Epinastine hydrochloride - Generic Drug Details

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

Epinastine hydrochloride is the generic ingredient in two branded drugs marketed by Allergan, Apotex, Breckenridge, Chartwell Rx, Epic Pharma Llc, Somerset Theraps Llc, and Sun Pharm Inds, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for epinastine hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for epinastine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	15
Patent Applications:	595
What excipients (inactive ingredients) are in epinastine hydrochloride?	epinastine hydrochloride excipients list
DailyMed Link:	epinastine hydrochloride at DailyMed

Recent Clinical Trials for epinastine hydrochloride

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

Sponsor	Phase
Alcon Research	Phase 4
Aston University	Phase 4
University of Worcester	Phase 4

See all epinastine hydrochloride clinical trials

Generic filers with tentative approvals for EPINASTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		0.05%	SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for epinastine hydrochloride

Drug Class	Adrenergic Receptor Agonist Histamine-1 Receptor Inhibitor
Mechanism of Action	Adrenergic Agonists Histamine H1 Receptor Antagonists
Physiological Effect	Decreased Histamine Release

Anatomical Therapeutic Chemical (ATC) Classes for epinastine hydrochloride

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for EPINASTINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELESTAT	Ophthalmic Solution	epinastine hydrochloride	0.05%	021565	1	2008-10-14

US Patents and Regulatory Information for epinastine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	EPINASTINE HYDROCHLORIDE	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	203384-001	Dec 7, 2016		DISCN	No	No
Epic Pharma Llc	EPINASTINE HYDROCHLORIDE	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	204055-001	May 5, 2017		DISCN	No	No
Allergan	ELESTAT	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021565-001	Oct 16, 2003		DISCN	Yes	No
Sun Pharm Inds	EPINASTINE HYDROCHLORIDE	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	091626-001	Oct 31, 2011		DISCN	No	No
Breckenridge	EPINASTINE HYDROCHLORIDE	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	090870-001	Mar 14, 2011		DISCN	No	No

Expired US Patents for epinastine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ELESTAT	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021565-001	Oct 16, 2003	7,429,602

Epinastine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epinastine Hydrochloride

Introduction to Epinastine Hydrochloride

Epinastine hydrochloride is an antihistamine used primarily to treat allergic conjunctivitis and other allergic conditions. It belongs to the class of drugs that block the action of histamine, a chemical released by the immune system in response to allergens. Here, we will delve into the market dynamics and financial trajectory of epinastine hydrochloride.

Market Size and Growth Projections

The global epinastine market has been experiencing significant growth. As of 2023, the market size was valued at approximately USD 604.75 million, and it is projected to reach USD 1.58 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 10.1% during the forecast period from 2024 to 2032[3].

Segmentation of the Market

The epinastine hydrochloride market is segmented based on several criteria:

• Type: The market is categorized into purity levels, such as purity ≥ 98% and purity ≥ 99%[1].
• Application: The drug is used in various forms, including tablets, capsules, ophthalmic solutions, and other applications[1].
• Geography: The market is analyzed across different regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1].

Driving Factors

Several factors are driving the growth of the epinastine hydrochloride market:

• Rising Prevalence of Allergic Conjunctivitis: The increasing incidence of allergic conjunctivitis and other allergic conditions is a significant driver. As more people seek effective and convenient treatment options, the demand for epinastine hydrochloride is expected to rise[3].
• Research and Development: Ongoing research and development activities aimed at improving the efficacy, safety, and convenience of epinastine hydrochloride are also fueling market growth. Studies exploring its potential in treating other allergic conditions, such as rhinitis, asthma, and psoriasis, are contributing to this trend[3].

Challenges and Restraints

Despite the growth, the market faces several challenges:

• COVID-19 Pandemic: The pandemic has had a significant impact on the market, causing supply chain disruptions, regulatory hurdles, and economic slowdowns. This has led to shortages, price fluctuations, and delays in the approval and launch of new formulations[3].
• Economic Factors: The pandemic has also reduced the disposable income and purchasing power of consumers in some regions, potentially hampering market growth[3].

