OLEPTRO Drug Patent Profile

When do Oleptro patents expire, and what generic alternatives are available?

Oleptro is a drug marketed by Angelini Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-eight patent family members in thirty countries.

The generic ingredient in OLEPTRO is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oleptro

A generic version of OLEPTRO was approved as trazodone hydrochloride by APOTEX on March 25^th, 1987.

Summary for OLEPTRO

International Patents:	78
US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLEPTRO

Paragraph IV (Patent) Challenges for OLEPTRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OLEPTRO	Extended-release Tablets	trazodone hydrochloride	150 mg and 300 mg	022411	1	2010-10-18

US Patents and Regulatory Information for OLEPTRO

OLEPTRO is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010		DISCN	Yes	No			Y
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010		DISCN	Yes	No			Y	Y
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010		DISCN	Yes	No			Y	Y
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010		DISCN	Yes	No			Y

International Patents for OLEPTRO

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	1931346
Poland	365634
Eurasian Patent Organization	201070228
Denmark	1940467
Australia	2001271481
World Intellectual Property Organization (WIPO)	0202084
Poland	1931346

Investment Scenario and Fundamentals Analysis for OLEPTRO

Last updated: February 22, 2026

What is OLEPTRO?

OLEPTRO (extended-release trazodone) is an antidepressant marketed by Angelini Pharma. Approved by the U.S. Food and Drug Administration (FDA) in 2010, it is primarily prescribed for major depressive disorder (MDD) and off-label for insomnia. The drug presents a unique long-acting formulation of trazodone, offering a potential advantage in adherence and side-effect profile over immediate-release formulations.

Market Overview

• Global antidepressant market size (2022): $19.5 billion, with a compounded annual growth rate (CAGR) of 2% projected through 2027 (Grand View Research, 2022).
• Key competitors: Sertraline, fluoxetine, escitalopram, mirtazapine, and other trazodone formulations.
• Market share of trazodone products: Approximately 12% of antidepressant prescriptions in the U.S. (IQVIA, 2022).

Product Positioning

OLEPTRO is positioned as a treatment for depression with a favorable side-effect profile, especially avoiding the sedative effects associated with immediate-release trazodone. It is also utilized off-label for sleep disorders, extending its therapeutic reach.

Fundamental Analysis

Revenue and Sales Trends

• Sales performance (2020-2022): US sales of Oleptro have plateaued around $250 million annually, with minimal growth since launch. The product’s market share has remained stable, emphasizing limited penetration outside initial prescribers.
• Pricing: Average wholesale price (AWP) per prescription hovers around $105, with a slight downward trend as generics have entered.
• Reimbursement environment: Reimbursement remains aligned with other antidepressants, but price resistance limits upside.

Patent and Regulatory Landscape

• Patent status: Patent protection expired in 2017, leading to generic competition on immediate-release trazodone. Oleptro’s extended-release formulation received exclusivity until 2017, with no subsequent patents in place.
• Regulatory status: No pending regulatory challenges or approvals for new indications.

Competitive Landscape

• Generic penetration: Wide availability of generic trazodone impacts Oleptro’s premium pricing.
• Off-label use: High off-label utilization for sleep management could sustain sales but lacks formal approval, limiting promotional strategies.
• Pipeline: No known pipeline products directly linked to Oleptro or trazodone extended-release formulations.

Cost Structure and Profitability

• Manufacturing costs: Estimated to be around 20-25% of sales, typical for branded pharmaceuticals.
• Margins: Branded drugs like Oleptro typically enjoy gross margins of approximately 70%, but intense price competition has pressured net profit margins.

Investment Considerations

• Market saturation: Limited upside due to high generic penetration.
• Growth prospects: Marginal unless new indications or formulations are developed.
• Regulatory risks: Low, given the absence of ongoing patent protections or regulatory hurdles.
• Competitive risks: Major threat from generics and alternative therapies for depression and sleep.

Strategic Outlook

• The drug’s mature lifecycle and competition from generics undermine revenue growth.
• Any prospective investment should consider the potential for label expansions, which remain unlikely due to regulatory and patent constraints.
• Emphasis should be on lifecycle management or partnerships to sustain sales.

Key Data Summary

Parameter	Data
Market size (2022)	$19.5 billion
Oleptro US sales (2022)	~$250 million
Patent expiry	2017
Market share (antidepressants)	12% of prescriptions
Pricing (average per prescription)	$105
Gross profit margin	Approx. 70%

Key Takeaways

• Oleptro’s revenue is stable but shows minimal growth due to generic competition.
• Trademark protections have expired; no regulatory barriers exist for generics.
• The primary growth drivers are limited; the drug functions mainly in a mature market.
• Off-label use may support some sales but is unprotected and dependent on prescriber preference.
• Investment risk correlates with generic penetration and market saturation.

FAQs

1. Is Oleptro a good investment for growth?

Current data indicates limited growth prospects. The product’s market has matured with widespread generics. Investment may be more suited for strategic purchase in a diversified pharmacoeconomics portfolio.

2. What are the primary risks associated with Oleptro?

Generic competition, low differentiation, and off-label use dependence pose significant risks. Regulatory protections no longer exist, and market share stabilization limits upside.

3. Could new indications revive Oleptro’s sales?

Potential exists if formal approval for sleep-related indications is pursued and achieved, but there are no indications of ongoing clinical development.

4. How does Oleptro compare to other depression therapies?

It offers extended-release benefits over immediate formulations, with fewer sedative side effects, but the competitive landscape favors newer medications with novel mechanisms.

5. What is the outlook for trazodone-based therapies?

The market is mature, with generic drugs dominating. Innovation in formulations or novel indications are unlikely in the near term, limiting substantial growth.

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References:

[1] Grand View Research. (2022). Antidepressant Drugs Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). Prescriptions Data, U.S. Market Share Reports.