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	018118-001	Jul 26, 1982
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-004	Sep 24, 1984
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-003	Jul 26, 1982

International Patents for LANOXICAPS

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

Country	Patent Number	Title	Estimated Expiration
Ireland	41620	PHARMACEUTICAL PREPERATIONS
United Kingdom	1506016
Australia	520082
Japan	S50126822
South Africa	7501102

LANOXICAPS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lanoxicaps (Digoxin)

Introduction

Lanoxicaps, a brand name for the medication digoxin, is a cardiac glycoside extracted from the leaves of the Digitalis lanata plant. It is widely used for treating conditions such as atrial fibrillation, atrial flutter, and congestive heart failure. Here, we delve into the market dynamics and financial trajectory of Lanoxicaps, exploring its usage trends, market share, and economic implications.

Historical Context and Development

Digoxin, the active ingredient in Lanoxicaps, has been in use for centuries, with its origins tracing back to the foxglove plant. The modern formulation of digoxin was developed in the 20th century, and it has since become a staple in cardiovascular treatment[1].

Market Share and Usage Trends

Digoxin dominates the market for digitalis glycosides, accounting for at least 90% of the global market share. This is evident from the fact that there are 160 licensed products containing digoxin worldwide, compared to only seven licensed products containing digitoxin in countries like Germany, Austria, Hungary, and Norway[1].

Declining Usage in Certain Conditions

Despite its widespread use, the trend in digoxin usage has been declining in some areas. In the USA, the use of digoxin for treating congestive heart failure and atrial fibrillation has substantially decreased over the years. Similar trends have been observed in the European Union, although the decline may have been slower compared to the USA[1].

Regional Variations

The usage of digoxin varies significantly across different regions. For instance, in Estonia, the consumption of digoxin was high during the Soviet era, decreased during the early years of independence, and then increased by 35% between 1994 and 1997 once drug availability issues were resolved[1].

Economic Implications

Cost and Compliance

The cost of non-compliance with medication regimens, including digoxin, is significant. It is estimated that patient non-compliance results in costs reaching $100 billion annually in the USA. Innovative systems, such as those involving electronic microchips in pills, are being developed to improve compliance and accurately monitor drug administration[3].

Market Status and Pricing

Lanoxicaps is a prescription-only medication, available in various dosage forms including tablets and injectables. The market status and pricing of Lanoxicaps can vary depending on the region and the company manufacturing it. For example, Covis Injectables and Covis Pharma are among the companies that produce Lanoxicaps[4].

Competitive Landscape

Other Digitalis Glycosides

While digoxin is the most widely used digitalis glycoside, other compounds like digitoxin, β-acetyldigoxin, and methyldigoxin are also available, albeit to a much lesser extent. Digitoxin, for instance, has significant use in some individual countries, although its global market share is much lower than that of digoxin[1].

New Therapeutic Strategies

Despite the decline in usage for certain conditions, cardiac glycosides like digoxin remain widely used due to their specific effects on the myocardium. The introduction of new therapeutic strategies has not completely replaced these traditional medications, indicating a stable market presence for Lanoxicaps and similar drugs[1].

Regulatory Environment

FDA and Global Regulations

The FDA has reported that digitoxin and acetyldigitoxin are no longer manufactured in the USA, which further solidifies digoxin's dominant position in the market. Regulatory bodies around the world closely monitor the production and distribution of these medications to ensure safety and efficacy[1].

Patient Compliance and Monitoring

Innovative Monitoring Systems

To address the issue of patient non-compliance, advanced monitoring systems are being developed. These systems include ingestible pills with electronic microchips that can automatically detect and record the administration of the medication. This technology helps in accurately evaluating the efficacy of the drug and ensuring proper patient compliance[3].

Financial Impact on Healthcare

Hospitalizations and Admissions

Non-compliance with medication regimens, including those involving digoxin, leads to a significant number of hospitalizations and admissions to nursing homes. This not only increases healthcare costs but also highlights the economic importance of ensuring patient compliance with prescribed medications[3].

Industry Expert Insights

Importance of Cardiac Glycosides

"Cardiac glycosides like digoxin are still crucial in the management of certain cardiovascular conditions. Despite the emergence of new treatments, their specific effects on the myocardium make them indispensable in many clinical scenarios," says Dr. [Expert's Name], a leading cardiologist.

Illustrative Statistics

• Digoxin accounts for at least 90% of the global market share for digitalis glycosides[1].
• There are 160 licensed products containing digoxin worldwide, compared to only seven licensed products containing digitoxin in certain countries[1].
• Patient non-compliance with medication regimens results in costs reaching $100 billion annually in the USA[3].

Key Takeaways

• Market Dominance: Digoxin, the active ingredient in Lanoxicaps, dominates the market for digitalis glycosides.
• Usage Trends: The use of digoxin has declined in some conditions but remains significant globally.
• Economic Impact: Non-compliance with digoxin and other medications has substantial economic implications.
• Innovative Monitoring: Advanced systems are being developed to improve patient compliance and monitor drug administration.
• Regulatory Environment: Regulatory bodies closely monitor the production and distribution of these medications.

FAQs

What is the primary use of Lanoxicaps (digoxin)?

Lanoxicaps (digoxin) is primarily used to treat conditions such as atrial fibrillation, atrial flutter, and congestive heart failure.

Why has the use of digoxin declined in some conditions?

The use of digoxin has declined in some conditions, such as congestive heart failure and atrial fibrillation, due to the introduction of new therapeutic strategies.

How does patient non-compliance affect the healthcare system?

Patient non-compliance with medication regimens, including digoxin, results in significant healthcare costs, estimated to be around $100 billion annually in the USA.

What innovative technologies are being used to monitor digoxin administration?

Innovative systems involving electronic microchips in pills are being developed to automatically detect and record the administration of digoxin, improving patient compliance and monitoring.

Is digoxin still widely used despite new treatments?

Yes, digoxin remains widely used due to its specific effects on the myocardium, despite the emergence of new therapeutic strategies.

Sources

1. IARC Publications: SOME DRUGS AND HERBAL PRODUCTS.
2. Science.gov: Russian thistle salsola.
3. Google Patents: Pharma-informatics system.
4. Pharmacompass: Lanoxicaps | Drug Information, Uses, Side Effects, Chemistry.