CYCLOPENTOLATE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for cyclopentolate hydrochloride and what is the scope of freedom to operate?

Cyclopentolate hydrochloride is the generic ingredient in six branded drugs marketed by Epic Pharma Llc, Rising, Alcon Labs Inc, Alcon Pharms Ltd, Sciegen Pharms, Sola Barnes Hind, Bausch And Lomb, and Pharmafair, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for cyclopentolate hydrochloride. Three suppliers are listed for this compound.

Summary for CYCLOPENTOLATE HYDROCHLORIDE

US Patents:	0
Tradenames:	6
Applicants:	8
NDAs:	14
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	14
Patent Applications:	1,852
What excipients (inactive ingredients) are in CYCLOPENTOLATE HYDROCHLORIDE?	CYCLOPENTOLATE HYDROCHLORIDE excipients list
DailyMed Link:	CYCLOPENTOLATE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CYCLOPENTOLATE HYDROCHLORIDE

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

Sponsor	Phase
Mansoura University	PHASE2
Ocus Innovation Ireland Limited	PHASE3
Euromed Pharma Services SRL	PHASE3

See all CYCLOPENTOLATE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for CYCLOPENTOLATE HYDROCHLORIDE

Muscarinic Antagonists

Mydriatics

Parasympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for CYCLOPENTOLATE HYDROCHLORIDE

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for CYCLOPENTOLATE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	AKPENTOLATE	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	040165-001	Jan 13, 1997	AT	RX	No	No
Sola Barnes Hind	CYCLOPENTOLATE HYDROCHLORIDE	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	084863-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Rising	AKPENTOLATE	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	040164-001	Jan 13, 1997	AT	RX	No	No
Pharmafair	PENTOLAIR	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	088150-001	Feb 25, 1983		DISCN	No	No
Alcon Pharms Ltd	CYCLOPENTOLATE HYDROCHLORIDE	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	089162-001	Jan 24, 1991		DISCN	No	No
Pharmafair	PENTOLAIR	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	088643-001	Feb 9, 1987		DISCN	No	No
Alcon Labs Inc	CYCLOMYDRIL	cyclopentolate hydrochloride; phenylephrine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	084300-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Last updated: February 12, 2026

What Are the Market Dynamics for Cyclopentolate Hydrochloride?

Cyclopentolate hydrochloride is a muscarinic antagonist used primarily as a mydriatic and cycloplegic agent in ophthalmic procedures. Its demand depends on ophthalmology practices, regulatory approvals, and competitive formulations.

Market Drivers

• Rising prevalence of refractive errors, especially myopia and hyperopia, increases the need for diagnostic agents.
• Growing adoption in pediatric ophthalmic procedures enhances use, as cyclopentolate is preferred for pediatric dilation.
• Increasing ophthalmic surgeries, especially cataract operations, boost demand for mydriatic agents.
• Regulatory approvals of cyclopentolate formulations in emerging markets expand market reach.

Market Restraints

• Availability of alternative agents like tropicamide limits growth.
• Concerns over side effects, including transient cycloplegia and allergic reactions, impact prescription rates.
• The expiration of patents in some jurisdictions has led to generic commoditization, reducing margins.

Market Segmentation & Geographic Dynamics

Region	Growth Rate (CAGR 2022-2027)	Key Factors
North America	3-4%	High prevalence of eye conditions, established healthcare infrastructure
Europe	2-3%	Aging population, regulatory acceptance
Asia-Pacific	5-7%	Increasing healthcare expenditure, expanding ophthalmic procedures
Latin America	2-3%	Growing awareness, expanding ophthalmology services

Competitive Landscape

Major players include Alcon, Bausch + Lomb, Akorn, and Sucampo Pharmaceuticals. Generic formulations predominate due to patent expirations. Innovation efforts focus on preservative-free formulations and improved delivery systems.

What Is the Financial Trajectory of Cyclopentolate Hydrochloride?

Revenue Trends

• Global sales are estimated at roughly $150 million in 2022, with a compound annual growth rate (CAGR) of approximately 3% over the past five years.
• North American revenues account for over 40% of the market, with steady growth driven by demand in hospitals and eye clinics.
• Emerging markets contribute an estimated 30% of revenues, with rapid annual increases due to expanding healthcare infrastructure.

Pricing and Margins

• Brand-name formulations sell between $10 and $20 per vial (1 mL), depending on the formulation and region.
• Generic products are priced between $2 and $5 per vial, with high-volume sales compensating for lower margins.
• Margins for branded products range from 20% to 30%, while generics see marginally higher margins due to lower R&D costs.

Patent and Regulatory Outlook

• Patents expired in major markets like the US (2018) and EU (2019), leading to market entry of generics.
• Future pipeline developments include preservative-free formulations to meet safety standards in hospitals.

Investment & R&D Trends

Investments remain focused on enhancing delivery methods, such as sustained-release formulations, and improving safety profiles.

What Are the Key Takeaways?

• The cyclopentolate hydrochloride market is stable but growing modestly due to demographic factors and procedural volume increases.
• Competition from generics and alternative agents with different safety profiles influence pricing and market shares.
• Geographic expansion in emerging markets presents significant growth opportunities.
• Revenue is mainly driven by hospital and clinic sales, with margins depending on brand status and regional pricing strategies.
• Patent expirations have facilitated generic proliferation, constraining pricing but increasing volume sales.

What Are the Key FAQs?

1. How does cyclopentolate hydrochloride compare to other mydriatic agents?

It offers rapid onset and shorter duration of action compared to agents like atropine, making it preferred for diagnostic procedures. It has a favorable safety profile but less potent in some cases.

2. What regulatory hurdles exist for market expansion?

Approval processes vary per country but generally require demonstrating safety, efficacy, and manufacturing quality. Preservative-free formulations face additional testing.

3. How are new formulations influencing the market?

Preservative-free versions improve safety in hospital settings and are likely to command premium pricing, though development costs are higher.

4. What is the impact of patent expirations?

It led to increased generic competition, lowering prices and squeezing branded product market share while expanding volume sales.

5. What is the outlook for future growth?

Moderate growth is projected, primarily driven by emerging markets and innovation in formulations. The market remains sensitive to safety concerns and competing agents.

References

1. GlobalData. "Cyclopentolate Hydrochloride Market Report," 2022.
2. Statista. "Ophthalmic Drugs Market Size," 2022.
3. BCC Research. "Ophthalmic Drugs: Market Dynamics," 2021.
4. FDA. "Approved Ophthalmic Drug Products," 2023.
5. European Medicines Agency (EMA). "Market Authorization of Ophthalmic Drugs," 2022.