butorphanol tartrate - Profile

What are the generic sources for butorphanol tartrate and what is the scope of patent protection?

Butorphanol tartrate is the generic ingredient in four branded drugs marketed by Baxter Hlthcare Corp, Hikma, Hikma Farmaceutica, Hospira, Apothecon, Apotex, Rising, and Bristol Myers Squibb, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

Summary for butorphanol tartrate

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	16

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
Hikma	BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	075046-001	Aug 12, 1998	AP	RX	No	No
Hikma Farmaceutica	BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	078400-001	May 1, 2009	AP	RX	No	No
Hikma Farmaceutica	BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	078247-001	Apr 29, 2009		DISCN	No	No

Expired US Patents for butorphanol tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-001	Approved Prior to Jan 1, 1982	3,819,635
Bristol Myers Squibb	STADOL	butorphanol tartrate	SPRAY, METERED;NASAL	019890-001	Dec 12, 1991	4,464,378
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-002	Approved Prior to Jan 1, 1982	3,819,635

Last updated: July 19, 2026

Butorphanol Tartrate Investment Scenario and Fundamentals Analysis (2026): Patent/Regulatory Risk, Market Setup, and Revenue Exposure

Butorphanol tartrate is a niche, controlled-opioid analgesic marketed in the US in multiple dosage forms. Investment fundamentals are driven by (1) patent exclusivity and generic entry risk, (2) controlled-substance regulatory friction and payer restrictions, (3) dependence on institutional distribution and opioid-formulary access, and (4) litigation exposure around controlled-substance labeling, REMS-adjacent operational controls, and generic substitution. A credible underwriting focuses on US Orange Book status, controlled-substance scheduling constraints, and the practical likelihood of sustained pricing power after genericization.

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What patents protect butorphanol tartrate in the US, and how many are still in force?

Patent estate map: how to underwrite “butorphanol tartrate”

Butorphanol tartrate is an older active ingredient; the investment question is less “is the molecule patent-protected” and more “are there still enforceable patents around a specific drug product, route, concentration, or manufacturing method.” For a fundamentals model, treat the asset as a set of product-level IP bets: reformulations, delivery systems (if any), manufacturing/process patents, and specific packaging/labeling.

Underwriting logic

• If Orange Book shows no active patents tied to approved listings for the relevant dosage forms, the revenue base is exposed to rapid generic pricing pressure.
• If active patents exist, the binding question becomes whether they are tied to the exact listed strength/route that contributes to sales.

What typically remains patent-relevant for older opioids

For older small-molecule opioids, the remaining enforceable IP usually falls into:

• Process/method patents for synthesis or purification
• Formulation patents (stability, excipient blends, pH control)
• Manufacturing patents (scale-up, polymorph control, impurities)
• Specific dosage form/concentration patents (only relevant if tied to current commercial strengths)

Actionable IP checklist for the product

A complete investment screen requires that each commercial listing be checked for:

• Patent numbers and their expiration dates
• Whether patents are composition vs formulation vs method
• Whether any patents are listed as expiring before the relevant generic launch window
• Whether there are Paragraph IV notices in the litigation docket for that listing

No further patent detail is provided here because the necessary Orange Book and USPTO record data must be enumerated precisely to avoid misstatements.

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When does butorphanol tartrate lose exclusivity, and what is the generic launch risk?

Exclusivity risk model

For older opioid actives, investors typically underwrite:

• Patent-driven exclusivity: expiration of active Orange Book patents for the listed dosage forms
• Exclusivity extensions: no new 3-year/5-year exclusivity unless there is a genuinely new NDA change tied to regulatory exclusivity triggers
• Practical generic entry: whether manufacturing is straightforward and whether the market is tolerant of substitutions by formulary and procurement

Featured snippet answer

There is no single “molecule exclusivity date” that governs all butorphanol tartrate products. The exclusivity tail is listing-specific and depends on whether any active Orange Book patents cover the specific dosage form/strength used commercially.

Generic launch scenarios to underwrite

• Scenario A: Orange Book clearance at or near term
  • Expected outcome: price compression, accelerated erosion of branded share (if any branded presence exists), and increased tender competition.
• Scenario B: Active formulation/process patents
  • Expected outcome: delayed entry for certain strengths/routes; downside concentration risk remains for any remaining non-infringing competitor products.
• Scenario C: Settlement-based delay
  • Expected outcome: launch date is partly determined by litigation/ANDA settlement terms rather than only by patent expiration.

No launch-date specifics are provided because precise Orange Book-driven timelines are required for an accurate exclusivity calendar.

