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PHERAZINE W/ CODEINE Drug Patent Profile
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Which patents cover Pherazine W/ Codeine, and when can generic versions of Pherazine W/ Codeine launch?
Pherazine W/ Codeine is a drug marketed by Halsey and is included in one NDA.
The generic ingredient in PHERAZINE W/ CODEINE is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.
US Patents and Regulatory Information for PHERAZINE W/ CODEINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Halsey | PHERAZINE W/ CODEINE | codeine phosphate; promethazine hydrochloride | SYRUP;ORAL | 088739-001 | Dec 23, 1988 | 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 |
PHERAZINE W/ CODEINE Market Analysis and Financial Projection
Pherazine W/ Codeine: investment scenario and fundamentals
Summary: Pherazine W/ Codeine is a fixed-dose combination product built around codeine (opioid) plus an antihistamine-anchored “Pherazine” backbone, typically positioned in markets as an antitussive for cough. The investment case is driven less by new chemistry (the molecule set is established) and more by patent/brand durability, regulatory status in key geographies, controlled-substance handling economics, and payer/formulary access. The strongest business fundamentals typically come from (1) brand lifecycle and (2) channel resilience in cough therapeutics, while the main value risks center on opioid regulation tightening, supply and compliance costs, and substitution to non-opioid antitussives.
What follows is a fundamentals-and-scenario framework for investing in the branded product “PHERAZINE W/ CODEINE.” It is built for decision-use: competitive positioning, revenue drivers, risk map, and patent and regulatory sensitivity. If the company’s rights and market authorization are not clearly attributable to the product name as sold in specific jurisdictions, the patent and exclusivity assessment cannot be completed accurately.
What is the product and how does it monetize?
Product form (commercial logic):
- A fixed-dose combination for cough using codeine plus a “Pherazine” component that historically corresponds to antihistamine phenothiazine-class formulations in legacy cough syrups (market naming varies by country).
- Typically sold as an OTC or Rx depending on jurisdiction and formulation strength, with strong compliance constraints due to the opioid component.
Monetization levers investors model:
- Volume from seasonal cough demand and prescriber behavior (or consumer demand if OTC).
- Net price realization shaped by payer and regulatory controls.
- Channel access: national distribution, pharmacy placement, and managed-care coverage where applicable.
- Supply reliability: opioid-containing products face procurement and manufacturing constraints that can swing availability and lost sales.
What drives long-term demand in cough therapeutics?
Demand fundamentals investors track:
- Seasonality: cough and URTI incidence peaks in winter and rainy seasons depending on geography.
- Treatment substitution: non-opioid antitussives and combination cough/cold products compete for shelf and formulary share.
- Safety perception: opioid risk scrutiny can shift clinicians and payers away from codeine-containing cough options.
- Regulatory tightening: labeling, age restrictions, and dispensing controls can cap addressable populations.
Key investment implication: The product’s durability depends on whether regulators and payers continue to allow codeine-based antitussives for mainstream use or shift preference to alternatives.
Is there patent protection and how does it affect value?
Patent-driven outcomes (what matters for an investor):
- Composition-of-matter exclusivity for the active ingredients is largely historically exhausted for codeine and the older antihistamine cores in most markets.
- Value typically rests on:
- Brand ownership (trademark and market exclusivity structures),
- Formulation-specific IP (if any), and
- Regulatory exclusivity for the exact marketed formulation where such regimes apply.
What investors need to underwrite:
- Whether PHERAZINE W/ CODEINE is sold under a company-owned authorization in each target country (marketing authorization dossier ownership).
- Whether there are secondary patents tied to stability, manufacturing process, or specific dosing regimens.
Constraints: No jurisdiction-anchored patent, exclusivity, or marketing authorization dossier data is provided in the request, so a complete patent-expiry map cannot be produced without risking inaccuracies.
How do regulations for codeine shape risk and revenue?
Core regulatory exposure categories:
- Age and indication restrictions: limitations by pediatric age and approved indications.
- Prescriber and dispensing controls: prescription requirements, quantity limits, and pharmacy training/compliance.
- Labeling and warnings: opioid risk warnings, contraindications, and clinician/patient counseling requirements.
- Supply-chain compliance: tighter controls on controlled-substance inventory, reporting, and audits.
Investment risk profile:
- A regulatory downgrade can reduce addressable populations and formulary inclusion in a step-change manner.
- Compliance costs typically rise as documentation, storage, and audit requirements intensify.
- Substitution effects can reduce both volume and pricing power even when the product remains legal.
Competitive landscape: what takes share from codeine cough syrups?
Main substitutable categories:
- Non-opioid antitussives (single agents or combinations).
- Dextromethorphan-based cough products (common competitive pressure).
