Share This Page
HIPPURAN I 131 Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Hippuran I 131, and what generic alternatives are available?
Hippuran I 131 is a drug marketed by Mallinckrodt and is included in one NDA.
The generic ingredient in HIPPURAN I 131 is iodohippurate sodium i-131. Additional details are available on the iodohippurate sodium i-131 profile page.
US Patents and Regulatory Information for HIPPURAN I 131
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt | HIPPURAN I 131 | iodohippurate sodium i-131 | INJECTABLE;INJECTION | 016666-001 | 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 |
Investment Scenario & Fundamentals Analysis for HIPPURAN I 131 (Hippuran Sodium Iodine I-131): Patent, Exclusivity, Regulatory, and Competitive Risk
HIPPURAN I 131 is a radiopharmaceutical used in nuclear medicine for diagnostic indications (notably renal imaging historically). Commercial and investment exposure is driven by (1) whether the specific listed NDA/ANDA pathway exists for the radiopharmaceutical in the U.S. with an Orange Book record, (2) the breadth and life of composition/formulation/manufacturing patents for the drug substance and ready-to-use preparations, (3) radioactive sourcing and batch-release constraints, and (4) the level of defensibility against alternative renal imaging agents and competing radiopharmaceutical supply chains.
This analysis cannot be completed to an “actionable” litigation-grade level without a verified product record and patent estate identifiers for the specific “HIPPURAN I 131” market entry (active ingredient, manufacturer, application number, listing status, and jurisdiction). Per your constraints, no partial or placeholder patent, exclusivity, litigation, FDA, or pricing/revenue conclusions are provided.
Key barrier for investment underwriting Investment-grade diligence requires at minimum: the exact FDA-regulated product listing (application type and number), the Orange Book/T&Cs record for exclusivity/patents, and the primary patent numbers and assignees tied to the U.S. product. Those identifiers are not present in the prompt, so a complete, accurate fundamentals and scenario analysis cannot be produced.
What is HIPPURAN I 131 and how is it used in nuclear medicine?
Answer (high level): HIPPURAN I 131 is a radiolabeled hippuran formulation (iodine I-131) used historically for renal imaging and related diagnostic nuclear medicine workflows. Investment relevance is tied to modality demand, reimbursement, and substitution by newer renal imaging agents.
Indications and payer relevance
- Renal function assessment and imaging has historically been the core use case.
- Investment sensitivity: if clinical practice shifts toward alternative tracers or SPECT/CT protocols with different agents, demand can erode even if the molecule itself remains available.
Administration and operational dependencies
- Radiopharmaceuticals depend on production scheduling, isotope availability, cold-chain handling, and qualified radiopharmacy distribution.
- Investment risk is often supply-chain operational rather than purely patent-driven.
What patents protect HIPPURAN I 131 in the US and EU?
Answer: Not determinable from the information provided.
Patent estate components that typically matter for radiopharmaceuticals
- Composition-of-matter (drug substance: hippuran/iodinated form)
- Manufacturing process (iodination chemistry, radiochemical purity controls)
- Formulation and preparation (ready-to-use vials, stabilizers)
- Quality controls and release testing (specific assay methods, sterility/endotoxin constraints)
- Method-of-use (imaging protocols, dosing regimens, patient selection)
Why jurisdiction matters
- Radiopharmaceuticals can be protected by a combination of composition and process patents with country-specific filings.
- Enforcement also depends on whether the product is marketed under a specific approved application with Orange Book listings.
When does HIPPURAN I 131 lose exclusivity in the US?
Answer: Not determinable from the information provided.
Exclusivity timelines investors use
- Hatch-Waxman patent-expiration mapping (Orange Book listed patents)
- 5-year and 3-year new chemical entity or other exclusivity (if applicable)
- 505(b)(2) or Rx-to-Rx reliance structures
- Any pediatric exclusivity or supplemental exclusivity extensions
- Radiopharmaceutical-specific manufacturing or NDA-dependent exclusivity not captured without the application record
What is the Orange Book status of HIPPURAN I 131?
Answer: Not determinable from the information provided.
Why Orange Book status is pivotal for underwriting
- Orange Book listings define the enforceable patent trigger points for generic and 505(b)(2) competitors.
- Without the product listing and application number, any statement about listed patents or their expirations would be speculative.
How many patents cover the formulation, process, and method of use for HIPPURAN I 131?
Answer: Not determinable from the information provided.
Typical count categories investors model
- Drug substance composition patents: 1–N
- Process/manufacturing patents: 1–N
- Formulation/presentation patents (vial composition, excipients): 0–N
- QC/release testing and stability: 0–N
- Method-of-use patents tied to imaging workflow: 0–N
Which companies manufacture or sell HIPPURAN I 131 and how does supply chain affect pricing?
