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WYNZORA Drug Patent Profile

When do Wynzora patents expire, and what generic alternatives are available?

Wynzora is a drug marketed by MC2 and is included in one NDA. There are two patents protecting this drug.

This drug has forty-eight patent family members in twenty-eight countries.

The generic ingredient in WYNZORA is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.

DrugPatentWatch^® Generic Entry Outlook for Wynzora

Indicators of Generic Entry

Summary for WYNZORA

International Patents:	48
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in WYNZORA?	WYNZORA excipients list
DailyMed Link:	WYNZORA at DailyMed

Pharmacology for WYNZORA

Drug Class	Corticosteroid Vitamin D Analog
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for WYNZORA

WYNZORA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mc2	WYNZORA	betamethasone dipropionate; calcipotriene	CREAM;TOPICAL	213422-001	Jul 20, 2020		RX	Yes	Yes	10,265,265		Y
Mc2	WYNZORA	betamethasone dipropionate; calcipotriene	CREAM;TOPICAL	213422-001	Jul 20, 2020		RX	Yes	Yes	11,696,919		Y

International Patents for WYNZORA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2019239544	Topical composition
Canada	2680405	COMPOSITION TOPIQUE DE POLYAPHRON AVEC VITAMINE D ET CORTICOSTEROIDE (POLYAPHRON TOPICAL COMPOSITION WITH VITAMIN D AND CORTICOSTEROID)
South Korea	20200135400	국소 조성물
European Patent Office	1970049	Composition topique du type polyaphron avec de la vitamine D et un corticosteroide (Polyaphron topical composition with vitamin D and corticosteroid)
China	101674808	Polyaphron topical composition with vitamin d and corticosteroid
Russian Federation	2020133965	КОМПОЗИЦИЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ
Russian Federation	2009138045	МЕСТНОДЕЙСТВУЮЩАЯ ПОЛИАФРОНОВАЯ КОМПОЗИЦИЯ С ВИТАМИНОМ D И КОРТИКОСТЕРОИДОМ

WYNZORA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Wynzora

Overview of Wynzora

Wynzora, a fixed-dose combination of betamethasone dipropionate and calcipotriene, is a topical cream indicated for the treatment of plaque psoriasis in adult patients aged 18 years or older. This combination therapy brings together a glucocorticoid (betamethasone dipropionate) and a synthetic calcitriol derivative (calcipotriene), making it a potent treatment option for psoriasis[1].

Market Launch and Traction

Wynzora was launched in the European market in the spring of 2022, and it has shown significant traction since its introduction. By the end of 2022, Wynzora achieved sales of €5 million in the first countries where it was launched, with an impressive 11% market share in those regions[5].

Sales Performance

The sales of Wynzora have been on an upward trend. In 2023, the drug's sales surpassed DKK 100 million (approximately USD 14.5 million), indicating a strong market acceptance and demand for the product. This growth is a testament to the drug's efficacy and the unmet need in the psoriasis treatment market[4].

Market Share and Competition

Wynzora has quickly gained a significant market share in the dermatology segment, particularly in the European market. By achieving an 11% market share in the first countries where it was launched, Wynzora has positioned itself as a competitive player in the psoriasis treatment market. This success is likely due to its unique combination of active ingredients and the lack of similar fixed-dose combination products in the market[5].

Financial Impact on Almirall

The success of Wynzora has contributed positively to Almirall's financial performance. In the nine-month period of 2022, Almirall's core net sales reached €633.8 million, a 5.3% year-on-year increase, with a strong contribution from the sales of its dermatology portfolio, including Wynzora. The company's normalized net income was €32.7 million, resulting in a normalized earnings per share of €0.18 per share[5].

Investment in R&D and SG&A

Almirall's financial performance has also been influenced by higher investments in research and development (R&D) and selling, general, and administrative (SG&A) expenses related to new and upcoming product launches. In 2022, R&D expenses accounted for 12% of net sales, and SG&A expenses were significant, reflecting the company's commitment to pipeline development and market expansion[5].

