TROPICAMIDE - Generic Drug Details

What are the generic sources for tropicamide and what is the scope of patent protection?

Tropicamide is the generic ingredient in four branded drugs marketed by Alcon, Alcon Labs Inc, Sandoz, Pharmafair, Epic Pharma Llc, Rising, Alcon Pharms Ltd, Bausch And Lomb, Miza Pharms Usa, Somerset Theraps Llc, and Watson Labs, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for tropicamide. Four suppliers are listed for this compound.

Summary for TROPICAMIDE

US Patents:	0
Tradenames:	4
Applicants:	11
NDAs:	15
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	41
Patent Applications:	6,549
Drug Prices:	Drug price trends for TROPICAMIDE
What excipients (inactive ingredients) are in TROPICAMIDE?	TROPICAMIDE excipients list
DailyMed Link:	TROPICAMIDE at DailyMed

See drug prices for TROPICAMIDE

Recent Clinical Trials for TROPICAMIDE

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

Sponsor	Phase
Yarmouk University	Phase 4
Jordan University of Science and Technology	Phase 4
Shanghai Eye Disease Prevention and Treatment Center	Phase 4

See all TROPICAMIDE clinical trials

Pharmacology for TROPICAMIDE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for TROPICAMIDE

Muscarinic Antagonists

Mydriatics

Anatomical Therapeutic Chemical (ATC) Classes for TROPICAMIDE

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for TROPICAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Somerset Theraps Llc	TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	207524-001	Dec 12, 2019	AT	RX	No	No
Miza Pharms Usa	TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	087637-001	Aug 9, 1982		DISCN	No	No
Sandoz	MYDRIACYL	tropicamide	SOLUTION/DROPS;OPHTHALMIC	084305-001	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes
Miza Pharms Usa	TROPICAMIDE	tropicamide	SOLUTION/DROPS;OPHTHALMIC	087636-001	Jul 30, 1982		DISCN	No	No
Pharmafair	MYDRIAFAIR	tropicamide	SOLUTION/DROPS;OPHTHALMIC	088274-001	Sep 16, 1983		DISCN	No	No
Alcon	MYDRIACYL	tropicamide	SOLUTION/DROPS;OPHTHALMIC	012111-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Epic Pharma Llc	TROPICACYL	tropicamide	SOLUTION/DROPS;OPHTHALMIC	040314-001	Sep 29, 2000	AT	RX	No	No

TROPICAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tropicamide

Introduction to Tropicamide

Tropicamide is a medication used to dilate the pupil, facilitating the examination of the eye. It is administered as eye drops and is often used in combination with other drugs like p-hydroxyamphetamine. Approved for medical use in the United States since 1960, tropicamide is listed on the World Health Organization's List of Essential Medicines[4].

Market Size and Growth Projections

The tropicamide market is expected to experience significant growth over the forecast period from 2023 to 2031. Here are some key projections:

• Market Size: The market is anticipated to grow substantially, with the global tropicamide market size expected to increase from its current value to a higher figure by 2031, driven by increasing awareness of eye-related diseases and the rising prevalence of conditions such as diabetic retinopathy, macular degeneration, and presbyopia[4].
• CAGR: The market is projected to grow at a notable Compound Annual Growth Rate (CAGR) during the forecast period, indicating a robust expansion in the market[4].

Market Segmentation

By Type

The tropicamide market is segmented based on the concentration of the drug:

• 0.005% and 0.01%: These are the primary concentrations in which tropicamide is available. The market dynamics vary based on the type, with different concentrations being preferred for different ophthalmic examinations[1].

By Distribution Channel

The market is also segmented by distribution channels:

• Hospitals: A significant portion of tropicamide is distributed through hospitals, where it is used for various ophthalmic procedures.
• Ophthalmic Clinics: These clinics are another major distribution channel, as they frequently use tropicamide for eye examinations.
• Pharmacies: Tropicamide is also available in pharmacies, catering to patients who need the medication for home use or follow-up care[4].

Regional Dynamics

North America

North America is a leading region in the tropicamide market, driven by a highly developed healthcare infrastructure and strong market presence. The region benefits from favorable reimbursement policies, a supportive regulatory environment, and significant investments in healthcare research. These factors contribute to the region's dominance in ophthalmic drug innovation, including tropicamide[3].

