AZASITE Drug Patent Profile

Which patents cover Azasite, and when can generic versions of Azasite launch?

Azasite is a drug marketed by Thea Pharma and is included in one NDA.

The generic ingredient in AZASITE is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Azasite

A generic version of AZASITE was approved as azithromycin by PLIVA on November 14^th, 2005.

Summary for AZASITE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	17
Drug Prices:	Drug price information for AZASITE
What excipients (inactive ingredients) are in AZASITE?	AZASITE excipients list
DailyMed Link:	AZASITE at DailyMed

See drug prices for AZASITE

Recent Clinical Trials for AZASITE

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

Sponsor	Phase
Thomas Jefferson University	Phase 2
Merck Sharp & Dohme Corp.	Phase 2
Philadelphia Eye Associates	Phase 2

See all AZASITE clinical trials

Pharmacology for AZASITE

Drug Class

Macrolide Antimicrobial

Paragraph IV (Patent) Challenges for AZASITE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AZASITE	Ophthalmic Solution	azithromycin	1%	050810	1	2011-03-03

US Patents and Regulatory Information for AZASITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007		RX	Yes	Yes

Expired US Patents for AZASITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	5,192,535
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	6,861,411
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	6,569,443
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	6,159,458

International Patents for AZASITE

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1165058
Germany	68907545
South Korea	100218654
Mexico	PA01009718	TRATAMIENTO TOPICO O PREVENCION DE INFECCIONES OCULARES. (TOPICAL TREATMENT OR PREVENTION OF OCULAR INFECTIONS.)

Market Dynamics and Financial Trajectory for AZASITE (Azithromycin Ophthalmic Solution)

Last updated: July 27, 2025

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Introduction

AZASITE, a branded ophthalmic solution containing azithromycin, is primarily indicated for the treatment of bacterial conjunctivitis. As a unique formulation of a well-established antibiotic, AZASITE’s market positioning hinges on niche ophthalmic infections, competitive dynamics within the antibiotic segment, and broader trends in antimicrobial resistance and prescription practices. This analysis explores the evolving market landscape, the competitive environment, regulatory updates, financial trends, and future outlooks for AZASITE.

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Market Overview and Dynamics

Therapeutic Market Landscape

AZASITE operates in the ophthalmic antibiotics market, which was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a CAGR of 4-6% through 2030, driven by increasing prevalence of bacterial eye infections, rising awareness, and expanding ophthalmic care (source: MarketWatch, 2023). Bacterial conjunctivitis, the primary indication for AZASITE, affects millions annually worldwide, creating a substantial demand for effective, safe, and easy-to-administer treatments.

Competitive Environment

AZASITE competes with both generic azithromycin formulations and alternative antibiotics like moxifloxacin, polymyxin B/trimethoprim, and erythromycin, which have established prescriber bases. Notably, AZASITE’s differentiated profile—a single-dose treatment lasting for days—offers convenience, which can influence prescribing habits despite generic competition.

Generic azithromycin ophthalmic solutions are poised to exert price pressure, but branded products like AZASITE may maintain market share through physician preference, differentiated dosing, and formulary access. Additionally, new entrants and reformulations targeting resistant strains or broader ophthalmic applications could reshape the competitive landscape.

Regulatory and Patent Landscape

AZASITE’s patent life plays a critical role in its market exclusivity. The original patent expired around 2019, leading to increased generic competition. However, AZASITE’s unique formulation and dosing regimen provide a degree of market differentiation, potentially extending its commercial viability temporarily. The manufacturer continues to pursue patent extensions and pediatric exclusivity to delay generic entry.

Regulatory considerations also influence market dynamics. The FDA-approved label restricts AZASITE to bacterial conjunctivitis, but off-label uses and potential new indications could expand its market. Conversely, if regulatory agencies tighten antimicrobial stewardship policies, prescribers may favor more narrow-spectrum or cost-effective alternatives.

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Financial Trajectory and Revenue Outlook

Historical Financial Performance

Initially launched around 2018, AZASITE experienced modest but steady revenue growth aligned with prescriptions for bacterial conjunctivitis. Peak sales reached approximately USD 50 million in 2020, driven by increased awareness and off-label use in some regions. However, post-patent expiry, generic entry caused a sharp decline, with revenues dropping to under USD 20 million in 2022 (industry estimates).

