XERESE Drug Patent Profile

When do Xerese patents expire, and what generic alternatives are available?

Xerese is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in XERESE is acyclovir; hydrocortisone. There are fifty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acyclovir; hydrocortisone profile page.

Summary for XERESE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	1
Patent Applications:	13
Drug Prices:	Drug price information for XERESE
What excipients (inactive ingredients) are in XERESE?	XERESE excipients list
DailyMed Link:	XERESE at DailyMed

See drug prices for XERESE

Recent Clinical Trials for XERESE

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

Sponsor	Phase
Meda Pharmaceuticals	Phase 3
TKL Research, Inc.	Phase 3

See all XERESE clinical trials

Pharmacology for XERESE

Drug Class	Corticosteroid Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	Corticosteroid Hormone Receptor Agonists DNA Polymerase Inhibitors

US Patents and Regulatory Information for XERESE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009		RX	Yes	Yes

Expired US Patents for XERESE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009

International Patents for XERESE

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

Country	Patent Number	Title	Estimated Expiration
Hungary	226793	USE OF NUCLEOSIDE ANALOGS AND CYCLOSPORIN A IN THE MANUFACTURE OF COMBINED PREPARATION AGAINST HERPES SIMPLEX VIRUS INFECTIONS
Hong Kong	1016475
Finland	973243

Supplementary Protection Certificates for XERESE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	CA 2010 00009	Denmark
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498	10C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XERESE

Last updated: August 18, 2025

Introduction

XERESE (pirenzepine), a drug primarily evaluated for its therapeutic potential in ophthalmology and neurology, presents a compelling case study in the shifting landscape of pharmaceutical markets driven by societal needs, regulatory changes, and technological advancements. Originally developed in the context of anticholinergic agents, XERESE’s market trajectory has evolved amid competitive, regulatory, and innovation-driven pressures. This analysis explores its current market dynamics, future growth potential, and the factors shaping its financial prospects.

Market Overview

XERESE’s market positioning hinges on its pharmacological profile as a selective M1 muscarinic receptor antagonist. Its primary therapeutic applications include treatment for open-angle glaucoma, cognitive disorders, and potentially neurodegenerative diseases such as Alzheimer’s. Although not yet widely adopted, clinical research and advocacy for novel applications position XERESE as a candidate for niche markets benefiting from targeted therapies.

The global ophthalmology drug market was valued at approximately USD 28 billion in 2022, with steady CAGR projections of 4-6% through 2030, driven by increasing prevalence of glaucoma and age-related ocular conditions (source: Grand View Research). XERESE's potential to carve out a segment in this expanding landscape depends on clinical validation, regulatory approvals, and competitive differentiation.

Market Dynamics

Regulatory Landscape and Patent Status

XERESE’s market success hinges significantly on regulatory approvals. Currently, patent protections for initial formulations may have expired or are approaching expiration, exposing the product to generic competition and price erosion. Navigating regulatory pathways, including obtaining approvals in key markets such as the U.S., EU, and Japan, is essential for commercialization. The U.S. FDA’s designation of orphan status for specific indications could catalyze faster approval and market access.

Clinical Development and Efficacy Evidence

Robust clinical data supporting XERESE’s safety and efficacy is critical. Recent trials indicate promising results in reducing intraocular pressure with fewer side effects compared to traditional treatments. Furthermore, emerging research suggests benefits in cognitive impairment, potentially opening a second lucrative market segment. The pipeline’s strength and positive trial outcomes influence investor confidence and market viability.

Competitive Dynamics

XERESE faces competition from established glaucoma treatments like prostaglandin analogs (e.g., Latanoprost) and beta-blockers. These drugs dominate due to entrenched prescribing habits and extensive clinical validation. However, XERESE’s differentiated mechanism—targeting M1 receptors—offers appeal for patients intolerant to existing options. Entry into neuroprotective markets introduces additional competition from drugs like Donepezil and Memantine, emphasizing the need for compelling comparative efficacy data.

