ELESTAT Drug Patent Profile

Which patents cover Elestat, and when can generic versions of Elestat launch?

Elestat is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in ELESTAT is epinastine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinastine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Elestat

A generic version of ELESTAT was approved as epinastine hydrochloride by APOTEX on October 31^st, 2011.

Summary for ELESTAT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	2
Patent Applications:	3,542
Drug Prices:	Drug price information for ELESTAT
What excipients (inactive ingredients) are in ELESTAT?	ELESTAT excipients list
DailyMed Link:	ELESTAT at DailyMed

See drug prices for ELESTAT

Recent Clinical Trials for ELESTAT

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

Sponsor	Phase
University of Worcester	Phase 4
Aston University	Phase 4
Merck Sharp & Dohme Corp.	Phase 4

See all ELESTAT clinical trials

Paragraph IV (Patent) Challenges for ELESTAT

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 ELESTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ELESTAT	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021565-001	Oct 16, 2003		DISCN	Yes	No

Expired US Patents for ELESTAT

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

International Patents for ELESTAT

See the table below for patents covering ELESTAT around the world.

Country	Patent Number	Title	Estimated Expiration
Czech Republic	302483	Vodný roztok s obsahem epinastinu (Aqueous solution containing epinastine)
Czech Republic	20021956
Australia	2006201541
Estonia	05395	Epinastiini sisaldavad lahused
Colombia	5251448	SOLUCIONES QUE CONTIENEN EPINASTINA
Peru	08262001

ELESTAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ELESTAT (Epinastine Ophthalmic Solution)

Introduction

ELESTAT, the brand name for epinastine hydrochloride ophthalmic solution, is an H1 receptor antagonist used to prevent itching associated with allergic conjunctivitis. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Approval and Availability

ELESTAT was approved by the FDA and has been available in the market since 2004. It is formulated as a 0.05% ophthalmic solution and is marketed by Allergan Inc., among other generic manufacturers[1][4].

Sales Performance

The sales performance of ELESTAT has been a significant factor in the financial reports of its manufacturers. In the first quarter of 2011, ELESTAT generated $10.2 million in sales, which was a decline from $13.4 million in the first quarter of 2010. This decline was part of a broader trend in the company's financial performance during that period[2].

Revenue Streams

ELESTAT's revenue is derived from both product sales and co-promotion agreements. For instance, in the first quarter of 2011, co-promotion revenue from ELESTAT was $2.7 million, down from $3.6 million in the same period of 2010. These figures indicate the fluctuating nature of the drug's market performance[2].

Global Market Reach

Allergan, the primary marketer of ELESTAT, has a strong global presence. The company's sales strategy includes a focus on emerging markets in Asia, Latin America, and Eastern Europe. This global reach has been a key factor in the overall financial health of the company, although ELESTAT's specific performance may vary by region[5].

Competitive Landscape

The ophthalmic market is competitive, with several other antihistamine and anti-allergic medications available. However, ELESTAT has maintained a niche position due to its efficacy in treating allergic conjunctivitis. The entry of generic versions could impact its market share, but as of the latest updates, all formulations of ELESTAT have been discontinued, which may affect its availability and sales[4].

Financial Impact on Allergan Inc.

Allergan Inc.'s financial reports reflect the company's broader strategy and performance. In 2011, despite the decline in ELESTAT sales, the company reported significant growth in other areas, such as RESTASIS® sales, which reached $697 million. The company's overall strategy of focusing on six distinct medical specialties and investing heavily in R&D has helped maintain its financial stability[5].

Operating Expenses and Restructuring

The financial performance of ELESTAT is also influenced by the overall operating expenses and restructuring efforts of Allergan Inc. In the first quarter of 2011, the company incurred significant restructuring charges related to the discontinuation of its pulmonary therapeutic operations. These charges, however, did not directly impact ELESTAT's sales but affected the company's overall financial health[2].

Pharmaceutical Market Trends

The broader pharmaceutical market trends also play a crucial role in the financial trajectory of ELESTAT. The US prescription drug market experienced a period of slow growth from 2005 to 2013 but saw a significant increase in 2014. Factors such as the strengthening of the innovation pipeline, consolidation among buyers, and reduced patent expirations influence prescription spending and, by extension, the sales of specific drugs like ELESTAT[3].

Generic Availability and Counterfeit Risks

The availability of generic versions of ELESTAT can impact its market dynamics. However, it is crucial to note that all formulations of ELESTAT have been discontinued, and any generic versions available online may be counterfeit and unsafe. This situation can affect the drug's market share and consumer trust[4].

Pricing and Affordability

The pricing of ELESTAT is another critical factor in its market dynamics. As of the available data, a 5ml bottle of ELESTAT 0.05% solution costs approximately $116.58. The affordability and pricing strategies can influence consumer choice and market share[1].

Key Takeaways

• ELESTAT's sales have fluctuated over the years, with a decline observed in 2011.
• The drug's market performance is part of Allergan Inc.'s broader financial strategy and global market reach.
• The ophthalmic market is competitive, and the discontinuation of ELESTAT formulations could impact its availability.
• Broader pharmaceutical market trends, such as innovation pipeline strength and buyer consolidation, influence ELESTAT's financial trajectory.
• Generic availability and counterfeit risks are significant concerns for consumer safety and market dynamics.

FAQs

What is ELESTAT used for?

ELESTAT (epinastine hydrochloride ophthalmic solution) is used to prevent itching associated with allergic conjunctivitis.

Who is the primary marketer of ELESTAT?

The primary marketer of ELESTAT is Allergan Inc.

How has the sales performance of ELESTAT been in recent years?

The sales performance of ELESTAT has fluctuated, with a decline observed in the first quarter of 2011 compared to the same period in 2010.

Are generic versions of ELESTAT available?

All formulations of ELESTAT have been discontinued, and any generic versions available online may be counterfeit and unsafe.

What are the broader market trends affecting ELESTAT's financial trajectory?

Broader market trends include the strengthening of the innovation pipeline, consolidation among buyers, and reduced patent expirations, which influence prescription spending and the sales of specific drugs like ELESTAT.

Cited Sources

1. DrugBank Online: Epinastine: Uses, Interactions, Mechanism of Action.
2. Business Wire: Inspire Reports First Quarter 2011 Financial Results.
3. PubMed: Has The Era Of Slow Growth For Prescription Drug Spending Ended?
4. Drugs.com: Generic Elestat Availability.
5. AnnualReports.com: 2011 Allergan Annual Report.