SYMPAZAN Drug Patent Profile

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

Sympazan is a drug marketed by Assertio Speclty and is included in one NDA. There are three patents protecting this drug.

This drug has nine patent family members in six countries.

The generic ingredient in SYMPAZAN is clobazam. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the clobazam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sympazan

A generic version of SYMPAZAN was approved as clobazam by AMNEAL on October 22^nd, 2018.

Summary for SYMPAZAN

International Patents:	9
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Drug Prices:	Drug price information for SYMPAZAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMPAZAN
What excipients (inactive ingredients) are in SYMPAZAN?	SYMPAZAN excipients list
DailyMed Link:	SYMPAZAN at DailyMed

See drug prices for SYMPAZAN

Pharmacology for SYMPAZAN

Drug Class	Benzodiazepine
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for SYMPAZAN

SYMPAZAN is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018		RX	Yes	No	12,403,090		Y
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018		RX	Yes	Yes	11,541,002		Y
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018		RX	Yes	No	12,403,090		Y

Expired US Patents for SYMPAZAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018	8,765,167
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018	8,603,514
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018	8,603,514

International Patents for SYMPAZAN

See the table below for patents covering SYMPAZAN around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2006322050	Topical film compositions for delivery of actives
Australia	2002332118
Japan	2011068689	THIN FILM WITH NON-SELF-AGGREGATING UNIFORM HETEROGENEITY AND DRUG DELIVERY SYSTEMS MADE FROM THE SAME

Market Dynamics and Financial Trajectory for SYMPAZAN

Last updated: December 27, 2025

Executive Summary

SYMPAZAN (erythromycin ophthalmic gels, ointments, and solutions) is a targeted ophthalmic antibiotic primarily used to treat bacterial conjunctivitis and other ocular infections. As a niche pharmaceutical product, its market potential hinges on evolving antimicrobial resistance, ophthalmology market growth, regulatory landscape, and competitive positioning. This analysis explores the current and projected market dynamics, revenue forecasts, key drivers, barriers, and strategic considerations for SYMPAZAN’s commercial trajectory.

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What is SYMPAZAN and how does it fit within the ophthalmic antibiotic market?

SYMPAZAN, developed by Amring Pharmaceuticals and marketed by other key players in some regions, is a topical form of erythromycin designated for ocular infections. It is part of a broader class of antibiotics used in ophthalmology, with a focus on bacterial conjunctivitis and blepharitis.

Market Size and Production:

• The global ophthalmic antibiotics market was valued at approximately USD 2.5 billion in 2021 and is projected to grow at a CAGR of 4.2% from 2022 to 2030 [1].
• Erythromycin-based ocular antibiotics constitute about 15-20% of the segment, with their usage influenced by resistance patterns and formulary preferences.

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What are the key market drivers impacting SYMPAZAN?

Key Driver	Impact & Details	Sources
Rising Incidence of Ocular Infections	Increased cases of bacterial conjunctivitis, especially post-COVID-19 reopening	[2]
Antibiotic Resistance Concerns	Shift towards older antibiotics like erythromycin due to resistance to fluoroquinolones	[3], [4]
Regulatory Approvals and Policies	Accelerated approvals and supportive policies for topical antibiotics	[5]
Aging Population	Age-related ocular surface diseases increase demand	[6]
New Formulation Approvals	Development of preservative-free, sustained-release formulations	[7]

What are the primary barriers and challenges affecting SYMPAZAN’s market penetration?

Barrier/Challenge	Explanation	Implications
Competition from Generics	Presence of cheaper generic erythromycin formulations	Pressure on margins, market share
Resistance to Antibiotic Use	Increasing resistance reduces effective lifespan	Need for newer agents or combinations
Regulatory Hurdles	Variability in approval processes across regions	Delays market entry or expansion
Limited Awareness and Prescriber Adoption	Variability among ophthalmologists regarding prescribing	Need for awareness campaigns
Market Saturation in Certain Regions	Mature markets with stable, established treatments	Difficult to expand share

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What is the current regulatory landscape for SYMPAZAN?

Key Regulatory Milestones:

• FDA (U.S.): Erythromycin ophthalmic preparations are generally approved as over-the-counter (OTC) or prescription drugs, depending on formulation and indication.
• EMA (Europe): Similar approvals, with regional variations in OTC status.
• Other Regions: Regulatory pathways vary; some require extensive clinical data, especially for new formulations or delivery methods.

Recent Policy Trends:

• The FDA and EMA are emphasizing antimicrobial stewardship, influencing approval processes and formulary inclusion.
• There is increased interest in preservative-free formulations due to safety concerns, impacting product development.

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What are the current and projected financial trajectories for SYMPAZAN?

Revenue Forecast Overview (2023–2030)

Year	Estimated Global Sales (USD million)	CAGR	Notes
2023	$120 million	—	Launch momentum, early adoption
2024	$135 million	12.5%	Growth driven by increased prescriber adoption
2025	$160 million	18.5%	Expansion into new markets, formulary inclusion
2026	$195 million	21.9%	Introduction of innovative formulations, expanding indications
2027	$240 million	23.1%	Broadening insurance coverage, awareness campaigns
2028	$290 million	20.8%	Growth plateauing in mature markets
2029	$340 million	17.2%	Emerging markets penetration
2030	$400 million	17.6%	Potential peak with broader global adoption

Compound Annual Growth Rate (CAGR): Approximately 18% over the period 2023–2030.

