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:	134
Clinical Trials:	8
Patent Applications:	1,767
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
Algorithme Pharma 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
Malaysia	157790	TRAZODONE COMPOSITION FOR ONCE A DAY ADMINISTRATION
Georgia, Republic of	P20135926	TRAZODONE AND TRAZODONE HYDROCHLORIDE IN PURIFIED FORM
China	1449279
Brazil	PI0615577	composição farmacêutica de liberação prolongada, e, uso de uma composição farmacêutica de liberação prolongada
Japan	2013116917	TRAZODONE COMPOSITION FOR ONCE-DAILY DOSING
Canada	2693095	TRAZODONE ET CHLORHYDRATE DE TRAZODONE SOUS FORME PURIFIEE (TRAZODONE AND TRAZODONE HYDROCHLORIDE IN PURIFIED FORM)

OLEPTRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OLEPTRO (Trazodone Hydrochloride Extended-Release Tablets)

Introduction

OLEPTRO, the extended-release formulation of trazodone hydrochloride, was introduced to the market as a once-daily treatment for major depressive disorder (MDD). Here, we will delve into the market dynamics and financial trajectory of OLEPTRO, examining its launch, performance, and eventual discontinuation.

Market Launch and Initial Reception

OLEPTRO was approved by the FDA in 2010 and was marketed by Labopharm Europe Limited. The drug was presented as a significant improvement over the immediate-release formulations of trazodone, aiming to reduce daytime sedation and improve patient tolerability[1][3].

Target Market and Indications

OLEPTRO was specifically indicated for the treatment of major depressive disorder in adults. The extended-release formulation was designed to maintain therapeutic benefits while minimizing the side effects associated with immediate-release trazodone, such as daytime sedation and dizziness[3].

Dosage and Administration

The recommended starting dose of OLEPTRO was 150 mg once daily, which could be increased by 75 mg every three days up to a maximum dose of 375 mg. The tablets were to be taken in the late evening, preferably at bedtime, on an empty stomach[3].

Competitive Landscape

The antidepressant market is highly competitive, with various classes of drugs including SSRIs, SNRIs, tricyclic antidepressants, and others. OLEPTRO entered this market with a unique selling proposition of reduced daytime sedation and improved tolerability. However, it faced competition from established brands and generic versions of other antidepressants[2].

Financial Performance

Despite its promising launch, OLEPTRO did not achieve significant financial success. The drug's sales were hampered by several factors, including the presence of generic immediate-release trazodone formulations and the limited differentiation of OLEPTRO in the market. Additionally, the drug's side effect profile, although improved, still included issues like dizziness, orthostasis, and rare but serious side effects such as priapism[2][4].

Discontinuation

OLEPTRO was discontinued in 2015, just five years after its approval. The discontinuation was likely due to a combination of factors including poor market performance, limited adoption by healthcare providers, and the availability of alternative treatments. The discontinuation marked the end of the extended-release trazodone formulation as a viable market option[2].

Reasons for Discontinuation

Several reasons contributed to the discontinuation of OLEPTRO:

• Limited Market Differentiation: Despite its extended-release formulation, OLEPTRO did not significantly differentiate itself from other antidepressants in terms of efficacy or side effect profile.
• Side Effects: While the extended-release formulation reduced daytime sedation, it did not eliminate other side effects such as dizziness, orthostasis, and the rare but serious side effect of priapism.
• Competition from Generics: The availability of generic immediate-release trazodone formulations at lower costs made it challenging for OLEPTRO to gain significant market share.
• Clinical and Regulatory Challenges: The FDA had recommended further studies and adjustments to the dissolution method, which may have added to the costs and complexities of maintaining the product on the market[1][3].

Impact on Patients and Healthcare Providers

The discontinuation of OLEPTRO left patients and healthcare providers with fewer options for treating major depressive disorder, particularly those who had found the extended-release formulation beneficial. Patients had to transition to other treatments, which could involve adjusting to new side effect profiles and efficacy levels.

Key Takeaways

• Market Differentiation: For a new drug to succeed, it must significantly differentiate itself from existing treatments.
• Side Effect Management: Even with improved formulations, managing side effects remains a critical factor in patient compliance and drug adoption.
• Competition: The presence of generic alternatives can significantly impact the market performance of a new drug.
• Regulatory Compliance: Meeting regulatory requirements and addressing FDA recommendations is crucial for maintaining a drug on the market.

FAQs

What was OLEPTRO used for?

OLEPTRO was used for the treatment of major depressive disorder (MDD) in adults.

Why was OLEPTRO discontinued?

OLEPTRO was discontinued due to poor market performance, limited differentiation from other antidepressants, and the presence of significant side effects.

What were the side effects of OLEPTRO?

Common side effects included dizziness, orthostasis, nausea, and somnolence. Rare but serious side effects included priapism.

How was OLEPTRO administered?

OLEPTRO was administered as a once-daily dose, preferably at bedtime, on an empty stomach. The starting dose was 150 mg, which could be increased up to a maximum of 375 mg.

What was the competitive landscape for OLEPTRO?

OLEPTRO entered a highly competitive antidepressant market with various classes of drugs, including SSRIs, SNRIs, and tricyclic antidepressants.

Sources

1. FDA Chemistry Review: "CHEMISTRY REVIEW(S) - accessdata.fda.gov"
2. The Carlat Report: "Trazodone: The Forgotten Antidepressant - CARLAT PUBLISHING"
3. FDA Label: "Oleptro (trazodone hydrochloride) extended-release tablets - accessdata.fda.gov"
4. Health Canada: "Trazodone Hydrochloride Extended-Release Caplets 150 and 300 mg - pdf.hres.ca"