CYCLOPENTOLATE HYDROCHLORIDE Drug Patent Profile

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

Cyclopentolate Hydrochloride is a drug marketed by Alcon Pharms Ltd, Sciegen Pharms, and Sola Barnes Hind. and is included in four NDAs.

The generic ingredient in CYCLOPENTOLATE HYDROCHLORIDE is cyclopentolate hydrochloride. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.

Summary for CYCLOPENTOLATE HYDROCHLORIDE

US Patents:	0
Applicants:	3
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	14
Patent Applications:	1,395
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
Consorzio per Valutazioni Biologiche e Farmacologiche	PHASE3
Ocus Innovation Ireland Limited	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
Alcon Pharms Ltd	CYCLOPENTOLATE HYDROCHLORIDE	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	089162-001	Jan 24, 1991		DISCN	No	No
Sola Barnes Hind	CYCLOPENTOLATE HYDROCHLORIDE	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	084863-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sciegen Pharms	CYCLOPENTOLATE HYDROCHLORIDE	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	205937-001	Dec 9, 2015		DISCN	No	No
Sola Barnes Hind	CYCLOPENTOLATE HYDROCHLORIDE	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	084150-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Cyclopentolate Hydrochloride Market Dynamics and Financial Trajectory

Last updated: August 31, 2026

Cyclopentolate hydrochloride is a mature, genericized ophthalmic drug used to produce mydriasis and cycloplegia before eye examinations and procedures. Its commercial profile is defined by low pricing, multiple suppliers, limited patent protection, and recurring clinical demand. No public company reports standalone cyclopentolate revenue, so financial analysis depends on prescription volume, product availability, channel pricing, and supplier participation rather than disclosed brand sales.

The product has little conventional exclusivity value. The original regulatory protections expired decades ago, generic ophthalmic solutions are available, and no meaningful biosimilar or patent cliff is pending. Revenue is likely to remain stable in aggregate, with periodic volatility from manufacturing interruptions, supplier exits, wholesaler inventories, and institutional purchasing contracts.

What is cyclopentolate hydrochloride used for?

Cyclopentolate hydrochloride is an anticholinergic ophthalmic agent that temporarily blocks muscarinic receptors in the iris sphincter and ciliary muscle. It is used primarily for:

• Cycloplegic refraction, particularly in pediatric patients
• Pupil dilation before ophthalmic examinations
• Diagnostic procedures involving the retina or posterior segment
• Certain ophthalmic procedures requiring temporary loss of accommodation

The main commercial strengths are 0.5% and 1% ophthalmic solutions. The 1% concentration is commonly associated with stronger cycloplegia, while the 0.5% concentration is used in selected patients and clinical settings. Product labeling identifies blurred vision, photophobia, ocular irritation, and systemic anticholinergic reactions as relevant safety considerations.[1]

Cyclopentolate competes clinically with tropicamide, atropine, homatropine, and phenylephrine. Tropicamide is widely used for routine dilation because of its shorter duration. Atropine remains relevant when prolonged cycloplegia is required, especially in selected pediatric or refractive-error settings.

How large is the cyclopentolate hydrochloride market?

The cyclopentolate market is a small specialty segment within ophthalmic pharmaceuticals. Public market databases generally aggregate the product into broader categories such as mydriatics, cycloplegics, ophthalmic generics, or diagnostic eye-care products.

There is no reliable public, drug-specific revenue figure for global cyclopentolate hydrochloride sales. Manufacturers typically report ophthalmic portfolios in aggregate, while generic suppliers do not disclose product-level net sales. This limits the usefulness of top-down market reports that assign a precise global value to cyclopentolate.

Market factor	Effect on cyclopentolate
Clinical demand	Recurring demand from optometry, ophthalmology, hospitals, and pediatric care
Pricing	Low because of generic competition
Volume sensitivity	High; revenue depends more on unit volume than price
Prescriber switching	Moderate, with substitution by tropicamide or atropine
Reimbursement exposure	Generally limited per prescription, but relevant for institutional buyers
Supply-chain sensitivity	Material because a small number of suppliers may serve individual markets
Patent dependence	Minimal
Biosimilar exposure	None
Brand premium	Limited outside markets with restricted generic access

The commercial market is therefore better characterized as a stable, low-value, high-competition product category rather than a growth pharmaceutical franchise.

What is the financial trajectory for cyclopentolate hydrochloride?

