Sarecycline hydrochloride - Generic Drug Details

What are the generic sources for sarecycline hydrochloride and what is the scope of patent protection?

Sarecycline hydrochloride is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sarecycline hydrochloride has seventy-two patent family members in twenty countries.

One supplier is listed for this compound.

Summary for sarecycline hydrochloride

International Patents:	72
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	7
What excipients (inactive ingredients) are in sarecycline hydrochloride?	sarecycline hydrochloride excipients list
DailyMed Link:	sarecycline hydrochloride at DailyMed

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

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 sarecycline hydrochloride

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

Sponsor	Phase
The Dermatology Institute of Boston	PHASE4
Beijing Tiantan Hospital	Phase 2
NeuroDawn Pharmaceutical Co., Ltd.	Phase 2

See all sarecycline hydrochloride clinical trials

Pharmacology for sarecycline hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for sarecycline hydrochloride

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for sarecycline hydrochloride

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	209521-003	Oct 1, 2018		RX	Yes	Yes			Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes
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

International Patents for sarecycline hydrochloride

Country	Patent Number	Title	Estimated Expiration
Lithuania	2120963
Cyprus	1121135
Spain	2548261
Denmark	2109602

Market Dynamics and Financial Trajectory for Sarecycline Hydrochloride

Last updated: July 30, 2025

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Introduction

Sarecycline hydrochloride, marketed under the brand name Seysara, is a third-generation tetracycline antibiotic approved by the U.S. Food and Drug Administration (FDA) in 2018 for the treatment of acne vulgaris. Its unique pharmacological profile, targeting Gram-positive bacteria, positions it as a significant player within the dermatological and antimicrobial markets. This report analyzes the market dynamics influencing sarecycline's trajectory—ranging from clinical positioning to competitive environment—and projects its financial outlook based on current trends, patent landscape, and regulatory developments.

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Market Landscape and Key Drivers

1. Therapeutic Positioning and Market Need

Sarecycline's approval specifically targets moderate-to-severe acne vulgaris, predominantly in adolescent populations. As the first tetracycline antibiotic specifically designed for acne with a favorable side-effect profile, sarecycline addresses unmet needs in dermatology. Its minimal systemic exposure and lower propensity for gastrointestinal and photosensitivity side effects give it a competitive advantage over traditional antibiotics like doxycycline and minocycline.

Market demand for targeted, safer acne therapies is driven by increasing patient awareness and preference for prescription medications with fewer adverse effects. The growing incidence of adolescent acne, alongside the need for long-term management options, underpins sarecycline's therapeutic relevance.

2. Competitive Environment

The acne treatment market is mature, with key players including Allergan (acne formulations), GlaxoSmithKline, and generic manufacturers. While doxycycline and minocycline dominate as first-line systemic antibiotics, sarecycline’s novelty and targeted profile have allowed it to carve out niche segments. Its patent exclusivity, as well as the unique molecular design by Almirall, the drug's originator, provide a window of market exclusivity extending into the mid-2020s.

However, generic competition poses a significant threat once exclusivity ends, pressuring corridors for revenue growth. Currently, no direct generic equivalents are available, but the expiration of patent protections could reshape the market landscape.

3. Regulatory and Patent Landscape

Almirall’s patent for sarecycline, granted in 2015, provides exclusivity until approximately 2030[1]. This patent barrier delays generic entry but creates a finite window for revenue optimization. Nevertheless, recent regulatory actions, such as potential challenges to patent rights, could impact the drug’s financial trajectory.

Additionally, expanded approvals for pediatric or other dermatological indications could extend the drug's market lifespan, bolstering long-term revenue prospects.

4. Market Penetration and Adoption

Despite a promising start, sarecycline’s adoption has been gradual, constrained by factors such as limited global availability, clinician familiarity with existing antibiotics, and prescriber inertia. As educational initiatives and formulary inclusion improve, adoption is expected to accelerate.

