PANTOPAQUE Drug Patent Profile

When do Pantopaque patents expire, and what generic alternatives are available?

Pantopaque is a drug marketed by Alcon and is included in one NDA.

The generic ingredient in PANTOPAQUE is iophendylate. Additional details are available on the iophendylate profile page.

Summary for PANTOPAQUE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for PANTOPAQUE

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

Last updated: July 29, 2026

PANTOPAQUE drug investment fundamentals, patent/exclusivity risk, and generic entry timing

PANTOPAQUE is a branded iodinated contrast media product (pantopaque). The investment case is driven by: (1) regulatory exclusivity and reliance on listed Orange Book patents (if any), (2) the strength and run-off schedule of formulation/process patents, (3) compendial and generic substitutability for iodinated contrast, and (4) procurement and supply-chain durability in hospital imaging procurement cycles.

What is PANTOPAQUE (pantopaque) and how is it used clinically?

PANTOPAQUE (pantopaque) is an older-generation iodinated contrast agent historically used for radiography and certain myelographic/neuroradiologic contrast applications. Market demand tracks clinical practice patterns and replacement by modern water-soluble iodinated agents for most indications.

Dose forms and administration

• Injectable contrast agent administered in radiology workflows.
• Use is typically tied to niche imaging protocols rather than broad first-line use where modern contrast agents dominate.

Clinical adoption trends that affect sales

• Long-tail demand persists only where legacy clinical protocols remain in use.
• Pricing and volume are influenced by hospital formulary decisions and imaging guideline updates.

How does PANTOPAQUE compare with modern iodinated contrast agents?

PANTOPAQUE competes indirectly with:

• Non-ionic, water-soluble iodinated contrast media used for CT and angiography.
• Newer contrast brands with better safety/tolerability profiles and easier handling.

Where PANTOPAQUE tends to persist

• Legacy use cases with established internal protocols.
• Settings with retained imaging equipment/protocols that still include older contrast agents.

Where PANTOPAQUE tends to lose

• Broad transition to modern non-ionic iodinated contrast.
• Substitution by readily available generics and multi-source products in the iodinated contrast category.

What patents protect PANTOPAQUE?

No patent estate data can be produced for PANTOPAQUE from the information available in this prompt alone. A defensible patent-protection map requires Orange Book listings and/or patent family disclosures tied to the specific branded product, including:

• Active ingredient coverage (pantopaque)
• Formulation and concentration
• Manufacturing process (sterility, particle size, stabilization)
• Method-of-use claims and labeling restrictions

Because those data are not present here, a complete patent list with expiration dates, assignees, and claim scope cannot be generated.

What is the Orange Book status of PANTOPAQUE?

A full Orange Book status check requires:

• the exact marketed product identifier(s) (strength, dosage form, NDA/ANDA linkage)
• Orange Book patent listing numbers and listed expiration dates

Those identifiers are not provided in the prompt, so the Orange Book status cannot be stated with the required precision.

When does PANTOPAQUE lose exclusivity?

Exclusivity timing for small-molecule injectable contrast depends on whether relevant exclusivity exists and whether patents are listed to the specific NDA/product in the Orange Book. The necessary inputs (NDA number, listed patents, and exclusivity periods) are not available here, so an exclusivity-runoff timeline cannot be produced.

How many patents cover PANTOPAQUE formulations and manufacturing methods?

A count by jurisdiction and claim type requires:

• patent family mapping
• jurisdictional filing (US, EP, JP, etc.)
• claim-level categorization (composition, method, process)

No patent-family inputs are provided, so a quantified patent-count and jurisdictional breakdown cannot be delivered.

Which companies are challenging PANTOPAQUE with Paragraph IV?

Paragraph IV certification is an FDA Hatch-Waxman construct for generic approvals tied to an NDA that lists patents in the Orange Book. Generics can also enter without Paragraph IV if patents are not listed or if the generic is non-infringing with a “carve-out” route.

No NDA identifier or Orange Book patent listing is provided here, so the Paragraph IV landscape for PANTOPAQUE cannot be generated.

What patent litigation affects PANTOPAQUE (in US courts or ITC)?

To report litigation that affects entry risk, the analysis needs:

• case captions
• docket numbers
• jurisdictions
• settlement terms and launch design-arounds

No litigation dataset is included in the prompt, so no litigation timeline can be produced.

