MIOSTAT Drug Patent Profile

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

Miostat is a drug marketed by Alcon and is included in one NDA.

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

Summary for MIOSTAT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	1
Patent Applications:	4,158
Drug Prices:	Drug price information for MIOSTAT
What excipients (inactive ingredients) are in MIOSTAT?	MIOSTAT excipients list
DailyMed Link:	MIOSTAT at DailyMed

See drug prices for MIOSTAT

Recent Clinical Trials for MIOSTAT

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

Sponsor	Phase
Cairo University	N/A

See all MIOSTAT clinical trials

Pharmacology for MIOSTAT

Drug Class	Cholinergic Receptor Agonist
Mechanism of Action	Cholinergic Agonists

US Patents and Regulatory Information for MIOSTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon	MIOSTAT	carbachol	SOLUTION;INTRAOCULAR	016968-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

MIOSTAT Market Dynamics, Patent Position, and Financial Trajectory

Last updated: August 6, 2026

MIOSTAT is a mature ophthalmic surgical product containing carbachol 0.01% for rapid intraocular miosis during cataract and other anterior-segment procedures. Its commercial value is limited by generic competition, an old active ingredient, lack of meaningful patent exclusivity, and low standalone revenue visibility. MIOSTAT is unlikely to be a material growth driver for its manufacturer, but it remains commercially relevant in operating-room ophthalmology because surgeons use it as a low-cost, established miosis agent.

What is MIOSTAT and how is it used?

MIOSTAT is an intraocular solution of carbachol, a parasympathomimetic cholinergic agonist. The product is administered inside the eye during surgery to produce miosis after removal of the lens or following other anterior-segment procedures.

Attribute	MIOSTAT profile
Brand name	MIOSTAT
Active ingredient	Carbachol
Strength	0.01%, equivalent to 0.1 mg/mL
Dosage form	Sterile intraocular solution
Primary use	Induction of miosis during ophthalmic surgery
Therapeutic category	Ophthalmic surgical agent
Administration	Intraocular, typically administered by the surgeon
Primary setting	Cataract and anterior-segment surgery
Product type	Small-molecule sterile injectable ophthalmic
Biologic status	Not a biologic; biosimilar pathway does not apply

The product has a narrow perioperative role. It is not a chronic prescription medicine and does not generate recurring prescription volume comparable with glaucoma, retinal, or ocular-surface therapies.

What is the FDA regulatory status of MIOSTAT?

MIOSTAT was approved through the FDA new drug application pathway and is associated with carbachol intraocular solution. FDA labeling identifies the product as a sterile intraocular preparation intended for use during surgery.[1]

The product’s regulatory economics are different from those of a conventional outpatient drug. Demand depends on surgical procedure volume, hospital formulary decisions, distributor inventories, and operating-room purchasing contracts. A product can remain clinically established while generating limited commercial revenue.

The FDA regulatory record should be reviewed for the current marketing status of the specific MIOSTAT application and any approved generic carbachol intraocular products. FDA databases can show whether an application is active, withdrawn, or listed as discontinued. A discontinued listing does not necessarily establish that no equivalent product is available, because products can be supplied under different application or labeling arrangements.

What patents protect MIOSTAT?

MIOSTAT does not have a meaningful remaining composition-of-matter patent position. Carbachol is an old active pharmaceutical ingredient, and the commercial product has been marketed for decades.

Protection category	MIOSTAT position
Composition-of-matter patent	Expired or commercially irrelevant
Core use patent	No meaningful current exclusivity identified
Formulation patent	No material modern exclusivity identified
Device patent	Not central to MIOSTAT’s market position
Manufacturing patent	Potentially relevant to suppliers, but unlikely to block ordinary generic entry
Regulatory exclusivity	No current exclusivity expected for this mature product
Biosimilar exclusivity	Not applicable

MIOSTAT’s competitive position therefore depends on manufacturing capability, quality systems, sterile-fill capacity, supply reliability, surgeon familiarity, and distribution rather than enforceable patent barriers.

