Last Updated: May 3, 2026

THALITONE Drug Patent Profile


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Which patents cover Thalitone, and when can generic versions of Thalitone launch?

Thalitone is a drug marketed by Casper Pharma Llc and Monarch Pharms and is included in two NDAs.

The generic ingredient in THALITONE is chlorthalidone. There are twenty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the chlorthalidone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Thalitone

A generic version of THALITONE was approved as chlorthalidone by SUN PHARM INDUSTRIES on July 21st, 1986.

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Summary for THALITONE
US Patents:0
Applicants:2
NDAs:2

US Patents and Regulatory Information for THALITONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Casper Pharma Llc THALITONE chlorthalidone TABLET;ORAL 019574-001 Dec 20, 1988 RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Casper Pharma Llc THALITONE chlorthalidone TABLET;ORAL 019574-002 Feb 12, 1992 BX RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Monarch Pharms THALITONE chlorthalidone TABLET;ORAL 088051-001 Nov 12, 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

International Patents for THALITONE

See the table below for patents covering THALITONE around the world.

Country Patent Number Title Estimated Expiration
New Zealand 207514 PREPARING SOLID STATE DISPERSIONS OF CHLORTHALIDONE(2-CHLORO-5-(1-HYDROXY-3-OXO-ISOINDOLINYL)-BENZENESULPHONAMIDE) ⤷  Start Trial
Australia 562929 ⤷  Start Trial
Yugoslavia 43349 ⤷  Start Trial
Hungary 191596 PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITION ⤷  Start Trial
Israel 71248 CHLORTHALIDONE DISPERSIONS,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM ⤷  Start Trial
Slovenia 8410458 Process for preparing a water soluble, pharmaceutically acceptable dispersion of chlortalidone in solid state ⤷  Start Trial
Mexico 9203256 COMPOSICION FARMACEUTICA DE CLORTALIDONA, EN FORMA DE TABLETA, SOLUBLE EN AGUA. ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

THALITONE Market Analysis and Financial Projection

Last updated: April 23, 2026

THALITONE (Thalitone, chlorthalidone): Investment Scenario and Fundamentals Analysis

What is THALITONE and what does it have in its fundamentals?

THALITONE is a brand of chlorthalidone (chlorthalidone, USP), a thiazide-like diuretic used primarily for:

  • Hypertension
  • Edema associated with cardiac, renal, or hepatic conditions

From a patent and investment standpoint, THALITONE’s core fundamentals are shaped by three realities:

  1. Chlorthalidone is an older, off-patent molecule in most markets, making long-term branded pricing power structurally limited.
  2. Therapeutic demand is stable because hypertension and diuretic use are chronic.
  3. Competitive pressure comes from generics, not new molecular entrants, so revenue growth for brand owners depends on pricing, tender position, distribution, and mix, not patent exclusivity.

Bottom line: THALITONE is best evaluated as a value-and-market-share asset in generics-driven categories rather than a classic “pipeline-led” growth story.


How is the product typically positioned clinically and commercially?

What does chlorthalidone treat, in practice?

Chlorthalidone is used across common chronic-care pathways:

  • First-line or add-on hypertension therapy depending on local guideline pathways and patient comorbidity
  • Edema management in patients requiring diuresis (dose and monitoring matter)

Clinicians commonly use it because it is orally administered and effective for volume control and blood pressure reduction. For investors, the implication is predictable baseline demand but limited upside from innovation.

How does that translate into commercial mechanics?

THALITONE’s commercial value usually depends on:

  • Market access and reimbursement (formularies, substitution rules, tender wins)
  • Pricing regime (regulated pricing in some geographies; periodic downward pressure in tender-based systems)
  • Supply chain reliability (diuretic volume is high and substitution is easy once generic is available)

Because generics substitute readily, brand owners face constant competitive pressure.


What does the patent landscape imply for upside?

Is there meaningful patent exclusivity for THALITONE?

Chlorthalidone is a mature active ingredient with no broad, long-duration blockbuster-style patent tail that investors should underwrite as a primary driver of THALITONE brand growth. In mature diuretic markets, the IP value typically sits with:

  • Local brand-specific registrations
  • Manufacturing process know-how (where protected)
  • Distribution contracts and tender standing

Investment implication: expect pricing pressure and limited revenue elasticity to new IP events. THALITONE is not a high-conviction “novel patent catalyst” thesis.


What are the key fundamental risk factors for THALITONE?

What drives downside?

