Last Updated: May 3, 2026

PROPOFOL Drug Patent Profile


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

Propofol is a drug marketed by Amneal, Aspiro, Avet Lifesciences, Dr Reddys, Hikma, Hospira, Innopharma, Nanjing King Friend, Sagent Pharms Inc, Teva Parenteral, and Watson Labs Inc. and is included in eleven NDAs.

The generic ingredient in PROPOFOL is propofol. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the propofol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Propofol

A generic version of PROPOFOL was approved as propofol by SAGENT PHARMS INC on January 4th, 1999.

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Summary for PROPOFOL

US Patents and Regulatory Information for PROPOFOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal PROPOFOL propofol INJECTABLE;INJECTION 217525-001 Aug 15, 2024 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Innopharma PROPOFOL propofol INJECTABLE;INJECTION 205576-001 Sep 16, 2020 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Dr Reddys PROPOFOL propofol INJECTABLE;INJECTION 205067-001 Nov 15, 2018 AB RX 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

PROPOFOL Market Analysis and Financial Projection

Last updated: April 25, 2026

PROPOFOL: Investment Scenario and Fundamentals Analysis

What is propofol and where does it fit in the drug market?

Propofol is a short-acting intravenous anesthetic used for induction and maintenance of anesthesia and for procedural sedation (notably for endoscopy and other minor procedures). Commercially, it is positioned as a long-standing, off-patent hospital cornerstone with high clinical adoption and recurring institutional purchasing rather than chronic outpatient use.

From a business fundamentals perspective, the propofol market is driven by:

  • Hospital and ambulatory surgery utilization (operating rooms, endoscopy units, sedation services)
  • Supply reliability and formulation quality (risk of shortages, sterility, and dosing consistency)
  • Regulatory and labeling constraints that shape competitive access for generic and reformulated products

How big is the addressable market and what does demand look like?

Propofol demand tracks procedure volumes and case mix. Growth is tied more to health system throughput than to new prescriber behavior, because propofol is already embedded in standard anesthesia workflows.

Demand drivers

  • Elective surgery volumes and endoscopy throughput
  • Sedation demand in outpatient settings
  • Contracting and formulary decisions at hospital groups
  • Substitution dynamics: when a facility switches brands, it typically does so on procurement and supply confidence, not on therapeutic differentiation

Price and volume economics

  • In mature markets, unit pricing tends to compress over time as generics and authorized competitors expand.
  • Revenue stability often stays high because propofol volume remains steady once patient pathways are established.
  • Margin volatility increases during supply disruptions, with downstream pricing and procurement renegotiations.

What does competitive structure look like?

Propofol has experienced decades-long market maturity. Competition is typically dominated by:

  • Authorized generics and full generics
  • Formulation variants (concentration, delivery system, excipient profile)
  • Brand-specific institutional relationships and distribution coverage

The competitive frontier for investment is usually not “new molecular entity” (propofol is not one). It is:

  • Reformulation and device integration
  • Supply chain resilience and tender execution
  • Patent life remaining around specific formulations or methods (where applicable)

What is the patent and exclusivity landscape risk?

The investment question for propofol is less “will the drug win?” and more “what part of the value chain is defensible?”

For a mature molecule like propofol, competitive pressure generally comes from:

  • Loss of composition-of-matter exclusivity in the underlying active
  • Generic entry at the molecule level
  • Reformulation patent cliffs around specific concentrations, delivery systems, or methods of use

In practice, investors underwrite profits to one of two buckets:

  1. Brand or formulation moat (new delivery system, improved stability, differentiation that survives procurement scrutiny)
  2. Operational advantage (cost position, reliable manufacturing, distribution, and tender wins)

How do reimbursement and procurement dynamics affect fundamentals?

Propofol is mostly bought and paid through institutional budgets and bundled procedure economics. This shapes investment fundamentals through procurement mechanics rather than classic payer reimbursement.

Key procurement levers

  • Tender pricing and multi-year supply agreements
  • Hospital formularies and substitution policies
  • Switching friction (nursing familiarity, pharmacy SOP compatibility)
  • Supply continuity (failure rates, lot-to-lot variability, availability)

What this means for investors

  • The base case is usually volume sustainability with pricing pressure.
  • Upside typically comes from winning supply contracts or maintaining supply leadership during constrained periods.
  • Downside often comes from aggressive generic pricing or manufacturing interruptions.

What are the main safety and regulatory factors that influence demand?

Propofol’s clinical position is supported by extensive experience, but safety requirements shape institutional behavior and labeling.

Clinical use requires careful dosing and monitoring because propofol causes sedation and anesthesia with risks including:

  • Respiratory depression and airway compromise if mismanaged
  • Hemodynamic effects (e.g., hypotension)
  • Severe adverse events when used outside appropriate settings

These considerations increase:

  • Reliance on protocol-based use
  • Preference for products with consistent formulation performance
  • Institutional insistence on trained administration and monitoring standards

From an investment perspective, this is not demand-killing. It is demand-stabilizing, because it reinforces propofol’s role within formal anesthesia and sedation systems rather than informal use.

Is there meaningful differentiation via formulation or delivery systems?

