Spironolactone - Generic Drug Details

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

Spironolactone is the generic ingredient in three branded drugs marketed by Cmp Dev Llc, Amneal, Hetero Labs Ltd Iii, Pfizer, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Annora Pharma, Ascot, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Oxford Pharms, Pharmobedient, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in twenty-nine 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-two suppliers are listed for this compound.

Summary for spironolactone

International Patents:	4
US Patents:	8
Tradenames:	3
Applicants:	27
NDAs:	29
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	292
Patent Applications:	7,099
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
DELPHINIUM	PHASE2
Boehringer Ingelheim	PHASE2
University Medical Center Groningen	PHASE2

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
Hetero Labs Ltd Iii	SPIRONOLACTONE	spironolactone	SUSPENSION;ORAL	218085-001	Feb 21, 2025	AB	RX	No	No
Pfizer	ALDACTONE	spironolactone	TABLET;ORAL	012151-010	Dec 30, 1983	AB	RX	Yes	Yes
Mylan	SPIRONOLACTONE	spironolactone	TABLET;ORAL	040424-002	Aug 20, 2001	AB	RX	No	No
Ivax Pharms	SPIRONOLACTONE	spironolactone	TABLET;ORAL	087108-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes			Y

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/000105For 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/005535In 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
Canada	3003028	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)
European Patent Office	3368045	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)
Morocco	43132	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE
World Intellectual Property Organization (WIPO)	2017075463
Canada	3003028	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)

Spironolactone Market Dynamics and Financial Trajectory (US and Major Markets): Revenue Drivers, Competitive Pressure, and Pricing Outlook

Last updated: July 24, 2026

Spironolactone is a mature, off-patent small molecule with broad generic availability in the US and multiple geographies. Financial trajectory is therefore driven less by patent value and more by (1) dose-form and brand-to-generic switching, (2) chronic disease prevalence (heart failure, cirrhosis/ascites, resistant hypertension), (3) reimbursement dynamics, and (4) constrained supply or regulatory actions affecting specific manufacturers. Net pricing typically trends downward, with revenue stability supported by high baseline demand and continued new prescriptions.

---

How is spironolactone priced and reimbursed in the US retail vs hospital channels?

Spironolactone is widely generic. Pricing is usually “commodity-like,” but channel mix matters. US revenue is typically supported by:

• Retail pharmacy: chronic prescriptions for heart failure and resistant hypertension. Generic fills dominate.
• Hospital and specialty workflows: cirrhosis-related ascites and inpatient heart failure protocols drive consistent volumes, but utilization is sensitive to formulary placement and order sets.

What constrains revenue upside: payer pressure and PBM contract structures that compress net prices once multiple A-rated generics compete on the same strength and dosage form.

What are the main factors that push net price down or up?

• Number of generic competitors at launch and post-launch
  Each incremental ANDA reduces allowable net pricing unless there is supply tightness or a formulation-specific differentiation.
• Formulary and interchangeability
  If a payer locks in a preferred supplier, competing generics can lose share even when they are interchangeable.
• Supply reliability
  Shortages can increase net price temporarily and lift realized revenue for the remaining suppliers.

---

What drives spironolactone demand growth: heart failure, ascites, or resistant hypertension?

Spironolactone is used across multiple therapeutic indications that have different epidemiology and prescribing patterns:

• Heart failure with reduced ejection fraction (HFrEF)
  Spironolactone use remains entrenched due to guideline positioning as an MRA option.
• Cirrhosis with ascites (and edema associated with hepatic disease)
  Demand is tied to liver disease prevalence and the rate of decompensation management.
• Resistant hypertension
  Increasing hypertension screening and multi-drug intensification can sustain use, though prescribing also follows guideline updates and tolerability.

How does indication mix affect quarterly volatility?

• Heart failure: tends to be stable with fewer abrupt utilization shifts but can show seasonal variation in hospitalizations.
• Ascites: can show more volatility tied to decompensation episodes and hospitalization rates.
• Resistant hypertension: influenced by outpatient prescribing patterns and adherence.

---

Which dosage strengths and formulations matter most for revenue?

For revenue, the highest-impact levers are commonly:

• Oral solid doses (tablet strengths are the standard commercial basis)
• Dose continuity across chronic therapy
  Small price differences across strengths can matter, but volume is often the dominant factor.

Are there economically meaningful differentiation levers?

Yes, but limited:

• Manufacturing scale and supply reliability
• Narrow differences in excipient/formulation that can affect tolerability or prescriber preference
• Packaging and labeling that support adherence

Spironolactone’s core molecule is not patent-protected in practice for most markets; differentiation tends to be operational rather than IP-led.

---

When do generic entry risks affect spironolactone revenues?

Because spironolactone is largely generics-only, the “entry risk” is less about blocking a first generic and more about subsequent waves of competition and facility-specific supply disruptions.

What typically happens after new generic launches?

• Net price compression is immediate when additional manufacturers gain share.
• Market share redistribution favors the supplier with best PBM placement and reliable supply.
• Revenue total remains stable because demand is inelastic, but margins shrink.

What triggers revenue rebounds?

• Supply constraints from specific manufacturers, sometimes driven by facility issues or regulatory holds.
• Shortage designations or allocation can temporarily move pricing for the constrained products.

---

How many manufacturers compete for spironolactone and how does that affect margins?

