CARBACHOL - Generic Drug Details

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

Carbachol is the generic ingredient in three branded drugs marketed by Pharmafair, Novartis, and Alcon, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for carbachol. One supplier is listed for this compound.

Summary for CARBACHOL

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	7
Patent Applications:	6,627
What excipients (inactive ingredients) are in CARBACHOL?	CARBACHOL excipients list
DailyMed Link:	CARBACHOL at DailyMed

Recent Clinical Trials for CARBACHOL

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

Sponsor	Phase
Visus Therapeutics	Phase 3
Visus Therapeutics	Phase 2
Hannover Medical School

See all CARBACHOL clinical trials

Pharmacology for CARBACHOL

Drug Class	Cholinergic Receptor Agonist
Mechanism of Action	Cholinergic Agonists

Medical Subject Heading (MeSH) Categories for CARBACHOL

Analgesics, Non-Narcotic

Cardiotonic Agents

Cholinergic Agonists

Miotics

Anatomical Therapeutic Chemical (ATC) Classes for CARBACHOL

N07AB	Choline esters
N07A	PARASYMPATHOMIMETICS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

S01EB	Parasympathomimetics
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for CARBACHOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	CARBASTAT	carbachol	SOLUTION;INTRAOCULAR	073677-001	Apr 28, 1995		DISCN	No	No
Alcon	MIOSTAT	carbachol	SOLUTION;INTRAOCULAR	016968-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Pharmafair	CARBACHOL	carbachol	SOLUTION;INTRAOCULAR	070292-001	May 21, 1986		DISCN	No	No

CARBACHOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carbachol

Introduction

Carbachol, a small molecule drug and a direct-acting miotic agent, has been a staple in ophthalmic surgeries for decades. Its role in inducing miosis and reducing intraocular pressure makes it a crucial component in the management of various ophthalmic conditions. Here, we delve into the market dynamics and financial trajectory of carbachol, exploring its usage, costs, and market preferences.

Historical Background and FDA Approval

Carbachol, also known as carbamoylcholine, was discovered in 1932 and initially used for various parasympathetic effects, including the treatment of migraines and induction of diuresis. It received FDA approval on September 28, 1972, marking its official entry into the pharmaceutical market[4].

Mechanism of Action and Therapeutic Uses

Carbachol acts as an agonist for both muscarinic and nicotinic acetylcholine receptors. This mechanism allows it to induce miosis during surgery and reduce intraocular pressure elevations in the first 24 hours after cataract surgery. Its resistance to hydrolysis by acetylcholinesterase results in a longer duration of action compared to other choline esters, making it particularly effective in ophthalmic procedures[2][4].

Market Segmentation and User Preferences

In the ophthalmic surgery market, carbachol is used under various brand names such as Miostat and Carbastat. Despite its efficacy and cost-effectiveness, user preferences vary among ophthalmologists. A survey indicated that 40% of respondents preferred acetylcholine (Miochol) over carbachol (Miostat), despite the higher cost and shorter duration of action of acetylcholine. This preference is largely due to a lack of awareness about the differences in cost and efficacy between the two medications[3].

Cost Analysis and Financial Implications

The cost analysis of carbachol versus acetylcholine reveals significant financial implications. Carbachol (Miostat) is substantially cheaper than acetylcholine (Miochol), with costs per unit of $13.08 and $63.72, respectively. A switch from Miochol to Miostat could result in considerable cost savings for ophthalmic surgery centers. For instance, one surgery center estimated a savings of $11,000 in one year by making this switch[3].

Market Availability and Pricing

Carbachol is available in various formulations, including intraocular solutions and powders. The pricing varies based on the formulation and the region. For example, Isopto Carbachol 3% solution can cost around $61.76 per 15ml bottle, while the 1.5% solution costs approximately $48.64 per 15ml bottle. The powder form is also available, priced around $53.1 per gram[4].

Competitive Landscape

The competitive landscape for miotic agents in ophthalmic surgeries is relatively niche, with carbachol and acetylcholine being the primary players. However, the preference for acetylcholine among some ophthalmologists, despite its higher cost, indicates a need for greater awareness and education about the benefits of carbachol. Other brands like Carboptic and Mioticol also exist, but carbachol remains a dominant player due to its efficacy and cost-effectiveness[4].

Regulatory and Safety Considerations

Carbachol has specific contraindications and blackbox warnings, particularly for patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, gastrointestinal spasm, urinary tract obstruction, or Parkinson's disease. These considerations are crucial for safe administration and to prevent adverse drug events[4].

Future Outlook and Market Trends

The future outlook for carbachol is promising, given its established role in ophthalmic surgeries and its cost-effectiveness. As more ophthalmologists become aware of the differences in cost and efficacy between carbachol and acetylcholine, there is likely to be a shift towards greater adoption of carbachol. Additionally, advancements in pharmaceutical technology and manufacturing could further reduce costs and improve accessibility.

Key Takeaways

• Cost-Effectiveness: Carbachol is significantly cheaper than acetylcholine, offering substantial cost savings for ophthalmic surgery centers.
• Duration of Action: Carbachol has a longer duration of action compared to acetylcholine, making it more effective in managing intraocular pressure post-surgery.
• User Preferences: Despite its advantages, carbachol faces preference challenges due to a lack of awareness among ophthalmologists.
• Market Availability: Carbachol is available in various formulations and regions, with varying prices.
• Regulatory Considerations: Carbachol has specific contraindications and safety warnings that must be considered.

FAQs

What is the primary use of carbachol in ophthalmic surgeries?

Carbachol is primarily used to induce miosis during surgery and to reduce intraocular pressure elevations in the first 24 hours after cataract surgery.

How does carbachol compare to acetylcholine in terms of cost?

Carbachol is significantly cheaper than acetylcholine, with costs per unit of $13.08 and $63.72, respectively.

What are the contraindications for carbachol?

Carbachol is contraindicated for patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, gastrointestinal spasm, urinary tract obstruction, or Parkinson's disease.

How long does the effect of carbachol last?

The effect of carbachol can last up to 24 hours after intraocular administration due to its resistance to hydrolysis by acetylcholinesterase.

What are the brand names under which carbachol is available?

Carbachol is available under brand names such as Miostat, Carbastat, Carboptic, and Mioticol.

Sources

1. Patsnap Synapse - Carbachol - Drug Targets, Indications, Patents.
2. EMD Millipore - Carbachol - CAS 51-83-2 - Calbiochem.
3. Retina Today - The Cost Efficiency of Miotics Use in Ophthalmic Surgeries.
4. DrugBank - Carbachol: Uses, Interactions, Mechanism of Action.
5. Sigma-Aldrich - Carbachol.