In mature anesthetic markets, differentiation typically comes through:

  • Concentration and dosing convenience for pharmacy and anesthesia teams
  • Improved handling (e.g., ease of opening, reduced dosing errors)
  • Excipient profile considerations for specific patient populations
  • Stability and shelf-life that reduce waste and restocking
  • Delivery system integration (where regulators and institutions accept device-based handling)

For valuation, investors focus on whether differentiation:

  • Reduces pharmacy errors or waste enough to matter in procurement terms
  • Improves supply reliability (manufacturing or distribution advantage)
  • Sustains formulary access against generics

What is the investment scenario for propofol under a base, bull, and bear case?

The scenario model for propofol should be built around three variables:

  1. Unit economics (net price trajectory)
  2. Supply stability (fulfillment and contract continuity)
  3. Share retention or gains (formulary and tender outcomes)

Base case

  • Continued generics-driven pricing pressure
  • Stable procedure volumes
  • Modest share stability for established suppliers with solid distribution

Implication: earnings are driven by operational execution and contract renewals, not clinical novelty.

Bull case

  • Supply constraints tighten pricing power temporarily
  • An incumbent maintains or gains tender share through reliable availability and favorable contract terms
  • Formulation variants hold premium placement in select hospital systems

Implication: revenue resilience and margin recovery can occur during periods of procurement disruption.

Bear case

  • Aggressive generic entry or price undercutting compresses net price
  • Manufacturing issues trigger lost tender volume or emergency re-procurement at worse terms
  • Formularies shift due to excipient sensitivities or protocol changes that favor competing products

Implication: margin compression is the main risk, with volume potentially offsetting partially via switching.

What valuation signals and metrics matter most for propofol exposure?

For investors evaluating exposure to propofol supply, manufacturing, or distribution, the key metrics are:

Operational

  • Manufacturing capacity utilization for injectable sterile products
  • Fill-finish capacity constraints and batch release performance
  • Lot failure rates and quality events (regulatory and financial impact)
  • On-time delivery and contract fill rate

Commercial

  • Hospital group tender win rate and renewal rates
  • Net price vs list price (rebates, discounts, contract pricing)
  • Mix shift by concentration/formulation and channel

Regulatory

  • Any label change that alters intended use constraints
  • Inspection outcomes that affect ability to supply

What are key catalysts and risk events to track?

For propofol, catalysts tend to be operational and regulatory rather than product-efficacy news.

Potential upside catalysts

  • Large tender awards or multi-year supply agreements
  • Supply shortages that tighten market availability (temporary)
  • Successful scale-up or conversion of formulation lines
  • Regulatory acceptance of an improved formulation/delivery system

Potential downside risks

  • Sterility assurance failures, recall events, or production shutdowns
  • Competitor undercutting with broader access to procurement contracts
  • Regulatory actions that restrict availability or require costly label updates
  • Procurement policy changes that alter substitution thresholds

What are practical investment implications by strategy type?

1) Manufacturing-focused

  • Best positioned when you have capacity, quality systems, and consistent batch performance
  • Value comes from supply reliability and cost position more than patent-protected pricing

2) Distribution or hospital contracting

  • Value comes from tender execution and service-level reliability
  • Monitor contract structures that can shift pricing quickly during market stress

3) Formulation and device differentiation

  • Value is only realized if differentiation survives procurement and is supported by regulatory compliance and institutional acceptance
  • Premium placement requires demonstrable practical value (handling, stability, waste reduction)

How does propofol exposure compare with typical generic-drug exposure?

Relative to many off-patent generics, propofol has a few structural differences:

  • It is used in high-acuity procedural settings with strict standardization, so substitution behavior is constrained by workflow and safety protocols.
  • Procedure-driven demand can be steadier than pure outpatient use drugs.
  • Supply interruptions create disproportionate market pricing volatility because alternatives may not be equally interchangeable in specific clinical workflows.

Where does demand risk come from despite strong clinical adoption?

Downside demand is less about patient rejection and more about utilization and policy:

  • Pandemic-like shocks to elective and procedural volume can reduce usage temporarily.
  • Hospital cost containment can accelerate formulary switching toward the lowest total acquisition cost.
  • Any shift in preferred sedation/anesthesia protocols can reduce propofol usage in specific subsegments, though this typically happens gradually.

Key Takeaways

  • Propofol is a mature, off-patent intravenous anesthetic with demand tied primarily to procedure volumes and institutional procurement rather than payer-driven adoption.
  • Investment fundamentals hinge on net price trajectory, supply reliability, and tender share. Clinical differentiation is not the base driver.
  • Base case is steady volume with pricing pressure; bull case comes from supply tightness and contract wins; bear case is margin compression from aggressive competition or manufacturing disruption.
  • The most actionable diligence is operational: quality track record, batch release performance, fill-finish capacity, and contract execution.

FAQs

1) Is propofol primarily a hospital product or outpatient product?
It is primarily hospital- and procedure-driven, with meaningful use in outpatient surgery and endoscopy centers where procedural sedation is standard.

2) What is the main driver of revenue for propofol sellers?
Hospital and procedural utilization plus tender-driven purchasing, which determines net price and volume.

3) How do generics affect propofol investment outcomes?
Generics typically compress pricing over time, shifting returns toward operational excellence, supply reliability, and contract execution.

4) What operational factors most influence propofol supply risk?
Sterile manufacturing performance, batch release reliability, and on-time delivery under institutional contracts.

5) Where can investors find real differentiation in propofol exposure?
In formulation and delivery-system variants that reduce handling friction, improve stability and shelf-life, or maintain institutional acceptance against generic substitution, plus in manufacturing and distribution advantages.


References

[1] U.S. Food and Drug Administration. Diprivan (propofol) prescribing information. FDA label documents.

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