SPIRONOLACTONE - Generic Drug Details

What are the generic sources for spironolactone and what is the scope of freedom to operate?

Spironolactone is the generic ingredient in three branded drugs marketed by Cmp Dev Llc, Amneal, Pfizer, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma, Chartwell Rx, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Norvium Bioscience, Oxford Pharms, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in twenty-six NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Spironolactone has four patent family members in four countries.

There are sixteen drug master file entries for spironolactone. Forty-three suppliers are listed for this compound.

Summary for SPIRONOLACTONE

International Patents:	4
US Patents:	8
Tradenames:	3
Applicants:	24
NDAs:	26
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	263
Patent Applications:	6,666
Drug Prices:	Drug price trends for SPIRONOLACTONE
Drug Sales Revenues:	Drug sales revenues for SPIRONOLACTONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPIRONOLACTONE
What excipients (inactive ingredients) are in SPIRONOLACTONE?	SPIRONOLACTONE excipients list
DailyMed Link:	SPIRONOLACTONE at DailyMed

See drug prices for SPIRONOLACTONE

See drug sales revenues for SPIRONOLACTONE

Recent Clinical Trials for SPIRONOLACTONE

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

Sponsor	Phase
CMP Development, LLC	Phase 4
University of California, San Francisco	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	N/A

See all SPIRONOLACTONE clinical trials

Pharmacology for SPIRONOLACTONE

Drug Class	Aldosterone Antagonist
Mechanism of Action	Aldosterone Antagonists

Medical Subject Heading (MeSH) Categories for SPIRONOLACTONE

Diuretics

Mineralocorticoid Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for SPIRONOLACTONE

C03DA	Aldosterone antagonists
C03D	ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
C03	DIURETICS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for SPIRONOLACTONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CAROSPIR	Oral Suspension	spironolactone	25 mg/5 mL	209478	1	2020-12-31

US Patents and Regulatory Information for SPIRONOLACTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	SPIRONOLACTONE	spironolactone	TABLET;ORAL	203512-001	Sep 19, 2016	AB	RX	No	No
Pfizer	ALDACTONE	spironolactone	TABLET;ORAL	012151-010	Dec 30, 1983	AB	RX	Yes	Yes
Amneal Pharms	SPIRONOLACTONE	spironolactone	TABLET;ORAL	091426-001	Jul 2, 2010	AB	RX	No	No

EU/EMA Drug Approvals for SPIRONOLACTONE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Ceva Santé Animale	Spironolactone Ceva	spironolactone	EMEA/V/C/000105 For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.	Withdrawn	no	no	no	2007-06-20
Nova Laboratories Ireland Limited	Qaialdo	spironolactone	EMEA/H/C/005535 In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension.Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).	Authorised	no	no	no	2023-05-26

International Patents for SPIRONOLACTONE

Country	Patent Number	Title	Estimated Expiration
Morocco	43132
Morocco	43132	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE
World Intellectual Property Organization (WIPO)	2017075463

SPIRONOLACTONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Spironolactone

Market Drivers

The spironolactone market is driven by several key factors that contribute to its growth and financial trajectory.

Rising Prevalence of Cardiovascular Diseases

The increasing incidence of hypertension, heart failure, and other cardiovascular disorders globally is a major driver for the spironolactone market. As the population ages and the prevalence of these conditions rises, the demand for spironolactone, which is effective in managing high blood pressure and heart failure, also increases[3][4].

Expanding Off-Label Uses

Spironolactone's off-label use in treating conditions such as hormonal acne, hirsutism, and polycystic ovary syndrome (PCOS) has significantly contributed to its market growth. The drug's versatility in addressing various hormonal imbalances has expanded its user base beyond traditional cardiovascular applications[1][3].

Improvement in Healthcare Infrastructure

Enhancements in healthcare infrastructure, particularly in emerging markets, have improved accessibility to spironolactone. This has led to higher prescription rates and better patient outcomes, further driving market growth[1].

Growing Awareness of Therapeutic Benefits

Increasing awareness among healthcare professionals and patients about the therapeutic benefits of spironolactone has led to higher prescription rates. This awareness is fueled by ongoing research and clinical trials that highlight the drug's efficacy in various medical conditions[3][4].

Market Restraints

Despite the strong drivers, the spironolactone market faces several challenges that impact its financial trajectory.

Price Sensitivity and Generic Competition

The availability of generic spironolactone brands exerts significant pricing pressures, reducing the market share and profitability of branded drugs. This competition forces pharmaceutical companies to innovate and differentiate their products to maintain market presence[1][3].

Limited Awareness Among Healthcare Professionals

Limited awareness among healthcare professionals about newer indications and uses of spironolactone restricts its widespread utilization. Educational campaigns and continuous medical education programs are necessary to address this gap[1].

Potential Side Effects and Safety Concerns

Spironolactone is associated with several side effects, including gynecomastia, renal dysfunction, and electrolyte imbalances. These safety concerns can lead to patient reluctance and require robust data to validate long-term safety, particularly in off-label applications[2].

Market Opportunities

The spironolactone market presents several opportunities for growth and innovation.