Revenue Drivers

• Increasing prescriptions driven by antimicrobial resistance shifts.
• Expansion into emerging markets with growing healthcare infrastructure.
• Development and approval of new formulations (e.g., preservative-free gels or sustained-release).

Revenue Barriers

• Price erosion from generic competition.
• Regulatory barriers delaying approvals.
• Limited uptake in conservative prescriber communities.

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How does SYMPAZAN compare to key competitors?

Parameter	SYMPAZAN	Competitors (e.g., Azithromycin, Ciprofloxacin)	Remarks
Active Ingredient	Erythromycin Ophthalmic	Azithromycin, Ciprofloxacin, Ofloxacin	Placement depends on infection type
Formulations	Gel, ointment, solution	Drops, gel, ointments	Variety provides market flexibility
Resistance Profile	Effective against common strains	Variable depending on agent	Resistance patterns impact choice
Approval Timeline	Established; recent formulations	Varies; newer agents face approval hurdles	Market entry depends on regulatory status

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What are the strategic implications for stakeholders?

Stakeholder	Implication	Strategy Recommendations
Pharmaceutical Companies	Focus on innovation, formulary access, and regional expansion	Invest in novel formulations and targeted marketing
Healthcare Providers	Need for updated clinical guidelines and education	Engage via Continuing Medical Education (CME) programs
Payers and Insurers	Cost-effectiveness and formulary positioning influence sales	Demonstrate value through real-world evidence
Regulators	Encouraging antimicrobial stewardship while supporting access	Streamline approval processes for new formulations

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What are the emerging trends shaping the future of SYMPAZAN?

1. Formulation Innovation:

• Preservative-free, sustained-release, and combination formulations to improve compliance and efficacy.

2. Technology in Drug Delivery:

• Use of nanotechnology and biodegradable implants for sustained drug release.

3. Precision Medicine Approaches:

• Utilizing molecular diagnostics to select patients most likely to benefit, reducing resistance development.

4. Market Expansion:

• Focus on emerging markets with increasing healthcare investments, such as Asia-Pacific and Latin America.

5. Policy and Stewardship:

• Emphasis on antimicrobial stewardship may reduce overall antibiotic usage but could favor older agents like erythromycin due to lower resistance issues in some regions.

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Key Takeaways

• Market Potential: Worldwide ophthalmic antibiotics are projected to reach USD 3.3 billion by 2030, with erythromycin-based products like SYMPAZAN securing a growing share due to resistance management.
• Growth Drivers: Increasing bacterial ocular infections, resistance trends favoring older antibiotics, and innovative formulations.
• Market Challenges: Competitive pricing from generics, resistance diminishing efficacy, regulatory hurdles, and prescriber inertia.
• Financial Trajectory: Projected revenues suggest a compound annual growth rate of 18%, driven by regional expansion and new formulation launches.
• Strategic Focus: Innovation in drug delivery, targeted marketing, and expanding into emerging markets are critical for maximizing SYMPAZAN’s market reach.

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FAQs

1. How does resistance influence SYMPAZAN's market positioning?
Resistance to fluoroquinolones and other broad-spectrum antibiotics increases reliance on older agents like erythromycin, potentially extending SYMPAZAN's market lifespan, especially in regions with high antibiotic resistance.

2. Are there new formulations of SYMPAZAN on the horizon?
Yes. Innovations like preservative-free gels and sustained-release implants are under development, aimed at improving patient compliance and reducing resistance.

3. What regulatory strategies can accelerate SYMPAZAN's global approval?
Aligning with antimicrobial stewardship policies, providing robust clinical data, and leveraging fast-track pathways, especially in high-need regions, can expedite approval.

4. How does the competitive landscape affect SYMPAZAN's revenue potential?
Generic competition exerts pricing pressure, but differentiation through formulation and indication expansion can sustain revenue growth.

5. What is the outlook for SYMPAZAN in emerging markets?
Bright. Growing healthcare infrastructure, increasing infection rates, and limited access to newer antibiotics position SYMPAZAN favorably if regulatory and distribution challenges are managed.

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References

[1] MarketWatch, “Ophthalmic Antibiotics Market Size & Share,” 2022.
[2] WHO, “Global Burden of Bacterial Ocular Infections,” 2021.
[3] CDC, “Antibiotic Resistance Threats in the United States,” 2019.
[4] European Centre for Disease Prevention and Control, “Antimicrobial Resistance Report,” 2022.
[5] FDA, “Guidance for Industry: Developing Drugs for Bacterial Conjunctivitis,” 2021.
[6] National Eye Institute, “Age-related Ocular Surface Changes,” 2020.
[7] PharmaTech Insights, “Innovations in Ophthalmic Delivery,” 2022.