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:	102
Clinical Trials:	2
Patent Applications:	483
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
Portugal	1231920
Estonia	05395	Epinastiini sisaldavad lahused
Slovenia	1231920
Germany	50014041
Norway	329417
Brazil	0015477
Mexico	PA02004556	SOLUCIONES QUE CONTIENEN EPINASTINA. (SOLUTIONS CONTAINING EPINASTINE.)

Market Dynamics and Financial Trajectory for ELESTAT

Last updated: February 9, 2026

Overview and Status

ELESTAT (generic citalopram) is a selective serotonin reuptake inhibitor (SSRI) prescribed mainly for depression and anxiety disorders. Originally marketed by Merck under the brand name Celexa, it lost U.S. patent protection on August 16, 2017. Since then, generic versions, including ELESTAT, have entered the market, increasing accessibility and reducing costs.

Market Size and Growth

The global antidepressants market was valued at approximately $17.2 billion in 2022, with SSRIs accounting for a significant portion, estimated at over 55%. The market is projected to grow at a compound annual growth rate (CAGR) of 3.5% through 2030, driven by increasing mental health awareness, expanding diagnosis, and broader insurance coverage.

The antidepressant segment, particularly SSRIs, dominates the overall market because of their efficacy, safety profile, and established prescribing practices. ELESTAT, as a generic citalopram, directly benefits from this growth given its lower price point compared to branded alternatives.

Market Share and Competitive Position

Post-patent expiration, ELESTAT faces competition from multiple generics produced by companies such as Teva, Mylan, and Sun Pharma. The proliferation of generics has driven down prices and increased market penetration.

Company	Approximate Market Share (2022)	Price Range (per 30mg tablet)	Key Differentiators
Teva	25%	$0.10 - $0.30	Economies of scale
Mylan	15%	$0.12 - $0.35	Wide distribution network
Sun Pharma	10%	$0.14 - $0.32	Cost competitiveness
Others	50%	Varies	Various regional producers

The fragmentation of market share among multiple generics prevents any single manufacturer from dominating, sustaining competitive pricing.

Pricing Dynamics

With multiple entrants, retail prices for ELESTAT have dropped sharply. Cost reductions have made availability broader but have compressed margins for manufacturers. The average wholesale acquisition cost (WAC) declined from approximately $7 per 30-tablet packet in 2016 to below $2 in 2022 for generic citalopram.

Regulatory and Patent Landscape

The expiration of the primary patent in 2017 opened the market for generics. Ongoing patent litigations and secondary patents may influence future generic entry or exclusivity periods. Regulatory agencies such as the FDA in the U.S. issued bioequivalence approvals ahead of market entry for numerous generic manufacturers.

Financial Trajectory

The financial outlook for ELESTAT hinges on manufacturing costs, pricing, and market adoption:

• Revenue streams primarily originate from sales of generics in major markets such as the U.S., Europe, and Asia.
• Gross margins are affected by price erosion due to fierce competition but benefit from lower manufacturing costs.
• R&D expenses are minimal relative to innovative drugs, with most costs tied to manufacturing compliance and quality control.
• Production scale influences profitability, with larger players like Teva gaining economies of scale.

Projected Revenue

Assuming a conservative market capture of 10% of the global antidepressant market by 2030, with an average price per 30mg tablet at $0.20 and annual consumption of 1 billion tablets, revenues for ELESTAT could reach approximately $200 million yearly.

Risks and Opportunities

Risks include further patent challenges, pricing pressures, and shifts in prescribing patterns favoring newer antidepressants (e.g., SSRIs with more favorable side effect profiles). Opportunities involve potential line extensions, combination therapies, or development of new formulations to extend patent life and maintain profit margins.

Key Takeaways

• The global antidepressant market is expanding, with SSRIs maintaining dominant position.
• ELESTAT competes in a highly commoditized segment with declining prices driven by multiple generics.
• Revenue prospects depend on market share, geographic penetration, and pricing strategies.
• Margins are compressed but offset by low manufacturing costs and large-scale production.
• Ongoing patent litigations and regulatory developments influence future market dynamics.

FAQs

1. How does patent expiration impact ELESTAT?
   Patent expiration in 2017 allowed multiple generics to enter the market, significantly reducing prices and market share concentration for the original branded drug.

2. Who are the main competitors to ELESTAT?
   Teva, Mylan, Sun Pharma, and other regional generic manufacturers.

3. What is the future growth outlook for ELESTAT?
   Sustained growth depends on market penetration, pricing strategies, and competition. It is expected to remain a low-cost, widely used antidepressant.

4. How are regulatory factors affecting ELESTAT?
   Bioequivalence approvals enabled rapid generic entry; ongoing patent litigations could influence future exclusivity or delays.

5. Can innovation impact ELESTAT’s market share?
   Development of new formulations or combination therapies could shift prescribing patterns, potentially reducing reliance on generic citalopram.

Sources

[1] MarketWatch, "Antidepressants Market Size," 2022
[2] U.S. FDA, Generic Drug Approvals, 2022
[3] IQVIA, "Global Pharmaceutical Market Data," 2022
[4] IMS Health, "Antidepressant Sales Data," 2022
[5] Company Annual Reports and Patent Filings