  1. Generic substitution and price compression
    • Once generics are established, branded revenue often trends down unless the brand is protected by rare local constraints or strong channel relationships.
  2. Regulatory and reimbursement tightening
    • Formularies can shift patient preference toward lower-cost alternatives.
  3. Supply constraints
    • Even for off-patent products, shortages can occur, but that usually creates short-term pricing relief rather than durable growth.
  4. Safety and monitoring requirements
    • Thiazide-like diuretics have known class risks (electrolytes, glucose, uric acid). This can shift prescribing patterns and increase scrutiny.

What upside levers actually matter for investment evaluation?

Where can THALITONE still win?

For an off-patent brand, upside usually comes from operational and commercial execution:

  1. Market share protection through channel strength
    • Strong pharmacy relationships and hospital formulary positions can defend share.
  2. Pricing execution in tender systems
    • Winning tenders with stable procurement terms can stabilize volumes even as unit prices fall.
  3. Portfolio-level cross-selling
    • Many holders manage diuretics and cardiovascular product lines together, improving total franchise economics.
  4. Manufacturing efficiency
    • Cost-of-goods improvements can preserve gross margin in the face of price compression.

Investment implication: the “engine” is not patent value; it is margin protection and distribution discipline.


How should investors benchmark THALITONE performance?

Which KPIs to track

Use a small set of indicators that directly map to generics economics:

  • Net sales (local currency and constant currency)
  • Gross margin vs. basket generics
  • Share by channel (retail pharmacy vs. institutional tender)
  • Price index vs. competing chlorthalidone brands/generics
  • Volume stability (units) despite unit price declines

What would “good” look like?

For THALITONE, “good” fundamental performance means:

  • Sales decline is slower than the market average, or
  • Unit volumes are stable while pricing drops, and gross margin holds longer than peers, or
  • Share gains occur at similar price levels

What is the competitive landscape for chlorthalidone?

Who competes?

THALITONE competes primarily with:

  • Generic chlorthalidone products
  • Sometimes other thiazide-like diuretics (depending on market prescribing preference)
  • Therapeutic substitutes like other diuretic classes or combination antihypertensives (less direct substitution in all markets)

How does competition affect valuation?

Valuation should treat this as a commodity-to-franchise hybrid:

  • Commodity pressure sets a lower bound on pricing
  • Franchise factors set a floor on share and margin duration

What does a realistic investment scenario look like?

Base case (most likely)

  • Continued price pressure
  • Stable-to-slow revenue decline
  • Margin stability if cost and share performance stay controlled

Upside case (execution-led)

  • Better-than-market share retention
  • Tender and channel gains
  • Manufacturing cost improvements that offset pricing erosion

Downside case (structural)

  • Faster-than-market share loss
  • Additional tender displacement by lower-cost generic suppliers
  • Margin compression from input cost spikes or contract repricing

Investment implication: this is a defensive cashflow profile if the holder has strong distribution and cost discipline, not a high-growth IP story.


Regulatory and labeling fundamentals that matter for diligence

How labeling typically informs risk

For diuretics, diligence should emphasize:

  • Current prescribing information
  • Class labeling requirements on monitoring
  • Contraindications and warnings relevant to electrolyte and metabolic parameters

Label alignment affects:

  • Physician comfort
  • Payer coverage decisions
  • Institutional procurement acceptance

Key Takeaways

  • THALITONE is chlorthalidone, a mature thiazide-like diuretic with chronic demand drivers (hypertension, edema).
  • IP-led upside is limited; valuation and investment returns hinge on share, pricing execution, and margin protection in a generics-driven category.
  • The most actionable diligence targets are channel share, tender performance, net sales trend, gross margin resilience, and manufacturing cost structure.
  • Treat THALITONE as a cashflow-and-market-share asset, not a pipeline or patent-catalyst play.

FAQs

1) Is THALITONE a “new drug” investment thesis?

No. THALITONE is a brand for chlorthalidone, a mature active ingredient where investment value usually comes from commercial execution and cost control, not new molecular exclusivity.

2) What are the primary revenue risks for THALITONE?

Generic substitution, pricing/tender pressure, and margin compression. The category is structurally exposed because substitution is straightforward.

3) What KPIs best reflect THALITONE’s fundamentals?

Track net sales trend, gross margin, unit volumes, share by channel, and price index relative to other chlorthalidone products.

4) What upside levers are realistic for an off-patent brand?

Market share retention, tender wins, manufacturing efficiency, and portfolio-level cross-selling.

5) What patient- and prescriber-level factors matter most?

Monitoring and known class safety considerations, plus alignment with current prescribing and labeling norms that influence institutional acceptance and payer coverage.


References

[1] U.S. National Library of Medicine. Chlorthalidone (systemic). DailyMed. https://dailymed.nlm.nih.gov/
[2] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
[3] World Health Organization. Guidelines for the management of hypertension. https://www.who.int/health-topics/hypertension

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