Last Updated: May 10, 2026

Digitoxin - Generic Drug Details


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

Digitoxin is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for digitoxin
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 71
Clinical Trials: 2
DailyMed Link:digitoxin at DailyMed
Recent Clinical Trials for digitoxin

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

SponsorPhase
University of Texas Southwestern Medical CenterPhase 1
Pamela L. Zeitlin, MD, PhDPhase 2
National Jewish HealthPhase 2

See all digitoxin clinical trials

Medical Subject Heading (MeSH) Categories for digitoxin
Anatomical Therapeutic Chemical (ATC) Classes for digitoxin

US Patents and Regulatory Information for digitoxin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly CRYSTODIGIN digitoxin INJECTABLE;INJECTION 084100-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Digitoxin Market Analysis and Financial Projection

Last updated: April 23, 2026

DIGITOXIN: Market Dynamics and Financial Trajectory

Digitoxin is a cardiac glycoside used for treatment of heart failure and atrial arrhythmias. Commercial positioning is shaped by mature-indication demand, constrained prescriber appetite versus newer heart-failure and arrhythmia options, and a supply chain that depends on a limited number of manufacturers for tablets and injectable material in certain geographies. The financial trajectory is therefore driven less by patent-led growth and more by recurring demand, pricing power in each market, and episodic supply disruptions.

Is DIGITOXIN still a meaningful commercial product?

Yes in regions where it remains marketed and reimbursed, but it behaves like an older, off-patent cardiovascular specialist asset rather than a growth franchise.

What the market looks like in practice

  • Therapeutic role is narrower than newer standard-of-care drugs in heart failure with reduced ejection fraction and many atrial fibrillation management pathways.
  • Clinical practice is conservative because digitoxin has a relatively long half-life and requires careful dosing and monitoring (interaction burden from other cardiovascular and metabolic drugs).
  • Demand is sticky when formularies include it, but the category is vulnerable to formulary exclusions, substitution to alternatives (for example, digoxin and other agents), and regional product discontinuations.

Commercial implication

  • DIGITOXIN volumes tend to track long-run cardiovascular maintenance demand more than innovation cycles.
  • The commercial base typically grows slowly or contracts modestly depending on substitution, reimbursement rules, and manufacturer coverage.

What market dynamics govern DIGITOXIN pricing and volume?

Pricing and volume move with three main levers: supply availability, payer and formulary design, and competitive substitution.

1) Supply coverage is a direct driver of availability

Digitoxin is an older molecule with fewer modern manufacturing players than high-volume generics. When supply tightens, prices can spike and backorders can lift net realizations temporarily. When supply normalizes, price pressure returns.

Observed dynamic pattern for older small-molecule cardiovascular brands/generics

  • Short-term retail price sensitivity rises during shortages.
  • Contracting and wholesaler inventory cycles amplify quarter-to-quarter revenue volatility.
  • Manufacturing restarts or lifecycle changes can shift unit mix between tablets and any injectable presentations still marketed in certain countries.

2) Formulary placement determines durable demand

Where digitoxin is included on formularies for atrial arrhythmias or heart failure, demand remains stable. Where formularies prefer alternative glycosides or non-glycoside pathways, digitoxin loses share.

Key decision points

  • Drug–drug interactions and therapeutic monitoring requirements influence guideline and formulary stance.
  • Clinical pathways for atrial fibrillation and heart failure often reduce reliance on digitoxin relative to newer regimens.
  • Some markets prefer digoxin over digitoxin due to practical dosing characteristics and established local protocols.

3) Substitution risk is structural

Digitoxin competes primarily with:

  • Digoxin within the glycoside class
  • Other cardiovascular therapies that reduce the need for cardiac glycosides depending on indication
  • In some settings, rhythm-control strategies and rate-control agents for atrial fibrillation that displace glycosides

Commercial implication

  • Volume growth depends on retained formulary access and consistent supply, not new patient acquisition.

How does the financial trajectory typically evolve for DIGITOXIN?

For an older, largely off-patent molecule, the financial trajectory is usually defined by steady but limited growth, periodic revenue dips, and margin compression over time.

Typical revenue mechanics

  • Units track stable clinical use in geographies that still list the product.
  • Net price erodes over time under competitive tendering, generic entry, and payer pressure.
  • Gross margin compresses if manufacturers compete on price or if the product has low throughput and higher manufacturing costs per unit.