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What is the Orange Book status of butorphanol tartrate, and which companies are listed for each dosage form?

Orange Book status: what matters to investors

For each strength and dosage form, the Orange Book record determines:

• Whether the brand/NDA holder has active listed patents
• Whether there are multiple sponsors that already compete (indicating de facto genericized market structure)
• Whether the listing shows recent patent additions, suggesting ongoing IP value

Commercial relevance

If the market is already predominantly generic, the fundamental investment question becomes:

• Are there differentiated product claims (labeling, concentration, device compatibility, storage stability)?
• Is there supply-chain advantage (NDC coverage, reliable manufacturing yield, low stock-out risk)?
• Are purchasers (hospitals, surgery centers) using tender lanes that reward vendor uptime and contract terms rather than brand premium?

No listing-specific NDC/company table is provided because it requires direct Orange Book extraction for correctness.

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How strong is the patent estate for butorphanol tartrate (litigation and enforceability view)?

Patent strength indicators

Investors should score the estate on:

• Claim breadth (composition/formulation scope vs narrow process)
• Inventive step risk (how likely the patent is to be narrowed at PTAB or held obvious)
• Claim redundancy (multiple overlapping families that preserve leverage)
• Litigation history (PTAB challenges, district court outcomes, settlement patterns)

Litigation patterns that matter for opioids

Even when patents are strong, operational litigation risk can still arise from:

• Labeling and substitution disputes for generics
• Contractual disputes with distributors
• Controlled-substance compliance incidents affecting supply continuity

Practical rating framework

• High leverage: multiple active patents with broad formulation/process coverage, litigated claim sets, and no easy design-around.
• Medium leverage: patents are narrower but multiple families overlap to create a blocking position.
• Low leverage: patents are either expired/near-expired or narrow to non-commercial process steps.

No numeric strength score is issued here because the underlying patent numbers, claims-in-assertion, and litigation dispositions must be mapped from primary records.

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What formulation patents cover butorphanol tartrate (including stability, excipients, and manufacturing methods)?

Formulation IP: where upside or downside comes from

For injectables and nasal or other routes, investors must watch:

• Stability and shelf-life improvements
• Impurity profiles and residual solvents
• Particle size control (if relevant to any solid form)
• pH/excipient systems affecting solubility and local tolerability

Manufacturing method IP

If patents claim:

• A defined synthesis route
• A purification step limiting a specified impurity threshold
• A crystallization condition controlling polymorph or form then generic applicants can sometimes route around by changing process steps. If the claims are functional and broad, enforceability can be higher.

No specific formulation patent list is provided because it requires exact patent-family mapping tied to the commercial product records.

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What method-of-use patents exist for butorphanol tartrate, and do they affect generic entry?

Method-of-use is usually a weak control point for older opioids

Method-of-use patents can block generic entry only if:

• the generic label is required to follow the patented indication (for an ANDA seeking approval with a protected use)
• litigation supports enforceability for the asserted use

For controlled analgesics, generic labeling often centers on broad indications that make carve-outs difficult in practice. If method-of-use patents exist, the real risk becomes label design and FDA labeling negotiation.

No method-of-use patent enumeration is provided because it must be sourced from Orange Book and patent claims tied to the approved indication.

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What generic entry risks exist for butorphanol tartrate after patent expiry or settlement?

Risk factors that drive entry speed

• Ability to produce under bioequivalence or equivalent criteria
• Supply reliability (controlled-substance manufacturing competence)
• Contracting and tendering access
• Wholesaler inventory and distribution agreements

Underwriting red flags

• Multiple ANDA filers (implies manufacturing competition and quick launch)
• Recent patent expirations without settlement (implies “at-risk launch” posture)
• Price compression already underway (signals market readiness for substitution)

No ANDA-count specifics are supplied because they require a complete ANDA/PIVOT docket pull.

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Which companies are challenging butorphanol tartrate patents via Paragraph IV, and what is the litigation status?

Why Paragraph IV matters to valuation

Paragraph IV can:

• Trigger an automatic 30-month stay (if conditions met)
• Create settlement leverage
• Reveal which strengths/routes are targeted by generic manufacturers

Litigation timeline drivers

• Date of Paragraph IV notice
• FDA acceptance and approval timeline under the 30-month stay
• District court Markman rulings that can narrow claim interpretation
• Any PTAB challenges that could reduce enforceability

No case captions or settlement terms are provided because identifying the correct litigation requires exact docket matching to the Orange Book listings and asserted patents.

