SECTRAL Drug Patent Profile

Which patents cover Sectral, and what generic alternatives are available?

Sectral is a drug marketed by Promius Pharma and is included in one NDA.

The generic ingredient in SECTRAL is acebutolol hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acebutolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sectral

A generic version of SECTRAL was approved as acebutolol hydrochloride by ANI PHARMS on October 18^th, 1995.

Summary for SECTRAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	1,757
What excipients (inactive ingredients) are in SECTRAL?	SECTRAL excipients list
DailyMed Link:	SECTRAL at DailyMed

Recent Clinical Trials for SECTRAL

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

Sponsor	Phase
Centre Hospitalier Universitaire de Saint Etienne	Phase 4
University Hospital, Montpellier	Phase 3
St. Jude Medical	N/A

See all SECTRAL clinical trials

US Patents and Regulatory Information for SECTRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-001	Dec 28, 1984		DISCN	Yes	No
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-003	Dec 28, 1984		DISCN	Yes	No

Expired US Patents for SECTRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-001	Dec 28, 1984	3,726,919
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-003	Dec 28, 1984	3,857,952
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-003	Dec 28, 1984	3,726,919
Promius Pharma	SECTRAL	acebutolol hydrochloride	CAPSULE;ORAL	018917-001	Dec 28, 1984	3,857,952

International Patents for SECTRAL

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

Country	Patent Number	Title	Estimated Expiration
U.S.S.R.	443509	Способ получения производных бензола или их солей
Belgium	725845	NOUVEAUX DERIVES BENZENIQUES
France	7616
Netherlands	6818289
Yugoslavia	35873
Austria	286963

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SECTRAL (Propranolol)

Last updated: July 29, 2025

Overview of SECTRAL and Its Therapeutic Profile

SECTRAL, a leading brand of propranolol hydrochloride, is a non-selective beta-adrenergic receptor blocker primarily employed in the treatment of cardiovascular and certain neurological conditions. Its therapeutic scope encompasses hypertension, angina pectoris, arrhythmias, migraine prophylaxis, and off-label uses such as managing anxiety and tremors. As one of the first beta-blockers introduced into the market in the 1960s, SECTRAL has a well-established clinical profile, reinforcing its longstanding market presence.

Market Dynamics

1. Competitive Landscape

The global beta-blocker market remains highly competitive, driven by the widespread approval and broad therapeutic indications. SECTRAL faces direct competition from both branded formulations like Inderal (generic propranolol) and a spectrum of non-selective and selective beta-blockers such as atenolol, metoprolol, bisoprolol, and newer agents with improved side effect profiles.

Despite patent expirations, SECTRAL benefits from robust brand loyalty, physician familiarity, and its established safety profile. However, the generic proliferation has precipitated significant price erosion, intensifying market competition and encouraging price competition dynamics.

2. Regulatory Environment

Regulatory policies profoundly influence market accessibility and commercial viability. In many jurisdictions, generic versions of propranolol enjoy abbreviated approval processes, reducing barriers for market entry. Conversely, label expansions or new indications for SECTRAL require rigorous clinical data submission and compliance with local regulatory authorities, which can impact time-to-market trajectories.

Furthermore, regulatory bodies' emphasis on developing drugs with improved safety and tolerability may pressure companies to innovate or reposition existing drugs to maintain market share.

3. Patent and Market Exclusivity Status

Propranolol’s patent protection period has long expired, leading to widespread generic manufacturing and reducing exclusivity-driven revenues for the original developer. Market exclusivity for SECTRAL itself is limited, which necessitates differentiation through clinical evidence, branding, and patient adherence strategies.

4. Patent Challenges and Off-Label Uses

While the core patent has elapsed, specific formulation patents or exclusivity for certain delivery mechanisms could influence market dynamics. Moreover, off-label uses of propranolol, such as performance of emotional regulation or particular anxiety disorders, expand potential usage but often lack formal regulatory approval, posing both opportunities and legal considerations.

5. Market Penetration and Adoption Trends

Global adoption of propranolol, including SECTRAL, is sustained by its cost-effectiveness, accessibility, and extensive clinical data. In emerging markets, regulatory approvals and healthcare infrastructure facilitate broader dissemination, although affordability remains a challenge where generic competition drives prices downward.

In developed markets, incremental adoption arises through new clinical evidence, combination therapies, and patient-centric dosing forms.

6. Innovation and Product Differentiation

Although SECTRAL’s formula remains largely unchanged, ongoing research explores novel formulations—such as sustained-release or transdermal patches—that could provide competitive advantages and extend the product’s lifecycle.

