Phenylephrine hydrochloride; tropicamide - Generic Drug Details

What are the generic drug sources for phenylephrine hydrochloride; tropicamide and what is the scope of freedom to operate?

Phenylephrine hydrochloride; tropicamide is the generic ingredient in one branded drug marketed by Eyenovia and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Phenylephrine hydrochloride; tropicamide has forty-four patent family members in fourteen countries.

Summary for phenylephrine hydrochloride; tropicamide

International Patents:	44
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	26
DailyMed Link:	phenylephrine hydrochloride; tropicamide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for phenylephrine hydrochloride; tropicamide

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SPRAY, METERED;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for phenylephrine hydrochloride; tropicamide

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

Sponsor	Phase
National and Kapodistrian University of Athens	Phase 4
Eyenovia Inc.	Phase 4
Ocuphire Pharma, Inc.	Phase 3

See all phenylephrine hydrochloride; tropicamide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for phenylephrine hydrochloride; tropicamide

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AX	Other agents for treatment of hemorrhoids and anal fissures for topical use
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for phenylephrine hydrochloride; tropicamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No

International Patents for phenylephrine hydrochloride; tropicamide

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2593056
Japan	2013535250
China	103124541
Chile	2013000153
Japan	2017213381	遠隔治療及び遠隔モニタリングを実施する方法及びシステム (METHOD AND SYSTEM FOR PERFORMING REMOTE TREATMENT AND REMOTE MONITORING)

Supplementary Protection Certificates for phenylephrine hydrochloride; tropicamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	92923	Luxembourg		PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728

Phenylephrine Hydrochloride and Tropicamide: Market Dynamics and Financial Trajectory

Introduction

Phenylephrine hydrochloride and tropicamide are two critical pharmaceuticals widely used in medical practices, particularly in ophthalmology and respiratory care. This article delves into the market dynamics, financial trajectory, and key factors influencing the demand and supply of these drugs.

Phenylephrine Hydrochloride Market Overview

Market Size and Growth

The phenylephrine hydrochloride market has experienced significant growth in recent years. As of 2022, the market size was valued at USD 777.6 million and is projected to reach USD 1.6 billion by 2032, growing at a CAGR of 7.7% during the forecast period[4].

Drivers of Growth

Several factors contribute to the robust growth of the phenylephrine hydrochloride market:

• Increasing Prevalence of Respiratory Diseases: The rise in conditions such as the common cold, allergies, and sinusitis drives the demand for phenylephrine-based drugs. For instance, around 28.9 million adults in the U.S. were diagnosed with sinusitis in 2022, according to the CDC[3].
• Preference for Non-Sedating Decongestants: Phenylephrine is favored over pseudoephedrine due to its non-sedating properties, making it a popular choice in over-the-counter cold and allergy medications[3].

Market Segmentation

The phenylephrine hydrochloride market is segmented by application, mode of use, and region. The oral segment dominates the market, with a significant market share, while the tablets segment is the largest in terms of product type[3][4].

Regional Performance

North America holds a substantial market share, with the U.S. expected to exhibit a CAGR of 6.9% between 2024 and 2032. Other regions, such as Germany and India, are also expected to experience significant growth during the forecast period[3].

Challenges and Restraints

Financial Instability and Narrow Profit Margins

Generic drug manufacturers often face financial instability and narrow profit margins, which can lead to abrupt cessation of operations and careful production planning to avoid surplus inventory. This instability can result in supply-demand mismatches and rising prices[2].

Manufacturing Problems

Manufacturing issues at generic drug companies can lead to substandard products, which may be banned by federal inspectors. This not only affects the supply chain but also increases costs and reduces availability[2].

Regulatory Impact

Regulatory actions, such as the FDA's approval of specific formulations, can significantly impact the market. For example, the FDA's approval of Paragon's phenylephrine hydrochloride ophthalmic solution led to the withdrawal of other generic manufacturers from the market, resulting in price increases and supply shortages[2].

Tropicamide Market Dynamics

Clinical Use

Tropicamide is primarily used in ophthalmology for dilating pupils during eye examinations. It is often used in conjunction with other drugs like phenylephrine hydrochloride to achieve optimal dilation.

