XIPERE Drug Patent Profile

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

Xipere is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There are four patents protecting this drug.

This drug has eighty-eight patent family members in nineteen countries.

The generic ingredient in XIPERE is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xipere

A generic version of XIPERE was approved as triamcinolone acetonide by SUN PHARMA CANADA on October 1^st, 1986.

Summary for XIPERE

International Patents:	88
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	4,516
Drug Prices:	Drug price information for XIPERE
What excipients (inactive ingredients) are in XIPERE?	XIPERE excipients list
DailyMed Link:	XIPERE at DailyMed

See drug prices for XIPERE

Pharmacology for XIPERE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for XIPERE

XIPERE is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb Inc	XIPERE	triamcinolone acetonide	SUSPENSION;INJECTION	211950-001	Oct 22, 2021		RX	Yes	Yes	12,419,833		Y
Bausch And Lomb Inc	XIPERE	triamcinolone acetonide	SUSPENSION;INJECTION	211950-001	Oct 22, 2021		RX	Yes	Yes	9,937,075		Y
Bausch And Lomb Inc	XIPERE	triamcinolone acetonide	SUSPENSION;INJECTION	211950-001	Oct 22, 2021		RX	Yes	Yes	8,636,713
Bausch And Lomb Inc	XIPERE	triamcinolone acetonide	SUSPENSION;INJECTION	211950-001	Oct 22, 2021		RX	Yes	Yes	9,636,332

International Patents for XIPERE

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112012027416
China	116327482	用于眼部注射的设备和方法 (Apparatus and method for ocular injection)
Eurasian Patent Organization	032039	УСТРОЙСТВО ДЛЯ ПРОВЕДЕНИЯ ГЛАЗНОЙ ИНЪЕКЦИИ (APPARATUS FOR OCULAR INJECTION)
South Korea	102467714
China	104921868

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XIPERE

Last updated: July 27, 2025

Introduction

XIPERE (triamcinolone acetonide injection) serves as a novel pharmaceutical intervention for the treatment of macular edema associated with retinal vein occlusion (RVO), diabetic macular edema (DME), and other ocular conditions. Its role within the ophthalmology market underscores a broader strategic shift towards specialized, targeted therapies designed to address unmet clinical needs. Analyzing XIPERE’s market dynamics and financial trajectory entails evaluating regulatory milestones, competitive landscape, patient adoption prospects, reimbursement considerations, and technological innovations shaping its growth potential.

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Regulatory and Market Entry Milestones

XIPERE’s journey in regulatory and commercial landscapes commenced following its approval by the FDA in 2020 for the treatment of macular edema following RVO. Its regulatory dossier emphasized the drug's localized corticosteroid activity, offering a favorable safety and efficacy profile relative to systemic therapies. Regulatory milestones significantly influence market penetration; approval generally catalyzes early adoption and facilitates strategic positioning within ophthalmic treatment paradigms. Continuous post-approval surveillance and potential supplemental approvals, particularly for broader indications, remain critical components of its long-term market establishment.

Competitive Landscape and Market Position

The ophthalmology market, especially treatments for retinal vein occlusion and diabetic macular edema, is highly competitive, featuring notable corticosteroids and anti-VEGF (vascular endothelial growth factor) agents. Key competitors include:

• Anti-VEGF agents (e.g., ranibizumab, aflibercept, bevacizumab): Standard-of-care for DME and RVO, characterized by robust payer reimbursements and extensive clinical data.
• Other corticosteroid implants (e.g., dexamethasone intravitreal implant – Ozurdex): Established corticosteroid options with proven efficacy.
• Emerging therapies (e.g., gene therapies, biosimilars): Future entrants aimed at improving durability and reducing treatment burden.

XIPERE’s differentiator lies in its optimized delivery system and tailored pharmacokinetics, presenting an alternative for patients non-responsive or intolerant to existing treatments. Its positioning hinges on demonstrating superior safety when compared to intravitreal corticosteroid implants, addressing concerns like intraocular pressure elevation.

Market Adoption and Patient Demographics

The global ophthalmology market is poised for steady growth, driven by increasing prevalence of vision-threatening conditions attributable to aging populations, diabetes, and hypertension. According to the American Academy of Ophthalmology, diabetic retinopathy and RVO incidences are projected to rise sharply in the coming decade [1].

XIPERE targets a niche segment—patients with macular edema refractory to or unsuitable for anti-VEGF therapy. Adoption rates depend on clinicians’ confidence in its safety profile, ease of administration, and comparative efficacy. The drug’s injectable format aligns with current clinical workflows but requires clinician education and reimbursement mechanisms to optimize uptake.

Reimbursement and Pricing Strategy

Reimbursement policies profoundly impact XIPERE’s financial trajectory. The drug’s positioning as a laser-free, minimally invasive treatment with a favorable safety profile suggests potential for premium pricing within specialized retinal therapy niches. Payer acceptance hinges on demonstrated value, including reduced treatment frequency and diminished complication rates.

