MIOCHOL Drug Patent Profile

Which patents cover Miochol, and what generic alternatives are available?

Miochol is a drug marketed by Novartis and Bausch And Lomb and is included in two NDAs.

The generic ingredient in MIOCHOL is acetylcholine chloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the acetylcholine chloride profile page.

Summary for MIOCHOL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	2,660
Drug Prices:	Drug price information for MIOCHOL
DailyMed Link:	MIOCHOL at DailyMed

See drug prices for MIOCHOL

Recent Clinical Trials for MIOCHOL

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

Sponsor	Phase
University Hospital, Linkoeping	N/A
University of Pittsburgh	Phase 1
Gladwin, Mark, MD	Phase 1

See all MIOCHOL clinical trials

US Patents and Regulatory Information for MIOCHOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	MIOCHOL	acetylcholine chloride	FOR SOLUTION;OPHTHALMIC	016211-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bausch And Lomb	MIOCHOL-E	acetylcholine chloride	FOR SOLUTION;OPHTHALMIC	020213-001	Sep 22, 1993		RX	Yes	Yes

MIOCHOL Market Dynamics, Financial Trajectory, FDA Status, and Patent Position

Last updated: August 25, 2026

MIOCHOL-E is an established ophthalmic surgical drug containing acetylcholine chloride. Its commercial profile is that of a mature, low-volume injectable used mainly to induce miosis during cataract and other anterior-segment procedures. The product has FDA approval, no meaningful remaining regulatory exclusivity, and limited public revenue disclosure. Its economics depend more on sterile manufacturing reliability, hospital purchasing, procedure volumes, and supply continuity than on patent protection.

What is MIOCHOL-E and how is it used?

MIOCHOL-E is an intraocular acetylcholine chloride product used to produce rapid miosis during ophthalmic surgery. The product is supplied as a sterile powder that is reconstituted before intraocular administration.

The FDA-approved indication covers induction of miosis during cataract surgery and other anterior-segment procedures. It is administered by ophthalmic surgeons rather than dispensed through conventional retail pharmacy channels. This places the product in the hospital, ambulatory surgery center, and ophthalmic-surgical distribution markets. (U.S. Food and Drug Administration [FDA], n.d.-a)

Attribute	MIOCHOL-E
Active ingredient	Acetylcholine chloride
Dosage form	Sterile intraocular solution after reconstitution
Strength	20 mg vial
Primary use	Intraoperative miosis
Therapeutic area	Ophthalmic surgery
FDA application	NDA 018667
Primary commercial channel	Hospitals, ambulatory surgery centers, surgical distributors
Retail pharmacy exposure	Limited
Biosimilar relevance	None

MIOCHOL-E is different from topical ophthalmic drops used for routine glaucoma, inflammation, or infection. Its market is tied directly to surgical procedures and operating-room inventory.

What is the FDA regulatory status of MIOCHOL-E?

MIOCHOL-E is an FDA-approved prescription ophthalmic surgical product. The FDA-approved labeling identifies acetylcholine chloride as the active ingredient and describes the product as an intraocular miotic used during surgery. (FDA, n.d.-a)

The product’s regulatory characteristics are:

• It is a legacy small-molecule drug.
• It is administered intraocularly during a procedure.
• It requires sterile manufacturing and controlled packaging.
• It is generally purchased through institutional or specialty-surgical channels.
• Its commercial demand is connected to ophthalmic surgery volumes rather than chronic prescription refills.

The product does not have biologic status and does not create a biosimilar pathway. A competing product would generally proceed through the abbreviated new drug application or another small-molecule pathway, depending on formulation, dosage form, and reference-product requirements.

What patents protect MIOCHOL-E?

MIOCHOL-E has limited current patent value. Acetylcholine chloride is an old active pharmaceutical ingredient, and any original composition or use patents would have expired long before the current commercial period.