Market Impact

While specific market size data for tropicamide is not as readily available as for phenylephrine hydrochloride, its demand is closely tied to the ophthalmic sector. The increasing number of eye examinations and surgeries drives the demand for tropicamide.

Challenges in Ophthalmic Care

The lack of easy and inexpensive access to essential ophthalmic drugs like phenylephrine hydrochloride has clinical consequences, including the need for alternative, often less effective, treatments. This underscores the critical role of tropicamide and other ophthalmic drugs in maintaining eye health[2].

Financial Trajectory

Revenue Projections

The phenylephrine hydrochloride market is expected to grow significantly, with revenue projected to reach USD 1.6 billion by 2032. This growth is driven by increasing demand and expanding applications in respiratory and ophthalmic care[4].

Cost Implications

The rising prices of generic ophthalmic drugs, including phenylephrine hydrochloride, have significant cost implications for healthcare institutions. For example, the price of phenylephrine eyedrops has increased dramatically, from around $5 to $100 per bottle, affecting the budget of ophthalmic clinics and surgery centers[2].

Competitive Landscape

Key Players

The phenylephrine hydrochloride market is highly competitive, with key players such as Divi's Laboratories Limited, Aarti Pharmalabs Limited, and VBShilpa holding significant market shares. These companies engage in strategic acquisitions, mergers, collaborations, and partnerships to maintain their competitive edge[4].

Strategic Initiatives

Companies in the phenylephrine hydrochloride market are adopting multi-pronged approaches, including product launches, investments, and partnerships, to address the rising demand for phenylephrine drugs. This competitive landscape is crucial for understanding the market's dynamics and potential opportunities for growth[3].

Regulatory Considerations

FDA Evaluations

The FDA plays a critical role in regulating the use of phenylephrine hydrochloride, particularly in over-the-counter (OTC) nasal decongestants. Evaluations by the FDA can significantly impact the market, affecting the GRASE (Generally Recognized as Safe and Effective) status of oral phenylephrine and influencing industry practices[5].

Key Takeaways

• Robust Growth: The phenylephrine hydrochloride market is expected to grow significantly, driven by increasing demand for respiratory and ophthalmic care.
• Challenges: Financial instability, narrow profit margins, and manufacturing problems pose significant challenges to the market.
• Regional Performance: North America, particularly the U.S., dominates the market, with other regions like Germany and India showing promising growth.
• Regulatory Impact: FDA actions can significantly affect the market dynamics and availability of these drugs.
• Clinical Importance: Both phenylephrine hydrochloride and tropicamide are crucial in their respective clinical applications, with no substitutes available in many cases.

FAQs

Q: What are the primary drivers of growth in the phenylephrine hydrochloride market?

A: The primary drivers include the increasing prevalence of respiratory diseases, preference for non-sedating decongestants, and expanding applications in ophthalmic care.

Q: Why have prices for ophthalmic generics like phenylephrine hydrochloride skyrocketed?

A: Prices have increased due to financial instability at generic companies, narrow profit margins, and manufacturing problems leading to supply shortages.

Q: What is the projected market size of the phenylephrine hydrochloride market by 2032?

A: The market is projected to reach USD 1.6 billion by 2032, growing at a CAGR of 7.7% during the forecast period.

Q: How does the FDA's regulatory actions impact the phenylephrine hydrochloride market?

A: FDA actions can affect the GRASE status of oral phenylephrine, influence industry practices, and impact the availability and pricing of these drugs.

Q: What are the clinical consequences of the lack of easy access to phenylephrine hydrochloride in ophthalmic care?

A: The lack of access can lead to clinical consequences, including the need for alternative treatments, which may be less effective, and significant cost implications for healthcare institutions.

Sources

1. Market Research Intellect: Global Phenylephrine Hydrochloride API Market Size, Trends and ...
2. EyeNet: EyeNet investigates the forces at work behind rising prices and ...
3. GMI Insights: Phenylephrine Drugs Market Size & Share Report, 2024 – 2032
4. GMI Insights: Phenylephrine Hydrochloride Market Size Report, 2032
5. FDA: FDA Briefing Document: Oral Phenylephrine in the CCABA Monograph