SEYSARA Drug Patent Profile

When do Seysara patents expire, and when can generic versions of Seysara launch?

Seysara is a drug marketed by Almirall and is included in one NDA. There are four patents protecting this drug.

This drug has seventy-one patent family members in twenty countries.

The generic ingredient in SEYSARA is sarecycline hydrochloride. One supplier is listed for this compound. Additional details are available on the sarecycline hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Seysara

Seysara was eligible for patent challenges on October 1, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 9, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SEYSARA

International Patents:	71
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	1
Patent Applications:	60
Drug Prices:	Drug price information for SEYSARA
What excipients (inactive ingredients) are in SEYSARA?	SEYSARA excipients list
DailyMed Link:	SEYSARA at DailyMed

See drug prices for SEYSARA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SEYSARA

Constraining patent/regulatory exclusivity:

9,255,068

NDA:

209521

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SEYSARA

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

Sponsor	Phase
Derm Research, PLLC	Phase 4

See all SEYSARA clinical trials

Pharmacology for SEYSARA

Drug Class	Tetracycline-class Drug
Mechanism of Action	P-Glycoprotein Inhibitors

US Patents and Regulatory Information for SEYSARA

SEYSARA is protected by five US patents.

This potential generic entry date is based on patent 9,255,068.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-001	Oct 1, 2018		RX	Yes	No	8,513,223
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-001	Oct 1, 2018		RX	Yes	No	8,318,706		Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-002	Oct 1, 2018		RX	Yes	No	9,481,639
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes	8,318,706		Y	Y

International Patents for SEYSARA

When does loss-of-exclusivity occur for SEYSARA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Croatia

Denmark

European Patent Office

Hungary

Japan

Lithuania

Poland

Portugal

Slovenia

Spain

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SEYSARA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2455367	Dérivés de tétracycline pour le traitement d'infections bactériennes, virales et parasites (Tetracycline derivatives for the treatment of bacterial, viral and parasitic infections)
Japan	2018039846	細菌感染、ウイルス感染、および寄生虫感染の治療のためのテトラサイクリン誘導体 (TETRACYCLINE DERIVATIVES FOR TREATMENT OF BACTERIAL, VIRAL AND PARASITIC INFECTIONS)
Japan	6876082
Spain	2463457

Market Dynamics and Financial Trajectory for SEYSARA (Sarecycline)

Introduction

SEYSARA (sarecycline) is a groundbreaking once-daily oral antibiotic derived from tetracycline, approved by the FDA in October 2018 for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older. This article delves into the market dynamics and financial trajectory of SEYSARA, highlighting its impact on the pharmaceutical landscape and the financial performance of its associated companies.

Market Need and Competition

Acne vulgaris is one of the most common dermatological conditions, affecting approximately 90% of the world's population at some point in their lives. Despite its prevalence, the acne treatment market had been relatively stagnant for several years prior to SEYSARA's approval[1].

SEYSARA entered a market with existing treatments but few new innovations. It competes with other late-stage pipeline drugs such as Foamix Pharmaceuticals’ FMX-101 and Dermira’s olumacostat glasaretil. However, SEYSARA's unique profile as a narrow-spectrum tetracycline-derived antibiotic with anti-inflammatory properties positions it as a significant player in this space[1].

FDA Approval and Launch

The FDA approval of SEYSARA was based on positive results from two identical Phase III registration studies. The drug was launched in the U.S. in January 2019 by Almirall SA, following the acquisition of the U.S. medical dermatology portfolio from Allergan PLC[2][4].

Marketing and Distribution

SEYSARA is marketed by Almirall SA in the U.S., while Paratek Pharmaceuticals retains the development and commercialization rights for the rest of the world. This strategic partnership has been crucial in expanding the drug's reach and market penetration[4].

Financial Performance

Initial Expectations

At the time of its launch, SEYSARA was expected to achieve peak sales of $150 million to $200 million. This optimism was driven by its innovative status as the first new chemical entity approved for acne treatment in a decade[2].

