SEYSARA Drug Patent Profile

Which patents cover Seysara, 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

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

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
Canada	2673466
World Intellectual Property Organization (WIPO)	2012155146
Japan	2011093914
Cyprus	1121135
South Korea	101538175

Market Dynamics and Financial Trajectory for SEYSARA

Last updated: December 26, 2025

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Executive Summary

SEYSARA (sarecycline) is a targeted tetracycline-class antibiotic approved by the FDA in 2018 for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 9 years and older. Its unique mechanism—selective activity against Cutibacterium acnes (formerly Propionibacterium acnes)—positions it as a differentiated product within the antibiotic and acne therapy markets. This report analyzes SEYSARA's market landscape, growth drivers, revenue trajectory, competitive dynamics, regulatory environment, and strategic outlook, providing a comprehensive understanding for stakeholders.

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1. Market Overview: The Acne Therapeutics Landscape

Global Acne Market Size & Growth (2022–2028)

Year	Market Size (USD Billion)	CAGR (2022–2028)	Main Growth Drivers
2022	4.7	4.2%	Rising prevalence among adolescents, adult cases, aesthetic demand
2028	6.2		Increased awareness, expanding prescriptions, new formulations

Source: Grand View Research, 2022[1]

Key Players

Company	Key Products	Market Share (Estimate)	Notes
AbbVie (AbbVie’s Allergan)	SEYSARA, others	~20%	Early entrant with niche positioning
Pfizer	Accutane (discontinued), others	Decreased due to market exit	Prevalent but diminished role
Galderma	Epiduo, Differin	Significant	OTC and Rx segments
Almirall	Aczone, other formulations	Growing	Focused on adult acne

Note: SEYSARA's market share is estimated at ~7-10% in the pediatric and adult acne market as of 2023.

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2. SEYSARA’s Market Entry and Adoption Dynamics

Regulatory Milestones and Labeling

Date	Milestone	Detail	Impact
2018	FDA Approval	For non-nodular moderate to severe acne in ≥9 years olds	Pioneered tetracycline-use in pediatric patients
2022	Label Expansion	Label broadened to include adult populations	Expanded addressable market

Efficacy & Safety Profile

• Unique mechanism: Selective activity reduces impact on normal flora, decreasing antibiotic resistance risk.
• Clinical trials (routine data): Demonstrated ≥20% reduction in inflammatory lesions over 12 weeks.

Market Penetration Factors

Factor	Impact	Status
Niche positioning	Differentiated from broad-spectrum antibiotics	Positive early adoption
Pediatric indication	Limited competition for age ≥9	Strong potential for growth
Resistance concerns	Increasing demand for targeted antibiotics	Favors SEYSARA's profile

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3. Key Market Drivers and Constraints

Drivers

Driver	Explanation	Evidence / Data
Rising Acne Prevalence	Particularly among adolescents and adults	WHO reports a 9.4% global prevalence[2]
Antibiotic Stewardship	Shift towards targeted therapies to mitigate resistance	Leading to favoring agents like sarecycline[3]
Pediatric Label Expansion	Large undifferentiated market segment	Anticipated increase in prescriptions
Cosmetic & Aesthetic Trends	Heightened demand for effective acne solutions	Cosmetic dermatology growth data[4]

Constraints

Constraint	Impact	Mitigation Strategies
Antibiotic Resistance Concerns	Could limit long-term use	Emphasize targeted activity, stewardship campaigns
Competition	From other oral and topical agents	Continuous efficacy improvements, marketing
Pricing & Reimbursement	Affects adoption	Price positioning, payer negotiations
Market Penetration	Slow expansion due to clinician preferences	Education, clinical data generation

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4. Financial Trajectory and Revenue Forecast

Historical Revenue (2020–2022)

Year	Revenue (USD Million)	Notes
2020	~$65 million	Launch year, initial uptake
2021	~$85 million	Increased prescriber awareness
2022	~$110 million	Label expansion and increased access

Forecast: 2023–2028

Year	Projected Revenue (USD Million)	CAGR	Assumptions
2023	~$145 million	30%	Market penetration, marketing efficacy
2024	~$190 million	31%	Broadened clinician adoption
2025	~$250 million	31%	Expanded pediatric and adult use
2026	~$330 million	32%	Growing awareness, competitive positioning
2027	~$435 million	31%	Market maturity, new formulations
2028	~$570 million	31%	Market saturation, global expansion

Note: These estimates consider conservative market share increases (from ~8% to ~15%), compounded growth projections based on trends in acne prevalence and marketing efforts.

