Last Updated: May 11, 2026

BUTORPHANOL TARTRATE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Butorphanol Tartrate

A generic version of BUTORPHANOL TARTRATE was approved as butorphanol tartrate by HIKMA on August 12th, 1998.

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Recent Clinical Trials for BUTORPHANOL TARTRATE

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SponsorPhase
Shanghai Zhongshan HospitalN/A
Jiangsu Hengrui Pharmaceutical Co., Ltd.Phase 4
The First Affiliated Hospital with Nanjing Medical UniversityPhase 4

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Pharmacology for BUTORPHANOL TARTRATE
Medical Subject Heading (MeSH) Categories for BUTORPHANOL TARTRATE
Anatomical Therapeutic Chemical (ATC) Classes for BUTORPHANOL TARTRATE

US Patents and Regulatory Information for BUTORPHANOL TARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare Corp BUTORPHANOL TARTRATE butorphanol tartrate INJECTABLE;INJECTION 075697-001 Oct 23, 2001 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira BUTORPHANOL TARTRATE PRESERVATIVE FREE butorphanol tartrate INJECTABLE;INJECTION 074626-001 Jan 23, 1997 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira BUTORPHANOL TARTRATE butorphanol tartrate INJECTABLE;INJECTION 075559-001 Mar 20, 2000 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma Farmaceutica BUTORPHANOL TARTRATE butorphanol tartrate INJECTABLE;INJECTION 078247-001 Apr 29, 2009 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising BUTORPHANOL TARTRATE butorphanol tartrate SPRAY, METERED;NASAL 075759-001 Aug 8, 2001 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

BUTORPHANOL TARTTRATE: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is butorphanol tartrate’s market position?

Butorphanol tartrate is an opioid analgesic sold in the U.S. and other markets in multiple dosage forms, with commercial demand driven by acute pain and peri-procedural use cases and constrained by opioid risk controls. In practice, the market behaves like a constrained opioid segment: steady baseline volume, periodic pricing pressure, and recurring scrutiny from regulators and payers.

Key market structure drivers:

  • Product plurality and competition: Butorphanol is one of several opioid options for acute and procedural pain, including short-acting opioid competitors and non-opioid analgesics.
  • Regulatory and payer friction: Risk-management programs, formulary controls, step edits in some settings, and opioid utilization management compress net pricing.
  • Formulation-specific economics: Revenue is split across routes (notably nasal and injectable in major markets), with route choice influencing channel economics, reimbursement patterns, and inventory cycles.

How have market dynamics shaped pricing and volume?

The market dynamics follow typical branded-to-generic and opioid-utilization patterns:

  • Net price compression over time: Where generic competition exists, list prices decline and discounts deepen; where branded products persist (typically due to legacy exclusivity or specialty positioning), pricing remains more resilient but still tracks opioid utilization restrictions.
  • Demand cyclicality tied to care settings: Procedural and emergency care utilization moves with patient volumes, surgical scheduling, and throughput pressures.
  • Utilization management reduces share-growth: Many payers apply opioid controls that limit opioid switching and restrict higher-risk or less-preferred agents.

Operationally, butorphanol tartrate’s commercial trajectory tends to reflect:

  • Modest volume growth or flat demand, not category-wide expansion.
  • Net revenue growth only when route mix improves (for example, shifts toward formulations with better reimbursement access) or when supply stabilizes.

What does the financial trajectory typically look like by lifecycle stage?

Butorphanol tartrate’s financial path is governed by lifecycle forces common to older small-molecule opioid products:

  • Early commercial phase: Adoption occurs where the product is positioned for acute and procedural pain. Revenue is more sensitive to clinician preference and formulary inclusion.
  • Mid lifecycle: Competition increases and price concessions rise. Growth slows as utilization management tightens.
  • Late lifecycle: Revenue stabilizes near replacement-level demand, with earnings driven more by channel execution (contracts, procurement terms) and route-specific throughput than by brand innovation.

For investors and business planners, the key pattern is that value is earned through retention of institutional accounts (hospitals, ambulatory surgery networks, emergency departments) and stability of supply, not through sustained high-price growth.

What market forces matter most for revenue sustainability?

The most material revenue drivers for butorphanol tartrate are policy, channel access, and operational execution:

1) Opioid regulation and risk controls

  • Payer utilization management and provider documentation requirements constrain ad hoc switching.
  • Regulatory scrutiny influences adoption in new formularies and renewal of existing contracts.

2) Reimbursement and formulary status

  • Where formulary access is narrow, volumes become sensitive to authorization processes and step therapy.
  • Where contracts are broad, revenue holds steady but pricing faces continued pressure.

3) Route and setting mix

  • Injectable use is sensitive to hospital procurement and anesthesia protocols.
  • Nasal formulations are sensitive to ED and acute-care workflow fit and to payer policies around opioid selection for certain indications.

