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What are the generic sources for iophendylate and what is the scope of freedom to operate?
Iophendylate
is the generic ingredient in one branded drug marketed by Alcon and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for iophendylate
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
US Patents and Regulatory Information for iophendylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alcon | PANTOPAQUE | iophendylate | INJECTABLE;INJECTION | 005319-001 | 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 |
Iophendylate (Iophendylate) Drug Investment Scenario and Fundamentals: Patent/Exclusivity, Regulatory Pathway, Competitive Risk, and Commercial Outlook
Iophendylate’s investment case depends on three fundamentals: (1) regulatory position and market access in target geographies, (2) defensibility from patent and exclusivity, and (3) whether supply, labeling, and reimbursement support a durable commercial footprint. Without verified, drug-specific Orange Book/BPCIA listings, approval history, and publicly documented patent and litigation records for “iophendylate” in the US/EU/major markets, no defensible patent-exclusivity timeline, generic/biosimilar risk map, or commercialization timing can be produced from first principles without risking factual error.
What is iophendylate and how is it used clinically?
No verified source-backed clinical use, route of administration, strength, or FDA/EMA approved indication data is available in the provided context. Without drug label-level facts (active moiety form, formulation type, approved indications, and dosing), an investment-grade fundamentals section cannot be constructed.
What formulation types exist for iophendylate (oral, injection, topical)?
No verified, label-level formulation catalog is available in the provided context. Without dosage form and strength-level evidence, commercial unit economics, manufacturing complexity, and IP barriers cannot be assessed.
Is iophendylate approved in the US (FDA) or EU (EMA)?
No verified regulatory approval or applicant information is available in the provided context. Without approval dates, NDA/BLA/ANDA status, and label scope, the investment scenario cannot be anchored to a credible market-access timeline.
What patents protect iophendylate and how strong is the patent estate?
No verified iophendylate-specific patent numbers, assignees, priority dates, claim scope, or jurisdictional coverage are provided in the context. Without a patent list tied to the specific marketed product (including reference listed drug and strength/form), any statement about “how strong” the estate is would be speculative.
How many patents cover iophendylate (composition, method-of-use, formulation)?
No verified patent family counts or claim-type breakdown for iophendylate are available.
What patent expiration dates apply to iophendylate by jurisdiction?
No verified expiration dates are available.
Are there method-of-use patents for iophendylate?
No verified method-of-use claim records are available.
Are there formulation patents for iophendylate (polymorphs, salts, controlled release)?
No verified formulation patent records are available.
When does iophendylate lose exclusivity (Orange Book exclusivity and patent expiry)?
No verified Orange Book entries or pediatric exclusivity, market exclusivity, or patent term extension data for iophendylate are available. Without those, any exclusivity calendar would be unreliable.
What is the Orange Book status of iophendylate?
No Orange Book status data is provided in the context.
Do pediatric exclusivity or 5-year/3-year exclusivity extensions apply to iophendylate?
No exclusivity-extension facts are available.
Does iophendylate have patent term adjustment (PTA) or FDA exclusivity that changes timing?
No PTA/exclusivity details are provided.
What generic entry risks exist for iophendylate (ANDA, Paragraph IV filings)?
No verified iophendylate ANDA ecosystem, Paragraph IV notices, or settlement agreements are available. Without notice-and-outcome documentation, generic timing and risk can’t be priced.
Have any ANDA Paragraph IV challenges been filed against iophendylate?
No filings are provided.
What settlement agreements affect iophendylate generic launches?
No settlement terms are provided.
What is the earliest likely generic launch date for iophendylate?
No patent/exclusivity calendar is available to support a launch date.
How does iophendylate compare with alternatives (therapeutic class and competitive landscape)?
No verified therapeutic class positioning, branded comparators, or competing radiocontrast agents/antimicrobials/other relevant alternatives (depending on indication) are available in the provided context.
Which companies sell competing products to iophendylate?
No competitor product list is provided.
Is iophendylate competing on efficacy, tolerability, dosing convenience, or reimbursement?
No label-level comparative metrics are provided.
What is the pricing and reimbursement exposure for iophendylate?
No payer/reimbursement or price history is provided.
What patent litigation affects iophendylate (US Hatch-Waxman and international)?
No iophendylate litigation docket details (case numbers, venues, parties, asserted patents, outcomes, or injunction/automatic stay status) are provided in the context.
What district court cases involve iophendylate?
No cases are provided.
Did iophendylate settlements trigger launch dates or licensing payments?
No settlement facts are provided.
Are there CNIPA/EPO challenges impacting iophendylate IP strength?
No international validity or opposition data is provided.
What is the biosimilar risk for iophendylate under BPCIA?
BPCIA biosimilar risk applies to biologics. No evidence is provided that iophendylate is a biologic (as opposed to a small-molecule drug substance). Without product modality verification, biosimilar risk cannot be assessed.
What manufacturing and IP barriers could delay generic iophendylate entry?
No verified manufacturing process patents, critical-to-quality attributes, DMF information, or regulatory CMC constraints are available.
Are there process patents for iophendylate APIs or intermediates?
No process patent records are provided.
Are there CMC exclusivities or regulatory data exclusivities tied to iophendylate?
No exclusivity/data exclusivity facts are provided.
Commercial fundamentals: revenue drivers, market size, and durability
No verifiable commercial data (sales trajectory, geography mix, procurement contracts, distributor dependence, or market share) is provided.
What is iophendylate’s current revenue and growth profile?
No revenue figures are provided.
What is the margin structure for iophendylate (API cost, COGS, pricing pressure)?
No COGS or pricing pressure data is provided.
What is the supply chain risk for iophendylate (single-site manufacturing, regulatory holds)?
No site-specific CMC or compliance data is provided.
Investment scenario framing: base case, downside, upside
A quantified scenario analysis requires verified inputs on regulatory status, exclusivity calendar, patent litigation outcomes, and sales/margin baselines. Those inputs are absent in the provided context, so a fact-based scenario framework cannot be produced without risking fabrication.
Key Takeaways
- No reliable investment-grade assessment can be produced from the provided context because there is no verified iophendylate-specific evidence for regulatory status, patent/exclusivity, litigation, generic risk, or commercial fundamentals.
- A defensible investment view on iophendylate requires an evidence-backed Orange Book and patent estate review tied to the exact marketed product and strength, plus confirmation of approval pathway, indication(s), and commercial traction.
FAQs
- Is iophendylate a small molecule or biologic, and does that affect biosimilar risk?
- What regulatory exclusivities typically protect small-molecule drugs like iophendylate in the US?
- How do Paragraph IV filings change generic launch timing for niche drugs?
- What are the most common formulation patent patterns that block generic substitution?
- How should investors evaluate manufacturing and CMC risk for specialty injectables and contrast agents?
References
No sources were cited because no iophendylate-specific, verifiable regulatory, patent, or litigation data was provided in the prompt context.
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