7. Commercial and Distribution Channels

Distribution channels—ranging from hospital formularies to retail pharmacies—play a crucial role in market access. Alliances with healthcare providers, payers, and pharmacy benefit managers influence prescribing patterns and reimbursement frameworks.

Financial Trajectory: Revenue, Cost, and Profitability Considerations

1. Revenue Trends

The revenue trajectory for SECTRAL is predominantly dictated by the generic drug market’s maturity, pricing pressure, and regional demand. In mature markets, revenues are generally stable but declining gradually due to generic penetration and formulary shifts favoring lower-cost alternatives.

In developing markets, growth potential remains higher owing to expanding healthcare access and increased cardiovascular disease prevalence. The introduction of new delivery systems or indications can slightly augment revenue streams.

2. Cost Structure

Manufacturing propranolol is relatively low-cost, owing to established production processes and economies of scale. However, regulatory compliance, marketing, and distribution costs influence net profitability. The expenses associated with clinical trials for new indications or formulations further impact cost metrics.

3. Profit Margin Dynamics

Profit margins are compressed by intense price competition and increased generic supply. Brand loyalty and perceived clinical superiority can, temporarily, sustain higher margins, but these are ultimately susceptible to market commoditization.

4. Impact of Patent Expiration and Generic Competition

Patent expiration spurred a decline in SECTRAL’s revenue share, replaced by cheaper generics. Consequently, the original manufacturer’s profit margins have decreased, emphasizing the importance of marketing, brand loyalty, and operational efficiencies.

5. Market Expansion and Portfolio Diversification

Future revenues may be enhanced through developing fixed-dose combination products, extended-release formulations, or novel delivery methods. Venturing into new indications supported by clinical research can also serve as revenue catalysts.

6. Regional Revenue Variability

Sales performance varies significantly across regions. North America and Europe constitute mature markets with stable but declining revenues. In contrast, emerging economies exhibit growth potential, driven by escalating cardiovascular disease incidence and expanding healthcare infrastructure.

Strategic Outlook

Given the observed market trends, the financial trajectory for SECTRAL is characterized by gradual revenue decline in traditional markets due to generics, balanced by growth opportunities in emerging markets and through formulation innovations. Persistent competition necessitates strategic branding and diversification tactics to sustain profitability.

Key Takeaways

• Market Landscape: SECTRAL operates in a saturated, highly competitive landscape with widespread generic competition, challenging its ability to sustain premium pricing.

• Regulatory and Patent Factors: Patent expirations have diluted exclusivity, though regulatory pathways for new formulations and indications can potentially revive growth prospects.

• Regional Dynamics: Emerging markets offer growth avenues, but price sensitivity and healthcare infrastructure pose challenges.

• Innovation as a Lifeline: Formulation innovations, such as sustained-release versions, and expansion into novel therapeutic areas are critical for maintaining a revenue edge.

• Financial Outlook: Revenues are expected to plateau or decline in mature markets but can be offset by expanding patient populations globally and product differentiations.

Properly navigating patent landscapes, leveraging regulatory opportunities, and exploring innovative formulations will be essential for maintaining SECTRAL’s market position and financial sustainability.

FAQs

1. How has patent expiration affected SECTRAL’s market share?
Patent expiration has led to a surge of generic manufacturers producing propranolol, significantly reducing SECTRAL’s market share and profit margins in regions where generics dominate.

2. Are there any upcoming formulations or indications extending SECTRAL’s commercial life?
While no recent patent claims have been granted for new formulations, research exists into sustained-release and transdermal patches that could offer competitive advantages if successfully approved.

3. What regions offer the highest growth potential for SECTRAL?
Emerging markets such as Asia-Pacific and Latin America present higher growth potential due to increasing cardiovascular disease burden and expanding healthcare access.

4. How does competition from selective beta-blockers impact SECTRAL’s position?
Selective beta-blockers with improved safety profiles and fewer side effects are often prescribed over non-selective agents like SECTRAL, impacting its market share in certain indications.

5. What strategic steps can manufacturers take to sustain revenues from SECTRAL?
Strategies include developing combination therapies, seeking regulatory approvals for new indications, innovating delivery methods, and expanding into underserved markets.

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Sources

[1] GlobalBeta-Blocker Market Report, 2022.
[2] Regulatory Affairs Publications, FDA and EMA guidelines.
[3] Industry analysis via IQVIA and PharmSource.
[4] Patent and market exclusivity databases, World Intellectual Property Organization.