4) Supply chain reliability

  • Opioid controlled-substance manufacturing has operational bottlenecks. Any supply disruption can create temporary share gains for competitors, followed by revenue drag when allocation normalizes.

What is the patent and exclusivity landscape that shapes competition?

Butorphanol tartrate is an older active ingredient, and the market is typically characterized by limited patent leverage across the underlying compound. Commercial competitiveness often shifts from patent protection to:

  • Formulation and device IP
  • Manufacturing process IP
  • Labeling-specific extensions
  • Regulatory exclusivity for specific dosage forms or concentrations

The competitive outcome is usually:

  • Generic entry reduces pricing headroom.
  • Institutional buying shifts to lowest net cost while still maintaining a reliability floor.

How does the controlled-substance framework affect financial outcomes?

Controlled-substance status influences both cost and go-to-market mechanics:

  • Higher compliance and inventory handling costs: secure storage, controlled distribution, reporting, and audit readiness.
  • Stronger customer concentration risk: hospital and integrated delivery networks may account for a material portion of purchases, making revenue sensitive to group purchasing organization (GPO) terms and contract renewals.
  • Allocation effects during supply issues: constrained supply can temporarily raise urgency in purchasing, then normalize into pricing pressure when supply returns.

Financially, this produces a profile with:

  • Lower volatility than novel opioids (because the product is entrenched),
  • But reduced upside, because policy and generic competition cap net pricing.

What is the most likely financial trajectory for 2025-2028?

Given the structural characteristics of older opioid products, the most likely trajectory is:

  • Flat-to-low single digit revenue growth, driven by volume stability and minor route mix improvement.
  • Continued margin compression when net prices decline faster than cost-to-serve efficiencies improve.
  • Earnings stability only when supply chain performance and contract terms offset discounting.

In scenario terms, the downside risk is more pronounced than upside:

  • Downside: tighter opioid restrictions, payer narrowing, or step therapy that excludes butorphanol in certain lines of care.
  • Upside: temporary supplier gaps favoring allocation, or improved reimbursement access for a particular route.

Where does cash generation come from in this category?

For established opioids such as butorphanol tartrate, cash generation usually comes from:

  • Working capital discipline: controlled-substance inventory planning reduces write-offs and expiration risk.
  • Procurement economics: favorable purchasing terms for raw materials and packaging.
  • Manufacturing utilization: stable volume supports better plant throughput and lowers unit manufacturing cost.
  • Contract retention: renewals with large hospital systems stabilize revenue and reduce commercial spend per unit.

Key business implications for R&D and investment decisions

  • Incremental value is in differentiation, not the core active ingredient. Commercial upside typically comes from a more advantageous delivery format, better adherence to institutional workflows, or clearer payer outcomes.
  • Market-entry strategy should focus on channel mechanics: contract win rates, GPO presence, and reimbursement pathways matter more than generic “demand creation.”
  • Risk controls are a commercial variable: the product’s fit in opioid stewardship programs affects renewal rates and throughput.

Key Takeaways

  • Butorphanol tartrate operates in a mature, constrained opioid segment with steady baseline demand and net price pressure driven by payer controls and generic competition patterns.
  • The financial trajectory is most consistent with flat-to-low single digit revenue growth and margin sensitivity to net pricing and compliance cost-to-serve.
  • Sustainability depends on institutional contract retention, route mix, and supply chain reliability, not on patent-led upside.
  • Commercial planning should treat opioid stewardship and reimbursement access as direct drivers of volume and price, not as background regulatory context.

FAQs

1) What drives demand for butorphanol tartrate most consistently?

Use in acute and procedural pain settings, institutional procurement, and patient throughput in ED and peri-procedural workflows.

2) Why does net pricing typically trend down for older opioid products?

Generic competition and formulary-based utilization management shift purchasing toward lowest net cost, compressing discount-free price.

3) What is the biggest margin headwind for commercial butorphanol tartrate?

Continued discounting and rising compliance and controlled-substance handling costs.

4) What is the most reliable lever for revenue stability?

Institutional contract renewal and dependable supply that avoids allocation losses to competitors.

5) Does the patent landscape materially change the near-term financial outlook?

For mature, older active ingredients, competitive dynamics are usually dominated by generic and channel economics rather than new patent-led exclusivity.


References

[1] U.S. Food and Drug Administration. (n.d.). Drug databases and labeling information for opioid analgesics. https://www.accessdata.fda.gov/ (accessed via relevant label entries)
[2] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act and regulations framework. https://www.dea.gov/ (accessed via regulations pages)
[3] Centers for Medicare & Medicaid Services (CMS). (n.d.). Opioid-related payment, coverage, and utilization management policy resources. https://www.cms.gov/ (accessed via policy pages)

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