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-two 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:	72
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	1
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

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.

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
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-002	Oct 1, 2018		RX	Yes	No
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-001	Oct 1, 2018		RX	Yes	No			Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes			Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-002	Oct 1, 2018		RX	Yes	No
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-001	Oct 1, 2018		RX	Yes	No

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
South Korea	20090098986	박테리아, 바이러스 및 기생충 감염의 치료를 위한 테트라시클린 유도체 (TETRACYCLINE DERIVATIVES FOR THE TREATMENT OF BACTERIAL, VIRAL AND PARASITIC INFECTIONS)
European Patent Office	3488853	COMPOSÉS DE TÉTRACYCLINE SUBSTITUÉS POUR LE TRAITEMENT DE TROUBLES INFLAMMATOIRES DE LA PEAU (SUBSTITUTED TETRACYCLINE COMPOUNDS FOR TREATMENT OF INFLAMMATORY SKIN DISORDERS)
World Intellectual Property Organization (WIPO)	2008079363
Poland	2707003
European Patent Office	2450347
Canada	2925939
Slovenia	2707003

SEYSARA: Market Landscape and Financial Projections

Last updated: February 19, 2026

SEYSERA (oral sarecycline) generated $39.6 million in net sales in 2022, a 25.4% increase from $31.6 million in 2021. This growth positions the drug within the acne vulgaris treatment market, a segment characterized by sustained patient demand and evolving therapeutic options. The drug's performance is directly linked to its patent exclusivity and market penetration strategy.

What is SEYSARA's Competitive Position?

SEYSERA competes in the global acne vulgaris market, estimated to reach $12.1 billion by 2028, growing at a compound annual growth rate (CAGR) of 4.5% from 2021 to 2028. Key competitors include topical and oral antibiotics, retinoids, and hormonal therapies. SEYSERA's differentiation lies in its broad-spectrum activity, favorable tolerability profile compared to some tetracyclines, and convenience as an oral monotherapy [1].

The competitive landscape includes:

• Tetracycline Antibiotics: Doxycycline, minocycline, and sarecycline itself. SEYSERA is a fourth-generation tetracycline designed for improved gastrointestinal tolerability.
• Topical Treatments: Benzoyl peroxide, topical retinoids (tretinoin, adapalene, tazarotene), and topical antibiotics (clindamycin, erythromycin).
• Other Oral Agents: Isotretinoin (for severe, recalcitrant acne), spironolactone (off-label for hormonal acne in women).

The market share distribution is influenced by factors such as treatment guidelines, physician prescribing habits, insurance formulary coverage, and patient adherence. SEYSERA's targeted approach for moderate to severe acne vulgaris, as identified in its clinical trials, dictates its market segmentation.

What is SEYSERA's Patent Exclusivity Status?

All patents covering SEYSERA's composition of matter and method of use are held by Almirall, S.A. The key U.S. composition of matter patent, U.S. Patent No. 8,173,665, was granted on May 8, 2012, and is scheduled to expire on May 8, 2029. Orange Book listings confirm this patent and its expiration date.

Additional patents related to methods of treatment and formulations may extend market exclusivity beyond the primary composition of matter patent, depending on their scope and expiration dates. The absence of generic competitors as of December 31, 2022, indicates that no Paragraph IV challenges have successfully invalidated the core patents.

Patent expiration dates are critical for anticipating generic entry. The expiration of U.S. Patent No. 8,173,665 in May 2029 presents a clear timeline for potential generic competition. While further patent litigation or new patent filings could alter this timeline, the current outlook points to this expiration as a significant event for SEYSERA's market exclusivity.

What is SEYSERA's Financial Performance and Trajectory?

SEYSERA's net sales demonstrate consistent growth:

• 2022: $39.6 million (+$7.9 million or +25.4% from 2021) [2]
• 2021: $31.6 million (+$17.8 million or +128.6% from 2020) [2]
• 2020: $13.8 million [2]

This substantial year-over-year growth in net sales indicates increasing market adoption and effective commercialization strategies. The significant jump from 2020 to 2021 reflects a ramp-up in market penetration following its launch. The continued, albeit slower, growth in 2022 suggests sustained demand.

The drug's financial trajectory is influenced by:

• Prescription Volume: An increase in the number of prescriptions written by dermatologists and other healthcare providers.
• Pricing: The average selling price (ASP) of SEYSERA, which is subject to market dynamics and payer negotiations.
• Market Access: The extent to which SEYSERA is covered by commercial and government insurance plans.
• Commercialization Efforts: Investments in marketing, sales force, and patient support programs.

Almirall's investor presentations and financial reports are the primary sources for granular financial data. Future projections will depend on the continued success of these commercial activities and the absence of disruptive market events.

What are the Key Drivers of SEYSERA's Sales?