Cyclopentolate revenue is likely to follow a mature generic-drug trajectory:

1. Stable or slowly growing demand from ophthalmic examinations.
2. Flat or declining average selling prices where multiple generics compete.
3. Periodic price increases during shortages or supplier withdrawals.
4. Margin pressure for manufacturers and distributors.
5. Greater revenue concentration among suppliers that maintain reliable inventory.

A manufacturer with a broad ophthalmic portfolio can obtain strategic value from cyclopentolate even when the product generates modest revenue. The product can support customer relationships with ophthalmology clinics, hospitals, surgery centers, wholesalers, and government purchasers. Its value is often linked to portfolio completeness and supply reliability rather than high gross margin.

No standalone cyclopentolate revenue, operating profit, or unit-volume disclosures appear in the public reporting of major diversified pharmaceutical companies. Public company filings normally combine ophthalmic generics with other products or report them within broader geographic or therapeutic segments.[2]

What drives cyclopentolate revenue?

The main revenue drivers are:

• Number of eye examinations and pediatric refraction visits
• Ophthalmology clinic and optometry capacity
• Generic supplier count
• Wholesale and institutional contract pricing
• Product availability in the relevant country
• Relative use of tropicamide and atropine
• Clinical preference for stronger cycloplegia
• Pediatric ophthalmology demand
• Regulatory supply interruptions

The product has limited exposure to innovation-driven pricing. There is no meaningful expectation that a conventional cyclopentolate solution will generate premium pricing without a differentiated delivery system, preservative-free presentation, combination product, or specialized packaging.

When does cyclopentolate hydrochloride lose exclusivity?

Cyclopentolate hydrochloride lost meaningful market exclusivity many years ago. The active ingredient and conventional ophthalmic use are long established, and generic versions have entered multiple markets.

The original U.S. branded product, Cyclogyl, was approved by the Food and Drug Administration as an ophthalmic cycloplegic and mydriatic. FDA product records identify Cyclogyl under NDA 016859.[3] Any original regulatory exclusivity associated with that approval has expired.

Exclusivity category	Current commercial relevance
Active-ingredient exclusivity	Expired
Original product exclusivity	Expired
New chemical entity exclusivity	Not applicable to current market
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No current meaningful protection
Conventional formulation patent protection	No material barrier identified
Biosimilar exclusivity	Not applicable
Generic regulatory pathway	Established

Cyclopentolate is therefore a post-exclusivity product. The key commercial question is not when exclusivity ends, but whether a supplier can maintain approval, manufacturing capacity, quality compliance, and distribution.

What patents protect cyclopentolate hydrochloride products?

The conventional cyclopentolate hydrochloride ophthalmic solution has little current patent value. The active compound is old, and the basic use of the drug for mydriasis and cycloplegia is established medical practice.

No active, commercially significant patent estate is generally associated with the conventional 0.5% or 1% solution. The following categories could create protection for a particular product, but they do not appear to define the standard generic market:

• Novel preservative-free formulations
• Sustained-release ocular delivery systems
• Combination products
• Specialized single-dose containers
• New dosing regimens tied to a specific indication
• Improved penetration or reduced systemic absorption
• Device-enabled delivery systems

These patents would protect a differentiated product rather than the ordinary cyclopentolate molecule itself. Their commercial strength would depend on claim scope, written-description support, obviousness risk, enablement, and whether the product generated a clinically meaningful advantage.

How strong is the cyclopentolate patent estate?

The patent estate for standard cyclopentolate hydrochloride solution is weak or effectively absent as a barrier to generic entry. Patent strength is limited by:

• The age of the active ingredient
• Extensive clinical use
• Established ophthalmic dosage forms
• Availability of prior-art formulations
• Low technical complexity of conventional solutions
• Generic substitution through abbreviated approval pathways

A new formulation could have stronger protection, but a formulation patent would face invalidity and design-around risks. Competitors could potentially alter preservatives, container systems, concentrations, excipients, or dosing instructions while retaining the same active ingredient.

What is the FDA regulatory status of cyclopentolate hydrochloride?

Cyclopentolate hydrochloride ophthalmic solution is an FDA-regulated prescription ophthalmic drug. Approved products are used as mydriatic and cycloplegic agents. FDA labeling covers administration, contraindications, warnings, adverse reactions, and storage requirements.[1]

Generic products generally enter through abbreviated new drug applications, provided they demonstrate pharmaceutical equivalence and bioequivalence or satisfy applicable FDA requirements for the product type. The principal regulatory barriers are manufacturing quality, sterility assurance, container-closure integrity, stability, labeling conformity, and supply continuity.

