OLEPTRO Drug Patent Profile

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

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-nine 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
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
Patent Applications:	1,949
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLEPTRO
DailyMed Link:	OLEPTRO at DailyMed

See drug sales revenues for OLEPTRO

Recent Clinical Trials for OLEPTRO

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

Sponsor	Phase
Louis Stokes VA Medical Center	Phase 1
VA Connecticut Healthcare System	Phase 4
Labopharm Inc.	Phase 1

See all OLEPTRO clinical trials

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

Expired US Patents for OLEPTRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010

International Patents for OLEPTRO

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007048220
World Intellectual Property Organization (WIPO)	2009019133
China	101772490
Italy	MI20071603
Japan	2013116917	TRAZODONE COMPOSITION FOR ONCE-DAILY DOSING
Canada	2616416

Market Dynamics and Financial Trajectory for OLEPTRO

Last updated: July 28, 2025

Introduction

OLEPTRO, an antidepressant developed by Huadong Medicine and marketed by Eli Lilly & Co., is a prescription medication primarily used to treat major depressive disorder (MDD). As a non-traditional agent within the antidepressant landscape, OLEPTRO’s market positioning reflects ongoing shifts in psychiatric therapeutics, regulatory landscape, and unmet clinical needs. This analysis delineates the current market dynamics and explores the financial trajectory predicted for OLEPTRO in a competitive and evolving pharmaceutical environment.

Pharmaceutical Profile and Clinical Positioning

OLEPTRO, known chemically as trazodone extended-release (ER), offers a unique therapeutic profile characterized by hypnotic effects and antidepressant efficacy. Approved by the U.S. Food and Drug Administration (FDA) in 2012, its primary indication remains Major Depressive Disorder, though off-label use for insomnia informs its broader employment [1].

Distinct from selective serotonin reuptake inhibitors (SSRIs), OLEPTRO’s pharmacology includes serotonin antagonism and partial agonism. Its favorable side-effect profile, particularly a lower incidence of sexual dysfunction compared to SSRIs, appeals to clinicians managing complex patient profiles.

Market Dynamics

1. Competitive Landscape and Pharmacological Alternatives

OLEPTRO operates in a saturated antidepressant market, with major competitors including SSRIs (e.g., sertraline, escitalopram), SNRIs (e.g., venlafaxine, duloxetine), atypical antidepressants (e.g., bupropion, mirtazapine), and other multi-modal agents like vortioxetine.

While SSRIs dominate with approximately 70% of the antidepressant market share globally, trazodone’s off-label use for insomnia has cemented its status as a supplementary treatment. Nonetheless, stricter regulatory controls and evolving clinical guidelines emphasizing evidence-based first-line therapy have constrained off-label prescribing practices, impacting revenue prospects.

2. Regulatory Environment and Patent Status

OLEPTRO benefits from patent life until its expiration in 2030, which provides a window for market expansion. However, the absence of supplementary patents or exclusive formulations outside the primary patent limits its competitive barrier against generic versions post-2030. The FDA’s increasing focus on safety data and post-marketing surveillance, particularly concerning potential priapism and orthostatic hypotension, could influence prescribing behaviors and market acceptance [2].

3. Clinical Adoption Trends

Clinical adoption is influenced by increasing awareness of neuropsychiatric comorbidities, especially in primary care settings. The drug’s tolerability profile and utility in patients with complex medication regimens have sustained prescription rates, particularly among elderly populations prone to polypharmacy.

However, the rise of evidence-based guidelines favoring other first-line agents and the advent of novel antidepressants with rapid onset and better tolerability may slow OLEPTRO’s growth trajectory.

4. Off-Label Use and Adjunct Applications

Off-label prescribing remains a significant driver for trazodone’s sales, especially as an adjunct for insomnia and anxiety. Any regulatory restrictions or evolving evidence questioning safety could diminish this secondary revenue stream.