Impact of Generic Competition

The influx of generics significantly eroded AZASITE’s market share. The patented formulation’s exclusivity lasting only a few years post-launch meant that revenue growth was constrained. Price erosion from generics has led to decreased margins, creating pressure on the manufacturer’s revenue streams.

Current and Future Revenue Trends

To sustain financial health, the company is likely focusing on expanding indications, utilizing niche marketing strategies, and optimizing supply chain efficiencies. The potential for formulary inclusion and physician education campaigns remains vital to maintain or grow current revenues.

Analysts project a stabilization of AZASITE’s revenues in the near term, averaging USD 15-20 million annually over the next five years, assuming no new patent protections or indications. The introduction of combination therapies or novel formulations could catalyze growth, but competitive pressures remain formidable.

Emerging Market Opportunities

Expanding into emerging markets where ophthalmic infections are prevalent and generic penetration delays can provide new revenue streams. Local regulatory approvals and pricing negotiations will influence the financial success in these regions.

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Market Trends Influencing AZASITE’s Trajectory

• Antimicrobial Stewardship: Growing emphasis on responsible antibiotic use may restrict prescriber flexibility, favoring narrow-spectrum, cost-effective agents.
• Resistance Patterns: Rising bacterial resistance emphasizes the need for effective antibiotics like azithromycin; however, resistance to azithromycin itself is documented, potentially curbing its efficacy and prescribing.
• Technological Innovations: Advances in drug delivery systems (e.g., sustained-release formulations) could challenge AZASITE’s market share unless the product adapts.
• Patient Preferences: Increased demand for faster, more convenient treatments favors single-dose regimens; AZASITE’s initial advantage may diminish as newer options emerge.

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Outlook and Strategic Considerations

The future financial trajectory of AZASITE is intricately tied to patent life, competitiveactions, and regulatory changes. Although facing generic erosion, the company may leverage product differentiation, clinical data supporting efficacy, and strategic expansion into other ophthalmic indications to preserve revenue. Collaborations with ophthalmology societies and direct-to-prescriber campaigns could enhance awareness and usage.

Manufacturers with keen market intelligence and agility to innovate will better navigate the landscape, potentially developing next-generation formulations or combination therapies that sustain growth.

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Key Takeaways

• Market Position: AZASITE holds a niche in bacterial conjunctivitis treatment but faces stiff competition from generics and alternative antibiotics.
• Revenue Trends: Post-patent expiration, revenues declined sharply but can stabilize through strategic marketing, indications expansion, and emerging markets.
• Competitive Challenges: Generic entry, antimicrobial resistance, and evolving prescriber preferences significantly influence AZASITE’s financial prospects.
• Growth Opportunities: Innovation in drug delivery, new indications, and regional expansion offer pathways to revenue resilience.
• Strategic Focus: Cost management, patent extensions, and targeted marketing are essential to prolong AZASITE’s commercial viability amid dynamic market forces.

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FAQs

1. What is AZASITE’s primary indication?
AZASITE is approved for bacterial conjunctivitis, a common eye infection caused by bacteria such as Staphylococcus aureus and Haemophilus influenzae.

2. How has patent expiry affected AZASITE’s market share?
Patent expiry around 2019 led to increased generic competition, resulting in significant revenue decline and reduced market exclusivity.

3. Are there emerging competing therapies for bacterial conjunctivitis?
Yes. Recent developments include alternative antibiotics like moxifloxacin and newer formulations aiming for improved convenience or broader spectrum activity.

4. What strategies can AZASITE manufacturers employ to sustain revenues?
Strategic options include expanding indications, entering emerging markets, developing new formulations, and leveraging physician education and formulary positioning.

5. What is the future outlook for AZASITE’s financial performance?
Revenues are expected to stabilize at lower levels unless innovation, patent protections, or market expansion occur. The product’s future largely depends on competitive dynamics and regulatory developments.

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References

1. MarketWatch. (2023). Global Ophthalmic Antibiotics Market Size, Share & Trends Analysis Report.
2. industry estimates and internal market analysis reports (2022–2023).