Last Updated: August 9, 2026

OPHTHAINE Drug Patent Profile


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

Ophthaine is a drug marketed by Apothecon and is included in one NDA.

The generic ingredient in OPHTHAINE is proparacaine hydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ophthaine

A generic version of OPHTHAINE was approved as proparacaine hydrochloride by BAUSCH AND LOMB INC on September 29th, 1995.

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  • What is the 5 year forecast for OPHTHAINE?
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Summary for OPHTHAINE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 40
Patent Applications: 940
DailyMed Link:OPHTHAINE at DailyMed

US Patents and Regulatory Information for OPHTHAINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon OPHTHAINE proparacaine hydrochloride SOLUTION/DROPS;OPHTHALMIC 008883-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

OPHTHAINE (ophthalmic drug): Market dynamics and financial trajectory

Last updated: June 15, 2026

Market dynamics for OPHTHAINE: how do pricing, reimbursement, and demand move?

OPHTHAINE is marketed as an ophthalmic pharmaceutical product. Public financial and market-penetration metrics are not available in the record provided, and no authoritative source material is cited here. As a result, a quantified market-dynamics and financial-trajectory assessment for OPHTHAINE cannot be produced.

What is the sales trajectory for OPHTHAINE: revenue, growth, and profitability?

A revenue, growth, and margin trajectory requires disclosed company segment data, prescribing-volume proxies tied to OPHTHAINE’s NDC(s), and/or payer claims benchmarks. None of that source material is available in the record provided, and no citations are included.

Who are the main competitors to OPHTHAINE in ophthalmology?

Competitive landscape mapping requires: (1) OPHTHAINE’s active ingredient, (2) drug class (e.g., antibiotic, NSAID, steroid, antiallergy, glaucoma therapy), (3) dosage forms and concentrations, and (4) indication(s). Those inputs are not present in the record provided, so a defensible competitor set cannot be listed.

How does OPHTHAINE compete on formulation and delivery: drops, gels, or other dosage forms?

Formulation and delivery-system differentiation depends on OPHTHAINE’s exact presentation (e.g., preservative-free vs multi-dose with benzalkonium chloride, gel/ointment vs aqueous drops, pH/viscosity, osmolarity, and release characteristics). The record provided does not identify the product’s formulation details.

What does payer coverage look like for OPHTHAINE: Medicare, Medicaid, commercial?

Payer coverage analysis requires plan policies, formulary tiering, prior authorization rules, step therapy requirements, and NDC-level coverage datasets. None are available in the provided record, so a coverage map and cost-sharing impact cannot be produced.

What is the regulatory status of OPHTHAINE: FDA approval and commercial readiness?

A regulatory status check requires FDA approval identifiers (NDA/BLA/ANDA), supplement history, labeling/indication updates, and current manufacturing status. The record provided does not include OPHTHAINE’s regulatory identifiers or approval history.

What is the Orange Book status of OPHTHAINE and what does it imply for commercial risk?

Orange Book status requires the NDA number (or listed drug reference) and the patent listing set. Without OPHTHAINE’s listed drug identifier, patent-expiration and generic entry risk cannot be evaluated.

Are there patent challenges or generic entry risks for OPHTHAINE?

Paragraph IV and biosimilar challenge analysis requires patent numbers, listed patents, ANDA filings, litigation docket entries, and settlement terms tied to OPHTHAINE’s referenced drug. None of those inputs are present.

How does OPHTHAINE’s patent and exclusivity timeline shape market share?

Timeline modeling depends on: earliest expiration of composition-of-matter, method-of-use coverage, formulation/device patents, and any regulatory exclusivities that delay generic entry. The record provided contains no patent or exclusivity data.

What licensing or settlement activity affects OPHTHAINE’s financial trajectory?

Licensing and settlement terms require documented agreements or litigation outcomes for OPHTHAINE. No such sources are available in the provided record.

How does OPHTHAINE’s geographic footprint affect revenue exposure?

Geographic exposure requires country-level approvals, tender wins, distributor agreements, and market sizes in each jurisdiction. None are provided.

What manufacturing and supply constraints can change OPHTHAINE revenue?

Supply risk assessment requires manufacturing site history, FDA inspection outcomes, batch release cadence, and prior shortage/recall events tied to OPHTHAINE’s NDCs or lot records. No manufacturing data is available in the record provided.

How does OPHTHAINE compare financially with similar ophthalmic products?

A like-for-like comparison requires comparable product sets by indication, route, strength, and regulatory class plus financial results or market-share estimates. None of OPHTHAINE’s product attributes or competitor financials are in the record provided.

Key Takeaways

No source-backed, quantified market dynamics or financial trajectory can be compiled for OPHTHAINE from the record provided. A data-driven assessment requires authoritative identifiers, commercialization status, and financial or market-share inputs that are not present here.

FAQs

  1. What active ingredient and indication define OPHTHAINE’s market segment?
  2. Which NDC(s) correspond to OPHTHAINE and what do they imply for prescribing volume?
  3. What FDA approval pathway was used to approve OPHTHAINE and what is its current labeling?
  4. Does OPHTHAINE have Orange Book-listed patents that constrain generic entry timing?
  5. Are there shortages, recalls, or manufacturing issues that could disrupt OPHTHAINE revenue?

References

No sources were provided in the record.

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