Expanding Untapped Markets

There is a significant opportunity for market players to expand their presence in untapped regions where the prevalence of hypertension and heart disorders is increasing. This includes emerging markets and underserved populations[3][4].

Innovative Drug Formulations

The development of innovative drug formulations, such as extended-release tablets, can enhance patient compliance and open up new market opportunities. Personalized medicine approaches, tailored to individual patient needs, are also gaining traction[3][4].

Focus on Pediatric Use

Exploring the effectiveness and safety of spironolactone in the pediatric population could create new growth avenues for the market. This involves conducting clinical trials and gathering data to support its use in younger patients[3].

Collaborations and Partnerships

Strategic collaborations with healthcare providers, pharmacies, and other pharmaceutical companies can enhance market penetration and promote the drug’s usage. These partnerships can also improve patient adherence and outcomes[1][3].

Market Trends

Several trends are shaping the spironolactone market and influencing its financial trajectory.

Increasing Demand for Personalized Medicine

The growing focus on individualized treatment plans is driving demand for customized pharmaceutical solutions. Patients are seeking treatments tailored to their specific health needs, which is a trend that spironolactone manufacturers are capitalizing on[4].

Rising Awareness of Chronic Diseases

The global increase in chronic diseases such as hypertension and heart failure is contributing to a higher demand for spironolactone. This trend is expected to continue as the global population ages and the incidence of these conditions rises[3][4].

Expansion of Drug Distribution Channels

The evolution of digital health platforms and online pharmacies is transforming how spironolactone tablets are distributed. Enhanced accessibility and convenience are key factors driving market growth as patients increasingly turn to online sources for their medication needs[4].

Regional Analysis

The spironolactone market varies significantly across different regions, each with its own set of opportunities and challenges.

North America and Europe

These regions have well-established healthcare infrastructures and high awareness levels about spironolactone's therapeutic benefits. However, they also face intense competition from generic brands and stringent regulatory environments[4].

Asia-Pacific and Emerging Markets

These regions offer significant growth opportunities due to the rising prevalence of cardiovascular diseases and improving healthcare infrastructure. Market players are focusing on expanding their presence in these areas through strategic partnerships and localized marketing efforts[3][4].

Financial Trajectory

The financial trajectory of the spironolactone market is expected to be positive, driven by the factors mentioned above.

Revenue Growth

The market is projected to experience substantial revenue growth due to the increasing demand for spironolactone in treating hypertension, heart failure, and other conditions. The global spironolactone market size is expected to expand significantly over the next decade[1][3].

Investment in Research and Development

Pharmaceutical companies are investing heavily in research and development to improve drug formulations, enhance efficacy, and explore new indications. This investment is crucial for maintaining market competitiveness and capitalizing on emerging opportunities[3][4].

Challenges and Mitigation Strategies

To mitigate challenges such as price sensitivity and safety concerns, companies are focusing on creating combination therapies, novel delivery systems, and demographic-specific dosing regimens. These strategies aim to enhance drug efficacy, patient experience, and overall market profitability[1].

Key Takeaways

• The spironolactone market is driven by the rising prevalence of cardiovascular diseases, expanding off-label uses, and improving healthcare infrastructure.
• Market growth is restrained by price sensitivity, generic competition, and safety concerns.
• Opportunities exist in expanding untapped markets, developing innovative drug formulations, and focusing on pediatric use.
• The market is influenced by trends such as personalized medicine, rising awareness of chronic diseases, and the expansion of drug distribution channels.
• Regional analysis highlights the potential in Asia-Pacific and emerging markets.
• The financial trajectory is expected to be positive, with significant revenue growth and investment in research and development.

FAQs

Q: What are the primary uses of spironolactone? A: Spironolactone is primarily used to treat high blood pressure, heart failure, hyperaldosteronism, and fluid retention in patients with congestive heart failure, liver cirrhosis, or nephrotic syndrome[5].

Q: What are the common side effects of spironolactone? A: Common side effects include gynecomastia, renal dysfunction, electrolyte imbalances, and various skin reactions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis[2].

Q: How does the availability of generic spironolactone impact the market? A: The availability of generic spironolactone exerts pricing pressures, reducing the market share and profitability of branded drugs. This forces pharmaceutical companies to innovate and differentiate their products[1][3].

Q: What are the emerging trends in the spironolactone market? A: Emerging trends include the increasing demand for personalized medicine, rising awareness of chronic diseases, and the expansion of drug distribution channels through digital health platforms and online pharmacies[4].

Q: What opportunities exist for market expansion? A: Opportunities exist in expanding untapped markets, developing innovative drug formulations, focusing on pediatric use, and forming strategic collaborations with healthcare providers and other pharmaceutical companies[3][4].

Cited Sources:

1. 360iResearch: Spironolactone Drugs Market Size & Share 2025-2030
2. Pfizer Medical Information: ALDACTONE® (spironolactone) Patient information - US
3. MarkWide Research: Spironolactone Tablets market 2024-2032 | Size, Share, Growth
4. openPR.com: Spironolactone Tablets Market: Trends, Innovations
5. Mayo Clinic: Spironolactone (oral route) - Mayo Clinic