XELPROS Drug Patent Profile

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

Xelpros is a drug marketed by Sun Pharm and is included in one NDA. There are two patents protecting this drug.

This drug has nineteen patent family members in seventeen countries.

The generic ingredient in XELPROS is latanoprost. There are twenty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xelpros

A generic version of XELPROS was approved as latanoprost by AMRING PHARMS on March 22^nd, 2011.

Summary for XELPROS

International Patents:	19
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	4,860
Drug Prices:	Drug price information for XELPROS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XELPROS
What excipients (inactive ingredients) are in XELPROS?	XELPROS excipients list
DailyMed Link:	XELPROS at DailyMed

See drug prices for XELPROS

US Patents and Regulatory Information for XELPROS

XELPROS is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185-001	Sep 12, 2018		DISCN	Yes	No	9,539,262
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185-001	Sep 12, 2018		DISCN	Yes	No	9,629,852		Y

International Patents for XELPROS

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

Country	Patent Number	Title	Estimated Expiration
China	101835473
Japan	5646331
New Zealand	584555	STABILISED OPHTHALMIC COMPOSITION COMPRISING A PROSTAGLANDIN AND A POLYETHYLENE GLYCOL HYDROXYSTEARATE SUCH AS SOLUTOL HS 15
Japan	2011508724
Brazil	PI0818459

Supplementary Protection Certificates for XELPROS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0364417	61/1997	Austria		PRODUCT NAME: LATANOPROST UND SEINE THERAPEUTISCH AKTIVEN UND PHYSIOLOGISCH ANNEHMBAREN DERIVATE; NAT. REGISTRATION NO/DATE: 1-22019 19970627; FIRST REGISTRATION: SE 12716 19960718
0364417	97C0128	France		PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718
0364417	9690031-1	Sweden		PRODUCT NAME: LATANOPROST
3461484	C202130024	Spain		PRODUCT NAME: NETARSUDIL O UN ENANTIOMERO, DIASTEREIOISOMERO, SAL O SALVADO DEL MISMO EN COMBINACION CON LATANOPROST O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1502; DATE OF AUTHORISATION: 20210107; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1502; DATE OF FIRST AUTHORISATION IN EEA: 20210107
0364417	SPC/GB97/014	United Kingdom		PRODUCT NAME: LATANOPROST (I.E. 13,14-DIHYDRO-17-PHENYL-18,19,20-TRINOR-PGF-ALPHA-ISOPROPYLESTER); NAT. REGISTRATION NO/DATE: 00032/0220 19961216; FIRST REGISTRATION: SE 12716 19960718; SPC EXTENSION AUTHORISATION: PL00057/1057-008 20101216

Market Dynamics and Financial Trajectory for XELPROS

Last updated: August 3, 2025

Introduction

XELPROS (cevimeline hydrochloride) is a prescription medication approved for the treatment of dry mouth (xerostomia) in patients with Sjögren's syndrome, a chronic autoimmune disorder. Since its approval, XELPROS has carved out a niche within the dry mouth therapeutics market, yet its overall commercial trajectory and market dynamics are shaped by evolving healthcare paradigms, competitive forces, and regulatory environments. This report analyzes the current market landscape, key drivers influencing its financial performance, and projections shaping its future outlook.

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Market Landscape and Therapeutic Context

XELPROS entered the market with the unique mechanism of stimulating salivary secretion via muscarinic receptor agonism. As a targeted therapy for Sjögren's syndrome-associated dry mouth, it occupies a specialized segment in the larger autoimmune and symptomatic relief markets.

The global Sjögren’s syndrome and dry mouth market is projected to grow steadily, driven by increased diagnosis and demographic shifts toward aging populations. According to MarketWatch, the autoimmune disease market is expected to reach USD 38.2 billion by 2025, with dry mouth therapeutics capturing a significant share due to ongoing unmet needs [1].

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Market Dynamics influencing XELPROS

1. Demographic Trends and Disease Prevalence

The prevalence of Sjögren's syndrome affects the demand for XELPROS. Estimated to affect 0.5–1% of the population worldwide, predominantly women over 40, the disease's rising recognition augments market potential. Aging populations amplify prevalence rates, boosting patient demand for symptomatic treatments like XELPROS [2].

2. Competitive Landscape

While XELPROS remains the sole approved pharmacological treatment specifically targeting salivary secretion in Sjögren's patients, other therapeutic options include saliva substitutes, systemic immunomodulators, and off-label uses of cholinergic agents such as pilocarpine. However, these alternatives have limitations in efficacy and tolerability, positioning XELPROS as a preferred treatment option for certain patients.

Novel therapies entering the pipeline, including biological agents targeting underlying autoimmune mechanisms, may impact demand for symptomatic treatments in the future. Nevertheless, as of 2023, XELPROS maintains a strong, albeit niche, market position [3].

3. Regulatory and Reimbursement Environment

Approval and reimbursement policies exert substantial influence on XELPROS's financial trajectory. In major markets like the US and Europe, coverage decisions depend on cost-effectiveness assessments and formulary placements. XELPROS's pricing strategy and approval status significantly impact patient access and sales volume.