Ophthalmic products have higher manufacturing sensitivity than many oral generics because contamination, particulate matter, preservative performance, and container defects can trigger recalls or production interruptions.

What is the Orange Book status of cyclopentolate hydrochloride?

The FDA Orange Book identifies approved prescription drug products and, where applicable, patents and regulatory exclusivity. Cyclopentolate products are associated with an old reference product and generic approvals, but the standard product does not have a current, commercially meaningful patent barrier comparable to newer branded ophthalmic drugs.[4]

Orange Book issue	Cyclopentolate position
Reference product	Cyclogyl and related approved reference products
Dosage form	Ophthalmic solution
Strengths	Commonly 0.5% and 1%
Generic pathway	ANDA-based generic competition
Listed patent barrier	No material standard-product barrier
Current exclusivity	None of commercial significance
Therapeutic-equivalence relevance	Important for generic substitution where listed

Orange Book status can differ by product, strength, manufacturer, and market. A specific generic product may have its own labeling or approval conditions even when the active ingredient is widely genericized.

Which companies are challenging cyclopentolate hydrochloride exclusivity?

Cyclopentolate does not have an active branded exclusivity contest comparable to high-value products facing multiple Paragraph IV challenges. Generic competition is primarily entry competition among manufacturers rather than litigation against a live patent estate.

Potential suppliers include generic ophthalmic manufacturers, specialty pharmaceutical companies, contract manufacturers, and regional distributors. The supplier field can change because companies discontinue low-margin products, transfer applications, or exit sterile ophthalmic manufacturing.

Are there Paragraph IV challenges for cyclopentolate?

Paragraph IV litigation is not a central commercial risk for conventional cyclopentolate hydrochloride solution. Paragraph IV certifications arise when an ANDA applicant challenges listed patents for a reference product. With no significant active patent barrier for the standard product, the incentive to litigate is low.

The more relevant risks are:

• FDA approval delays
• Complete response letters
• Sterility or manufacturing observations
• Product recalls
• API or packaging shortages
• Discontinuation by a low-volume supplier
• State or institutional purchasing exclusions

What litigation affects cyclopentolate hydrochloride?

Cyclopentolate is not known for a major current patent-litigation docket involving the standard U.S. ophthalmic solution. The product’s litigation exposure is more likely to involve product liability, labeling, manufacturing quality, supply agreements, or adverse-event claims than patent infringement.

Potential litigation exposure includes accidental systemic anticholinergic effects, pediatric dosing errors, contamination, preservative reactions, and packaging or dispensing mistakes. FDA labeling warns that systemic absorption can occur and that serious reactions are possible, particularly in vulnerable patients.[1]

Are there licensing deals for cyclopentolate hydrochloride?

No major, publicly disclosed licensing transaction is central to the cyclopentolate market. Commercial arrangements are more likely to involve:

• Contract manufacturing
• Regional distribution
• Product transfers between generic companies
• Wholesale supply agreements
• Portfolio acquisitions
• Private-label ophthalmic products

A licensing agreement for a novel cyclopentolate delivery system could have strategic value, but the conventional solution is unlikely to command substantial upfront payments or milestone economics.

What generic launch scenarios exist for cyclopentolate?

Base case: stable generic supply

Multiple approved suppliers continue to serve the market. Prices remain low, and volume tracks eye-care utilization. Manufacturers earn modest but recurring revenue.

Downside case: supplier contraction

One or more manufacturers exit because of low margins or manufacturing problems. Shortages emerge, allowing remaining suppliers to raise prices temporarily. The effect is more likely to be episodic than structural.

Upside case: differentiated formulation

A preservative-free, single-dose, pediatric-friendly, or combination presentation gains adoption. The product may obtain higher pricing, but commercial success would depend on clinical differentiation and payer or institutional acceptance.

Substitution case: use shifts to alternatives

Tropicamide captures routine dilation, while atropine retains selected cycloplegic uses. Cyclopentolate remains concentrated in cases where stronger or longer cycloplegia is clinically preferred.

How does cyclopentolate compare with competing ophthalmic drugs?