Answer: Not determinable from the information provided.
Investment-relevant supply chain variables
- Isotope sourcing and contract terms for I-131 procurement
- Radiopharmacy network reach and distribution lead times
- Batch release failure rates (quality system robustness)
- Regulatory inspections and deviations history (impact on availability)
- Tendering and hospital purchasing cycles
What patent litigation or Paragraph IV challenges affect HIPPURAN I 131?
Answer: Not determinable from the information provided.
What matters in litigation for radiopharmaceuticals
- Whether challenges are directed to Orange Book patents
- Injunction and launch timing outcomes
- Settlement structures such as “carve-outs,” launch staging, or licensing terms
- Litigation jurisdiction and venue because enforcement is not uniform
Do biosimilars apply to HIPPURAN I 131, and what is the biologics risk profile?
Answer: Not determinable from the information provided.
Relevance criteria
- Biosimilar frameworks apply to biologics licensed under BLA pathways.
- HIPPURAN I 131 is a radiopharmaceutical small molecule complex with isotope labeling, but the market’s regulatory classification must be confirmed for biosimilar applicability.
How does HIPPURAN I 131 compare with alternative renal imaging radiotracers in clinical use and substitution risk?
Answer: Not determinable from the information provided.
Investment-relevant substitution drivers
- Clinical outcomes evidence
- Imaging resolution and workflow compatibility
- Safety profile and radiation dose comparisons
- Reimbursement coverage and hospital protocol standardization
- Availability reliability and isotope-specific lead time constraints
What generic entry risks exist for HIPPURAN I 131?
Answer: Not determinable from the information provided.
Underwriting model inputs
- Orange Book patent status and their expiration dates
- If any listed patents are formulation/process that restrict 505(b)(2)/generic substitution
- Whether a “design-around” route is available without infringing
- Whether manufacturing or QC method patents create de facto barriers
What manufacturing and IP barriers block competitors from making HIPPURAN I 131?
Answer: Not determinable from the information provided.
Barrier types investors evaluate
- Radiochemical manufacturing steps that are hard to replicate at scale
- Tight impurities or radiochemical purity specifications tied to patented methods
- Release testing protocols protected by patents or trade secret controls
- Qualified supplier networks and regulatory validated processes
What regulatory status does HIPPURAN I 131 have with the FDA (NDA/ANDAs, labeling, and changes)?
Answer: Not determinable from the information provided.
Investment-relevant FDA events
- Approval pathway (NDA vs 505(b)(2) vs legacy vs compounded vs distributor label)
- Label changes and indications retained or withdrawn
- Safety communications affecting demand
- Recalls, deviations, or warning letters affecting supply continuity
- Manufacturing supplement approvals and validation upgrades
How should investors model revenue exposure for HIPPURAN I 131 under IP and competitive pressure?
Answer: Not determinable from the information provided.
Revenue sensitivity framework
- Demand: patient volumes and imaging utilization trends
- Price: contract vs cash-pay dynamics in radiopharmacy procurement
- Supply: isotope availability and production uptime
- Competition: substitution by other renal tracers
- IP: timing to first meaningful entry or design-around sales
Key Takeaways
- An investment-grade fundamentals and patent/exclusivity scenario for “HIPPURAN I 131” cannot be completed accurately without a verified FDA product record (application number and Orange Book listing) and a mapped patent estate (numbers, assignees, expiration dates).
- For radiopharmaceuticals, the limiting factor is often operational supply continuity and regulatory listing status, not only composition patent protection.
- A defensible underwriting model requires: Orange Book status, patent expiration mapping, and verified competitor/launch or litigation records tied to the specific U.S. product entry.
FAQs
-
Does HIPPURAN I 131 have an FDA Orange Book listing with patent-expiration dates?
Not determinable from the provided information. -
Are there Paragraph IV challenges or settlements related to HIPPURAN I 131 in the U.S.?
Not determinable from the provided information. -
What is the likely regulatory pathway for generic or 505(b)(2) versions of HIPPURAN I 131?
Not determinable from the provided information. -
Does HIPPURAN I 131 face biosimilar-style competition risks?
Not determinable from the provided information. -
How do isotope supply constraints for I-131 affect investment returns for HIPPURAN I 131 manufacturers?
Not determinable from the provided information.
References (APA)
No sources are provided because no verifiable product record, FDA application, Orange Book listing, patent numbers, litigation docket, or regulatory events were included in the prompt.
More… ↓
