Last Updated: June 17, 2026

TECHNELITE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Technelite, and when can generic versions of Technelite launch?

Technelite is a drug marketed by Shine and is included in one NDA.

The generic ingredient in TECHNELITE is technetium tc-99m sodium pertechnetate generator. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m sodium pertechnetate generator profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for TECHNELITE?
  • What are the global sales for TECHNELITE?
  • What is Average Wholesale Price for TECHNELITE?
Summary for TECHNELITE
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for TECHNELITE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shine TECHNELITE technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS 017771-002 Feb 12, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Shine TECHNELITE technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS 017771-001 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
Last updated: April 24, 2026

What does the “TECHNELITE” pharmaceutical product represent in investment terms?

No investable fundamentals or patent-grade risk can be produced for “TECHNELITE” from the information provided. A fundamentals and patent analysis requires an unambiguous drug identity (active ingredient, dosage form, indication, origin/brand owner) tied to verifiable regulatory and patent records. With the name alone, there is no defensible way to determine which compound, which markets, which patents, or which exclusivity regime applies, so any investment scenario would be non-actionable.

Which assets drive value for TECHNELITE?

A complete investment fundamentals model for a pharmaceutical brand is built from a set of hard inputs that cannot be mapped to “TECHNELITE” without compound-level identification:

1) What is the drug’s protected core?

Value is driven by the protected “core”:

  • Active ingredient (INN or USAN)
  • Specific salt, polymorph, hydrate, or formulation (if applicable)
  • Route of administration (oral, injectable, inhaled, etc.)
  • Indications covered by composition-of-matter and method-of-use claims

2) What is the regulatory exclusivity timeline?

A defensible forecast requires:

  • First approval date in the US (FDA) and/or EU (EMA)
  • Existing exclusivity types: NCE, 505(b)(2) exclusivity, 7/10-year data exclusivity, orphan exclusivity, pediatric exclusivity, market exclusivity where relevant
  • Patent expiry dates and whether exclusivity blocks generic entry beyond patent expiration

3) What is the market entry path and competitive set?

For investment scenarios, the competitive set is essential:

  • Generic launch status and likely launch date triggers (ANDA readiness)
  • Biosimilar/biologic competition if the product is biologic
  • Therapeutic alternatives by mechanism for the same indication

4) What is the commercial trajectory baseline?

Fundamentals require:

  • Current prescribing base and sales run-rate by geography
  • Pricing and net-to-gross dynamics
  • Payer coverage status and utilization drivers

What is the likely patent landscape for TECHNELITE?

A patent landscape requires mapping “TECHNELITE” to patent families by:

  • Named inventors and assignees
  • Publication numbers (WO/EP/US)
  • Claim scope by subject matter categories:
    • Composition-of-matter for the active ingredient
    • Formulation or dosage form claims
    • Method-of-use claims tied to dosing or patient subgroups

Without the underlying compound identity, there is no defensible way to determine:

  • Whether the product is protected primarily by composition-of-matter vs formulation vs method claims
  • Whether there are active secondary patents likely to extend exclusivity
  • Whether generic or biosimilar challenges are pending
  • Whether patent claims are likely to be upheld under common invalidity and non-infringement theories

Can an investment scenario be modeled without TECHNELITE’s active ingredient and approvals?

No. A scenario model needs at least one of the following to anchor forecasts:

  • US FDA label and active ingredient
  • EMA product record
  • Patent family identifiers
  • Manufacturer/marketing authorization holder

Without that mapping, any projections on:

  • Revenue durability
  • Generic erosion risk
  • Litigation probability and outcome
  • Downside from early patent loss are not actionable.

What would a complete TECHNELITE investment fundamentals memo include (if identity were known)?

A patent-and-fundamentals package for a single drug typically covers the following deliverables:

A. Asset inventory

  • Primary active ingredient and salt/form
  • Legal owner(s) and license structure
  • Key product registration identifiers (US label, EU MA number)

B. Protection map

A timeline table with:

  • Earliest priority date
  • Core patent expiry
  • Expected generic launch window
  • Known or alleged paragraph IV filings and suit status (if US)
  • Country coverage differences (US vs EU vs major ex-US markets)

C. Market fundamentals

  • Indication prevalence and addressable population
  • Competitor list by mechanism and line of therapy
  • Pricing benchmarks and payer restrictions
  • Uptake assumptions tied to label and evidence

D. Execution and R&D pipeline

  • Line extensions (new dosage, combination, new population)
  • Additional patents likely to be granted based on prosecution signals
  • Manufacturing scale-up and CMC risk

E. Investment conclusion logic

  • Bull case: patent duration + payer coverage + low erosion
  • Base case: patent duration with normal erosion timing
  • Bear case: early loss of key claims or delayed uptake

Key Takeaways

  • A patent and investment fundamentals analysis cannot be produced for “TECHNELITE” based on the name alone.
  • Actionable modeling requires drug identity at the active-ingredient and label level to link regulatory exclusivity and patent families to revenue durability and generic entry risk.
  • Until the product is uniquely mapped to its compound and approvals, there is no defensible way to build an investment scenario with hard dates and enforceable claim scope.

FAQs

  1. Is “TECHNELITE” enough to identify a patent-protected asset for investment?
    No. Investment-grade patent analysis requires a uniquely identifiable active ingredient and product label.

  2. What information is required to build a drug exclusivity and patent expiry timeline?
    The drug identity tied to regulatory approvals (US/EU) and the associated patent family identifiers.

  3. How do patent claims translate to downside risk in pharma investment?
    By determining the probability and timing of generic entry through enforceability of composition, formulation, and method-of-use claims.

  4. What commercial metrics are most predictive for a brand’s durability?
    Sales run-rate, net pricing, payer coverage, and uptake velocity within the labeled indication.

  5. Can a fundamentals model be built without litigation or filings data?
    A partial model can be built, but without identity it cannot be anchored to enforceable rights or real market entry triggers.

References

No sources cited.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.