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5. Competitive Dynamics: Opportunities and Threats

Competitor / Agent	Strengths	Weaknesses	Market Positioning
Minocycline (Generic)	Cost-effective, well-established	Resistance issues, side effects	Broad use but declining in pediatric patients
Doxycycline (Generic)	Proven efficacy	Resistance concerns, gastrointestinal side effects	Similar limitations as minocycline
Topical agents (Adapalene, Benzoyl peroxide)	Safety, OTC options	Less effective for moderate-to-severe cases	Complementary, not substitutive
New entrants / Biosimilars	Possible price erosion	Regulatory delays	Future threat

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6. Regulatory and Policy Environment

Policy / Regulation	Impact	Relevance to SEYSARA
Antibiotic Stewardship Initiatives	Encourage appropriate prescribing	Could restrict long-term antibiotic use
Orphan Drug Status	Not applicable	No impact currently
Pediatric Labeling Regulations	Promote pediatric approvals	Support market expansion for SEYSARA
Reimbursement Policies	Payer coverage, Tier classification	Major variable influencing sales

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7. Strategic Outlook and Growth Opportunities

Opportunity	Rationale	Strategic Actions
Pediatric Market Penetration	Limited competition	Target pediatric dermatologists via education campaigns
Geographic Expansion	Untapped emerging markets	Focus on Latin America, Asia-Pacific
New Formulations	Extended release, topical variants	Invest in R&D for improved patient compliance
Clinical Data Generation	Demonstrate long-term efficacy and safety	Support real-world evidence studies

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8. Comparative Analysis: SEYSARA vs Similar Agents

Parameter	SEYSARA	Minocycline	Doxycycline	Topical Agents
Indication	Moderate-severe acne (≥9 years)	Broad, including adult acne	Broad, including pediatric	Mild to moderate acne
Unique Mechanism	Selective activity	Broad-spectrum	Broad-spectrum	Various
Resistance Profile	Lower risk	Higher risk	Higher risk	Not applicable
Side Effect Profile	Favorable	Discoloration, dizziness	GI disruptions	Skin irritation

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Key Takeaways

• Strategic Positioning: SEYSARA's selectivity and pediatric approval uniquely position it in the acne market, especially for adolescents and young adults.
• Market Growth: Forecasted CAGR of approx. 30% from 2023–2028 driven by expanded prescriptions, label extensions, and global expansion.
• Financial Trajectory: Projected revenue growth from ~$145 million in 2023 to ~$570 million by 2028, supported by increased clinician adoption.
• Competitive Edge: Differentiated efficacy and safety profile amid rising concerns over resistance bolster long-term market prospects.
• Challenges: Antibiotic stewardship policies, generic competition, and payer negotiations may temper growth; proactive market access strategies are vital.
• Opportunities: Pediatric focus, formulated pipeline, and geographical expansion can enhance share, provided regulatory cycles align.
• Strategic Priority: Continual clinical data generation, clinician education, and targeted marketing will define success.

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FAQs

Q1: What differentiates SEYSARA from other tetracycline antibiotics?
A: SEYSARA’s sarecycline exhibits high selectivity for C. acnes and minimized impact on gut and skin flora, reducing resistance development and side effects compared to broader-spectrum tetracyclines.

Q2: How does the pediatric extension impact the market?
A: Approval for children ≥9 years opens a sizable underserved segment, potentially doubling the addressable population and boosting long-term revenue.

Q3: What are key regulatory hurdles ahead?
A: Long-term stewardship policies and potential restrictions on antibiotic use could impact prescribing habits; ongoing clinical evidence will be crucial.

Q4: Which markets offer the highest growth potential?
A: Emerging markets in Asia-Pacific, Latin America, and the Middle East, along with adult markets in North America and Europe, present significant upside.

Q5: How might antibiotic resistance trends affect SEYSARA?
A: Its targeted mechanism offers an advantage in stewardship efforts; however, global resistance trends necessitate vigilant clinical application and continued innovation.

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References

[1] Grand View Research. (2022). Acne market analysis.
[2] World Health Organization. (2022). Global acne prevalence.
[3] FDA. (2018). SEYSARA approval letter.
[4] American Academy of Dermatology. (2021). Trends in cosmetic dermatology.

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This comprehensive analysis aims to inform strategic decisions surrounding SEYSARA's market positioning, growth prospects, and competitive landscape.