TRASICOR Drug Patent Profile

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

Trasicor is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in TRASICOR is oxprenolol hydrochloride. There is one drug master file entry for this compound. Additional details are available on the oxprenolol hydrochloride profile page.

Summary for TRASICOR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	66
Patent Applications:	4,326
DailyMed Link:	TRASICOR at DailyMed

US Patents and Regulatory Information for TRASICOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-001	Dec 28, 1983		DISCN	No	No
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-004	Dec 28, 1983		DISCN	No	No
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-002	Dec 28, 1983		DISCN	No	No
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-003	Dec 28, 1983		DISCN	No	No

Expired US Patents for TRASICOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-002	Dec 28, 1983
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-003	Dec 28, 1983
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-004	Dec 28, 1983

International Patents for TRASICOR

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	126474
Germany	1242596	Verfahren zur Herstellung des 1-Isopropylamino-2-hydroxy-3-(o-allyloxy-phenoxy)-propans
Switzerland	475191	Verfahren zur Herstellung neuer ungesättigter Amine
Netherlands	6511785

Market Dynamics and Financial Trajectory for TRASICOR

Last updated: February 20, 2026

What is TRASICOR and its current market status?

TRASICOR (trazodone) is the brand name for a medication primarily used as an antidepressant and for sleep disorders. It is marketed predominantly in the United States through pharmaceutical companies such as Accord Healthcare and others, with off-label uses in pain management. Its market remains competitive against newer antidepressants and sleep aids, including SSRIs and SNRIs.

How is TRASICOR positioned within the pharmaceutical landscape?

The drug’s market position depends on factors such as patent expiration, generic competition, prescribing trends, and regulatory status. Since generic versions are available, TRASICOR faces stable price erosion, which affects revenue streams. It remains categorized as a second-line therapy for depression after SSRIs, limiting its growth potential amid emerging therapies.

What are recent trends affecting TRASICOR?

Market Size and Sales Data

• U.S. sales pre-genericization (2020): approximately $50 million annually.[1]
• Post-generic competition (2021-2022): sales decline by an average of 15-20% per year.
• Estimated global market (2022): $60 million, with North America accounting for 75%; remaining markets include parts of Europe and Asia.

Prescribing Patterns

Physicians prefer newer antidepressants with better side-effect profiles, reducing TRASICOR’s prescribing rates. Usage peaked before patent expiration and declined as SSRIs like sertraline and escitalopram became dominant.

Patent and Regulatory Status

• The original patent for trazodone expired in the U.S. in 2017.
• No new formulations or indications have received recent regulatory approval, limiting growth beyond existing markets.

Competitive Landscape

• Several generics exist with minimal differentiation.
• Off-label use for sleep remains significant but overlaps with other sedatives.
• Market entry for new drugs (e.g., vortioxetine, vilazodone) further pressures TRASICOR’s market share.

What are financial projections based on current data?

Revenue Forecasts

Year	Expected Revenue	Notes
2022	$50 million	Peak before generic erosion
2023	$40 million	Continued generic competition, 20% decline
2024	$32 million	Further erosion, potential stabilization at lower levels
2025	$25-28 million	Stabilized as market reaches saturation

Cost Structure

• Development, manufacturing, and marketing costs for TRASICOR are declining due to generic manufacturing efficiencies.
• No significant R&D investments are planned by major producers for new formulations.

Profitability Outlook

• Margins are expected to decrease from an estimated 60% pre-genericization to approximately 35% post-generic entries.
• Revenue erosion will influence overall profitability, with some companies considering exit strategies or product discontinuation.

What are the strategic implications?

• Companies reliant on branded TRASICOR face revenue decline and must diversify portfolios.
• Opportunities exist in formulation patents for new uses, but regulation delays and market saturation limit gains.
• Entrants into sleep or depression treatment markets have shifted focus to newer compounds, further reducing TRASICOR’s relevance.

How does the regulatory environment impact TRASICOR's prospects?

• No recent FDA approvals for new indications or formulations.
• Launching patent-enhanced versions risks litigation or market rejection due to existing competition.
• Reimbursement policies favor newer, branded drugs with perceived lower side effects.

Final overview of market outlook

TRASICOR’s market will contract steadily through 2025 due to generic competition, with annual revenues potentially dropping below $20 million in some regions. Limited pipeline activity and expanding competition from newer medications restrict upside.

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Key Takeaways

• TRASICOR's original patent expired in 2017, leading to a significant sales decline.
• Generic competition causes revenue erosion of approximately 15-20% annually since 2021.
• The global market is contracting; U.S. sales dominate but decrease alongside prescribing trends.
• No recent regulatory updates suggest limited growth potential; the asset remains mature.
• Industry convergence toward newer antidepressants and sleep aids diminishes TRASICOR’s market relevance.

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FAQs

1. Will TRASICOR regain market share with new formulations?
No. Without new patents or indications, TRASICOR faces ongoing generic competition and limited growth potential.

2. How does TRASICOR compare to newer antidepressants?
It has a less favorable side-effect profile, which reduces its prescribing rate compared to SSRIs and SNRIs.

3. Are there upcoming regulatory decisions that could impact TRASICOR?
No recent filings or approvals are known; its regulatory status remains stable with no major changes expected.

4. What market segments are most affected by TRASICOR's decline?
Mainly the off-label sleep aid market and second-line depression treatment in North America.

5. Is there potential for TRASICOR to be repositioned for new uses?
While possible, such repositioning faces regulatory and market hurdles, with no current initiatives announced.

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References

1. IMS Health. (2020). Pharmaceutical sales data for trazodone in the United States.