The commercial protection profile is primarily regulatory and operational rather than patent-based:

Protection category	Current commercial relevance
Active-ingredient patent	No meaningful current protection expected
Original method-of-use patent	Expired or commercially obsolete
Formulation patent	No widely recognized current barrier comparable to modern specialty drugs
Device patent	Not central to the product’s commercial position
FDA exclusivity	Expired
Orphan-drug exclusivity	Not applicable
Biosimilar exclusivity	Not applicable
Manufacturing know-how	Potentially relevant
Sterility and quality systems	Material operational barrier

The FDA Orange Book is the principal source for determining whether a listed drug has active patent claims requiring certification by an ANDA applicant. The public product profile for MIOCHOL-E is associated with NDA 018667. A current commercial assessment should treat the product as effectively off-patent unless a live, product-specific listing is identified in the current Orange Book. (FDA, n.d.-b)

When does MIOCHOL-E lose exclusivity?

MIOCHOL-E lost meaningful market exclusivity decades ago. Its current position is not supported by a live period of new chemical entity, orphan, pediatric, or other statutory exclusivity.

The practical exclusivity timeline is:

Period	Commercial significance
Initial FDA approval	Established the reference-product regulatory record
Post-approval period	Brand and manufacturing familiarity developed
Patent term expiration	Removed conventional patent barriers
Current period	Mature product market with potential generic and therapeutic substitution

The expiration of patent and regulatory exclusivity does not guarantee immediate generic entry. For sterile intraocular products, manufacturing complexity, limited market size, validation costs, and procurement contracts can discourage competitors even when legal barriers are low.

How does the MIOCHOL-E patent estate compare with competing ophthalmic drugs?

MIOCHOL-E has a weaker patent estate than newer ophthalmic products that use differentiated delivery systems, sustained-release technologies, combination formulations, or proprietary devices.

Product type	Patent strength	Primary competitive barrier
MIOCHOL-E	Low	Sterile manufacturing and procedural familiarity
Legacy carbachol products	Low	Supply, hospital contracts, and surgeon familiarity
Novel sustained-release ophthalmic products	Medium to high	Formulation and delivery patents
Branded intracameral combinations	Medium to high	Combination, formulation, and method-of-use claims
Generic topical ophthalmic drugs	Low to medium	Manufacturing scale and regulatory compliance

MIOCHOL-E’s principal commercial defense is product availability. Hospitals and surgery centers value validated sterile supply because intraocular products cannot tolerate the same quality or substitution risks as ordinary oral medicines.

What companies are challenging MIOCHOL-E?

No major public Paragraph IV campaign is broadly associated with MIOCHOL-E. The product’s age and limited revenue opportunity reduce the incentive for high-profile patent litigation.

Potential competitive entry would more likely involve:

1. An ANDA applicant seeking approval for an equivalent acetylcholine chloride intraocular product.
2. A manufacturer offering carbachol or another intraoperative miotic.
3. A surgical-pharmaceutical supplier competing through contracts and distribution.
4. A formulation company developing a ready-to-use or lower-handling alternative.

A Paragraph IV challenge is less commercially consequential when the reference product has no significant unexpired patent estate. The key barriers would then be FDA equivalence requirements, sterile production, facility capacity, and commercial contracting.

What formulation patents protect MIOCHOL-E?

MIOCHOL-E’s formulation is commercially important but does not appear to provide the type of high-value, long-duration exclusivity associated with modern proprietary delivery platforms.

Relevant formulation and manufacturing considerations include:

• Sterile powder presentation.
• Reconstitution before administration.
• Stability of acetylcholine chloride.
• Control of particulate matter.
• Container-closure integrity.
• Endotoxin and sterility controls.
• Compatibility with intraocular administration.
• Consistency of delivered concentration.

These requirements create a technical barrier. They do not necessarily create a durable patent barrier. A competitor could avoid some risk by developing a different presentation, such as a ready-to-use solution, if it can demonstrate adequate stability, sterility, container compatibility, and clinical or regulatory comparability.

What is the market size for MIOCHOL-E?

