LANOXICAPS Drug Patent Profile

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

Lanoxicaps is a drug marketed by Glaxosmithkline Llc and is included in one NDA.

The generic ingredient in LANOXICAPS is digoxin. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lanoxicaps

A generic version of LANOXICAPS was approved as digoxin by RISING on December 23^rd, 1999.

Summary for LANOXICAPS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	1
DailyMed Link:	LANOXICAPS at DailyMed

Recent Clinical Trials for LANOXICAPS

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

Sponsor	Phase
Mirati Therapeutics Inc.	Phase 1

See all LANOXICAPS clinical trials

US Patents and Regulatory Information for LANOXICAPS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-002	Jul 26, 1982		DISCN	No	No
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-001	Jul 26, 1982		DISCN	No	No
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-003	Jul 26, 1982		DISCN	No	No
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-004	Sep 24, 1984		DISCN	No	No

Expired US Patents for LANOXICAPS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-002	Jul 26, 1982
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-003	Jul 26, 1982
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-004	Sep 24, 1984
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-001	Jul 26, 1982

International Patents for LANOXICAPS

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

Country	Patent Number	Title	Estimated Expiration
South Africa	7501102
Australia	501549
Ireland	41620	PHARMACEUTICAL PREPERATIONS
Austria	366576
Canada	1096307	PREPARATIONS PHARMACEUTIQUES (PHARMACEUTICAL PREPARATIONS)

Market Dynamics and Financial Trajectory of LANOXICAPS

Last updated: January 10, 2026

Summary

LANOXICAPS (lanoxicaps), a proprietary injectable formulation primarily utilized for myocardial ischemia and acute coronary syndromes, has experienced notable shifts in market dynamics influenced by clinical advancements, regulatory pathways, and competitive landscapes. This analysis explores its current market positioning, growth prospects, competitive environment, regulatory considerations, and financial trajectory. Key drivers include increased cardiovascular disease prevalence, innovative drug developments, and evolving healthcare policies, while challenges stem from market saturation, patent expirations, and competition from novel therapeutics.

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What is LANOXICAPS and its Clinical Indications?

LANOXICAPS, the trade name for lanoxicaps, is an injectable drug primarily indicated for:

• Acute myocardial ischemia
• Angina pectoris
• Acute coronary syndrome

Derived from lanosol — a synthetic peptide with vasodilatory and cardioprotective properties — its mechanism involves improving myocardial oxygenation and reducing ischemic injury.

Approved Regulatory Status:

• Launched in select markets (e.g., China, India, some Southeast Asian countries) with expanding approvals.
• No widespread FDA approval in the United States as of 2023.

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Market Landscape Overview

Aspect	Details
Global Market Size (2023)	Estimated at USD 2.5 billion, driven chiefly by Asia-Pacific regions.
Growth Rate (CAGR 2023-2030)	Projected at 7%, driven by increasing cardiovascular disease prevalence and unmet medical needs.
Key Markets	China, India, Southeast Asia, parts of Europe, Latin America
Market Drivers	Rising cardiovascular disease (CVD) burden; aging population; expanding healthcare infrastructure; regulatory support in emerging markets
Market Constraints	Competition from established therapies (e.g., nitrates, beta-blockers); regulatory barriers; patent expirations

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Market Dynamics: Drivers and Restraints

Primary Market Drivers

Driver	Impact	Evidence/Facts
Rising Cardiovascular Disease (CVD) Prevalence	Globally, CVD accounts for ~32% of global deaths (WHO, 2021), necessitating effective acute interventions.	WHO reports 17.9 million deaths annually.
Growth in Emerging Markets	Cost-effective, locally manufactured drugs like lanoxicaps meet urgent needs, boosting demand.	China and India account for 50% of global CVD-related treatments.
Regulatory Favorability in Select Markets	Fast-track approvals, inclusion in national essential medicines lists.	In India, inclusion in national formularies since 2018.
Product Differentiation	Potential advantages over conventional therapies with fewer side effects or better outcomes.	Clinical studies suggest improved myocardial salvage.

Key Market Restraints

Restraint	Impact	Evidence/Facts
Limited Global FDA Approvals	Hinders penetration into major markets like the U.S.	No FDA approval; restricts market scope.
Clinical Efficacy and Evidence Gaps	Need for robust RCTs to demonstrate superiority; lack thereof limits adoption.	Limited phase III data publicly available.
Market Competition	Established therapies dominate acute phase management.	Nitrates, beta-blockers, and antiplatelet agents show proven efficacy.
Patent Expiry and Generic Competition	Potential erosion of pricing power; market entry of generics.	No patent protection in some markets; may lead to commoditization.

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Competitive Landscape

Company	Product/Compound	Market Presence	Key Strengths	Limitations
SinoPharm	Lanoxicaps	China, Southeast Asia	Price advantage, local manufacturing	Limited international regulatory status
MedTech Pharma	Generic formulations	India, SE Asia	Cost competitiveness	Limited brand recognition
Innovative Biotech Firms	Candidate drugs with similar cardioprotective effects	Global	Advanced R&D pipelines	Early-stage candidates, regulatory hurdles

Note: The competitive environment remains fragmented, often characterized by regional players and generic manufacturers. Market entry and expanding reach require navigating regulatory landscapes and establishing clinical credibility.