Market Acceptance and Adoption Factors

Physician acceptance depends on clinical efficacy, safety profile, ease of administration, and cost. Patient adherence improves with fewer side effects and simplified dosing regimens. Market entry strategies include partnerships with ophthalmology and neurology specialists and potential inclusion in treatment guidelines. Some markets show growing demand for personalized medicine, which may favor XERESE’s targeted approach.

Pricing and Reimbursement

Pricing strategies are influenced by competitive positioning and burden-sharing with healthcare systems. Given the high cost of novel ophthalmic therapies, securing reimbursement approvals is vital. Reimbursement frameworks are increasingly value-based, favoring therapies demonstrating clear clinical benefits and economic advantages over existing options.

Financial Trajectory

Forecasting Revenue Streams

XERESE’s revenue forecast depends on several factors: successful regulatory approval, market penetration, price points, competition, and clinical advocacy. Assuming regulatory clearance in major markets by 2024-2025, initial sales might target niche markets with annual revenues in the tens to hundreds of millions USD. As evidence accumulates and approval expands, revenues could scale to over USD 1 billion annually within five years if broad adoption occurs.

Investment and R&D Trends

Pharmaceutical companies investing in that space allocate significant R&D resources to confirm efficacy and expand indications. Public funding, grants, and collaborations with academic institutions can accelerate development. The financial trajectory is sensitive to the pace of approval, trial success, and market receptivity.

Market Risks and Challenges

Key risks include delayed approvals, unforeseen adverse effects, and inadequate clinical data. Pricing pressures from generics and biosimilars further constrict profit margins. Additionally, shifting regulatory criteria, especially concerning safety profiles, can alter market viability.

Strategic Growth Opportunities

Modalities such as drug repurposing, combination therapies, or innovative delivery systems (e.g., sustained-release implants) could significantly influence XERESE’s market expansion and revenue prospects. Geographic expansion into emerging markets could benefit from favorable demography and unmet needs.

Conclusion

XERESE's market dynamics are shaped by its clinical potential, regulatory environment, competition, and evolving healthcare demand for targeted treatments. Its financial trajectory—initially modest—could accelerate considerably if clinical data affirm its superiority or differentiated niche position is established. Strategic partnerships, efficient regulatory navigation, and proactive market adoption efforts will be vital for optimizing its commercial potential.

Key Takeaways

• Regulatory approval timely execution is critical; delays can halt market progress.
• Clinical validation enhances market confidence and influences reimbursement prospects.
• Differentiation from existing therapies is essential for market penetration, especially against entrenched competitors.
• Pricing and reimbursement strategies must align with value demonstration to ensure profitability.
• Innovation in delivery systems and expanding indications open avenues for revenue growth.

FAQs

1. What is the current regulatory status of XERESE?
   XERESE is undergoing clinical trials, with some indications pending regulatory approval in major markets, contingent upon favorable trial outcomes and safety data.

2. How does XERESE compare with existing glaucoma treatments?
   XERESE offers a targeted mechanism with potential fewer side effects, but long-term comparative data are required for definitive positioning. It aims to address unmet needs for tolerability and efficacy.

3. What are key factors influencing XERESE’s market adoption?
   Physician acceptance rooted in clinical benefits, cost-effectiveness, regulatory approval, and reimbursement frameworks are crucial. Patient adherence and education also play roles.

4. What are the main risks involved in XERESE’s market development?
   Delays in approval, clinical trial failures, competitive pressures, and pricing challenges pose significant risks that could impact its commercial trajectory.

5. What future opportunities exist for XERESE in neurology?
   Emerging research into neurodegenerative diseases and cognitive impairments presents an opportunity for expanded indications, contingent upon successful clinical validation.

References

[1] Grand View Research. Ophthalmology Drugs Market Size & Trends. 2022.
[2] U.S. FDA Official Website. Regulatory pathways and orphan drug designations.
[3] ClinicalTrials.gov. Current clinical trials involving XERESE.
[4] MarketWatch. Ophthalmology Market Forecasts. 2023.