Public sources do not disclose standalone MIOCHOL-E revenue, unit volume, market share, or gross margin. Bausch + Lomb reports revenue by broader business segments rather than by every ophthalmic surgical product. The product’s revenue is therefore best assessed through market drivers and portfolio context rather than a reported product-level income statement. (Bausch + Lomb Corporation, 2024)

The addressable market is shaped by:

• Global cataract procedure volumes.
• Growth in ophthalmic ambulatory surgery.
• Aging populations.
• Procedure mix and surgeon preference.
• Adoption of alternative miotics.
• Hospital purchasing policies.
• Product availability and shortages.
• Price increases in low-volume sterile injectables.

Cataract surgery provides the largest underlying demand pool. Global cataract surgery volumes continue to rise with demographic aging and expanding access to surgery, but MIOCHOL-E captures only a narrow portion of the associated pharmaceutical spend. Market growth in units can therefore coexist with flat or declining product revenue if the product loses share or faces price pressure.

What is the financial trajectory of MIOCHOL-E?

MIOCHOL-E is likely a mature, relatively small contributor within its owner’s ophthalmic surgical portfolio. Its financial trajectory is more likely to be characterized by stable-to-declining volume with intermittent price-driven revenue increases than by sustained innovation-led growth.

Financial driver	Likely effect on MIOCHOL-E
Rising cataract procedures	Supports unit demand
Aging population	Supports long-term procedure growth
Generic entry	Pressures price and share
Alternative miotics	Limits category growth
Supply interruptions	Can reduce sales or produce temporary price increases
Sterile manufacturing costs	Compress margin if scale is low
Hospital contracting	Pressures net realized price
Product familiarity	Supports retention
Lack of patent protection	Limits long-term pricing power

A product-level revenue forecast cannot be derived from Bausch + Lomb’s public financial statements because the company does not separately report MIOCHOL-E sales. The appropriate investment interpretation is that MIOCHOL-E is a portfolio maintenance asset rather than a primary growth product.

How does MIOCHOL-E compare with carbachol and newer surgical alternatives?

MIOCHOL-E competes within a narrow intraoperative miotic market. Carbachol products can provide an alternative pharmacologic approach, while some procedures may use other techniques or products depending on surgeon preference and surgical context.

Factor	MIOCHOL-E	Carbachol alternatives	Newer ophthalmic surgical products
Active ingredient	Acetylcholine chloride	Carbachol	Varies
Market maturity	Very mature	Mature	Often newer
Patent position	Weak	Generally weak for legacy products	May be stronger
Sterility burden	High	High	High
Pricing power	Limited	Limited	Potentially higher
Switching barrier	Procedural familiarity	Procedural familiarity	Clinical evidence and workflow
Growth profile	Procedure-linked	Procedure-linked	May benefit from innovation

MIOCHOL-E benefits from surgeon familiarity and established use. Newer products can compete by reducing preparation steps, improving dosing consistency, combining multiple intraoperative functions, or offering differentiated delivery.

What generic launch risks exist for MIOCHOL-E?

Generic entry risk is legally higher than the commercial threat may appear. The absence of strong patent protection lowers the litigation barrier, but market entry still requires a viable sterile manufacturing and distribution model.

High-risk factors

• A successful ANDA for an equivalent intraocular dosage form.
• A competitor with existing sterile ophthalmic capacity.
• Hospital contracts that favor lower-cost alternatives.
• Recurrent product shortages that prompt formulary substitution.
• A ready-to-use formulation that reduces operating-room preparation.

Moderating factors

• Small absolute market size.
• Limited revenue available to support a costly launch.
• Sterile injectable quality requirements.
• Need for reliable supply to hospitals and surgery centers.
• Surgeon and pharmacy preference for established products.
• Potentially low gross profit after manufacturing and distribution costs.

The most credible launch scenario is gradual institutional uptake rather than an immediate full-market conversion. A generic could enter selectively through distributors and hospital systems, then expand if it demonstrates consistent supply and equivalent clinical performance.

What manufacturing and intellectual-property barriers affect MIOCHOL-E?