Drug	Main commercial role	Duration profile	Competitive position
Cyclopentolate	Cycloplegic refraction and dilation	Intermediate	Strong in pediatric and diagnostic cycloplegia
Tropicamide	Routine pupil dilation	Shorter	Broad use in standard examinations
Atropine	Prolonged cycloplegia	Longer	Useful in selected pediatric and therapeutic settings
Phenylephrine	Mydriasis without cycloplegia	Variable	Often used in combination
Homatropine	Mydriasis and cycloplegia	Intermediate to longer	Smaller commercial role

Cyclopentolate’s principal defense is clinical utility rather than intellectual property. Its position is strongest where clinicians need reliable cycloplegia and where tropicamide alone is insufficient.

What geographic markets matter most?

The United States, Europe, Japan, and other developed markets have mature generic access and relatively low pricing. Emerging markets can have greater variation in brand penetration, regulatory requirements, local manufacturing, and retail pricing.

Geographic commercial performance depends on:

• Local approval status
• Availability of sterile ophthalmic manufacturing
• National reimbursement policy
• Hospital procurement rules
• Pediatric ophthalmology capacity
• Presence of domestic manufacturers
• Import restrictions
• Pharmacist substitution rules

The same active ingredient can have different supplier concentration and pricing in each jurisdiction. A company with local manufacturing or established hospital contracts may hold stronger commercial leverage than a global company without local distribution.

What manufacturing and intellectual-property barriers exist?

Manufacturing is a more important barrier than intellectual property. Cyclopentolate hydrochloride solution requires validated sterile production, controlled filling, appropriate packaging, stability testing, and reliable quality systems.

Key manufacturing risks include:

• Microbial contamination
• Particulate contamination
• Inadequate preservative performance
• Container-closure defects
• Inconsistent fill volume
• API supply interruptions
• Batch-release failures
• FDA or other regulator observations

These barriers can reduce the number of dependable suppliers even when the product has no meaningful patent protection. In a low-price market, a manufacturer with efficient sterile capacity and reliable distribution can outperform a larger company with higher costs.

Key Takeaways

• Cyclopentolate hydrochloride is a mature generic ophthalmic drug with recurring clinical demand.
• The market is driven by volume, supply reliability, and institutional access rather than patent exclusivity.
• No meaningful current patent or regulatory exclusivity protects the conventional 0.5% or 1% ophthalmic solution.
• Paragraph IV litigation and biosimilar risk are not material commercial issues.
• Public companies do not generally report standalone cyclopentolate revenue.
• Financial performance is likely to remain stable at the category level, with price pressure offset by recurring examination volume.
• Manufacturing quality and sterile supply capacity are more important barriers than intellectual property.
• Differentiated formulations could create premium economics, but conventional solution products have limited pricing power.
• Tropicamide is the principal routine-dilation competitor, while atropine remains relevant for prolonged cycloplegia.
• Shortages, supplier exits, and portfolio rationalization are the most credible sources of near-term revenue volatility.

FAQs

Is cyclopentolate hydrochloride a branded or generic drug?

It is available as a generic ophthalmic drug and has also been marketed under brands such as Cyclogyl. Generic products account for the core commercial market.

Can cyclopentolate hydrochloride be purchased over the counter?

In the United States, cyclopentolate ophthalmic solution is a prescription product. It is administered under professional direction because of its ocular and systemic anticholinergic effects.

Does cyclopentolate hydrochloride have pediatric market exposure?

Yes. Pediatric refraction is a major clinical use because cycloplegia helps reduce the effect of accommodation during vision assessment. Pediatric use also increases the importance of dosing accuracy and safety controls.

What would make a new cyclopentolate product commercially differentiated?

A new product would need a practical advantage such as preservative-free packaging, reduced administration burden, improved tolerability, longer stability, lower systemic absorption, or a delivery device that improves dosing.

Is cyclopentolate hydrochloride vulnerable to pharmacy substitution?

Generic substitution is generally possible where an approved product has the relevant therapeutic-equivalence designation and local substitution rules permit it. Institutional purchasing policies and national regulations determine the actual level of substitution.

References

1. U.S. Food and Drug Administration. (n.d.). Cyclopentolate hydrochloride ophthalmic solution prescribing information. DailyMed.
2. Alcon Inc. (2024). Annual report for the year ended December 31, 2023. U.S. Securities and Exchange Commission.
3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Cyclogyl, NDA 016859.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.