challenges and Opportunities

The market for topical corticosteroids faces challenges such as increasing competition from generic alternatives and changes in regulatory environments. However, opportunities exist in expanding the indication of CUTIVATE to new patient populations and enhancing its formulation to improve efficacy and safety.

Key Takeaways

• Pharmacological Properties: CUTIVATE is a medium-potency topical corticosteroid with a half-life of the glucocorticoid-receptor complex of approximately 10 hours.
• Market Position: Operates in a competitive market influenced by patent protection, market exclusivity, and the availability of therapeutically equivalent drugs.
• Financial Performance: Part of GSK's broader financial success, though specific data for CUTIVATE is not detailed.
• Regulatory and Safety Studies: Can impact sales due to findings on HPA axis suppression.
• Pricing Dynamics: Influenced by patent protection, market exclusivity, and competition.
• Market Trends: Demand driven by prevalence of skin conditions and healthcare policies.

FAQs

Q1: What is the active ingredient in CUTIVATE Cream? A1: The active ingredient in CUTIVATE Cream is fluticasone propionate.

Q2: How does the potency of CUTIVATE compare to other topical corticosteroids? A2: CUTIVATE is classified as a medium-potency topical corticosteroid compared to other topical corticosteroids.

Q3: What are the potential side effects of using CUTIVATE Cream? A3: CUTIVATE Cream can cause HPA axis suppression, particularly when used over large body surface areas.

Q4: How does the pricing of CUTIVATE Cream get influenced? A4: The pricing of CUTIVATE Cream is influenced by factors such as patent protection, market exclusivity, and the availability of therapeutically equivalent drugs.

Q5: Who is the manufacturer of CUTIVATE Cream? A5: CUTIVATE Cream is manufactured by GlaxoSmithKline (GSK).

Sources

1. CUTIVATE - fluticasone propionate cream - FDA Label[1]
2. Cutera Announces Third Quarter 2024 Financial Results - Cutera[2]
3. 2023 Annual Report on Form 20-F - GSK[3]
4. Brand-Name Prescription Drug Pricing - GAO Report[4]