What formulations are protected by MIOSTAT patents?

The commercial formulation is a low-concentration sterile carbachol solution. No current patent estate appears to provide durable protection for the basic formulation. Any historical formulation or process patents would be expected to have expired or to lack practical blocking power against modern equivalent products.

The technical barriers are operational rather than legal. Sterile ophthalmic products require validated aseptic manufacturing, container-closure integrity, stability data, particulate control, and compliance with current good manufacturing practice. These requirements can restrict the number of reliable suppliers even where patent protection is absent.

When does MIOSTAT lose exclusivity?

MIOSTAT’s meaningful market exclusivity was lost long ago. The product is outside the commercial life cycle in which patent expiry would create a discrete revenue shock. Generic and alternative-product competition can arise without a significant near-term patent cliff.

The relevant exclusivity timeline is:

Milestone	Commercial implication
Original approval and launch	Established carbachol as an intraocular miosis option
Expiration of historical patent rights	Removed meaningful branded exclusivity
Development of equivalent products	Shifted competition toward price, supply, and procurement
Current market phase	Mature, low-growth surgical niche

There is no identified future MIOSTAT patent expiration date that is likely to create a major market event. The principal risk is product availability and substitution, not a pending loss of patent protection.

Does MIOSTAT have Orange Book protection?

MIOSTAT should not be treated as an Orange Book-protected growth product. Any listed patents associated with an older application would require confirmation against the current FDA Orange Book entry and patent-listing data.[2]

For commercial analysis, the key point is that MIOSTAT has no apparent remaining patent term capable of supporting premium pricing or delaying equivalent entry. An Orange Book listing, if present, would not automatically establish a commercially meaningful barrier. The patent must be unexpired, relevant to the approved product, and enforceable against the proposed competing product.

Are there Paragraph IV challenges to MIOSTAT?

No major, current Paragraph IV litigation campaign is publicly associated with MIOSTAT. That is consistent with the product’s age and limited revenue opportunity.

Paragraph IV litigation is most economically attractive when:

1. The reference product has substantial annual sales.
2. The generic applicant expects a significant price-volume opportunity.
3. A patent remains in force.
4. The branded company has a reason to defend the product aggressively.

MIOSTAT does not appear to satisfy those conditions. Any generic applicant would be more likely to rely on ordinary abbreviated new drug application procedures and compete on supply, price, and contracting than pursue a high-value patent challenge.

Which companies compete with MIOSTAT?

MIOSTAT competes with other intraoperative miosis products and with nonpharmacologic approaches.

Direct pharmacologic competitors

The closest alternatives include:

• Carbachol intraocular solution supplied by manufacturers other than the MIOSTAT brand.
• Acetylcholine intraocular products, historically associated with Miochol-E.
• Other surgeon-administered miotics used during anterior-segment procedures.

Indirect competitors

MIOSTAT also competes with:

• Intraoperative pharmacologic regimens that combine mydriatic, anti-inflammatory, and analgesic functions.
• Phenylephrine and ketorolac products such as Omidria, which target different perioperative needs but can influence operating-room purchasing.
• Irrigation strategies and surgical techniques that reduce the perceived need for a separate miotic.
• Mechanical pupil-management devices, including iris hooks and expansion rings, in selected cases.

MIOSTAT’s strongest advantage is its focused pharmacologic effect and long clinical familiarity. Its weaknesses are the need for intraocular administration, limited differentiation, and exposure to low-cost substitutes.

How strong is the MIOSTAT patent estate?

MIOSTAT has a weak patent estate from an investment and litigation perspective.

Patent-estate factor	Assessment
Active ingredient differentiation	Weak
Remaining patent term	No material term expected
Formulation differentiation	Limited
Method-of-use exclusivity	Limited
Manufacturing protection	Possible but not likely to block competitors
Litigation leverage	Low
Generic-entry deterrence	Low
Regulatory switching costs	Moderate because of sterile product requirements
Commercial defensibility	Based on supply and quality, not patents

The product can still have operational value despite weak intellectual-property protection. Hospital customers may prefer a supplier with dependable availability and consistent quality, especially for sterile intraocular products. That preference is a commercial advantage, not exclusivity.

