Cevimeline hydrochloride - Generic Drug Details

What are the generic sources for cevimeline hydrochloride and what is the scope of patent protection?

Cevimeline hydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma, Bionpharma, Hikma, Macleods Pharms Ltd, Novel Labs Inc, Rising, Rubicon Research, and Cosette, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for cevimeline hydrochloride. Eleven suppliers are listed for this compound.

Summary for cevimeline hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	8
Patent Applications:	321
What excipients (inactive ingredients) are in cevimeline hydrochloride?	cevimeline hydrochloride excipients list
DailyMed Link:	cevimeline hydrochloride at DailyMed

Recent Clinical Trials for cevimeline hydrochloride

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

Sponsor	Phase
BioTheraVision, Inc.	PHASE2
Ain Shams University	PHASE4
China Medical University Hospital	Phase 4

See all cevimeline hydrochloride clinical trials

Pharmacology for cevimeline hydrochloride

Drug Class	Cholinergic Receptor Agonist
Mechanism of Action	Cholinergic Muscarinic Agonists

Anatomical Therapeutic Chemical (ATC) Classes for cevimeline hydrochloride

N07AX	Other parasympathomimetics
N07A	PARASYMPATHOMIMETICS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for CEVIMELINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EVOXAC	Capsules	cevimeline hydrochloride	30 mg	020989	1	2009-02-27

US Patents and Regulatory Information for cevimeline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rubicon Research	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	216682-001	Apr 6, 2023	AB	RX	No	No
Apotex Inc	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	091260-001	Aug 25, 2011		DISCN	No	No
Rising	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	203775-001	Jun 4, 2014	AB	RX	No	No

Expired US Patents for cevimeline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989-002	Jan 11, 2000	4,855,290
Cosette	EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989-002	Jan 11, 2000	5,580,880
Cosette	EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989-002	Jan 11, 2000	5,340,821

Market Dynamics and Financial Trajectory for Cevimeline Hydrochloride

Last updated: July 27, 2025

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Introduction

Cevimeline hydrochloride is a selective muscarinic receptor agonist primarily prescribed for the treatment of xerostomia (dry mouth), typically associated with Sjögren’s syndrome. As a niche pharmaceutical agent, its market presence reflects evolving clinical needs, regulatory landscapes, and competition within the therapeutics market for autoimmune and saliva-stimulating treatments. This analysis explores the current market dynamics and forecasts the financial trajectory of cevimeline hydrochloride, offering insights for stakeholders considering investment, development, or competitive positioning.

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Pharmacological Profile and Clinical Adoption

Cevimeline hydrochloride, marketed under brand names like Evoxac (Eli Lilly), was approved by the U.S. Food and Drug Administration (FDA) in 1998. It acts as a muscarinic M3 receptor agonist, stimulating salivary secretion and offering symptomatic relief for xerostomia[^1^]. Its efficacy was demonstrated in clinical trials, particularly for Sjögren’s syndrome patients, where conventional therapies yield limited results[^2^].

Despite its targeted application, cevimeline's adoption remains limited relative to broader salivary stimulants or alternative therapies due to several factors:

• Efficacy Limitations: Efficacy varies among patients, with some experiencing minimal symptom relief.
• Side Effects: Muscarinic agonists can induce adverse effects such as sweating, nausea, and urinary urgency, which may restrict broader use.
• Market Competition: Alternatives, including pilocarpine hydrochloride (another oral saliva stimulant), often overshadow cevimeline in prescriptions due to longer market presence and established efficacy[^3^].

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Market Size and Growth Drivers

The global xerostomia treatment market was valued at approximately USD 1.5 billion in 2021, with projections indicating a compound annual growth rate (CAGR) of around 4%–6% through 2028[^4^]. Cevimeline hydrochloride’s role constitutes a small but significant niche within this broader market.

Key growth drivers include:

• Rising Prevalence of Sjögren’s Syndrome: An autoimmune disorder affecting 0.1%–4% of the population globally, with higher prevalence in women over 40[^5^]. As awareness and diagnosis improve, demand for effective therapeutic agents like cevimeline may increase.
• Enhanced Diagnostic Practices: Early detection of dry mouth symptoms and increased clinical focus on autoimmune disease management expand the targeted patient pool.
• Limited Emerging Alternatives: Currently, no novel, highly selective M3 agonists have gained regulatory approval specifically for xerostomia, shielding cevimeline from direct obsolescence.

However, challenges persist:

• Generic Competition: Cevimeline was initially marketed as a branded therapy, but patent expirations (if applicable) threaten the introduction of generics, exerting downward pressure on prices.
• Pricing and Reimbursement Policies: Healthcare budget constraints and reimbursement policies influence market penetration, especially in cost-sensitive regions.
• Patient and Physician Preferences: Preference for well-established agents, such as pilocarpine, limits the market share for cevimeline.

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Regulatory and Patent Landscape

Cevimeline’s patent protection has largely expired in major markets, such as the U.S. and Europe, allowing generic manufacturers to introduce copycat formulations. This development is crucial for financial projections, indicating potential revenue decline as generic options gain prominence.

