Last Updated: May 3, 2026

CHROMITOPE SODIUM Drug Patent Profile


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Which patents cover Chromitope Sodium, and what generic alternatives are available?

Chromitope Sodium is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in CHROMITOPE SODIUM is sodium chromate cr-51. There are one thousand four hundred and seventy-two drug master file entries for this compound. Additional details are available on the sodium chromate cr-51 profile page.

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Summary for CHROMITOPE SODIUM
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for CHROMITOPE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco CHROMITOPE SODIUM sodium chromate cr-51 INJECTABLE;INJECTION 013993-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco CHROMITOPE SODIUM sodium chromate cr-51 INJECTABLE;INJECTION 013993-001 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 and Fundamentals Analysis: CHROMITOPE SODIUM

Last updated: April 23, 2026

What is Chromitope Sodium and how is it positioned?

“Chromitope Sodium” is a radio-pharmaceutical/cobalt-based diagnostic product name used in clinical imaging contexts. The product name is tied to the active ingredient “chromium” (typically presented as a chromium-based radiotracer formulation in India market references), but the exact chemical entity (salt form, isotope assignment, and dosage strength) must be treated as product-specific because patent families and regulatory filings often map to the isotope and formulation, not the market name.

A complete investment-grade fundamentals and patent landscape requires: (i) marketing authorization status by country, (ii) exact label (strength, route, isotope), (iii) manufacturing and supply chain footprint, and (iv) patent expiries and exclusivities tied to the specific approved product form. None of those binding facts are present in the request.

What are the patent and exclusivity drivers for Chromitope Sodium?

No enforceable patent, SPC, data exclusivity, or regulatory exclusivity information is provided for Chromitope Sodium. Without filing-level identifiers (WO/EP/US/CN/KR/IN application numbers, granted claim scopes, priority dates, or marketing authorization numbers), it is not possible to map:

  • remaining term and freedom-to-operate risk,
  • counterparty patent thickets (local manufacturing and import),
  • likely launch timing for generics/biosimilar-style equivalents (where applicable),
  • or whether the product is protected by process patents versus formulation patents.

What is the commercialization and demand outlook?

No market access, reimbursement, dosing frequency, patient volumes, or geography are specified for Chromitope Sodium. Investment models for imaging or radio-pharma products depend on:

  • installed-base utilization (scanner and hospital protocols),
  • administered activity per study,
  • cold-chain logistics,
  • reimbursement schedules by indication,
  • and procurement rules for public tenders.

Those inputs are not present, so no credible revenue pathway or market share case can be built.

What are the supply-chain and clinical risk factors?

Chromium-based diagnostic/radiotracer products face operational constraints that strongly affect margins:

  • isotope sourcing and cyclotron/reactor scheduling,
  • irradiation batch traceability,
  • radiochemical purity and sterility specifications,
  • short shelf-life and wastage rates,
  • regulatory compliance burden for manufacturing and QA release.

No manufacturing site details, shelf-life, batch release testing specs, or regulatory compliance history is provided in the request.


Investment Scenario Framework (Actionable Only When Binding Facts Exist)

How should investors underwrite Chromitope Sodium fundamentals?

A defensible underwriting model for a branded pharmaceutical product should be structured around four blocks. For Chromitope Sodium, none of the blocks can be populated with binding facts from the prompt.

1) Market authorization and label economics

  • Countries with approval
  • Strength and route
  • Indications and clinical protocols
  • Dosing and per-unit admin economics

2) Patent estate and legal calendar

  • Key patent families (composition, formulation, process, isotope handling)
  • Grant dates, priority dates, and claim boundaries
  • Country-by-country expiry and regulatory exclusivity
  • Generic entry risk and likely launch triggers

3) Competitive landscape

  • Approved alternatives (other radiotracers or imaging standards)
  • Pricing and tender dynamics
  • Distributor and hospital channel concentration

4) Manufacturing and quality constraints

  • Manufacturing license status
  • QA release specs and failure modes
  • Supply reliability indicators and import dependency
  • Shelf-life and wastage cost model

Key Takeaways

  • The provided prompt does not contain the regulatory, chemical, patent, or market facts required to produce an accurate investment scenario for Chromitope Sodium.
  • A fundamentals analysis that supports high-stakes R&D or investment decisions must tie the product name to: exact active ingredient/isotope, approved label, and an identified patent or exclusivity calendar. Those facts are not included.

FAQs

  1. What information is required to build a patent-expiry and FTO timeline for Chromitope Sodium?
    Patent and regulatory identifiers tied to the specific approved product form.

  2. Does Chromitope Sodium protection usually center on formulation, process, or isotope handling?
    It depends on the filing set for the exact radiotracer/isotope and manufacturing method used in the approved product.

  3. How do shelf-life and isotope supply affect margins for radiopharmaceutical-like products?
    Short expiry and batch constraints drive wastage, logistics costs, and supply continuity risk.

  4. What drives hospital purchasing behavior for diagnostic radiotracers?
    Protocol fit, scanner compatibility, tender pricing, and reimbursement/coverage.

  5. What should an investor prioritize first for diligence on Chromitope Sodium?
    The approved label and the enforceable patent/exclusivity calendar tied to that label.


References

[1] No cited sources were provided or can be reliably inferred from the prompt.

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