What settlement agreements govern PANTOPAQUE generic entry?

Settlement intelligence depends on:

• public court filings
• FDA generic program updates linked to litigation
• consent decrees and stipulations

No settlement references are available in the prompt, so no agreement analysis can be stated.

What generic entry risks exist for PANTOPAQUE?

For iodinated contrast agents, generic entry risk is often shaped less by “brand exclusivity” and more by:

• formulation substitutability
• manufacturability and sterility assurance
• stability and particle properties
• procurement tender cycles
• hospital trust and supply continuity

A quantified entry-risk conclusion requires actual patent and regulatory status, which is not available here.

How does PANTOPAQUE’s competitive landscape look versus other iodinated contrast brands?

PANTOPAQUE sits in a crowded and mature therapeutic area where:

• multiple manufacturers supply contrast agents
• hospitals use group purchasing and tendering
• switching costs can be low when safety and imaging quality are comparable

Investment fundamentals hinge on whether PANTOPAQUE maintains differentiated niche use, stable procurement, and supply reliability.

What is the FDA regulatory status of PANTOPAQUE?

Regulatory status requires the NDA number or marketed product listing and inspection history:

• current approval status
• manufacturing site approvals
• safety communications
• labeling and indication set

No NDA/product identifiers are provided, so the FDA status cannot be precisely stated.

What manufacturing and IP barriers block biosimilar-like entry for PANTOPAQUE?

PANTOPAQUE is not a biologic; biosimilar frameworks do not apply. The relevant barriers are:

• sterile manufacturing and quality systems
• physicochemical equivalence
• stability under storage and handling
• supply chain continuity for hospital stocking

No product-specific CMC details are provided, so barriers cannot be made product-specific with actionable specificity.

What is the revenue exposure for PANTOPAQUE under plausible generic and tender scenarios?

A revenue exposure model requires:

• current sales by channel and geography
• payer or procurement contract structures
• unit pricing and volume trends
• inventory cycle and supply constraints

None of these inputs are available in the prompt, so a revenue exposure forecast cannot be generated.

How strong is the patent estate for PANTOPAQUE?

A patent strength assessment requires:

• number of relevant patents
• claim breadth (composition vs. process vs. method-of-use)
• prosecution history and likely invalidity risk
• enforcement history and litigation posture

No patent data is provided, so patent strength cannot be evaluated.

Investment scenario: what are the key drivers and downside catalysts?

Key upside drivers

• Retention of niche indications where older contrast agents remain protocolized.
• Supply reliability and low disruption risk, which matters in imaging.
• Procurement contracts that sustain stable volumes even as competitors expand.

Primary downside catalysts

• Protocol shifts that reduce use of older contrast agents.
• Competitive substitution to multi-source modern non-ionic iodinated contrast.
• Regulatory or manufacturing disruptions at key sites, including recalls or quality holds.

Investment scenario decision tree (timing and risk gating)

A business-ready investment decision normally gates on:

1. Regulatory and exclusivity clarity: Orange Book patent listings and FDA approval status tied to the specific product.
2. Patent defensibility: composition/process claims with clear expiration/run-off.
3. Entry probability: Paragraph IV challenges, non-Paragraph IV generic pathways, and any litigation.
4. Commercial stickiness: hospital protocol persistence and tender outcomes.

Because Orange Book/regulatory identifiers and patent/litigation inputs are missing, the investment scenario cannot be converted into a date-driven risk schedule.

Key Takeaways

• PANTOPAQUE is an iodinated contrast media product whose long-run economics depend on niche clinical persistence and supply stability in hospital imaging procurement.
• The investment-risk framework requires Orange Book patent listing, exclusivity periods, and litigation/Paragraph IV intelligence tied to the exact NDA/product; those inputs are not available in the prompt.
• Competitive pressure from modern iodinated contrast brands and multi-source supply is structurally persistent in this category.

FAQs

1. Is PANTOPAQUE protected by US Orange Book patents?
2. What is the FDA approval status of pantopaque injection?
3. Are there any Paragraph IV ANDA filings for pantopaque?
4. What CMC/sterility issues commonly affect generic entry for injectable iodinated contrast?
5. How do hospital imaging protocols influence demand for older iodinated contrast agents like PANTOPAQUE?

References (APA)

1. None provided from the prompt.