Regulatory developments, including approvals or withdraws in emerging markets and amendments to labeling, impact market availability. Importantly, regulators in some jurisdictions require warnings for side effect profiles, which can influence prescribing behavior.

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Financial Trajectory and Market Forecast

Revenue Trends:
Current revenue estimates for cevimeline hydrochloride are modest, constrained by limited indications and competition. In the U.S., Evoxac’s revenue peaked in the early 2010s, with estimates around USD 20–30 million annually[^6^]. As patent protections diminish and generics penetrate, revenues are projected to decline at a CAGR of approximately 10–15% over the next five years.

Impact of Generics:
Generic entry is expected to reduce branded drug prices by as much as 60–80%. This downward pressure can substantially erode profit margins for original manufacturers. However, smaller biotech or generic firms might see opportunities to capture market share by offering cost-effective alternatives.

Potential Market Expansion:
Novel delivery mechanisms—such as targeted formulations or combination therapies—may revive interest in cevimeline. Additionally, repositioning for other indications, although currently unapproved, could present future revenue streams if supported by clinical research.

Regulatory and Market Risks:

• Patent Challenges: Ongoing patent litigations can delay generic entry or extend exclusivity.
• Market Acceptance: Limited awareness among physicians and patients restricts expansion.
• Pricing Pressures: Payers favor generic and off-label competition, constraining revenue trajectories.

In sum, a conservative forecast indicates a declining revenue trajectory, with potential stabilization if new formulations, expanded indications, or market niche opportunities are developed.

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Strategic Implications for Stakeholders

For pharmaceutical companies involved with cevimeline hydrochloride or its generics, strategies should focus on:

• Cost Competitiveness: Reducing manufacturing costs to maintain margins amid declining branded revenues.
• Market Diversification: Exploring new indications or formulations to broaden applications.
• Intellectual Property Assets: Protecting formulations or delivery methods to extend lifecycle.
• Targeted Marketing: Educating physicians and patients about the benefits relative to other therapies.

Meanwhile, investors should monitor patent status, regulatory approvals, and emerging clinical data for potential market disruptions or growth opportunities.

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Conclusion

Cevimeline hydrochloride’s market dynamics are shaped predominantly by patent expirations, competitive pressures, and the demographic profile of conditions it treats. Its financial trajectory indicates a decline in revenue in the absence of innovation or new indications but retains niche value in the unmet needs of specific patient subsets. Strategic positioning, regulatory navigation, and ongoing clinical research will determine the extent of its longevity and profitability.

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Key Takeaways

• Cevimeline hydrochloride remains a targeted treatment for xerostomia with a limited but steady market niche.
• Patent expiries and generic competition are significant drivers of revenue decline, projected to continue over the next five years.
• Rising Sjögren’s syndrome prevalence could bolster demand, but competition from established alternatives like pilocarpine persists.
• Innovation in formulations and new indications could alter the financial trajectory favorably.
• Companies should optimize costs, protect IP, and expand clinical research to sustain relevance and profitability.

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FAQs

1. What are the primary factors influencing the decline of cevimeline hydrochloride’s market share?
Patent expirations allowing generics, competition from alternative saliva stimulants like pilocarpine, limited new indications, and side effect profiles contribute to declining market share.

2. Are there ongoing clinical trials exploring new uses for cevimeline hydrochloride?
Currently, clinical trials are limited. Most research focuses on improving existing formulations or comparing efficacy and tolerability with other agents. No major trials are underway for new indications as of 2023.

3. How does the side effect profile impact the market adoption of cevimeline?
Muscarinic side effects such as sweating, nausea, and urinary urgency limit widespread use, especially where contraindications exist or side effects outweigh perceived benefits.

4. What opportunities exist for pharmaceutical firms regarding cevimeline hydrochloride?
Opportunities include developing novel formulations, repositioning for new indications, entering emerging markets with unmet needs, and extending patent protections through formulation patents.

5. How might regulatory changes influence cevimeline hydrochloride’s future?
Stringent safety warnings, pricing regulations, and approvals for generic versions will influence its market presence. Conversely, regulatory support for new formulations or indications could revive its commercial prospects.

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References

[1] U.S. FDA. Evoxac (Cevimeline Hydrochloride) Prescribing Information, 1998.
[2] Fox RI. Sjögren’s syndrome. Lancet. 2005;366(9482):321-331.
[3] Bouwens E, et al. Comparative efficacy of pilocarpine and cevimeline in dry mouth management. J Oral Med. 2010;65(2):52-58.
[4] MarketsandMarkets. Xerostomia Treatment Market by Type, Region - Global Forecast to 2028. 2021.
[5] Kassan SS, Moutsopoulos HM. Sjögren’s syndrome: Autoimmunity and clinical aspects. Ann Rev Med. 2004;55:21-36.
[6] IQVIA. Pharmaceutical Market Reports, 2010–2020.