- Broader cough and cold combination products that bundle actives and can occupy more shelf space.
- Generic substitution where brand loyalty is weak and pricing is the dominant factor.
Investor focus:
- Whether PHERAZINE W/ CODEINE is brand-protected (lower generic erosion) or already widely generic.
- Whether physicians treat it as a first-line option or as a later-line alternative.
Investment scenario: base case, downside, and upside
Base case (most likely for legacy codeine cough brands)
- Revenue tracks seasonality and market share with modest pricing pressure.
- Share is stable if the product retains:
- A recognized clinical position in cough,
- Stable distribution and supply,
- Acceptable regulatory status.
Fundamentals behind the base case:
- Mature market dynamics with limited growth catalysts.
- Margin supported by manufacturing scale and distribution maturity.
Downside case (regulatory and substitution shock)
- Formulary access deteriorates due to heightened opioid restrictions or stricter labeling that suppresses uptake.
- Substitution accelerates as prescribers and payers shift to non-opioid antitussives.
- Supply interruptions or controlled-substance compliance issues tighten availability and drive lost sales.
Fundamentals that break in downside:
- Volume falls faster than price can offset.
- Market share erodes to competing antitussives and combination products.
Upside case (brand durability and channel expansion)
- The product expands into underpenetrated regions with stable regulatory frameworks.
- Reimbursement strengthens through favorable formulary inclusion.
- Brand loyalty and pharmacy stocking patterns stabilize net realization and reduce generic share loss.
Fundamentals that improve in upside:
- Higher volume without proportional margin degradation.
- Better order fill rates and reduced compliance-related disruptions.
Financial model inputs investors should use (practical underwriting checklist)
Because no dosing strength, unit economics, or geographic sales split is provided, the model must be structured with variables the investor can map to operational data:
| Model driver | What to measure | Why it matters |
|---|---|---|
| Seasonality factor | Quarterly demand index | Captures cough and URTI peaks |
| Net price realization | Rx/OTC effective price after rebates | Determines margin resilience under generic pressure |
| Share and elasticity | TRx or prescription counts by segment | Shows whether the product is substitutable |
| Controlled-substance cost | Storage, audit, reporting, security costs | Affects COGS and gross margin |
| Channel conversion | Pharmacy stocking and distribution fill rate | Impacts lost sales risk |
| Regulatory headwinds | Any age/label/dispensing restrictions | Can reduce addressable population |
What are the key diligence points for an investor?
Rights and exclusivity
- Ownership of marketing authorization and dossier.
- Existence of formulation or process patents tied to the exact marketed product.
- Trademark and brand strategy strength.
Regulatory status and enforcement posture
- Age/indication constraints by region.
- Controlled-substance scheduling and dispensing rules by channel (retail vs institutional).
- Any recent regulatory actions, label changes, or risk communications.
Commercial durability
- Evidence of prescribing or dispensing stickiness relative to non-opioid alternatives.
- Competitor price positioning and substitution velocity.
- Forecast assumptions for seasonality and channel coverage.
Operational reliability
- Manufacturing capacity for controlled-substance inventory.
- Compliance systems maturity for audits and reporting.
- Logistics reliability by distribution region.
Key Takeaways
- PHERAZINE W/ CODEINE is a legacy-style cough combination where investment returns depend on market authorization durability, controlled-substance economics, and brand resilience, not on fresh chemistry.
- The upside case needs stable regulatory permission for codeine cough use plus channel expansion or stronger formulary inclusion.
- The downside case is dominated by opioid regulation tightening and rapid substitution to non-opioid antitussives, compounded by compliance and supply risk.
- A complete patent and exclusivity valuation cannot be produced from the provided prompt without risking inaccurate mapping to jurisdictions and exact marketed formulations.
FAQs
1) Is PHERAZINE W/ CODEINE likely to have strong patent exclusivity?
Not in a typical way for established actives; value is usually anchored in marketing authorization ownership, brand durability, and any formulation-specific IP rather than broad composition-of-matter exclusivity.
2) What is the biggest near-term risk for codeine antitussive brands?
Regulatory restrictions that reduce the eligible patient population and dispensing flexibility.
3) What competitive category most threatens share?
Non-opioid antitussives and broader cough/cold combination products that capture shelf and prescribing preference.
4) How do controlled-substance rules affect profitability?
They raise operating overhead via storage, reporting, audit readiness, and tighter inventory handling, and can increase lost sales during supply disruptions.
5) What drives upside for this type of product?
Geographic expansion where codeine cough use remains commercially accessible, plus stable payer/formulary positioning and strong channel fill rates.
References
No sources were provided in the prompt, and the request did not include jurisdiction-specific product authorization, label strength, or patent identifiers. Therefore, no citations can be generated without risking incorrect attribution.
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