SEYSARA Drug Patent Profile

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

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

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	209521-002	Oct 1, 2018		RX	Yes	No	9,481,639
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	209521-003	Oct 1, 2018		RX	Yes	Yes	8,318,706		Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-002	Oct 1, 2018		RX	Yes	No	8,513,223

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
Australia	2007338681	Substituted tetracycline compounds for treatment of inflammatory skin disorders
Canada	2892739	UTILISATION DE COMPOSES A BASE DE TETRACYCLINE SUBSTITUEE DANS LE TRAITEMENT D'AFFECTIONS CUTANEES INFLAMMATOIRES (SUBSTITUTED TETRACYCLINE COMPOUNDS FOR TREATMENT OF INFLAMMATORY SKIN DISORDERS)
Japan	6574572
Slovenia	2109602
Lithuania	2707003

Market Dynamics and Financial Trajectory for SEYSARA

Last updated: July 27, 2025

Introduction

SEYSARA (sarecycline) is a prescription antibiotic marketed by Almirall, S.A., primarily approved for the treatment of acne vulgaris in patients aged nine and older. Launched in 2018, SEYSARA harnesses a targeted tetracycline class mechanism, offering a novel approach amid a crowded dermatological and antibiotic landscape. Its market dynamics, competitive positioning, and financial trajectory are shaped by regulatory factors, evolving clinical perceptions, market competition, and broader pharmaceutical industry trends.

Market Landscape and Therapeutic Positioning

Indications and Market Penetration

SEYSARA is uniquely positioned as a targeted, once-daily oral antibiotic tailored for moderate to severe acne in adolescents and adults. Acne vulgaris remains a prevalent dermatological condition, with estimates indicating that up to 85% of adolescents experience some form of acne (source: American Academy of Dermatology). The global acne treatment market was valued at approximately $4.3 billion in 2022 and is projected to grow at a CAGR of 4-5% over the next five years [1].

SEYSARA's FDA approval in 2018 opened a substantial market niche that blends antibiotics with reduced propensity for selection of resistant bacteria, owing to its specific pharmacodynamic properties. However, the overall market penetration remains nuanced due to the presence of entrenched competitors, including doxycycline, minocycline, and other topical or systemic therapies.

Competitive Landscape

The competitive landscape involves both established antibiotics and emerging therapies. Traditional antibiotics like doxycycline and minocycline dominate due to their longstanding clinical use and familiarity among prescribers. However, increased concerns over antibiotic resistance and microbiome disruption drive interest toward targeted agents like SEYSARA.

Biologic treatments and novel compounds like topical dapsone and hormonal therapy options pose additional competition, especially for refractory cases. The acceptance of SEYSARA hinges on its perceived safety profile and efficacy, particularly in minimizing microbiome impact and resisting bacterial resistance—a growing market demand [2].

Market Drivers and Challenges

Market Drivers

• Growing Incidence of Acne: Persistent prevalence of acne cases in adolescents and young adults sustains demand for effective oral therapies.

• Antibiotic Stewardship: Rising awareness of antibiotic resistance propels demand for targeted antibiotics like sarecycline, which exhibit narrower spectra of activity.

• Patient Preference: The convenience of once-daily oral administration enhances patient compliance, especially among adolescents.

• Clinical Efficacy and Safety: Clinical trials report sarecycline’s comparable efficacy to other tetracyclines but with fewer gastrointestinal side effects and lower risk of photosensitivity [3].

Market Challenges

• Pricing and Reimbursement: As a branded product, SEYSARA's pricing must align with payer policies and cost-effectiveness benchmarks, limiting penetration in price-sensitive markets.

• Limited Indications: Current FDA-approved use restricts sales volume primarily to acne vulgaris, with off-label uses limited.

• Competitive Therapies: Entrenched use of doxycycline and minocycline, especially in primary care, can hinder rapid market penetration.

• Resistance Development: Emerging bacterial resistance could diminish long-term clinical utility, impacting sales forecasts.

Financial Trajectory and Sales Outlook

Historical Sales Performance

Following its launch in 2018, SEYSARA experienced steady adoption in the US dermatology market. In 2021, Almirall reported global net sales of approximately €587 million, with dermatology segment accounting for a significant share, though exact contribution from SEYSARA remained undisclosed [4]. North America, primarily the US, represents the largest market, driven by high acne prevalence and established prescribing habits.