SEYSERA's sales are driven by:

• Clinical Efficacy: Demonstrated effectiveness in treating moderate to severe acne vulgaris in clinical trials. The drug targets inflammatory lesions and demonstrates a favorable safety profile compared to older tetracyclines.
• Tolerability Profile: SEYSERA is designed to minimize gastrointestinal side effects commonly associated with other oral antibiotics. This improved tolerability can lead to higher patient adherence.
• Physician Adoption: Increased prescribing by dermatologists, influenced by positive clinical data, peer recommendations, and formulary status.
• Market Expansion: Growth in the overall acne treatment market and Almirall's efforts to expand SEYSERA's market reach.
• Insurance Coverage: Favorable formulary placement and reimbursement policies from major payers, reducing out-of-pocket costs for patients.

The drug's label indications for moderate to severe acne vulgaris, in patients aged 9 years and older, defines its primary target population.

How Does SEYSERA's Regulatory Landscape Impact its Market?

SEYSERA received U.S. Food and Drug Administration (FDA) approval on October 2, 2018. The regulatory pathway for acne treatments involves rigorous clinical trials demonstrating both safety and efficacy. Post-market surveillance continues to monitor for adverse events.

The regulatory environment for antibiotics, in general, is evolving due to concerns about antibiotic resistance. While SEYSERA's distinct mechanism and therapeutic use position it within the current guidelines for acne management, any shifts in antimicrobial stewardship policies could indirectly influence its long-term market access.

Key regulatory considerations include:

• FDA Approval Status: Confirmed for the U.S. market.
• Label Indications: Approved for moderate to severe acne vulgaris in patients 9 years and older.
• Post-Market Commitments: Any ongoing studies or reporting requirements mandated by the FDA.
• International Approvals: Status of SEYSERA in other major markets (e.g., European Union, Canada), which would expand its global revenue potential. As of early 2023, Almirall has been focused on the U.S. market for SEYSERA.

The regulatory framework supports SEYSERA's current market position, but future policy changes related to antibiotic use could present headwinds.

What is the Projected Financial Outlook for SEYSERA?

Predicting precise future financial performance requires access to proprietary sales forecasts. However, based on historical growth trends and market dynamics, the following can be inferred:

• Continued Growth: Absent significant market disruption or generic entry before patent expiry, SEYSERA is likely to experience continued, albeit potentially moderating, sales growth in the near to medium term. The 25.4% growth in 2022 indicates strong momentum.
• Impact of Patent Expiry: The expiration of the U.S. composition of matter patent in May 2029 will be a critical inflection point. Generic competition following patent expiry will almost certainly lead to a significant decline in SEYSERA's revenue, as is typical for branded pharmaceuticals.
• Pre-Expiry Strategies: Almirall's strategies in the years leading up to patent expiry will focus on maximizing sales, potentially through market expansion, lifecycle management initiatives (if applicable), and reinforcing physician and patient loyalty.

Without specific sales targets from Almirall, a quantitative projection is speculative. However, the current trend suggests a revenue stream that will likely peak in the period preceding patent expiry. The rate of sales decline post-expiry will be dependent on the number and pricing of generic entrants.

Key Takeaways

• SEYSERA generated $39.6 million in net sales in 2022, marking a 25.4% year-over-year increase.
• The drug's primary U.S. composition of matter patent expires on May 8, 2029, signaling a clear timeline for potential generic competition.
• SEYSERA is positioned within a growing acne vulgaris market, competing with a range of established topical and oral therapies.
• Key drivers of SEYSERA's sales include its clinical efficacy, favorable tolerability profile, and increasing physician adoption.

Frequently Asked Questions

• When did SEYSERA receive FDA approval? SEYSERA received FDA approval on October 2, 2018.
• What is the primary indication for SEYSERA? SEYSERA is indicated for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older.
• What is the expiration date of the main patent for SEYSERA in the U.S.? The key U.S. composition of matter patent is set to expire on May 8, 2029.
• What was the net sales of SEYSERA in 2021? SEYSERA's net sales in 2021 were $31.6 million.
• Which company holds the patents for SEYSERA? Almirall, S.A. holds the patents for SEYSERA.

Citations

[1] Global Acne Vulgaris Market Size, Share & Trends Analysis Report by Treatment Type (Drug Therapy, Devices, Procedures), By Drug Class (Antibiotics, Retinoids, Hormonal Agents, Others), By Route of Administration (Topical, Oral), By End-Use (Hospitals, Clinics, Home Use), By Region, And Segment Forecasts, 2022 - 2030. (n.d.). Grand View Research. Retrieved from https://www.grandviewresearch.com/industry-analysis/acne-vulgaris-market

[2] Almirall, S.A. (2023). Annual Report 2022. Retrieved from https://www.almirall.com/en/investors/financial-reports