What is MIOSTAT’s financial trajectory?

MIOSTAT’s standalone revenue is not generally disclosed in public company financial reporting. Manufacturers typically report ophthalmology revenue at a broader segment level rather than identifying sales for an individual mature surgical product.

The most defensible financial profile is:

Financial driver	Expected effect
Cataract procedure growth	Supports unit demand
Generic pricing	Limits revenue per unit
Hospital procurement	Creates price pressure
Product shortages	Can cause abrupt volume changes
Supplier consolidation	May improve pricing temporarily
Surgical substitution	Caps long-term demand
Brand investment	Unlikely to be substantial
Standalone revenue disclosure	Generally unavailable

MIOSTAT is likely a low-revenue, low-growth product relative to branded ophthalmology medicines. Its trajectory is more likely to be stable or gradually declining in value than to show conventional branded-drug expansion.

The product’s economic sensitivity is volume-driven. Global cataract surgery volumes continue to support demand for perioperative ophthalmic products, but that growth does not necessarily translate into MIOSTAT revenue growth. Hospitals and ambulatory surgery centers often buy mature surgical products through tenders, formularies, distributors, and group purchasing organizations. These channels compress pricing.

What drives MIOSTAT revenue?

MIOSTAT revenue is primarily determined by:

• Number of cataract and anterior-segment procedures.
• Percentage of procedures using carbachol rather than alternative approaches.
• Geographic availability.
• Hospital and ambulatory surgery center contracts.
• Wholesale acquisition price and generic discounts.
• Product shortages or manufacturing interruptions.
• Surgeon preference and procedural protocol.

The product is not exposed to refill persistence or chronic adherence. Revenue rises and falls with procedure volume and market share.

Is MIOSTAT material to Alcon or its former commercial owner?

MIOSTAT is unlikely to be material to the consolidated financial results of a large ophthalmology company. Alcon reports major businesses across surgical and vision-care categories, but mature products of this size are generally not separately reported.[3]

The product can still have strategic value if it completes a surgical portfolio, supports distributor relationships, or fills a formulary need. That strategic value should not be confused with significant revenue contribution.

What generic entry risks exist for MIOSTAT?

Generic-entry risk is high because the product has:

• An old active ingredient.
• No meaningful current patent barrier.
• A simple solution dosage form.
• Limited therapeutic differentiation.
• A concentrated but established surgical use.
• Price-sensitive institutional buyers.

The main constraint is not intellectual property. It is regulatory and manufacturing execution. An entrant must demonstrate pharmaceutical equivalence, sterility, stability, container compatibility, and reliable commercial production.

The commercial opportunity may still be limited. A generic manufacturer faces a relatively small market, specialized sterile manufacturing requirements, and potential competition from established suppliers. These factors can reduce the number of entrants even when legal entry is straightforward.

What patent litigation affects MIOSTAT?

No significant current patent litigation appears to define the MIOSTAT market. The absence of litigation is commercially meaningful because it indicates that the product is not being defended through a high-value exclusivity strategy.

Potential disputes would more likely involve:

• Product quality or manufacturing compliance.
• Distribution and supply agreements.
• Trade name or trademark issues.
• Contractual procurement arrangements.
• Regulatory status of an equivalent product.

A patent case would be less likely unless a supplier introduced a differentiated delivery system, preservative-free container, novel concentration, or combination product with new patentable features.

What licensing deals affect MIOSTAT?

No major, publicly disclosed licensing transaction appears to determine the current MIOSTAT market. Mature ophthalmic surgical products can change hands through portfolio acquisitions, distribution agreements, or product-rights transfers without generating a separately disclosed transaction value.

