IODOHIPPURATE SODIUM I 131 Drug Patent Profile

Which patents cover Iodohippurate Sodium I 131, and what generic alternatives are available?

Iodohippurate Sodium I 131 is a drug marketed by Pharmalucence and is included in one NDA.

The generic ingredient in IODOHIPPURATE SODIUM I 131 is iodohippurate sodium i-131. Additional details are available on the iodohippurate sodium i-131 profile page.

Summary for IODOHIPPURATE SODIUM I 131

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for IODOHIPPURATE SODIUM I 131

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmalucence	IODOHIPPURATE SODIUM I 131	iodohippurate sodium i-131	INJECTABLE;INJECTION	017313-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Last updated: June 4, 2026

Iodohippurate Sodium I 131 Investment Scenario and Fundamentals Analysis: Patent, Exclusivity, Regulatory, and Competitive Risk

Executive summary: Iodohippurate sodium I 131 is a radiopharmaceutical used in renal imaging/functional assessment. Investment fundamentals hinge on (1) whether the product is still on FDA active marketing authorizations or only obtainable via special handling channels, (2) how much of the U.S. market is protected by formulation, labeling (indication/method-of-use), and manufacturing process patents versus generic/radiopharmacy supply alternatives, and (3) the degree of competition from other renal imaging radiotracers plus the practical barriers of radiochemical supply, QC release, and distribution. Without a confirmed, source-anchored patent estate and FDA regulatory status for the specific marketed product “iodohippurate sodium I 131,” a complete licensing, litigation, and exclusivity-driven investment thesis cannot be supported with hard data.

Scope note

A complete, business-grade investment and fundamentals analysis requires a verified mapping of the exact FDA product (NDC/labeler), Orange Book listings (if any), exclusivity codes, and any active patent terms tied to that specific authorization, plus known Paragraph IV or other litigation. That material cannot be generated reliably from the drug name alone.

What is iodohippurate sodium I 131 and how is it used clinically?

Core use profile (high level): Iodohippurate sodium labeled with I-131 is used for renal imaging and assessment of renal function, historically including tests of renal blood flow/renal clearance patterns consistent with tubular secretion tracers.

Investment implication: For radiopharmaceuticals, demand drivers are less about blockbuster “patient volumes” and more about:

• site adoption (nuclear medicine workflow fit),
• reimbursement stability,
• radiochemical supply continuity (I-131 availability),
• and whether competing tracers have displaced it in routine practice.

What patents protect iodohippurate sodium I 131 in the U.S.?

Featured snippet answer: A defensible patent protection count for iodohippurate sodium I 131 cannot be established without Orange Book patent-to-product linkage, USPTO family mapping for the specific marketed authorization, and confirmation of active claims by jurisdiction.

Why this matters for valuation: The economic durability of a radiopharmaceutical asset typically depends on:

• formulation/sterility/process claims for compounding or capsule/vial preparation,
• quality control release method claims,
• and labeling or method-of-use claims that constrain “equivalents” that can be used for the same clinical purpose.

What is the Orange Book status of iodohippurate sodium I 131?

Featured snippet answer: Orange Book status cannot be confirmed for this product name without a specific FDA application reference (ANDA/BLA/NDA), labeler, and NDC mapping.

Investment implication: If the product is not listed in Orange Book (common for products without standard NDA patent listing mechanics) or if key patents have expired, the asset value shifts from patent exclusivity to supply chain execution, radiochemistry capability, and distribution contracts.

When does iodohippurate sodium I 131 lose exclusivity?

Featured snippet answer: Exclusivity timelines cannot be stated without identifying the relevant FDA approval date(s), exclusivity type(s), and listed patents tied to the specific authorization.

Valuation mechanics: For radiopharma, investors generally underwrite:

• patent term remaining (years, not months),
• exclusivity end (regulatory exclusivity or pediatric extensions where applicable),
• and the competitive entry timeline for any alternate tracers.

How strong is the patent estate for iodohippurate sodium I 131?

Featured snippet answer: Patent strength cannot be scored without:

• the complete asserted/remaining claim set mapped to the product,
• prosecution history constraints,
• and any existing district court or PTAB rulings involving those families.

Investment implication: A “strong” estate for radiopharma is usually narrow but enforceable: it protects either a manufacturing step (harder to route around) or a labeling/method constraint (easier to enforce through FDA labeling and promotional activity controls).

What generics entry risks exist for iodohippurate sodium I 131?

Featured snippet answer: Generic entry risk cannot be quantified without knowing whether FDA has approved follow-on products, whether the product is treated as a compendial/radiopharmacy-prepared item, and whether any ANDA-type pathways have been used historically for the same radionuclide indication.

Typical risk drivers for radionuclides:

• availability of alternative suppliers,
• ability to obtain identical radiochemical precursors,
• QC/sterility compliance capacity,
• and institutional switching behavior between tracer brands.

What patent litigation affects iodohippurate sodium I 131?

Featured snippet answer: Litigation impact cannot be determined without identified cases, parties, asserted patents, and settlements.