Competition in mature generics markets typically compresses margins to low single digits or sub-single-digit levels at the net-price level, with profitability concentrated in:

• manufacturers with scale
• strong procurement and manufacturing efficiency
• those with preferred payer positioning

What is the economic pattern across generic manufacturers?

• Most firms chase volume at low prices.
• A smaller subset maintains profitability when they avoid stockouts, secure contracting advantages, and run efficient manufacturing.

---

What is the expected financial trajectory for spironolactone (revenue, margin, and cash flow)?

Given generic maturity, the typical financial shape is:

• Revenue: relatively stable-to-slightly declining, with growth driven by underlying therapeutic demand and utilization shifts that are modest in magnitude.
• Gross margin: under persistent pressure due to price competition.
• Operating leverage: limited by continued administrative and regulatory costs, though scale can sustain profitability for dominant suppliers.
• Cash flow: generally strong in mature generics, assuming stable supply and no major compliance events.

Where does upside come from?

• Volume increases from persistent use in chronic therapy
• Market share gains through contracting and consistent supply
• Short-term pricing lift during supply disruptions

Where does downside come from?

• Additional generic entrants and rebids
• PBM re-contracting that forces down net price
• Regulatory quality issues that remove product from distribution

---

How does spironolactone compare with other diuretics (furosemide, hydrochlorothiazide) on market dynamics?

Spironolactone competes indirectly for diuretic and MRA-treated populations:

• Hydrochlorothiazide (HCTZ) is widely used and often cheaper, with strong OTC and low-cost generic positioning.
• Furosemide is used heavily inpatient and outpatient but is also commodity-like generics.
• Spironolactone has a distinct role as an MRA. That differentiation supports a steadier demand base tied to guideline-based use in heart failure and ascites rather than broad first-line diuretic substitution.

Does spironolactone lose demand to SGLT2 inhibitors or other heart failure therapies?

Heart failure treatment regimens evolve. However, MRAs remain relevant. Even when other agents expand, MRAs usually do not fully displace spironolactone due to different mechanisms and guideline positioning.

---

What regulatory and quality events can affect spironolactone supply and revenue?

In mature generics, revenue swings usually come from operational or compliance events:

• FDA warning letters, inspection outcomes, or consent decrees for specific facilities
• product-specific recalls
• manufacturing interruptions leading to shortages

How do supply interruptions translate into financial results?

• constrained supply can produce temporary net-price increases
• revenue can shift toward the least-constrained suppliers
• litigation or corrective action costs can hit operating income for affected manufacturers

---

What does the competitive landscape look like for spironolactone brands vs generics?

The economic reality is that brand revenue is likely small relative to generic volumes in most markets. Brand competitiveness is limited once multiple generics are available.

Who typically wins share?

• suppliers with preferred formulary positioning
• those with strong distribution relationships
• manufacturers with fewer stockouts and consistent manufacturing throughput

---

How does spironolactone’s revenue exposure vary by geography and regulatory environment?

Geographic dynamics track local generic penetration:

• US: high generic saturation, frequent contract-driven net price reductions.
• EU/UK: similarly mature generics markets with tender and reimbursement pressures.
• Emerging markets: may show higher pricing variability depending on local manufacturing capacity and import dependence.

Revenue exposure is typically lower where competition is entrenched and stable, and higher where supply constraints or import reliance can cause abrupt price movements.

---

What is the patent estate impact on spironolactone’s financial trajectory?

Spironolactone is a widely genericized molecule; the “patent estate” impact on pricing is typically already played out. Financial trajectory is therefore dominated by:

• generic competition
• contracting and distribution efficiency
• supply reliability

---

Key Takeaways

• Spironolactone’s financial trajectory is primarily shaped by mature-generic economics: stable demand offset by persistent net price compression.
• Revenue is supported by chronic indications in heart failure, cirrhosis-related ascites, and resistant hypertension, but upside is limited by PBM and payer contracting dynamics.
• Margin pressure persists with each additional generic entrant, while temporary pricing and revenue lifts can occur during supply constraints affecting specific manufacturers.
• Competitive advantage is operational: manufacturing scale, quality performance, and distribution/formulary positioning.

---

FAQs

1) Why does spironolactone revenue stay resilient despite generic competition?
Because it is used for chronic conditions with relatively inelastic demand and established guideline-driven use, so volume persists even as net prices decline.

2) What typically causes quarter-to-quarter revenue swings for mature generic spironolactone?
Supply disruptions, formulary rebids, and channel mix changes between inpatient and retail prescribing.

3) How do PBM contracts and formulary placements affect spironolactone net pricing?
They can rapidly shift share among equivalent generics and force net price reductions through rebids and preferred product status.

4) Does spironolactone compete directly with other diuretics like furosemide and thiazides?
Indirectly; it serves distinct clinical roles as an MRA, so it competes by regimen selection rather than by being a full substitute across all indications.

5) What operational factors most influence long-run profitability for spironolactone manufacturers?
Manufacturing efficiency, stable supply, and low compliance-risk exposure, which determine whether a firm can maintain share at contracted net prices.

---

References (APA)

1. FDA Orange Book. U.S. Food and Drug Administration. (Accessed 2026).
2. FDA Drug Shortages. U.S. Food and Drug Administration. (Accessed 2026).