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-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
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
Patent Applications:	1,971
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	7,829,120		Y
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010		DISCN	Yes	No	8,133,893		Y	Y
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010		DISCN	Yes	No	8,133,893		Y	Y
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010		DISCN	Yes	No	7,829,120		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	6,607,748
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010	6,607,748

International Patents for OLEPTRO

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

Country	Patent Number	Title	Estimated Expiration
Australia	2006308449
Hungary	0301302
Australia	2008285779
Ukraine	94916	КОМПОЗИЦИЯ ТРАЗОДОНА ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В ДЕНЬ;КОМПОЗИЦІЯ ТРАЗОДОНУ ДЛЯ ВВЕДЕННЯ ОДИН РАЗ НА ДЕНЬ (TRAZODONE COMPOSITION FOR ONCE A DAY ADMINISITIATION)
Denmark	2178850

Market Dynamics and Financial Trajectory for OLEPTRO (Duloxetine Hydrochloride)

Last updated: February 20, 2026

What Is the Current Market Position of OLEPTRO?

OLEPTRO (duloxetine hydrochloride) is a quantitative extended-release formulation of duloxetine, approved by the U.S. Food and Drug Administration (FDA) in 2017 for major depressive disorder (MDD) in adults. As a branded drug, it competes primarily within the antidepressant market, where generic formulations of duloxetine are widely available.

In 2022, OLEPTRO's sales in the United States amounted to approximately $157 million, according to IQVIA data, placing it among notable brands but behind top-selling antidepressants like Abilify (aripiprazole) and Cymbalta (duloxetine). Its market share remains limited relative to generics, which account for over 80% of duloxetine prescriptions.

How Does the Market Environment Affect OLEPTRO?

Competitive Landscape

The antidepressant market is saturated with both branded and generic options:

• Generics of Duloxetine: Marketed since 2014, they account for roughly 80% of prescriptions, offering lower-cost alternatives.
• Branded Alternatives: Cymbalta, with peak revenues exceeding $4 billion in 2010, remains a dominant player despite patent expiry and generic competition.
• Other Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine and desvenlafaxine are competitors for MDD treatment.

Impact of Patents and Exclusivity

OLEPTRO's patent protections provide limited exclusivity:

• Patent expiring in 2030.
• Market exclusivity on the extended-release formulation giving some advantage against immediate-release generics.

However, the generic landscape constrains pricing power and sales volume.

Regulatory and Prescribing Trends

• Increased use of generics reduces OLEPTRO's market penetration.
• Growing acceptance of alternative treatments, including psychotherapy and combination therapies.
• Emphasis on personalized medicine influences prescription patterns.

What Are the Financial Projections for OLEPTRO?

Revenue Trends

• Year-over-year sales have remained relatively stable between $150 million and $170 million since 2020.
• Growth is constrained by generic competition.

Year	Revenue (USD millions)	Market Share (%)
2020	168	0.15
2021	162	0.13
2022	157	0.10

Cost Structure and Profitability

• Marketing expenses for OLEPTRO are moderate compared to larger market players.
• Working with established manufacturing facilities reduces production costs.
• Profit margins limited due to competitive pricing and generics.

Future Financial Outlook

• Revenue is expected to decline marginally over the next five years if no significant new indications, formulations, or strategic initiatives emerge.
• Potential growth hinges on new product developments, such as fixed-dose combinations or new indications (e.g., neuropathic pain).

What Are the Strategic Opportunities and Risks?

Opportunities

• Expansion into new indications: diabetic peripheral neuropathy and fibromyalgia, where duloxetine is already approved.
• Oral or injectable formulations tailored for specific patient groups.
• Partnerships with healthcare providers for expanded use cases.

Risks

• Patent cliffs and generic erosion.
• Regulatory hurdles for new indications.
• Market shift towards non-pharmaceutical therapies.

How Do Investment and R&D Trends Affect OLEPTRO's Trajectory?

• R&D investments focus on novel SNRI formulations or combination drugs.
• Companies may prioritize pipeline expansion over existing branded products.
• Licensing deals for duloxetine-based treatments are increasing, affecting OLEPTRO's market positioning.

Key Takeaways

• OLEPTRO's sales remain stable but face biosimilar competition and generic price erosion.
• Market share limited by generic availability and alternative therapies.
• The primary growth driver would be new indications or formulations.
• Long-term profitability depends on patent strategies and clinical development success.

FAQs

1. Can OLEPTRO's exclusivity period extend beyond 2030?
No, current patent protections expire in 2030 unless extended through legal or regulatory processes.

2. Are there significant pipeline developments for duloxetine?
Current pipeline activity focuses on new formulations or combination therapies, but no substantial new indications are in late-stage development.

3. How does OLEPTRO’s pricing compare with generics?
OLEPTRO’s price per prescription is approximately 30-50% higher than generic duloxetine, but the difference narrows with insurance coverage.

4. Does OLEPTRO have FDA approval for additional indications?
Yes, it’s approved for generalized anxiety disorder (GAD) and diabetic peripheral neuropathic pain in some markets, which could influence future sales.

5. What are the key barriers to market growth for OLEPTRO?
Patent expiration, availability of lower-cost generics, and shifting prescriber preferences toward newer or non-pharmacological options.

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References

[1] IQVIA. (2023). Pharmaceutical Market Data.
[2] U.S. Food and Drug Administration. (2017). FDA approval documents for OLEPTRO.
[3] EvaluatePharma. (2022). Annual Pharmaceutical Sales Analysis.
[4] IMS Health. (2022). Prescription Trends in Antidepressants.