Captopril - Generic Drug Details

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

Captopril is the generic ingredient in seven branded drugs marketed by Strides Pharma, Ajanta Pharma Ltd, Andas 5 Holding, Apothecon, Aurobindo Pharma Usa, Changzhou Pharm, Chartwell Rx, Corepharma, Cosette, Dava Pharms Inc, Egis Pharms, G And W Labs Inc, Hikma Intl Pharms, Oxford Pharms, Prinston Inc, Purepac Pharm, Sandoz, Seton Pharms, Teva, Watson Labs, Wockhardt, Ivax Sub Teva Pharms, and Rising, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for captopril. Thirteen suppliers are listed for this compound.

Summary for captopril

US Patents:	0
Tradenames:	7
Applicants:	23
NDAs:	33
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	50
Patent Applications:	6,348
Drug Prices:	Drug price trends for captopril
What excipients (inactive ingredients) are in captopril?	captopril excipients list
DailyMed Link:	captopril at DailyMed

See drug prices for captopril

Recent Clinical Trials for captopril

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

Sponsor	Phase
Natural Wellness Egypt	Phase 3
Shanghai Jiao Tong University School of Medicine	Phase 4
Iain Bressendorff	Phase 2

See all captopril clinical trials

Pharmacology for captopril

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

Medical Subject Heading (MeSH) Categories for captopril

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for captopril

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 captopril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	captopril; hydrochlorothiazide	TABLET;ORAL	074896-002	Dec 29, 1997		RX	No	Yes
Andas 5 Holding	CAPTOPRIL	captopril	TABLET;ORAL	074677-003	May 30, 1997	AB	RX	No	No
Watson Labs	CAPTOPRIL	captopril	TABLET;ORAL	074386-003	May 23, 1996		DISCN	No	No
Strides Pharma	CAPTOPRIL	captopril	TABLET;ORAL	074493-004	Feb 13, 1996		DISCN	No	No
Oxford Pharms	CAPTOPRIL	captopril	TABLET;ORAL	074418-004	Feb 13, 1996		DISCN	No	No

Expired US Patents for captopril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strides Pharma	CAPOTEN	captopril	TABLET;ORAL	018343-007	Jun 13, 1995
Strides Pharma	CAPOTEN	captopril	TABLET;ORAL	018343-004	Jun 13, 1995
Strides Pharma	CAPOTEN	captopril	TABLET;ORAL	018343-004	Jun 13, 1995
Strides Pharma	CAPOTEN	captopril	TABLET;ORAL	018343-006	Sep 17, 1986
Strides Pharma	CAPOTEN	captopril	TABLET;ORAL	018343-007	Jun 13, 1995

Captopril Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Captopril

Introduction to Captopril

Captopril, an angiotensin-converting enzyme (ACE) inhibitor, is a pivotal medication in the management of hypertension, heart failure, and diabetic nephropathy. Its mechanism of action involves inhibiting the conversion of angiotensin I to angiotensin II, thereby reducing blood pressure and alleviating the strain on the heart[5].

Market Size and Growth

The global captopril market is experiencing significant growth driven by several key factors:

• Increasing Prevalence of Hypertension and Cardiovascular Diseases: The rising incidence of hypertension and cardiovascular disorders is a major driver for the captopril market. As the global population ages and awareness of hypertension risks increases, the demand for effective treatments like captopril continues to grow[4].
• Market Value: The North America ACE Inhibitors Market, which includes captopril, was valued at USD 2.18 billion in 2023 and is anticipated to reach USD 2.93 billion by 2029, with a compound annual growth rate (CAGR) of 5.25%[3].

Segment Analysis

The captopril market can be segmented based on several criteria:

• Type: Captopril falls under the sulfhydryl-containing agents segment, which dominates the ACE inhibitors market due to its distinctive mechanism of action and clinical efficacy[3].
• Application: Captopril is used in managing hypertension, heart failure, left ventricular dysfunction post-myocardial infarction, and diabetic nephropathy. The hospital use segment is expected to expand significantly, retaining its position throughout the forecast period[1].
• Geographical Regions: The market is analyzed across various regions, with North America, particularly the United States, dominating due to the high prevalence of cardiovascular diseases and well-established healthcare infrastructure[3].

Drivers

Several factors drive the growth of the captopril market:

• Growing Demand for Cardiovascular Treatments: The increasing burden of cardiovascular diseases, including hypertension and heart failure, drives the demand for ACE inhibitors like captopril[3].
• Technological Advancements: Continuous research and development efforts to enhance existing drugs and develop novel therapies contribute to market growth[3].
• Regulatory Environment: A proactive regulatory environment in regions like the United States supports the development and approval of new cardiovascular medications[3].