What to expect in real financial statements

  • Revenue tends to show low single-digit growth or mild contraction across years, depending on geography mix.
  • Currency effects can be meaningful if the product is distributed across regions with different tender cycles.
  • Inventory-driven quarter movements can occur during supply disruptions or distribution relabeling.

What does the investment case look like for DIGITOXIN?

The investment case is dominated by risk management and supply-chain positioning rather than innovation upside.

Where DIGITOXIN can still be investable

  • Manufacturers with secured supply and reliable regulatory standing can sustain a stable revenue base.
  • Firms with distribution scale can benefit from stable demand even with low growth.
  • If a supplier exits a geography, an incumbent with intact manufacturing can win contracts.

Where the risk sits

  • Regulatory and manufacturing continuity risk because older molecules still require ongoing GMP compliance.
  • Formulary drift risk where payers narrow access to cardiac glycosides.
  • Substitution risk as clinical guidelines increasingly tilt to other agents.

How do patents and exclusivity typically affect DIGITOXIN’s market?

Digitoxin is a historical small molecule. Its commercialization economics are generally not driven by product-specific patent expiration cycles in the way modern biologics and late-stage small molecules are.

Commercial implication

  • Profit pools are shaped by:
    • generic competition,
    • market-by-market tender and reimbursement structures,
    • and supply continuity, rather than by long-duration patent tailwind.

Market-by-Market Financial Drivers (Framework)

Because digitoxin’s commercial footprint depends heavily on local authorization and reimbursement, revenue performance is best modeled by geography-specific drivers.

Driver What moves DIGITOXIN revenue Typical direction
Formulary access Number of reimbursed prescriptions Stabilizes or declines
Tender dynamics Contract price and unit mix Downward pressure
Competitive substitution Share vs digoxin and other agents Downward or stable
Supply continuity Availability and ability to fulfill demand Volatile around disruptions
Distribution reach Wholesaler and hospital penetration Stabilizes over time
Regulatory status Product continuity in key markets Step changes on renewals/discontinuations

Product and Sales Mix Considerations

DIGITOXIN sales often distribute across presentation and market mix in a way that affects financial outcomes.

  • Tablet vs injectable: tablets usually anchor routine outpatient and institutional use; injectable exposure depends on local clinical protocols and hospital formulary.
  • Geographic mix: markets with continued digitoxin reimbursement sustain unit demand; markets shifting to alternatives compress revenue.
  • Inventory management: shortages can cause short-term revenue and fulfillment spikes, followed by normalization.

Key Takeaways

  • DIGITOXIN acts like an older cardiovascular specialist asset with stable but limited demand where it remains reimbursed.
  • Market dynamics are dominated by formulary placement, substitution risk, and supply continuity, not by innovation or patent-led expansion.
  • The financial trajectory is typically characterized by low-growth or mild contraction, tender-driven price erosion, and episodic volatility tied to manufacturing and distribution.

FAQs

  1. What drives DIGITOXIN demand most?
    Reimbursement and formulary placement for atrial arrhythmias and heart-related indications, plus substitution patterns versus digoxin and other cardiovascular therapies.

  2. Is DIGITOXIN a growth product?
    It behaves as a mature asset: revenue changes usually track market coverage, supply availability, and pricing pressure rather than new uptake waves.

  3. Why can DIGITOXIN revenue fluctuate?
    Supply disruptions, inventory cycles, and tender timing can cause quarter-to-quarter swings even when underlying clinical demand is stable.

  4. What is the biggest competitive threat?
    Substitution, especially by digoxin and other guideline-preferred cardiovascular treatments that reduce reliance on cardiac glycosides in some patient pathways.

  5. Where can manufacturers protect profitability?
    By maintaining regulatory and manufacturing continuity, securing contracting positions in covered markets, and sustaining reliable supply that prevents lost fulfillment during shortages.


References

[1] U.S. Food and Drug Administration. (n.d.). Drug Products, Compare to: DIGITOXIN. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] European Medicines Agency. (n.d.). Digitoxin-related assessments and public information (where available). EMA. https://www.ema.europa.eu/
[3] DailyMed. (n.d.). Digitoxin (digoxin) drug labeling and prescribing information. National Library of Medicine. https://dailymed.nlm.nih.gov/

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