Sales Growth Projections

Analysts project that SEYSARA's sales will grow at a CAGR of approximately 10-12% over the next five years, driven by increased market adoption and expanding geographic reach, including Europe and select emerging markets. Factors influencing this trajectory include:

• Efficacy and safety data reinforcing prescriber confidence.
• Broader awareness among dermatologists and primary care physicians.
• Entry into new indications or expanded labels, possibly for rosacea or other inflammatory skin conditions.

Revenue Enhancers and Potential Risks

Revenue growth may be enhanced through:

• Market Expansion: Regulatory approvals outside the US could significantly boost sales.
• Combination Therapies: Integrating SEYSARA with other dermatological agents, as explored in clinical research, might open new therapeutic avenues.
• Direct-to-Consumer Campaigns: Enhanced marketing could increase awareness and demand.

Conversely, risks such as patent challenges, generic competition, and disruptions from emerging class innovations could impact profit margins and market share.

Regulatory and Strategic Factors Influencing Market Dynamics

Regulatory Environment

Regulatory agencies are increasingly scrutinizing antibiotics due to resistance concerns, prompting post-marketing studies and stewardship programs. These measures might impose constraints on prescribing patterns or sales volumes.

Strategic Partnerships

Almirall’s collaborations with healthcare providers, dermatological societies, and patient advocacy groups can influence prescribing practices and market acceptance. Strategic partnerships with payers may facilitate favorable reimbursement landscapes.

Innovation and Pipeline Development

Continued research into sarecycline’s longer-term effects, off-label uses, and formulation improvements will shape its financial trajectory. Additionally, Almirall’s pipeline expansion into other dermatological conditions could diversify revenue streams.

Conclusion

SEYSARA’s market dynamics are influenced by its positioning as a targeted antibiotic amid rising antibiotic stewardship priorities, competition, and evolving dermatological treatments. Its financial trajectory is cautiously optimistic, with growth driven by increased awareness, expanding geographic markets, and potential label expansions. However, challenges from entrenched competitors, pricing pressures, and resistance concerns necessitate strategic agility.

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Key Takeaways

• Market Potential: The global acne treatment market remains robust, with SEYSARA positioned as a novel, targeted therapy appealing to clinicians prioritizing antibiotic stewardship.
• Growth Drivers: Clinical efficacy, safety profile, and patient compliance are central to increasing adoption, especially among adolescents.
• Challenges: Price sensitivity, competition, and resistance concerns pose barriers to rapid market expansion.
• Revenue Outlook: Analysts forecast steady growth, with potential accelerations through geographic expansion and off-label indications.
• Strategic Focus: Ongoing clinical research, market expansion, and partnership development are critical to maximizing SEYSARA’s financial performance.

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FAQs

1. What distinguishes SEYSARA from other tetracycline antibiotics?
   SEYSARA exhibits a narrower spectrum of activity with purported reduced propensity for resistance development and lower gastrointestinal and photosensitivity adverse effects, which may improve safety and tolerability compared to traditional doxycycline or minocycline.

2. How does antibiotic resistance impact SEYSARA’s market prospects?
   Rising resistance to broad-spectrum antibiotics drives demand for targeted agents like sarecycline. However, the development of resistance to sarecycline could still diminish its long-term durability, emphasizing the importance of stewardship and monitoring.

3. Are there any plans to expand SEYSARA’s approved indications?
   While current approvals focus on acne vulgaris, ongoing research might open pathways for other inflammatory skin conditions, but no definitive regulatory filings are announced yet.

4. What is the main obstacle to SEYSARA’s broader market penetration?
   Entrenched prescribing habits for traditional antibiotics, pricing strategies, and competitive therapies pose significant barriers unless offset by demonstrable clinical or safety advantages.

5. How does SEYSARA’s patent status influence its financial outlook?
   Patents protect market exclusivity, supporting premium pricing and sales longevity. Patent challenges or expirations could introduce generics, compressing margins and impacting revenue forecasts.

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Sources

[1] American Academy of Dermatology Association. "Acne Statistics."
[2] Zaenglein, AL, et al. "Guidelines of care for the management of acne vulgaris." Journal of the American Academy of Dermatology, 2016.
[3] Thiboutot, D., et al. "Efficacy and safety of sarecycline, a novel tetracycline derivative, in the treatment of acne vulgaris." Journal of Drugs in Dermatology, 2018.
[4] Almirall Annual Report 2021.