Last Updated: June 24, 2026

PINDAC Drug Patent Profile


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

Pindac is a drug marketed by Leo Pharm and is included in one NDA.

The generic ingredient in PINDAC is pinacidil. Additional details are available on the pinacidil profile page.

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Summary for PINDAC
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 68
Patent Applications: 1,729
DailyMed Link:PINDAC at DailyMed

US Patents and Regulatory Information for PINDAC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Pharm PINDAC pinacidil CAPSULE, EXTENDED RELEASE;ORAL 019456-001 Dec 28, 1989 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Leo Pharm PINDAC pinacidil CAPSULE, EXTENDED RELEASE;ORAL 019456-002 Dec 28, 1989 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
Last updated: April 23, 2026

Market dynamics and financial trajectory for PINDAC (pindolol)

Pindac is a branded form of pindolol, a non-selective beta blocker with intrinsic sympathomimetic activity (ISA). Its commercial trajectory is shaped by (1) mature-cycle beta-blocker competition, (2) the switch from branded originators to generics and parallel supply, and (3) regulatory and payer dynamics typical for off-patent cardiovascular generics. Market outcomes since peak earlier-year adoption have generally been defined by price compression, share reallocation to lower-cost generics, and channel-driven demand rather than major clinical innovation.

What is PINDAC’s market role?

Drug identity

  • Active ingredient: pindolol
  • Class: beta-adrenergic blocker (non-selective) with ISA
  • Therapeutic positioning: cardiovascular use cases where beta blockers are indicated, typically including hypertension and selected cardiac conditions depending on labeling by jurisdiction.

Market characterization

  • Pindolol is a long-established small-molecule beta blocker.
  • The branded format “PINDAC” trades in a market that is structurally generic-dominated in most geographies where it is sold.

Implication for market dynamics

  • Demand is primarily therapeutic-class demand (patients and prescribers need beta blocker therapy) rather than brand-led demand.
  • Commercial performance depends on procurement price, formulary placement, interchangeability, and supply reliability.

How do market dynamics play out for pindolol brands?

Competition vs differentiation

Pindolol competes against:

  • Other beta blockers with similar clinical roles (selective and non-selective agents).
  • Generic versions of pindolol itself where interchangeability exists.
  • Alternatives that may have better tolerability perceptions or dosing convenience in specific payer formularies.

Because the mechanism is not unique, differentiation usually comes from:

  • Price
  • Availability
  • Packaging and dosing form consistency
  • Institutional contracting

Price compression and tender effects

For off-patent small-molecule cardiovascular drugs:

  • Prices typically decline as generic supply expands and tender rounds reset net prices.
  • Brand survival tends to depend on whether the branded product still wins contracts, often at a discount to maintain shelf placement.

Switching behavior

Where substitution is allowed:

  • Pharmacists can switch to lower-cost generics.
  • Prescribers may switch to competing beta blockers under payer-driven policies.
  • Net effect is that branded share erodes even when total class demand holds.

Exogenous demand drivers

Class demand for beta blockers responds to:

  • Epidemiology of hypertension and cardiovascular disease management
  • Treatment guideline emphasis in each jurisdiction
  • Primary care and cardiology prescribing patterns

For Pindolol, no new clinical category growth is expected absent a distinct late-stage differentiation, which is uncommon for older beta blockers.


What is the financial trajectory pattern for PINDAC?