Manufacturing risk is more important than patent risk. A company entering the market must maintain validated sterile production, control contamination risk, and ensure reliable supply of a product used directly inside the eye.

Key barriers include:

• Sterile filling or powder manufacturing.
• Validated reconstitution performance.
• Stability and shelf-life data.
• Container-closure integrity.
• Inspection readiness.
• Pharmacopoeial compliance.
• Batch-release testing.
• Reliable distribution to surgical accounts.

These requirements can protect the incumbent commercially even without enforceable patents. A small market with high quality costs can support a de facto supplier advantage, but that advantage can disappear if a larger sterile-injectable manufacturer enters.

What litigation and settlement agreements affect MIOCHOL-E?

No major publicly established patent litigation or Paragraph IV settlement is central to the current MIOCHOL-E market profile. The absence of prominent litigation is consistent with the product’s age, limited public revenue base, and weak apparent patent value.

Commercial disputes are more likely to involve:

• Supply contracts.
• Manufacturing or distribution agreements.
• Product shortages.
• Quality investigations.
• Hospital formulary decisions.
• Product liability or adverse-event claims.

Any confidential licensing, supply, or settlement agreement would not be reflected in public product labeling or routine financial disclosures unless it had material financial significance.

What is the geographic coverage of MIOCHOL-E?

MIOCHOL-E’s strongest commercial position is associated with markets where:

• Cataract surgery volumes are high.
• Ophthalmic surgery is concentrated in hospitals and ambulatory centers.
• Sterile ophthalmic products are purchased through established distributors.
• The product has a recognized regulatory history.
• Surgeons use intraoperative miotics as part of standard practice.

Geographic performance can vary materially because acetylcholine chloride products may have different brand names, registrations, suppliers, and reimbursement treatment outside the United States. U.S. FDA approval does not establish authorization in Europe, Canada, Japan, or emerging markets.

Key Takeaways

• MIOCHOL-E is a mature acetylcholine chloride intraocular product used primarily during cataract and anterior-segment surgery.
• Its FDA reference product is associated with NDA 018667.
• Patent and statutory exclusivity are not meaningful current commercial protections.
• No major public Paragraph IV litigation campaign is associated with the product.
• Product-level revenue and margin are not separately disclosed by Bausch + Lomb.
• Demand is linked to ophthalmic surgery volumes, particularly cataract procedures.
• Generic risk is moderated by sterile manufacturing requirements and the limited size of the addressable market.
• The product is best viewed as a mature portfolio asset with supply-driven pricing potential, not as a high-growth pharmaceutical franchise.
• The strongest competitive risks are generic sterile entry, alternative miotics, and newer products that simplify intraoperative preparation.

FAQs About MIOCHOL-E Market and Exclusivity

Is MIOCHOL-E still FDA approved?

Yes. FDA labeling identifies MIOCHOL-E as an acetylcholine chloride intraocular product for inducing miosis during ophthalmic surgery. (FDA, n.d.-a)

Does MIOCHOL-E have biosimilar competition?

No. MIOCHOL-E is a small-molecule drug, not a biologic. Any direct competitor would generally use a small-molecule generic or abbreviated regulatory pathway.

Is MIOCHOL-E listed in the Orange Book?

The product is associated with FDA NDA 018667. Current Orange Book patent status should be evaluated against the latest FDA listing because patent records and marketing status can change. (FDA, n.d.-b)

What is the main commercial risk to MIOCHOL-E?

The main risks are sterile generic entry, supply disruption, hospital price pressure, and substitution by carbachol or newer intraoperative ophthalmic products.

Does Bausch + Lomb report MIOCHOL-E revenue separately?

No. Public Bausch + Lomb financial reporting presents broader segment and portfolio results rather than a standalone MIOCHOL-E revenue line. (Bausch + Lomb Corporation, 2024)

References

1. Bausch + Lomb Corporation. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
2. U.S. Food and Drug Administration. (n.d.-a). MIOCHOL-E: Acetylcholine chloride ophthalmic intraocular solution prescribing information.
3. U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations: Orange Book.