MIOCHOL-E Drug Patent Profile

When do Miochol-e patents expire, and what generic alternatives are available?

Miochol-e is a drug marketed by Bausch And Lomb and is included in one NDA.

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

Summary for MIOCHOL-E

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	3
Patent Applications:	1,147
DailyMed Link:	MIOCHOL-E at DailyMed

Recent Clinical Trials for MIOCHOL-E

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-E clinical trials

US Patents and Regulatory Information for MIOCHOL-E

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

Expired US Patents for MIOCHOL-E

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	MIOCHOL-E	acetylcholine chloride	FOR SOLUTION;OPHTHALMIC	020213-001	Sep 22, 1993

International Patents for MIOCHOL-E

See the table below for patents covering MIOCHOL-E around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	72209
Estonia	200000625
World Intellectual Property Organization (WIPO)	9955304

MIOCHOL-E Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Miochol-E

Introduction

Miochol-E, an acetylcholine chloride intraocular solution, is a brand-name medication manufactured by Bausch + Lomb and approved by the FDA for use in ophthalmic surgeries. Here, we delve into the market dynamics and financial trajectory of Miochol-E, highlighting its usage, costs, and comparative analysis with other similar medications.

Approval and Formulation

Miochol-E was approved by the FDA on September 22, 1993, and is available in a formulation of 20MG/VIAL for ophthalmic use[1].

Market Presence

Currently, there is no therapeutically equivalent generic version of Miochol-E available in the United States. This lack of generic competition can influence its market pricing and usage[1].

Cost Analysis

A significant aspect of Miochol-E's market dynamics is its cost. The medication is more expensive compared to its alternative, Miostat (carbachol intraocular solution 0.01%). The cost per unit of Miochol-E is $63.72, whereas Miostat costs $13.08 per unit[2][4].

Usage in Ophthalmic Surgeries

Miochol-E and Miostat are used to induce miosis during ophthalmic surgeries and to reduce intraocular pressure (IOP) spikes after cataract surgery. Despite the higher cost, Miochol-E remains a preferred choice for many ophthalmologists, largely due to a lack of awareness about the differences in cost and efficacy between the two medications[2][4].

Survey Findings

A survey involving 102 retina specialists revealed that:

• 69% of respondents use these miotic medications in less than 5% of their surgeries.
• 40% prefer Miochol-E, 16% prefer Miostat, and 44% have no preference.
• A significant majority (65%, 74%, and 91%) are unaware of the differences in duration of action, mechanism of action, and cost between Miochol-E and Miostat[2][4].

Financial Implications

The cost difference between Miochol-E and Miostat has substantial financial implications for ophthalmic surgery centers. For instance, a surgery center that purchased 237 units of Miochol-E in one year could have saved an estimated $11,000 by switching to Miostat[2][4].

Mechanism and Duration of Action

Miochol-E acts as a parasympathomimetic agent, mediating direct effects at cholinergic receptors and being rapidly degraded by the acetylcholinesterase enzyme. In contrast, Miostat (carbachol) has a longer duration of action. This difference in mechanism and duration can impact the choice of medication, although it is often overlooked by practitioners[4].

Industry Trends and Awareness

The preference for Miochol-E despite its higher cost and shorter duration of action highlights a lack of awareness among ophthalmologists about the cost and efficacy differences between these medications. Increasing awareness and education could shift market dynamics, potentially leading to a greater adoption of the more cost-effective Miostat[2][4].

Potential Savings

By switching from Miochol-E to Miostat, ophthalmic surgery centers can achieve significant cost savings. This shift could be particularly beneficial in a healthcare environment where cost containment is increasingly important. For example, a complete switch at one surgery center resulted in an estimated savings of $11,000 in one year[2][4].

Regulatory and Safety Considerations

It is crucial to note that any medication purchase, especially online, should be from reputable sources to avoid counterfeit medications. The absence of a generic version of Miochol-E also means that any generic versions available online could be fraudulent and potentially unsafe[1].

Conclusion

Miochol-E's market dynamics are characterized by its high cost, limited awareness among practitioners about its comparative efficacy and cost, and the absence of a generic equivalent. The financial trajectory of Miochol-E is influenced by these factors, making it a costly choice for ophthalmic surgeries despite its widespread use.

Key Takeaways

• Miochol-E is a brand-name medication with no generic equivalent available.
• It is more expensive than its alternative, Miostat.
• Lack of awareness among ophthalmologists about cost and efficacy differences affects its usage.
• Significant cost savings can be achieved by switching to Miostat.
• Increasing awareness and education could shift market preferences.

FAQs

1. Is there a generic version of Miochol-E available? No, there is currently no therapeutically equivalent generic version of Miochol-E available in the United States[1].

2. How does the cost of Miochol-E compare to Miostat? Miochol-E costs $63.72 per unit, while Miostat costs $13.08 per unit[2][4].

3. Why do ophthalmologists prefer Miochol-E over Miostat? The preference for Miochol-E is largely due to a lack of awareness about the differences in cost and efficacy between the two medications[2][4].

4. What are the potential savings from switching from Miochol-E to Miostat? A surgery center could save an estimated $11,000 in one year by switching from Miochol-E to Miostat[2][4].

5. What are the implications of using counterfeit medications? Using counterfeit medications can be potentially unsafe. It is crucial to purchase medications from reputable sources to avoid such risks[1].

Sources

1. Drugs.com - Generic Miochol-E Availability
2. Retina Today - The Cost Efficiency of Miotics Use in Ophthalmic Surgeries
3. ASHP - Strategic Directions in System Formulary, Drug Policy, and High-Cost Drugs Whitepaper
4. Retina Today - The Cost Efficiency of Miotics Use in Ophthalmic Surgeries