Asia-Pacific

The Asia-Pacific region is expected to exhibit rapid growth due to increasing consumer awareness and a rising burden of ophthalmic disorders. This region presents lucrative opportunities for market expansion, driven by growing healthcare investments and an aging population[3].

Europe, Middle East, Africa, and South & Central America

These regions also contribute to the global market, with varying growth rates. Europe has a well-established healthcare system, while the Middle East, Africa, and South & Central America are growing markets with increasing demand for ophthalmic care[4].

Market Drivers

Increasing Prevalence of Eye-Related Disorders

The rising prevalence of eye-related disorders such as diabetic retinopathy, macular degeneration, and presbyopia is a significant driver for the tropicamide market. As these conditions become more common, the demand for diagnostic tools like tropicamide increases[4].

Advancements in Drug Development

Technological advancements in drug formulation and delivery systems are also driving the market. Innovations such as combination therapies and new pharmacologic agents enhance the efficacy of ophthalmic care, including the use of tropicamide[3].

Aging Population

An aging population is another key driver, as older individuals are more prone to eye-related disorders. This demographic shift increases the demand for ophthalmic examinations and treatments, thereby boosting the tropicamide market[3].

Market Restraints

Lack of Skilled Ophthalmologists

The shortage of skilled ophthalmologists in some regions can hamper market growth. The lack of trained professionals limits the capacity for ophthalmic examinations and treatments, reducing the demand for tropicamide[4].

Non-Compliance with Treatment

Non-compliance with tropicamide treatment can also restrain market growth. Patients may not adhere to the prescribed treatment regimen, which can affect the overall market demand and growth[4].

Financial Constraints

Generic drug manufacturers face low profit margins, around 5%, compared to brand-name drug manufacturers who enjoy margins over 30%. This financial constraint can lead to production breakdowns, quality issues, and eventual drug shortages, impacting the tropicamide market[2][5].

Financial Trajectory

Revenue Forecast

The tropicamide market is expected to generate significant revenue during the forecast period. The market size is projected to increase from its current value to a higher figure by 2031, driven by the factors mentioned above[4].

Profit Margins

The profit margins for generic tropicamide manufacturers are slim, around 5%. This low margin can lead to financial instability and may cause companies to cease operations or exit the market, affecting the overall supply and pricing of the drug[2][5].

Market Concentration

The market concentration is relatively high, with a few key players dominating the market. This concentration can lead to reduced competition, which may result in price increases as fewer manufacturers remain in the market[3].

Key Takeaways

• The tropicamide market is poised for significant growth driven by increasing eye-related disorders and advancements in drug development.
• North America leads the market, while the Asia-Pacific region is expected to grow rapidly.
• Lack of skilled ophthalmologists and non-compliance with treatment are key restraints.
• Financial constraints, including low profit margins for generic manufacturers, can impact market dynamics.
• The market is expected to generate substantial revenue during the forecast period.

FAQs

What are the primary drivers of the tropicamide market?

The primary drivers include the increasing prevalence of eye-related disorders, advancements in drug development, and an aging population.

Which region is expected to lead the tropicamide market?

North America is currently leading the tropicamide market, driven by its well-developed healthcare infrastructure and strong market presence.

What are the main restraints affecting the tropicamide market?

The main restraints include the lack of skilled ophthalmologists, non-compliance with treatment, and financial constraints faced by generic drug manufacturers.

How do profit margins affect the tropicamide market?

Low profit margins for generic manufacturers can lead to financial instability, production breakdowns, and eventual drug shortages, impacting the market's overall supply and pricing.

What is the expected growth rate of the tropicamide market?

The market is projected to grow at a notable Compound Annual Growth Rate (CAGR) during the forecast period from 2023 to 2031.

Sources

1. Market Research Intellect: Global Tropicamide Eye Drop Market Size, Trends and Projections.
2. American Academy of Ophthalmology: The State of Generic Drugs.
3. Mordor Intelligence: Ophthalmic Drugs Market Size Research - Industry Trends & Share.
4. The Insight Partners: Tropicamide Market Strategies and Share 2031.
5. American Academy of Ophthalmology: EyeNet investigates the forces at work behind rising prices and shortages.