Actual Performance

Despite initial high expectations, SEYSARA's performance in the U.S. market has faced challenges. The drug's peak sales in the U.S. and China are now estimated to be limited to $30-40 million, significantly lower than initial projections. This underperformance has led to an impairment loss on the Seysara asset due to market pressure[3].

However, SEYSARA has shown a steady improvement in total prescriptions (TRx) and market share in the U.S. In 2021, it contributed to a 30% year-on-year growth in net sales and increased its market share to 5% of the oral antibiotic (OAB) market. Improved commercial coverage and increased market access have been key factors in this rebound[5].

Impact on Almirall's Financials

Almirall's overall financial performance has been influenced by SEYSARA, though not as positively as initially anticipated. In 2021, Almirall reported a net loss of €40.9 million, largely due to impairment charges associated with SEYSARA and other assets. Despite this, the company's core net sales and EBITDA showed significant growth, driven by the performance of other growth drivers like Ilumetri and Klisyri[5].

Market Expansion and Future Plans

Global Expansion

SEYSARA is set to be launched in China in 2024, marking another significant step in its global expansion. This launch is part of Almirall's strategy to strengthen its presence in key geographies[3].

Strategic Focus

Almirall continues to focus on expanding its market share in medical dermatology, with a particular emphasis on innovative products and strategic collaborations. The company is exploring opportunities in non-melanoma skin cancer and rare dermatology diseases, which could provide new avenues for growth[3].

Challenges and Opportunities

Challenges

SEYSARA faces challenges in the U.S. market, including underperformance and generic erosion. The global dermatology sales have also seen a slight decline, which affects the overall market dynamics[3].

Opportunities

Despite the challenges, SEYSARA's unique profile and the growing need for effective acne treatments present opportunities for growth. Almirall's strong performance in Europe, particularly with products like Ilumetri and Klisyri, indicates a robust dermatology portfolio that can support SEYSARA's market position[3].

Key Takeaways

• Innovative Treatment: SEYSARA is the first new chemical entity approved for acne treatment in a decade, offering a unique therapeutic option.
• Market Dynamics: The drug competes in a relatively stagnant market but has shown steady improvement in TRx and market share.
• Financial Performance: Initial expectations were high, but actual performance has been lower than projected, leading to impairment charges.
• Global Expansion: SEYSARA is set to be launched in China in 2024, expanding its global reach.
• Strategic Focus: Almirall is focusing on expanding its market share in medical dermatology through innovative products and strategic collaborations.

FAQs

Q: What is SEYSARA, and how is it used?

A: SEYSARA (sarecycline) is a once-daily oral antibiotic derived from tetracycline, approved for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older.

Q: Who markets SEYSARA in the U.S.?

A: SEYSARA is marketed by Almirall SA in the U.S., following the acquisition of the U.S. medical dermatology portfolio from Allergan PLC.

Q: What were the initial sales expectations for SEYSARA?

A: Initial peak sales expectations for SEYSARA were between $150 million and $200 million.

Q: How has SEYSARA performed in the market?

A: Despite initial high expectations, SEYSARA's peak sales in the U.S. and China are now estimated to be limited to $30-40 million. However, it has shown a steady improvement in TRx and market share.

Q: What are the future plans for SEYSARA?

A: SEYSARA is set to be launched in China in 2024 as part of Almirall's global expansion strategy.

Sources

1. Clinical Trials Arena: Expert Insights: Allergan's and Paratek's Seysara set to Propel a Stagnant Pharmaceutical Landscape in Treatment of Acne Vulgaris.
2. CNMV: MAR 19\20190225_CORP_FY Results.
3. Investing.com: Earnings call: Almirall reports solid growth, eyes future expansion.
4. BioSpace: FDA Approves SEYSARA™ (Sarecycline) for the Treatment of Moderate to Severe Acne.
5. BioSpace: Almirall's Full-Year 2021 Results - BioSpace.