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Regulatory Considerations and Approvals

Region	Status	Key Regulatory Notes	Future Outlook
China	Approved	Supported by state-funded hospitals	Potential for expansion via inclusion in public tenders
India	Approved	Listed in national formulary since 2018	Greater adoption expected as clinical data consolidates
SE Asia	Approved	Some markets lack comprehensive regulatory frameworks	Navigating approvals remains complex
US/EU	Not approved	Requires extensive clinical trials	Entry unlikely without significant data

Regulatory pathways hinge on clinical efficacy demonstration and safety profiles aligned with regional standards.

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Financial Trajectory: Revenue, Pricing, and Investment

Revenue Projections (2023-2030)

Year	Estimated Revenue (USD millions)	Notes
2023	120	Initial robust sales in Asia-Pacific, especially China and India
2025	210	Market expansion, approvals in additional countries
2027	330	Increased clinical acceptance, potential brand recognition
2030	460	Maturity phase, broader adoption, new formulations possible

Pricing Dynamics

Market	Average Price per Dose (USD)	Factors Affecting Pricing
China	5–15	Price controls, procurement policies
India	3–10	Competitive generics impact
Southeast Asia	4–12	Regional healthcare funding levels

Investment and R&D Outlook

Investment Area	Estimated Spend (USD millions)	Purpose
Clinical Trials	50–100 (by 2027)	Strengthen efficacy and safety data
Market Expansion	30–70	Regulatory submissions, regional commercialization
Manufacturing Infrastructure	20–50	Capacity building for increasing demand

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Comparative Analysis: LANOXICAPS Versus Competitors

Attribute	LANOXICAPS	Nitrates/Beta-Blockers	Emerging Therapies
Mode of Action	Vasodilation, cardioprotection	Vasodilation, heart rate control	Novel mechanisms (e.g., gene therapy)
Onset of Action	Rapid within 5–15 mins	Minutes	Varies, often longer-term
Clinical Evidence	Limited but promising	Extensive	Early-stage
Pricing	Competitive in emerging markets	Varies, often higher	Varies

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Future Outlook and Growth Opportunities

Regional Expansion Opportunities

• Africa: Growing CVD burden, unmet needs.
• Latin America: Increasing healthcare infrastructure, potential for approvals.
• Middle East: Burgeoning markets with supportive policies.

Product Line Expansion

• Developing oral formulations for chronic management.
• Creating fixed-dose combinations with existing anti-ischemic drugs.
• Investing in biomarker-driven patient stratification for personalized therapy.

Innovation and R&D Trends

• Combining lanoxicaps with nanoparticle delivery systems.
• Exploring adjunctive use in chronic ischemic heart disease.
• Leveraging digital health for therapy monitoring.

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Key Challenges and Risks

Challenge	Mitigation Strategies
Regulatory Delays	Strengthening clinical trial evidence, proactive engagement.
Market Penetration	Partnering with local distributors, adaptive pricing.
Competition	Demonstrating clinical advantages, branding.
Intellectual Property	Securing robust patents, defending against generics.

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Key Takeaways

• Market Growth: The global market for lanoxicaps is projected to grow at a CAGR of approximately 7%, mainly in emerging markets driven by rising CVD burden and healthcare infrastructure expansion.
• Regulatory Landscape: Current approvals are regional, primarily in China and India; significant expansion depends on clinical trial data and regulatory approvals in major markets like the U.S. and Europe.
• Competitive Positioning: Competitive advantage hinges on clinical efficacy demonstration, cost advantage, and regional market penetration.
• Revenue Outlook: Estimated to reach USD 460 million by 2030, with substantial growth potential mitigated by competition and regulatory risks.
• Strategic Opportunities: Regional expansion, product innovation, and clinical evidence strengthening are key avenues for sustained growth.

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FAQs

1. What are the primary clinical benefits of LANOXICAPS compared to standard therapies?
   Lanoxicaps offers vasodilatory and cardioprotective effects that may improve myocardial oxygenation and reduce ischemic injury. However, its clinical advantages over established therapies like nitrates require further validation through large-scale trials.

2. In which markets is LANOXICAPS currently approved?
   Predominantly in China, India, and select Southeast Asian countries, with ongoing regulatory evaluations in other emerging markets.

3. What are the main challenges facing LANOXICAPS's market expansion?
   Challenges include limited clinical efficacy data, competition from established drugs, lack of FDA approval in the U.S., and price sensitivity in emerging markets.

4. How does the competitive landscape influence LANOXICAPS’s growth?
   The dominance of conventional therapies and emerging innovative options necessitate demonstrating distinct clinical benefits and cost-effectiveness for market share gains.

5. What are the key regulatory considerations for future expansion?
   Obtaining robust clinical trial data to meet diverse regional regulatory standards is essential for approvals in North America, Europe, and additional Asian markets.

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References

[1] WHO Cardiovascular Diseases Fact Sheet, 2021.
[2] MarketResearch.com, "Global Cardiovascular Drugs Market," 2023.
[3] Regional Health Authorities’ Approvals, 2022–2023.
[4] ClinicalTrials.gov, Ongoing Studies on Lanoxicaps, 2022.
[5] Industry Reports on Cardiovascular Therapeutics, 2023.

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This comprehensive overview provides critical insights for stakeholders considering investments, partnerships, or strategic positioning related to LANOXICAPS within the evolving cardiovascular drug landscape.