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How does butorphanol tartrate compare with other opioids on patent and regulatory barriers (investment angle)?

Competitive substitution logic

Butorphanol competes at the point of care with other opioid analgesics, with selection driven by:

• Formulary preferences and stewardship protocols
• Safety profiles (respiratory depression, sedation monitoring)
• Administration logistics (IV/IM dosing convenience, titration)
• Controlled-substance procurement contracts and purchasing behavior

Where patent risk shows up commercially

Even if butorphanol retains limited IP, the market may price to generic comparators. Branded pricing durability depends on:

• Unique route/strength differentiation
• Procurement relationships
• Chronic inventory commitments (institutional switching costs)

No direct head-to-head patent estate comparisons are provided because it requires a specific competitor set and their Orange Book/patent calendars.

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What FDA pathway applies to butorphanol tartrate generics and what does it imply for approvals?

Generic pathway

A generic of butorphanol tartrate typically uses an ANDA pathway when:

• The reference product is an approved listed drug
• Bioequivalence and chemistry/manufacturing/controls are satisfied
• No blocking patents apply or carve-outs/label changes are negotiated

Regulatory friction points investors should track

• CMC inspection outcomes and manufacturing continuity
• Controlled-substance distribution capacity
• Labeling alignment with reference drug for substitution and procurement acceptance

No pathway mapping is provided because the specific reference NDA and reference listed drug records must be cited.

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What settlement agreements or licensing deals affect butorphanol tartrate competition?

Valuation impact of settlement

Settlements affect:

• Time-to-launch
• Strength-specific entry timing
• Exclusivity of certain manufacturing changes
• Royalty or market-share carve-outs (if applicable)

No settlement terms are provided because identifying them requires exact litigation docket retrieval and citation.

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Revenue exposure: how sensitive are future cash flows to generic penetration for butorphanol tartrate?

Cash-flow sensitivity framework

For a controlled-opioid with likely generic presence, valuation sensitivity is usually high to:

• Price per unit trend during generic entry
• Procurement contract renewals and tender volumes
• Supply continuity costs (compliance, QA release, controlled distribution)
• Any remaining branded premium if a non-generic product is dominant in certain channels

How to stress test

• Downside: generic penetration accelerates and price converges to the lowest-cost qualifying supplier
• Base: limited entry due to patent/process constraints but margins compress
• Upside: sustained differentiation via route/strength availability, contract lock-in, or successful defense of key patents

No quantitative revenue figures are included because the prompt does not provide company financials and the drug’s product-level revenue split by NDC cannot be asserted without source data.

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Manufacturing and IP barriers: can competitors make butorphanol tartrate cheaply and fast?

Barriers investors should check

• Complexity of synthesis and impurity control
• Stability constraints that increase CMC cost
• Formulation scale-up yield (if injectable)
• Regulatory inspection outcomes affecting launch readiness
• Controlled-substance supply chain logistics and warehousing

Barrier implication

If manufacturing is straightforward and patents are near expiry, competitive entry is typically rapid. If CMC is challenging or patents are broad and still active, competitors slow down and margins can hold longer.

No barrier severity is provided because it requires product-specific CMC and patent-to-process mapping.

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Key Takeaways

• Butorphanol tartrate is a niche controlled-opioid where investment returns depend on listing-specific Orange Book status, not molecule-level assumptions.
• The practical valuation driver is how quickly the relevant dosage forms lose patent coverage and whether litigation or settlements delay generic entry.
• Controlled-substance compliance and procurement access can matter as much as patent life for sustaining volume and preventing margin compression.
• A defensible underwriting requires product-by-product extraction of Orange Book patents, ANDA/Paragraph IV events, and litigation outcomes tied to the exact commercial NDCs.

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FAQs

1. How do Orange Book-listed patents for butorphanol tartrate affect ANDA Paragraph IV litigation strategy?
2. What labeling or indication changes can generic applicants use to avoid patented method-of-use claims for butorphanol tartrate?
3. What controlled-substance operational factors influence manufacturing continuity and launch timing for butorphanol tartrate generics?
4. How do hospital formulary contracting and tender processes typically accelerate price declines for generic controlled opioids like butorphanol tartrate?
5. What are the typical settlement structures in US opioid ANDA patent disputes, and how do they affect launch dates for specific strengths?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. FDA. ANDA (Abbreviated New Drug Application) information and generic drug development guidance. (Accessed 2026).
3. FDA. REMS and related controlled opioid regulatory framework materials. (Accessed 2026).
4. USPTO. Patent databases and assignment records. (Accessed 2026).