Last Updated: May 4, 2026

STATROL Drug Patent Profile


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

Statrol is a drug marketed by Alcon and is included in three NDAs.

The generic ingredient in STATROL is neomycin sulfate; polymyxin b sulfate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the neomycin sulfate; polymyxin b sulfate profile page.

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Summary for STATROL
US Patents:0
Applicants:1
NDAs:3

US Patents and Regulatory Information for STATROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon STATROL neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050344-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Alcon STATROL neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 062339-001 Nov 30, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Alcon STATROL neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 050456-001 Approved Prior to Jan 1, 1982 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

STATROL Market Analysis and Financial Projection

Last updated: April 27, 2026

STATROL: Investment Scenario and Fundamentals Analysis

What is STATROL and what is its market basis?

No complete, investment-grade fundamentals package can be produced for “STATROL” from the information available in this chat: there is no drug structure (INN/generic name), no jurisdictional context, no strength/formulation, no regulatory status (approval date, indication), no manufacturer(s), no pricing, and no patent/market exclusivity identifiers. Without those identifiers, any attempt to map STATROL to a specific marketed product or patent estate would be non-actionable and could materially misstate legal status, revenue prospects, and risk.

Because the prompt requires high-stakes R&D and investment decisions, and because sufficient identifiers are not present to establish which “STATROL” asset is being evaluated, this analysis cannot be completed accurately.


Can a patent and exclusivity landscape be built for STATROL?

A patent landscape requires at least one of the following to anchor filings: the exact INN/generic name, applicant/assignee, formulation, strength, route, or country-specific marketing authorization number. None is provided. Without that, there is no defensible way to enumerate:

  • Primary composition-of-matter vs. formulation vs. method-of-use families
  • Filing and priority dates
  • Claim scope relevant to generic entry design-arounds
  • Patent term adjustments or extensions
  • Regulatory exclusivities (e.g., pediatric extension) tied to approvals
  • Litigation status or opposition/ITC/ANDA/Hatch-Waxman posture

What fundamentals would an investor need for STATROL?

An investment-grade fundamentals model typically depends on quantified inputs that must be tied to the correct product and label. For STATROL, the missing items include:

  • Commercial: approved indications, patient volumes, market size, pricing, payer coverage, formulary status, rebates, and net price trajectory
  • Clinical: trial phase pipeline linked to label expansion, endpoints, event rates, subgroup durability
  • Regulatory: current label, safety updates, REMS (if any), manufacturing site status, and supply constraints
  • IP: exclusivity end date, geographic coverage, and probability of generic entry
  • Financial/operational: revenue history, burn, cost to serve, gross margin, and milestone schedule

With no product identifiers, no claim chart, no label, and no financial or regulatory data, fundamentals cannot be computed without risking a wrong asset.


Key Takeaways

  • STATROL cannot be analyzed with required investment-grade specificity from the provided information.
  • Patent/exclusivity mapping, commercial fundamentals, and risk scoring depend on drug identity and regulatory identifiers that are not present here.
  • No actionable investment scenario can be produced without an unambiguous product definition and legal anchor.

FAQs

1) What does STATROL refer to in this context?

STATROL must be tied to an exact drug identity (INN/generic name, formulation, strength, and jurisdiction). That information is not provided here.

2) Can you evaluate STATROL’s exclusivity and generic entry risk without approval and patent identifiers?

No. Generic entry risk is driven by concrete approval dates, listed patents, and jurisdiction-specific exclusivity. Those inputs are missing.

3) What metrics drive the fundamentals model for a branded pharmaceutical asset?

Label/indication mix, net pricing and rebates, patient utilization, duration and durability of clinical benefit, manufacturing reliability, and IP barrier timing.

4) Can you build a patent landscape by brand name alone?

Not reliably. Brand names can map to multiple actives or formulations across countries, and “STATROL” alone is insufficient to uniquely identify the patent estate.

5) What would be the minimum data needed to produce an investable analysis?

Exact drug identity (INN), route/formulation, at least one jurisdictional marketing authorization identifier, and an anchor patent or applicant/assignee.


References

[1] No external sources were used because STATROL’s identity and associated regulatory/patent identifiers were not provided.

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