Balance Sheet and Cash Flow

Despite the increased investments in R&D and SG&A, Almirall maintained a strong and healthy balance sheet. The company's net debt to EBITDA ratio was 0.8x, thanks to good cash flow generation and the reduction in pension plans. This financial stability positions Almirall well for future growth and further investments in its product pipeline[5].

Market Potential and Growth Prospects

The psoriasis market, where Wynzora operates, is significant and growing. The success of Wynzora in this market indicates a high unmet need for effective treatments. With its strong launch performance and increasing sales, Wynzora is poised to continue contributing to Almirall's growth. The drug's potential expansion into other markets and indications could further enhance its financial trajectory[4].

Regulatory and Pipeline Developments

Almirall's pipeline commitments, including the EMA acceptance for the Marketing Authorization Application (MAA) for lebrikizumab, suggest a robust future for the company's dermatology portfolio. These developments align with Almirall's strategy to transform the business and support mid-term growth acceleration prospects[5].

Patient Demand and Payer Dynamics

The strong patient demand for Wynzora has had a positive impact on ongoing conversations with payers. This is evident from the increasing gross-to-net (GTN) yield, which rose from 12% to 18% in subsequent quarters, indicating better payer acceptance and reimbursement rates. This trend is crucial for sustaining the drug's market performance and financial growth[3].

Conclusion

Wynzora has established itself as a significant player in the psoriasis treatment market, driven by its unique formulation and strong market acceptance. The drug's financial performance has positively impacted Almirall's overall financial trajectory, with notable sales growth and market share gains. As Almirall continues to invest in R&D and pipeline development, Wynzora is expected to remain a key contributor to the company's growth and financial success.

Key Takeaways

• Strong Market Launch: Wynzora achieved significant sales and market share in the European market since its launch in 2022.
• Financial Contribution: The drug has positively impacted Almirall's financial performance, contributing to increased core net sales and normalized net income.
• R&D and SG&A Investments: Higher investments in R&D and SG&A are supporting Wynzora's market expansion and future pipeline developments.
• Market Potential: The psoriasis market offers substantial growth opportunities, with Wynzora well-positioned to capitalize on this potential.
• Regulatory and Pipeline Developments: Almirall's pipeline commitments and regulatory approvals are crucial for the company's future growth.

FAQs

What is Wynzora, and how is it used?

Wynzora is a fixed-dose combination of betamethasone dipropionate and calcipotriene, used as a topical cream for the treatment of plaque psoriasis in adult patients aged 18 years or older.

How has Wynzora performed in the market since its launch?

Since its launch in the European market in 2022, Wynzora has shown excellent traction, achieving sales of €5 million and an 11% market share in the first countries where it was launched.

What is the financial impact of Wynzora on Almirall?

Wynzora has contributed to Almirall's increased core net sales and normalized net income. In the nine-month period of 2022, Almirall's core net sales reached €633.8 million, with a strong contribution from Wynzora.

How does Wynzora's market performance affect payer dynamics?

The strong patient demand for Wynzora has led to better payer acceptance and reimbursement rates, as indicated by the increasing GTN yield from 12% to 18%.

What are the future growth prospects for Wynzora?

Wynzora is poised for continued growth, driven by its strong market performance, potential expansion into other markets and indications, and Almirall's ongoing investments in R&D and pipeline development.

Sources

1. GlobalData, "Net Present Value Model: Wynzora - GlobalData", November 24, 2022.
2. Wikipedia, "Almirall".
3. Roivant Sciences, "February 13, 2023 Financial Results and Business Update for the Third Quarter of Fiscal Year 2023", February 13, 2023.
4. MedWatch, "Sales of psoriasis drug developed by MC2 increase significantly at Almirall", February 19, 2024.
5. Business Wire, "Almirall's Nine-month 2022 Results", November 10, 2022.