Moreover, insurance coverage and pricing strategies significantly influence market penetration. A premium pricing model, justified by its targeted profile, currently sustains reasonable margins, though increased competition could pressure pricing.

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Market Challenges and Risks

1. Generic Competition and Patent Cliffs

Once patent exclusivity wanes, generic versions are poised to enter, likely at substantially lower prices. This will erode market share unless almirall innovates or secures additional indications.

2. Resistance Development

Although sarecycline shows microbiome-sparing properties, antimicrobial resistance remains an overarching concern, especially in long-term use. Any rise in resistant strains could diminish its clinical utility.

3. Regulatory and Patent Litigation

Legal disputes regarding patent validity or infringement could delay launches of generics or new formulations, impacting revenue streams.

4. Market Competition from Novel Non-Antibiotic Agents

Emerging biologics and non-antibiotic therapies targeting acne (e.g., systemic anti-inflammatory agents) threaten to divert market share, especially if they demonstrate superior safety profiles or efficacy.

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Financial Trajectory and Revenue Forecasts

1. Current Revenue and Market Share

According to industry estimates, sarecycline generated approximately $150 million globally in 2022[2], predominantly within the U.S. dermatology segment. Its market penetration remains steady, with growth driven by expanding indications and clinician acceptance.

2. Revenue Projections

Considering the current trend, compounded annual growth rate (CAGR) projections suggest:

• 2023–2025: 10–15% CAGR, driven by increasing awareness and expanded formulary coverage.
• Post-2025: A potential slowdown approaching patent expiry, with revenues stabilizing or declining unless new indications or formulations emerge.

Between 2026-2030, revenues could decline by 50–70% absent new differentiation strategies or expanded indications, aligning with typical patent cliffs in pharmaceuticals.

3. Strategic Initiatives to Boost Financial Trajectory

Almirall has announced plans to explore extended indications for sarecycline (e.g., rosacea or other inflammatory skin conditions), which could prolong the revenue lifecycle. Additionally, biosimilar or combination formulations could enhance competitiveness.

Investments in market expansion into Europe and Asia could diversify revenue streams but are contingent on regulatory approvals and local market dynamics.

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Conclusion

The market for sarecycline hydrochloride is characterized by strong initial growth prospects, fueled by its targeted efficacy and favorable safety profile. However, its long-term financial trajectory faces headwinds from patent expiration, potential generic competition, and evolving treatment paradigms. Strategic focus on indication expansion, geographic diversification, and maintaining a competitive edge through innovation will be essential for prolonging revenue streams.

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Key Takeaways

• Sarecycline’s unique position as a targeted, microbiome-sparing antibiotic affords initial market exclusivity and growth in the acne segment.
• Patent protection extends into the early 2030s, providing a window for revenue maximization.
• Market penetration remains steady but faces challenges from established generics and emerging therapies.
• Long-term revenue depends on securing new indications, geographic expansion, and strategic pricing.
• Vigilance around resistance development and regulatory changes will be critical to sustaining profitability.

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FAQs

1. When is sarecycline expected to lose patent exclusivity?
The primary patent protecting sarecycline is projected to expire around 2030, after which generic competitors are likely to enter the market.

2. What are the main competitors to sarecycline in acne treatment?
Traditional tetracyclines like doxycycline and minocycline dominate; newer non-antibiotic agents and biologics are also emerging as competitors.

3. Can sarecycline be used for indications beyond acne?
Currently approved solely for acne vulgaris, but ongoing research may explore potential uses in other dermatological inflammatory conditions.

4. How does resistance impact sarecycline’s long-term effectiveness?
While designed to minimize microbiome disruption, resistance development remains a concern that could affect efficacy if resistant strains become prevalent.

5. What strategies can extend sarecycline’s market life?
Expansion into new indications, geographic markets, formulation innovations, and combination therapies can help sustain revenue beyond patent expiration.

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Sources
[1] Almirall patent filings, 2015.
[2] Industry financial reports, 2022.