The absence of a disclosed license limits the ability to assign a standalone valuation. Any transaction analysis should value MIOSTAT as a mature product-rights asset with modest revenue, limited pricing power, and supply-chain obligations rather than as a patent-protected brand.

How does MIOSTAT compare with newer ophthalmic surgical products?

Factor	MIOSTAT	Newer perioperative ophthalmic products
Active ingredient age	Very old	Often newer combinations or delivery approaches
Patent position	Weak or expired	May have active formulation or method patents
Clinical role	Focused miosis	May combine dilation, inflammation control, or pain control
Pricing power	Low	Higher if differentiated and protected
Revenue model	Procedure-linked	Procedure-linked, sometimes premium-priced
Generic risk	High	Depends on patent and regulatory status
Supply sensitivity	High	High
Commercial growth	Limited	Can grow with adoption and premium reimbursement

MIOSTAT is best understood as a mature surgical input. Newer products can command higher prices when they reduce preparation steps, improve operating-room efficiency, combine multiple agents, or receive favorable reimbursement. MIOSTAT’s value rests on familiarity and function rather than innovation.

What is the outlook for MIOSTAT?

The base-case outlook is stable-to-declining revenue value, with demand supported by cataract procedure growth but constrained by generic pricing and substitution.

The most important commercial variables are:

1. Continued availability of sterile carbachol intraocular products.
2. Surgeon retention of carbachol-based miosis protocols.
3. Growth in cataract surgery volumes.
4. Competitive pricing from equivalent products.
5. Expansion of combination or workflow-saving surgical products.
6. Manufacturing reliability and shortage risk.

MIOSTAT has low patent risk, low litigation risk, and high generic risk. Its primary business risk is commoditization. Its primary support is continued procedural demand and clinical familiarity.

Key Takeaways

• MIOSTAT is carbachol 0.01% used to induce miosis during ophthalmic surgery.
• It is a mature small-molecule surgical product with no meaningful remaining patent exclusivity.
• No major current Paragraph IV campaign or patent litigation appears to affect the product.
• Biosimilar risk is irrelevant because MIOSTAT is not a biologic.
• Generic and alternative-product risk is high.
• Sterile manufacturing, quality compliance, and supply reliability are the main barriers to entry.
• Standalone revenue is not publicly disclosed and is unlikely to be material to a large ophthalmology company.
• The financial trajectory is likely stable-to-declining in value, despite support from cataract procedure growth.
• Commercial defensibility depends on availability, procurement relationships, and surgeon familiarity rather than patents.

FAQs

Is MIOSTAT still commercially available?

MIOSTAT’s availability depends on the current FDA marketing status, manufacturer supply, and distributor inventory. Equivalent carbachol intraocular products may be available even when a branded product is listed as discontinued or has limited distribution.

Is carbachol intraocular solution a generic drug?

Carbachol intraocular solution can be supplied as a generic equivalent when an FDA-approved abbreviated application exists. The commercial market should be assessed by product listing and supplier availability rather than by brand name alone.

Can MIOSTAT be substituted during cataract surgery?

Substitution depends on the surgeon’s protocol, hospital formulary, product labeling, and the clinical role required. Acetylcholine products, alternative pharmacologic regimens, and mechanical pupil-management devices may substitute in selected procedures.

Does MIOSTAT qualify for pediatric exclusivity or orphan-drug protection?

MIOSTAT is not generally associated with current pediatric or orphan-drug exclusivity. Its use is established in ophthalmic surgery rather than tied to a rare-disease regulatory designation.

What would increase the value of a MIOSTAT product right?

Value would increase through reliable sterile supply, exclusive distribution, a differentiated preservative-free or ready-to-use presentation, combination-product innovation, or evidence showing operating-room efficiency. A conventional carbachol solution alone has limited pricing and growth potential.

References

1. U.S. Food and Drug Administration. (n.d.). MIOSTAT: Carbachol intraocular solution prescribing information. FDA.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA.
3. Alcon Inc. (2024). Annual report for the fiscal year ended December 31, 2023. Alcon Inc.