Typical revenue curve for branded older beta blockers

For branded pindolol products, the financially observed pattern in mature markets generally follows:

  1. Earlier brand uptake (before widespread generic entry)
  2. Gradual share loss after generic introductions
  3. Accelerated net revenue compression with tender cycles and substitution
  4. Stabilization at a lower revenue base when the brand retains limited channel relevance (institutional contracts, brand preference in certain settings)

Key financial levers that determine the trajectory

For a mature beta blocker brand, trajectory usually hinges on:

  • Net price vs list price (tenders, rebates, discounts)
  • Channel mix (retail vs institutional)
  • Formulary placement (preferred vs non-preferred)
  • Supply continuity (manufacturing robustness and regulatory compliance)
  • Country-level substitution rules

What matters most for forecasting

For off-patent generics-heavy markets, the forecast error typically comes from:

  • Timing of generic stocking and tender resets
  • Policy changes enabling tighter substitution
  • Regulatory actions affecting market access for specific manufacturers

The financial trajectory is therefore more contract- and channel-dependent than innovation-dependent.


What does the regulatory and IP landscape imply for growth?

Patent expiration reality for older beta blockers

Pindolol is an older molecule; for branded markets, the dominant business consequence is:

  • Limited remaining exclusivity
  • High likelihood of multiple generic entrants
  • Reduced ability to defend price

Regulatory dynamics

Operational constraints for mature drugs:

  • Manufacturing approvals and renewals
  • Quality system compliance
  • Labeling updates and local submission requirements

These are important for keeping sales stable, but they typically do not create an upside growth inflection.


How does competitive positioning affect buyer economics?

Payer view

Payers generally favor:

  • Lowest-cost equivalent beta blockers within clinical interchangeability windows
  • Preferred formulary status and contracting terms

Provider view

Clinicians tend to prescribe by:

  • Established tolerability profiles
  • Dosing familiarity
  • Formulary access and patient-specific response history

When equivalent therapies exist, prescribers’ brand preference usually fades as cheaper options remain clinically acceptable.

Pharmacy view

Pharmacies respond to:

  • Reimbursement and substitution policy
  • Inventory economics
  • Dispensing rules and substitution permissions

This favors generics in most systems where substitution is straightforward.


Market sizing and performance signals: what to track for PINDAC?

Even without brand-level public financials, the market dynamics for pindolol brands can be tracked through:

  • Unit volume trends in beta blockers and pindolol-specific segments by country
  • Average transaction price and tender outcomes for cardiovascular generics
  • Formulary status changes by major payers
  • Parallel import effects where allowed

These signals determine whether PINDAC follows a:

  • Gradual erosion curve (stable volumes, declining net price)
  • Sudden step-down (tender or substitution policy shift)
  • Rare stabilization (brand remains preferred through contracting or supply strength)

Key takeaways

  • PINDAC is a branded pindolol product, a mature cardiovascular beta blocker in an off-patent, generic-led market.
  • Market dynamics are dominated by price compression, substitution, and tender/formulary mechanics, not clinical innovation.
  • The financial trajectory for similar branded older beta blockers typically shows share erosion and net revenue decline, with stabilization only when brand relevance remains in institutional channels or contracting.
  • The core forecasting variables are net price resets, contract timing, formulary access, and supply continuity, not new demand creation.

FAQs

1) Is PINDAC primarily competing with other beta blockers or other pindolol products?

It competes with both: other beta blockers for therapeutic coverage and generic pindolol equivalents for price-based substitution.

2) What usually drives revenue change for branded pindolol?

Net pricing through tenders/discounts and share loss from substitution are the dominant drivers.

3) Does PINDAC’s mechanism create meaningful brand differentiation?

No. Its beta-blocker class mechanism with ISA does not typically create strong brand-led differentiation once generics are established.

4) What is the most important market indicator to watch?

Formulary status and tender outcomes, because they determine both price and volume routing.

5) What does “stabilization” mean for a mature branded beta blocker?

It means revenues stop falling as fast because the brand retains some preferred access through contracting or channel dependence, even as overall market prices remain compressed.


References

[1] World Health Organization. (n.d.). ATC/DDD Index. WHO Collaborating Centre for Drug Statistics Methodology. https://www.whocc.no/atc_ddd_index/
[2] FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] European Medicines Agency. (n.d.). Medicine information and European public assessment reports. https://www.ema.europa.eu/en/medicines

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