The US FDA approved XELPROS in 2004, with subsequent European approval. Pricing strategies aligned with payer expectations and negotiation outcomes can either facilitate or hinder market penetration.

4. Innovation and Patent Landscape

XELPROS’s patent exclusivity has historically protected its market share. However, patent expirations or challenges may open pathways for biosimilars or generics, potentially eroding revenues. As of 2023, no biosimilar versions are explicitly authorized, providing a temporary advantage.

5. Clinical Evidence and Patient Acceptance

Clinical studies have established XELPROS's efficacy in improving salivary flow rates. Patient adherence depends on tolerability, side effects such as sweating or gastrointestinal symptoms, and ease of use. Improved formulations or delivery methods could enhance acceptance and adherence, positively impacting revenues.

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Financial Trajectory and Revenue Drivers

1. Revenue Sources

XELPROS's revenue primarily emanates from prescriptions filled across outpatient settings. Sales volume correlates with diagnostic penetration, physician prescribing habits, and patient awareness.

2. Sales Trends and Historical Performance

Since its launch, the drug has experienced modest but consistent growth. Peak sales occurred within the first five years post-approval, driven by initial market uptake and formulary placements. Recent years have seen a plateau, indicating maturity in the current market and potential saturation.

3. Market Penetration and Geographic Expansion

Domestic markets, notably the US, contribute the lion’s share of revenue. International expansion remains limited due to regulatory hurdles and market differences, though strategic efforts aim to increase penetration in European and Asian markets.

4. Cost Dynamics and Pricing Strategies

Pricing remains a pivotal factor; premium pricing is justified by targeted indication and clinical benefits. However, price pressure from insurers and health authorities necessitates strategic negotiations. Cost of goods sold (COGS), marketing, and compliance costs influence profitability margins.

5. Future Revenue Outlook

Projections suggest a slow but steady decline in revenues absent significant clinical breakthroughs or expanded indications. Innovative formulations, combination therapies, or new indications could rejuvenate growth. Conversely, patent challenges or competitive entry could accelerate revenue contraction.

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Future Outlook and Strategic Considerations

1. Pipeline and Label Expansion

Potential label extensions to broader dry mouth populations or autoimmune conditions could expand market size. Investment in clinical trials demonstrating efficacy in related indications could prove transformative.

2. Lifecycle Management Strategies

Developing novel delivery systems or combination therapies targeting Sjögren’s syndrome may enhance competitive edge. Strategic licensing and acquisition can also diversify revenue streams.

3. Market Challenges and Risks

Risks include regulatory delays, pricing pressures, generic competition post-patent expiration, and shifting focus toward biologics and personalized medicine. Maintaining clinical relevancy through innovation and market access strategies is essential.

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Key Takeaways

• Market Positioning: XELPROS’s niche positioning in Sjögren’s syndrome dry mouth management provides steady demand, especially in aging populations. However, its growth potential is limited by market maturity and competition from emerging therapies.

• Revenue Drivers: Prescription trends, regulatory approvals, reimbursement status, and patient adherence significantly influence its financial trajectory. A stable domestic market underpins current revenues, with international expansion offering future upside.

• Strategic Opportunities: Label extensions, novel delivery formulations, and pipeline diversification could bolster revenues. Proactive lifecycle management remains essential as patent protections wane.

• Risks and Challenges: Price sensitivity, regulatory hurdles, competitive pressures, and potential generic entries threaten future profitability. Maintaining clinical and market relevance is crucial.

• Forecast: Expect gradual revenue stabilization or modest decline in absence of transformative innovations. Long-term growth hinges on pipeline success and expanded indications.

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FAQs

1. What is the current patent status of XELPROS?

XELPROS’s primary patents expired or are nearing expiration, which may open avenues for generic manufacturing post-license protection, potentially impacting future sales revenues [4].

2. How does XELPROS compare to other dry mouth treatments?

XELPROS offers targeted salivary stimulation with demonstrated efficacy. In contrast, saliva substitutes provide symptomatic relief without stimulating saliva, and systemic drugs carry tolerability issues. Its specificity affords clinical advantages for certain patients.

3. What are the main barriers to market expansion for XELPROS?

Regulatory approval timelines, reimbursement negotiations, limited awareness, and competition from alternative treatments limit broader geographic dissemination and increased prescribing.

4. Are there ongoing clinical trials to expand XELPROS indications?

As of 2023, no major announced trials aim to extend XELPROS indications beyond Sjögren’s syndrome-related dry mouth, although research continues into related autoimmune disorders.

5. How might upcoming biosimilar or generic entries affect XELPROS’s revenue?

Generic entry post-patent expiration could lead to significant revenue declines unless the manufacturer implements strategic lifecycle management, such as new formulations or indications to maintain market share.

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References

[1] MarketWatch. "Autoimmune Disease Treatment Market Size, Growth, Trends." 2022.

[2] National Institute of Dental and Craniofacial Research. "Sjögren’s Syndrome." 2020.

[3] EvaluatePharma. "Pharmaceutical Pipeline Insights," 2023.

[4] U.S. Patent and Trademark Office. "Patent Status for Cevimeline Hydrochloride," 2022.