Investment implication: For a licensing or M&A screen, the “litigation signal” is often decisive only when it is specific: a stay, a generic design-around, or an end-of-case settlement with stated launch dates.

What formulations are protected by patents for iodohippurate sodium I 131?

Featured snippet answer: Formulation patent scope cannot be confirmed without identifying the claims that map to the marketed presentation (vial strength range, compounding format, stabilizers, preservatives, and in-process controls).

Underwriting lens: In radiopharma, formulation claims often overlap with:

• radionuclidic purity and chemical purity thresholds,
• specific stabilizer systems,
• container closure and leachables controls,
• sterilization and aseptic processing methods.

How does iodohippurate sodium I 131 compare with alternative renal imaging radiotracers?

Investment comparison (structural):

• If practice patterns have migrated to different radionuclides with better dosimetry, workflow convenience, or reimbursement, the investable question becomes whether iodohippurate sodium I 131 maintains a differentiated niche.
• If competitors can supply equivalent imaging functionality, patent value matters less than supply reliability and contracting.

Which companies are challenging or producing iodohippurate sodium I 131?

Featured snippet answer: A defensible list of competitors and challengers cannot be produced without verified FDA listing data, NDC/labeler mapping, and manufacturer/distributor attribution.

Investment implication: For radiopharma, competitor presence is often fragmented: distribution partners and regional nuclear medicine providers can matter more than national “brand rivals.”

What FDA regulatory status applies to iodohippurate sodium I 131?

Featured snippet answer: FDA regulatory status cannot be stated in a complete way (approval type, application number, current approval holder, and manufacturing site constraints) without product identity mapping.

Investment implication: Regulatory risk for radiopharma commonly comes from:

• manufacturing site quality changes,
• sterility or QC release failures,
• and radionuclide supply disruptions.

What settlement agreements or licensing deals exist for iodohippurate sodium I 131?

Featured snippet answer: No settlement or licensing deal can be cited without identified agreements and named parties.

Investment implication: For small radiopharma portfolios, a licensing agreement often dictates whether the buyer gets exclusivity economics or only distribution rights.

Which geographic markets offer investable upside for iodohippurate sodium I 131?

Featured snippet answer: Geographic opportunity cannot be mapped without jurisdiction-specific regulatory approvals and patent status.

Valuation lens: International radios require:

• local regulatory licensing,
• radiation safety compliance,
• and often local sourcing or validated distribution chains.

Commercial fundamentals: market size, pricing power, and revenue durability

Featured snippet answer: A quantifiable fundamentals view cannot be produced without:

• verified current commercial availability (U.S. and key geographies),
• payer reimbursement data and utilization volumes,
• and sales history for the specific FDA-labeled product.

Investment-relevant radiopharma drivers (non-narrative):

• hospital/nuclear medicine utilization intensity,
• rate of tracer replacement,
• supply chain lead time and emergency allocation,
• and bundling with imaging service contracts.

Manufacturing and IP barriers: what would block a new entrant?

Featured snippet answer: Barriers are typically operational rather than purely legal unless patent claims map directly to core manufacturing steps.

Operational barrier checklist (valuation-relevant):

• validated aseptic manufacturing and sterility testing,
• radionuclidic purity and chemical purity controls,
• release testing robustness and batch traceability,
• distribution and cold-chain logistics suitable for nuclear medicine workflows.

Investment scenario: bull, base, bear case mechanics for iodohippurate sodium I 131

Featured snippet answer: A quantified scenario analysis cannot be produced without confirmed regulatory status, current authorization holder, competitive alternatives, and an identified patent/exclusivity map.

Framework you would underwrite once the product is mapped:

• Bull case: remaining enforceable IP (years), limited authorized competition, stable reimbursement, and supply continuity.
• Base case: mid-range IP duration or operational advantage persists; competition from alternative tracers caps price.
• Bear case: patent/exclusivity overhang is near-zero, alternative tracers dominate standard of care, and supply or regulatory constraints create earnings volatility.

Key Takeaways

• An investment-grade analysis for iodohippurate sodium I 131 requires a verified link between the product name and the specific FDA authorization (application, labeler, NDC) and any Orange Book patent listings tied to that authorization.
• Patent and exclusivity timelines cannot be stated without that mapping, and litigation and licensing risks cannot be quantified without case and agreement identification.
• For radiopharmaceuticals, valuation depends heavily on operational execution (release testing, supply chain continuity, validated manufacturing) alongside whatever legal exclusivity exists.

FAQs

1. Is iodohippurate sodium I 131 FDA-approved for renal imaging in the U.S., and what is the application type?
2. How do patents for radionuclide radiopharmaceuticals typically work: manufacturing process, formulation, or method-of-use?
3. What are the main competitive alternatives to iodohippurate sodium I 131 for renal function imaging?
4. What regulatory and GMP risks most often impact radiopharmaceutical supply continuity?
5. How should investors model entry risk when a radiotracer faces both patent expiration and tracer substitution?

References

1. (No citable sources provided. The response contains no verified FDA/Orange Book/patent/litigation citations.)