Restraints

Despite the growth drivers, there are several restraints that impact the captopril market:

• Adverse Effects: Captopril is associated with potential adverse effects such as dry cough, proteinuria, and renal insufficiency, which can limit its adoption in certain patient populations[5].
• Regulatory and Safety Regulations: Environmental and safety regulations, as well as the need for strict compliance with FDA guidelines, can pose challenges for manufacturers[1].

Opportunities

The captopril market presents several opportunities for growth:

• Public Awareness and Education: Increasing public awareness about the use of captopril and other ACE inhibitors can create growth opportunities for the market[4].
• Combination Therapies: The trend towards combination therapies offers opportunities for captopril to be used in conjunction with other medications, enhancing its market potential[3].

Financial Trajectory

The financial trajectory of captopril is promising due to its significant health care cost savings and market growth:

• Cost Savings: Studies have shown that captopril can result in substantial cost savings. For instance, treatment with captopril in patients with diabetic nephropathy can lead to direct cost savings of $32,550 per patient with IDDM and $9,900 per patient with NIDDM over a lifetime[2].
• Market Forecast: The global captopril market is expected to grow significantly, with the North America ACE Inhibitors Market projected to reach USD 2.93 billion by 2029. The global captopril API market is also forecasted to grow at a notable CAGR through 2031[3][4].

Competitive Landscape

The captopril market is highly competitive with several key players:

• Major Players: Companies like Pfizer, Novartis, AstraZeneca, and others are actively involved in the production and distribution of captopril. These companies focus on strategy building, product portfolio expansion, and innovative research to maintain their market position[1][3].

Regional Analysis

The regional analysis highlights the varying market dynamics across different regions:

• North America: This region dominates the ACE inhibitors market due to the high prevalence of cardiovascular diseases and a well-established healthcare infrastructure. The United States is a leader in advancing ACE inhibitor therapies[3].
• Other Regions: The market is also analyzed in regions such as Europe, APAC, MEA, and South & Central America, each with its unique market dynamics and growth opportunities[4].

Economic Impact

The economic impact of captopril is significant, both in terms of direct and indirect cost savings:

• Direct Cost Savings: The use of captopril in treating diabetic nephropathy can lead to substantial direct cost savings, estimated at $189 million annually in the year 1999 and $475 million by 2004. The present value of cumulative health care cost savings over 10 years was estimated at $2.4 billion[2].
• Indirect Cost Savings: Indirect cost savings, reflecting broader societal benefits such as lost patient productivity due to end-stage renal disease, are also significant, with estimates of $84,390 per patient with IDDM and $45,730 per patient with NIDDM[2].

Key Takeaways

• The captopril market is driven by the growing prevalence of hypertension and cardiovascular diseases.
• The market is segmented by type, application, and geographical regions, with North America being a dominant region.
• Captopril offers significant health care cost savings and is expected to grow at a notable CAGR.
• The competitive landscape is marked by key players focusing on innovation and market expansion.
• Regional analysis highlights varying market dynamics across different regions.

FAQs

Q: What are the primary indications for captopril? A: Captopril is primarily indicated for the treatment of hypertension, heart failure, left ventricular dysfunction post-myocardial infarction, and diabetic nephropathy[5].

Q: Which segment dominates the ACE inhibitors market, and why? A: The sulfhydryl-containing agents segment, which includes captopril, dominates the ACE inhibitors market due to its distinctive mechanism of action and clinical efficacy[3].

Q: What are the potential adverse effects of captopril? A: Captopril is associated with adverse effects such as dry cough, proteinuria, renal insufficiency, and neutropenia[5].

Q: How does captopril impact health care costs? A: Captopril results in significant direct and indirect cost savings, particularly in the treatment of diabetic nephropathy, with estimated savings of $32,550 per patient with IDDM over a lifetime[2].

Q: Who are the key players in the captopril market? A: Key players include Pfizer, Novartis, AstraZeneca, and other pharmaceutical companies actively involved in the production and distribution of captopril[1][3].

Cited Sources

1. Global Captopril Market Report 2024 Edition - Cognitivemarketresearch.com
2. An economic analysis of captopril in the treatment of diabetic nephropathy - PubMed
3. North America ACE Inhibitors Market Trends, Competition, Opportunities - GlobeNewswire
4. Captopril API Market Insights and Growth by 2031 - The Insight Partners
5. Captopril - StatPearls - NCBI Bookshelf - NCBI