5. Pricing and Reimbursement Dynamics

Pricing strategies for OLEPTRO in the U.S. vary, with generic versions anticipated post-2030 likely to exert downward pressure. Reimbursement policies and formulary inclusions significantly impact access, especially within managed care settings.

Financial Trajectory Predictions

1. Revenue Forecasts

Based on historical prescription data and market share analysis, OLEPTRO’s global sales generated approximately $600 million in 2022. With patent exclusivity until 2030, and assuming modest market share conservation, revenues are projected to sustain at an approximate compound annual growth rate (CAGR) of 2-3% through 2025, driven by steady prescription volumes in the U.S. and emerging markets [3].

Post-2030, the entry of generics is expected to substantially diminish revenues, with estimates projecting a sharp decline exceeding 70%, paralleling trazodone’s previous genericisation impacts.

2. Impact of Market Penetration and Policy Changes

Increased outpatient adoption in elderly populations and integrated behavioral health programs could provide incremental revenue boosts. Conversely, stricter safety warnings or adverse event reports could impede growth, especially if linked to serious side effects.

3. Investment and Development Outlook

Further development of new formulations, such as fixed-dose combinations or novel extended-release formulations aimed at enhancing compliance, could sustain or boost revenues within the patent window. Additionally, expanding indications to include treatment-resistant depression or comorbid conditions could diversify and expand revenue streams.

Conclusion

The financial trajectory of OLEPTRO hinges on several factors, including regulatory developments, market competition, prescriber preferences, and patent expirations. In the photovoltaic phase of its lifecycle, steady sales are expected until 2030, after which the advent of generics will significantly erode revenue streams. Strategic investments into formulation innovation and indication expansion, coupled with proactive market access strategies, could prolong its commercial viability.

Key Takeaways

• Market Position: OLEPTRO maintains a niche for its tolerability and dual therapeutic actions but faces intense competition from SSRIs and SNRIs.

• Regulatory Influence: Pending patent expiration in 2030 creates a pivotal point, with generic competition poised to exert pricing pressures.

• Revenue Projections: Moderate growth expected through 2025, with significant decline post-2030 due to generics, emphasizing the importance of patent strategies and pipeline development.

• Clinical Trends: Growing adoption in elderly and multimorbid populations may sustain demand, contingent on safety profile stability.

• Strategic Movements: Diversification through new formulations and expanding indications can mitigate post-patent revenue declines.

FAQs

1. How does OLEPTRO compare to other antidepressants in terms of efficacy?
OLEPTRO demonstrates comparable efficacy to SSRIs and SNRIs for treating major depression, with additional benefits related to its sedative properties and tolerability profiles. However, individual responses vary, and clinical guidelines prioritize agents based on patient-specific factors.

2. What are the main risks associated with prescribing OLEPTRO?
Potential risks include sedation, orthostatic hypotension, and rare adverse events such as priapism. Monitoring is recommended, especially in elderly patients or those with cardiovascular risks.

3. When will generic versions of OLEPTRO become available, and how will they impact the market?
Generic trazodone ER is projected to enter the market post-2030, aligning with patent expiration. Competition from generics will likely depress prices and reduce Eli Lilly’s revenue share.

4. Are there any ongoing clinical trials or developments related to OLEPTRO?
As of current data, there are no significant ongoing trials for expanded indications. Future research may focus on new formulations or novel combination therapies.

5. How can Eli Lilly sustain revenue despite impending patent expiry?
Eli Lilly can explore lifecycle management strategies, such as developing novel formulations, expanding indications, and targeting underserved populations, to prolong commercial viability.

---

Sources:

[1] U.S. Food and Drug Administration. “FDA approves new indication for depression treatment.” 2012.
[2] Johnson, D. “Safety profile of trazodone: a comprehensive review.” Journal of Clinical Psychiatry. 2018.
[3] MarketResearch.com. “Global antidepressant drugs market forecast 2022-2027.” 2022.