Competitive Landscape

The competitive landscape of the epinastine hydrochloride market is characterized by the presence of several key players:

• Santen Pharmaceutical: Known for its strong presence in the ophthalmic segment and significant contributions to the epinastine market[3].
• Merck: A major pharmaceutical company with a diverse portfolio, including antihistamines like epinastine hydrochloride[3].
• Sun Pharma: Another prominent player in the pharmaceutical industry, involved in the production and distribution of epinastine hydrochloride[3].
• Other Players: Companies like Jigs Chemical, Apotex Corp, Akorn, Allergan, and Boehringer Ingelheim also play significant roles in the market[3].

Financial Performance and Projections

The financial performance of companies involved in the epinastine hydrochloride market is indicative of the market's overall health:

• Santen Pharmaceutical: In FY2023, Santen reported a revenue of JPY 302.0 billion, with a core operating profit of JPY 62.8 billion, representing a 41.9% year-over-year increase. The company has also made significant progress in its medium-long term growth strategy, including structural reforms and R&D advancements[2].
• Market Revenue Projections: The global epinastine market is expected to grow substantially, with projected revenues reaching USD 1.58 billion by 2032. This growth is driven by increasing demand and ongoing research and development activities[3].

Regional Market Dynamics

The market dynamics vary across different regions:

• Asia-Pacific: This region is experiencing significant growth, driven by market recovery in China and the increasing demand for ophthalmic solutions. Companies like Santen have reported strong performance in this region, with growth exceeding expectations in key markets such as glaucoma and dry eye treatments[5].
• North America and Europe: These regions are also on a recovery path, with companies implementing structural reforms and cost optimization strategies to improve profitability. For instance, Santen completed structural reforms in the Americas, leading to improved profitability[2].

Research and Development

Research and development activities are crucial for the growth of the epinastine hydrochloride market:

• Pharmacokinetics and Pharmacodynamics: Studies on the pharmacokinetics, pharmacodynamics, and pharmacogenetics of epinastine hydrochloride are aimed at optimizing its dosage and administration. This research helps in enhancing the therapeutic effects and safety of the drug[3].
• Combination Therapies: Investigations into the combination of epinastine hydrochloride with other drugs or agents are also underway to enhance its therapeutic efficacy[3].

Market Opportunities and Challenges

The market presents several opportunities and challenges:

• Opportunities: The expanding geographical reach and customer base, along with the potential use of epinastine hydrochloride in treating other allergic conditions, offer significant growth opportunities[3].
• Challenges: Supply chain disruptions, regulatory hurdles, and economic slowdowns pose challenges that need to be addressed to ensure sustained market growth[3].

Key Takeaways

• The global epinastine hydrochloride market is projected to grow significantly, reaching USD 1.58 billion by 2032.
• The market is driven by the rising prevalence of allergic conjunctivitis and ongoing research and development activities.
• Key players like Santen Pharmaceutical, Merck, and Sun Pharma are driving the market forward.
• Regional dynamics, especially in the Asia-Pacific region, are contributing to the market's growth.
• Challenges such as supply chain disruptions and economic slowdowns need to be addressed.

FAQs

Q: What is the projected market size of epinastine hydrochloride by 2032? A: The epinastine hydrochloride market is expected to reach USD 1.58 billion by 2032[3].

Q: What is the CAGR of the epinastine hydrochloride market during the forecast period? A: The market is expected to exhibit a CAGR of 10.1% from 2024 to 2032[3].

Q: Which are the key drivers of the epinastine hydrochloride market? A: The rising prevalence of allergic conjunctivitis and growing demand for effective treatment options are key drivers[3].

Q: Who are the top companies operating in the epinastine hydrochloride market? A: Top companies include Santen, Merck, Sun Pharma, Jigs Chemical, Apotex Corp, Akorn, Allergan, and Boehringer Ingelheim[3].

Q: How has the COVID-19 pandemic impacted the epinastine hydrochloride market? A: The pandemic has caused supply chain disruptions, regulatory hurdles, and economic slowdowns, affecting the production and distribution of epinastine hydrochloride[3].

Sources

1. Market Research Intellect: Global Epinastine Hydrochloride Market Size, Trends and Projections[1].
2. Santen Pharmaceutical: FY2023 Financial Results[2].
3. Business Research Insights: Epinastine Market Size, Share & Forecast Report, 2024-2032[3].
4. Market Research Reports: Epinastine Hydrochloride API - Global Market Share and Ranking[4].
5. Santen Pharmaceutical: Q2 FY2022 Financial Results[5].