Fosinopril sodium - Generic Drug Details

What are the generic sources for fosinopril sodium and what is the scope of patent protection?

Fosinopril sodium is the generic ingredient in four branded drugs marketed by Actavis Labs Fl Inc, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Prinston Inc, Ranbaxy Labs Ltd, Teva, Upsher Smith Labs, Watson Labs, Bristol Myers Squibb, Ani Pharms, Aurobindo Pharma, Avet Lifesciences, Mylan, Sandoz, and Sun Pharm Inds Ltd, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for fosinopril sodium. Seven suppliers are listed for this compound.

Summary for fosinopril sodium

US Patents:	0
Tradenames:	4
Applicants:	17
NDAs:	22
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	5
Patent Applications:	3,002
Drug Prices:	Drug price trends for fosinopril sodium
What excipients (inactive ingredients) are in fosinopril sodium?	fosinopril sodium excipients list
DailyMed Link:	fosinopril sodium at DailyMed

See drug prices for fosinopril sodium

See drug sales revenues for fosinopril sodium

Recent Clinical Trials for fosinopril sodium

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

Sponsor	Phase
Shanghai Changzheng Hospital	Phase 4
The First Affiliated Hospital of Zhengzhou University	Phase 4
Ruijin Hospital	Phase 4

See all fosinopril sodium clinical trials

Pharmacology for fosinopril sodium

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Medical Subject Heading (MeSH) Categories for fosinopril sodium

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for fosinopril sodium

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for fosinopril sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Invagen Pharms	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	077222-003	Apr 20, 2005	AB	RX	No	No
Invagen Pharms	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	077222-002	Apr 20, 2005	AB	RX	No	No
Apotex Inc	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	076906-001	May 17, 2005	AB	RX	No	No

Expired US Patents for fosinopril sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-003	May 16, 1991	4,384,123
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995	5,006,344*PED
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991	4,337,201*PED

Fosinopril sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fosinopril Sodium

Introduction

Fosinopril sodium, an angiotensin-converting enzyme (ACE) inhibitor, is widely used in the treatment of hypertension and heart failure. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

As of 2023, the global market size for fosinopril sodium is estimated to be approximately USD 1.2 billion. Projections indicate a significant growth, forecasting the market to reach USD 2.1 billion by 2032[4].

Consumer Demand and Market Trends

The increased demand for fosinopril sodium can be attributed to several market trends. The rising prevalence of hypertension and heart failure, coupled with the drug's efficacy in managing these conditions, has driven consumer demand. Additionally, the growing awareness of cardiovascular health and the need for effective antihypertensive medications have contributed to the market's expansion[1].

Competitive Landscape

Fosinopril sodium competes in a crowded market of antihypertensive drugs, including other ACE inhibitors and calcium channel blockers like amlodipine. However, studies have shown that fosinopril sodium has distinct advantages, particularly in reducing blood pressure in certain patient subgroups such as females, those with central obesity, insulin resistance (IR), and hypo-HDL-cholesterolemia[3].

Efficacy and Clinical Outcomes

The efficacy of fosinopril sodium has been well-documented in various clinical trials. It has been shown to significantly reduce both systolic and diastolic blood pressure, with peak reductions achieved 2 to 6 hours after dosing and a sustained antihypertensive effect for 24 hours. In patients with heart failure, fosinopril sodium has demonstrated benefits in reducing pulmonary capillary wedge pressure, mean arterial blood pressure, and systemic vascular resistance, while increasing cardiac index and stroke volume[2].

Patient Segments and Target Markets

Fosinopril sodium is effective across various patient segments, including adults and children with hypertension, as well as patients with heart failure. The drug's efficacy in specific subgroups, such as females and those with metabolic syndrome, makes it a preferred choice for these patient populations[3].

Pricing and Cost-Effectiveness

The pricing of fosinopril sodium is competitive within the antihypertensive market. Its cost-effectiveness is enhanced by its ability to be used in combination with other medications, such as thiazide diuretics, to achieve greater blood pressure-lowering effects than either agent alone. This combination therapy can reduce the overall cost of treatment while improving patient outcomes[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of fosinopril sodium. The drug has undergone extensive clinical trials and has been approved by regulatory bodies such as the FDA. Compliance with regulatory requirements and ongoing safety monitoring are essential for maintaining market presence and expanding indications[5].

Future Outlook

The future outlook for fosinopril sodium is promising, driven by increasing demand for effective antihypertensive medications and the drug's proven clinical benefits. As the global population ages and the prevalence of cardiovascular diseases rises, the market for fosinopril sodium is expected to continue growing.

Challenges and Opportunities

Despite the positive outlook, there are challenges to consider. The generic market for ACE inhibitors is highly competitive, which can impact pricing and market share. However, opportunities exist in expanding the drug's indications, particularly in pediatric populations and in combination therapies, which could further enhance its market position[3][5].

Key Takeaways

• Market Growth: The global fosinopril sodium market is projected to grow from USD 1.2 billion in 2023 to USD 2.1 billion by 2032.
• Efficacy: Fosinopril sodium is highly effective in reducing blood pressure and improving outcomes in patients with hypertension and heart failure.
• Competitive Advantage: The drug has a competitive edge in treating specific patient subgroups.
• Regulatory Compliance: Ongoing compliance with regulatory requirements is crucial for market presence.
• Future Outlook: The market is expected to grow due to increasing demand for antihypertensive medications.

FAQs

Q: What is the current market size for fosinopril sodium? A: As of 2023, the global market size for fosinopril sodium is approximately USD 1.2 billion[4].

Q: How effective is fosinopril sodium in reducing blood pressure? A: Fosinopril sodium significantly reduces both systolic and diastolic blood pressure, with peak reductions achieved 2 to 6 hours after dosing and a sustained effect for 24 hours[2].

Q: Which patient subgroups benefit most from fosinopril sodium? A: Fosinopril sodium is particularly effective in females, patients with central obesity, insulin resistance (IR), and hypo-HDL-cholesterolemia[3].

Q: Can fosinopril sodium be used in combination with other medications? A: Yes, fosinopril sodium can be used in combination with thiazide diuretics to achieve greater blood pressure-lowering effects than either agent alone[2].

Q: What are the future projections for the fosinopril sodium market? A: The market is projected to grow to USD 2.1 billion by 2032, driven by increasing demand for effective antihypertensive medications[4].

Sources

1. Global Fosinopril Sodium Market Economical Growth, Growth Statistics, Economic Crisis, Trends 2022-2030 - Ein Presswire
2. Fosinopril: Package Insert / Prescribing Information - Drugs.com
3. Efficacy of fosinopril and amlodipine in pediatric primary hypertension - PMC
4. Fosinopril Sodium Market Research Report 2032 - Dataintelo
5. N19-915S037 Fosinopril Clinical BPCA - FDA