Manufacturers likely pursue a tiered pricing strategy, integrating with existing ophthalmology drug reimbursement systems—such as Medicare and private insurers—to ensure broad accessibility while maintaining sustainable profit margins. Cost-effectiveness analyses establishing XIPERE as a value-added alternative could reinforce payer acceptance, especially in markets where anti-VEGF therapy costs are substantial.

Technological Innovations and Pipeline Developments

Advancements in drug delivery—such as sustained-release formulations and minimally invasive injection techniques—are pivotal in expanding XIPERE’s market reach. Ongoing research into combination therapies, and potential expansion into other ocular indications, could augment its financial trajectory.

Additionally, collaborations with key opinion leaders and ophthalmic societies will bolster clinical evidence dissemination, further promoting adoption. The drug’s integration into personalized medicine frameworks, leveraging biomarkers for treatment response, remains an aspirational yet feasible avenue for differentiation.

Financial Outlook and Growth Projections

Financial projections of XIPERE depend on several factors:

• Market Penetration: Initial adoption among retina specialists, scaling based on clinical efficacy and safety data.

• Revenue Impact: Estimations suggest that, within five years, XIPERE could secure a 10-15% share of the corticosteroid segment and gain incremental share within the broader DME/RVO markets.

• Revenue Estimates: Based on current treatment rates, and assuming an average annual treatment cost of approximately $3,500-$6,000 per patient [2], potential revenues could reach hundreds of millions annually in key markets like the US and Europe, contingent on approval of expanded indications.

• Profitability Dynamics: Favorable margins are anticipated given the drug's manufacturing efficiencies relative to larger biologics. However, high marketing and educational outreach investments are necessary to accelerate adoption.

• Patents and Lifecycle Management: Patent protections, coupled with pipeline expansions, will be instrumental in extending commercial viability and safeguarding revenue streams. Licensing and co-development agreements could further expand geographic footprint and indications.

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Global Market Considerations

Emerging markets present growth opportunities driven by escalating diabetes prevalence and ophthalmic disease burdens. Regulatory pathways, reimbursement frameworks, and healthcare infrastructure variances influence XIPERE’s accessibility and revenue in these regions. Strategic partnerships and tiered pricing models will be essential for expanding footprint in low- and middle-income countries.

Risks and Challenges

Potential market hurdles include:

• Competition from anti-VEGF therapies: Their established efficacy and widespread usage could limit XIPERE’s market share.
• Safety concerns: Intraocular pressure elevation and cataract formation remain hazards, possibly impacting clinician confidence.
• Regulatory delays or setbacks: Especially regarding expanded indications.
• Reimbursement barriers: Particularly in cost-conscious markets.

Key Takeaways

• Regulatory milestones for XIPERE solidify its position in retinal therapy, yet sustained commercial success hinges on demonstrating distinct advantages over existing treatments.
• Competitive landscape remains intense; investors should monitor advancements in anti-VEGF therapies and pipeline innovations.
• Reimbursement strategies will be decisive; value-based pricing and clear demonstration of clinical benefits facilitate payer acceptance.
• Technological advancements such as sustained-release devices and combination therapies could elevate market growth.
• Global expansion presents promising prospects, particularly with strategic collaborations tailored to diverse healthcare markets.

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FAQs

1. What sets XIPERE apart from other corticosteroids used in ophthalmology?
XIPERE features an innovative delivery system designed for targeted, sustained corticosteroid release with an improved safety profile, notably reducing intraocular pressure risks compared to traditional intravitreal corticosteroids like dexamethasone implants.

2. How does XIPERE compete against anti-VEGF treatments?
While anti-VEGF therapies remain first-line for DME and RVO, XIPERE offers an alternative for patients who are non-responsive or intolerant. Its localized, sustained release reduces treatment frequency, potentially enhancing patient compliance.

3. What is the current status of XIPERE’s reimbursement landscape?
Reimbursement is primarily characterized by insurance coverage for retinal injections, with payers recognizing the clinical benefits. Continued collection of health-economic data will be crucial in solidifying favorable reimbursement terms.

4. Are there plans for expanding XIPERE’s indications?
Yes, ongoing clinical trials explore its efficacy in other ocular conditions, such as uveitic macular edema. Expansion into these areas can diversify revenue sources and extend its market lifespan.

5. What risks could hinder XIPERE’s market growth?
Risks include competitive pressure from anti-VEGF agents, safety concerns requiring ongoing management, regulatory hurdles for new indications, and reimbursement challenges in cost-sensitive regions.

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References

[1] American Academy of Ophthalmology. "Diabetic Eye Disease." 2021.

[2] MarketWatch. "Ophthalmic Drug Market Trends." 2022.

[3] FDA. "XIPERE (triamcinolone acetonide) approval letter." 2020.