LEXETTE Drug Patent Profile

Which patents cover Lexette, and what generic alternatives are available?

Lexette is a drug marketed by Mayne Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in fourteen countries.

The generic ingredient in LEXETTE is halobetasol propionate. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lexette

A generic version of LEXETTE was approved as halobetasol propionate by FOUGERA PHARMS on December 16^th, 2004.

Summary for LEXETTE

International Patents:	27
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	1
Patent Applications:	4,964
Drug Prices:	Drug price information for LEXETTE
What excipients (inactive ingredients) are in LEXETTE?	LEXETTE excipients list
DailyMed Link:	LEXETTE at DailyMed

See drug prices for LEXETTE

Recent Clinical Trials for LEXETTE

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

Sponsor	Phase
Skin Sciences, PLLC	Phase 4

See all LEXETTE clinical trials

Paragraph IV (Patent) Challenges for LEXETTE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEXETTE	Topical Foam	halobetasol propionate	0.05%	210566	1	2021-01-28

US Patents and Regulatory Information for LEXETTE

LEXETTE is protected by two US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	LEXETTE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	210566-001	May 24, 2018	AB	RX	Yes	Yes	11,020,407		Y
Mayne Pharma	LEXETTE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	210566-001	May 24, 2018	AB	RX	Yes	Yes	10,857,159*PED				Y
Mayne Pharma	LEXETTE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	210566-001	May 24, 2018	AB	RX	Yes	Yes

International Patents for LEXETTE

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2018007343	COMPOSICION DE ESPUMA DE HALOBETASOL Y METODO DE USO DE LA MISMA. (HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF.)
South Korea	20180098300	할로베타솔 발포체 조성물 및 이의 사용 방법
Canada	3008753	COMPOSITION DE MOUSSE D'HALOBETASOL ET PROCEDE D'UTILISATION (HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF)
Canada	3008756	CORTICOSTEROIDE CONTENANT DES COMPOSITIONS DE MOUSSE ET SON PROCEDE DE FABRICATION (CORTICOSTEROID CONTAINING FOAM COMPOSITIONS AND METHOD OF MANUFACTURE THEREOF)

LEXETTE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LEXETTE (Halobetasol Propionate Foam)

Introduction to LEXETTE

LEXETTE, a formulation of halobetasol propionate foam, is a topical corticosteroid used primarily for the treatment of plaque psoriasis in adult patients. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Approval and Launch

LEXETTE was approved by the US Food and Drug Administration (FDA) in September 2021 for the treatment of plaque psoriasis in patients aged 12 and above. This approval marked a significant milestone for Mayne Pharma, the company behind the drug's commercialization[1][4].

Market Segment and Competition

LEXETTE operates within the broader topical corticosteroids market, which is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.36% from 2022 to 2030. The global topical corticosteroids market was valued at US$ 4.12 billion in 2022 and is projected to reach US$ 5.80 billion by 2030[1].

In the U.S. dermatology drugs market, LEXETTE competes with other topical treatments for psoriasis and other skin conditions. North America, particularly the United States, is a dominant region for this market due to increasing product launches and regulatory approvals[1][4].

Financial Performance and Revenue

The launch of LEXETTE has contributed significantly to Mayne Pharma's financial performance. The company reported a notable increase in revenue from the drug's sales. For instance, the approval and subsequent marketing of LEXETTE have helped Mayne Pharma in its strategic repositioning towards more sustainable therapeutic areas, such as dermatology[3].

Revenue Growth and Market Impact

Following its launch, LEXETTE has shown strong revenue growth. Mayne Pharma's focus on dermatology, including the acquisition and in-licensing of dermatology products like LEXETTE, has helped the company to expand its portfolio and leverage its established sales and marketing distribution capabilities[3].

The drug's commercial success is evident from the increased revenue and gross profit reported by Mayne Pharma. For example, the company's Generic Product Division, which includes LEXETTE, saw a significant impact from new product launches, despite facing competitive pressures in other generic products[3].

Regional Market Performance

LEXETTE's market performance is particularly strong in North America, where it has been approved for use in adolescents and adults. The FDA approval in September 2021 has enabled Mayne Pharma to capitalize on the growing demand for effective psoriasis treatments in this region[1].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the topical corticosteroids market, including LEXETTE. There was an increased incidence of skin injuries and atopic dermatitis among healthcare personnel due to infection-prevention measures, leading to a surge in the use of topical corticosteroids. This surge contributed to the growth of the market during the pandemic period[1].

Research and Development

The success of LEXETTE is also driven by ongoing research and development activities. For instance, the combination of topical corticosteroids with other treatments, such as IL-13 inhibitors like Lebrikizumab, has shown promising results in clinical trials. These advancements are expected to further enhance the market position of LEXETTE and similar topical corticosteroids[1].

Competitive Landscape

In the competitive landscape of topical corticosteroids, LEXETTE faces competition from other branded and generic products. However, its approval for use in adolescents and adults, along with its potent formulation, positions it as a strong contender in the market. Companies like GlaxoSmithKline, Merck & Co., and AstraZeneca are also key players in this market, but Mayne Pharma's strategic focus on dermatology has allowed LEXETTE to carve out a significant niche[1].

Future Outlook

The future outlook for LEXETTE is positive, driven by increasing awareness and consumption of dermatology drugs. The U.S. dermatology drugs market, in which LEXETTE operates, is expected to grow significantly over the forecast period of 2020 to 2027. This growth will be fueled by extensive R&D activities, new product launches, and expanding indications for existing treatments[4].

Key Takeaways

• Market Approval: LEXETTE was approved by the FDA in September 2021 for treating plaque psoriasis.
• Revenue Growth: The drug has contributed significantly to Mayne Pharma's revenue, especially in the dermatology segment.
• Regional Performance: North America is a dominant region for LEXETTE due to regulatory approvals and market demand.
• COVID-19 Impact: The pandemic increased the use of topical corticosteroids, including LEXETTE.
• R&D Activities: Ongoing research enhances the market position of LEXETTE and similar treatments.
• Competitive Landscape: LEXETTE competes with other branded and generic topical corticosteroids but holds a strong market position.

FAQs

Q: What is LEXETTE used for? A: LEXETTE (halobetasol propionate foam) is used for the treatment of plaque psoriasis in adult patients and adolescents aged 12 and above.

Q: When was LEXETTE approved by the FDA? A: LEXETTE was approved by the FDA in September 2021.

Q: How has the COVID-19 pandemic affected the market for LEXETTE? A: The pandemic led to an increased incidence of skin injuries and atopic dermatitis, resulting in a surge in the use of topical corticosteroids like LEXETTE.

Q: Which company is behind the commercialization of LEXETTE? A: Mayne Pharma is the company responsible for the commercialization of LEXETTE.

Q: What is the projected growth rate of the global topical corticosteroids market? A: The global topical corticosteroids market is expected to exhibit a CAGR of 4.36% from 2022 to 2030.

Sources

1. Coherent Market Insights: Topical Corticosteroids Market Size and Forecast to 2030
2. Roivant: Financial Results and Business Update for the Quarter Ended December 31, 2022
3. ASX Announcement: Mayne Pharma’s Recent Performance and Strategic Direction
4. PharmiWeb: U.S. Dermatology Drugs Market Size Share, Top Leading Countries, Companies, Consumption, Drivers, Trends, and Forecast 2020-2027