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Last Updated: March 19, 2026

TENSILON Drug Patent Profile


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Which patents cover Tensilon, and what generic alternatives are available?

Tensilon is a drug marketed by Pai Holdings Pharm and is included in one NDA.

The generic ingredient in TENSILON is edrophonium chloride. There are three drug master file entries for this compound. Additional details are available on the edrophonium chloride profile page.

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Summary for TENSILON
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for TENSILON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pai Holdings Pharm TENSILON edrophonium chloride INJECTABLE;INJECTION 007959-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pai Holdings Pharm TENSILON PRESERVATIVE FREE edrophonium chloride INJECTABLE;INJECTION 007959-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Last updated: February 4, 2026

mmary
TENSILON (edrophonium) is used primarily in diagnosing myasthenia gravis and in certain cardiac procedures. Its market is limited but stable, with potential growth in diagnostic applications and niche therapeutic uses. Investment considerations center on patent status, competitive landscape, regulatory environment, and pipeline developments.

What Is TENSILON Used For?
TENSILON is an acetylcholinesterase inhibitor. It is employed mainly in diagnostic testing for myasthenia gravis, enhancing muscle strength temporarily. It also has applications in detecting cholinergic crisis and facilitating intubation in certain cardiac surgeries.

Market Size and Forecast
The global diagnostic drug market for neuromuscular disorders was valued at approximately $1.2 billion in 2022, with expected compound annual growth rate (CAGR) of 3.5% through 2030. TENSILON’s market share is concentrated among specialized healthcare providers. Its therapeutic market is minimal, but demand persists in diagnostic settings.

Patent and Regulatory Landscape
TENSILON was developed in the 1940s, with U.S. patent protections expiring in the early 2000s. It is available as a generic medication in multiple countries. Regulatory pathways for approvals focus on compounding and off-label uses, limiting potential for new branded formulations.

Competitive Environment
Competitors include other cholinesterase inhibitors like neostigmine and pyridostigmine, primarily used for similar indications in myasthenia gravis management. The market for diagnostics relies on laboratory standards, with minimal proprietary differentiation.

Pipeline and Innovation
Current pipeline activity centers on developing novel biomarkers and diagnostic assays rather than new chemical formulations of edrophonium. No major clinical trials for new indications are underway as of 2023.

Supply Chain and Manufacturing
Manufacturing is straightforward, with established synthesis protocols. Supply chain stability is high but subject to generic production costs, which keep prices low. Major manufacturers include Teva, Pfizer, and specialty compounding pharmacies.

Financial Metrics and Investment Risks
Revenue generated from TENSILON is modest but steady. Risks include generic price erosion, regulatory restrictions on off-label use, and limited pipeline progression. Potential upside exists if expanded diagnostic techniques or new indications for related compounds emerge.

Key Investment Factors

  • Market stability: The diagnostic application remains essential for neuromuscular testing, with low regulatory hurdles.
  • Patent expiration: Limits exclusivity; generic competition is intense.
  • Pipeline activity: Focused on novel diagnostics; no new drug formulations expected soon.
  • Pricing dynamics: Low due to generic availability, constraining upside.
  • Regulatory environment: Favorable for existing uses; limited pathways for new claims.

Key Takeaways

  • TENSILON’s primary value lies in its diagnostic role, with a niche but stable market.
  • Patent expiration and generic competition reduce profit margins.
  • Limited pipeline activity diminishes prospects for pipeline-driven growth.
  • Market growth hinges on advances in diagnostic methodologies rather than new drug development.
  • Investment risk remains moderate, with stability offset by low revenue growth potential.

FAQs

1. What are the main drivers for TENSILON’s current market?
Its use in diagnostic tests for myasthenia gravis and cholinergic crisis detection sustains demand in specialized healthcare settings.

2. How does patent expiration affect TENSILON’s market?
Loss of patent protections in early 2000s led to widespread generic availability, increasing competition and reducing prices.

3. Are there opportunities for growth with TENSILON?
Limited direct growth potential exists; future opportunities depend on innovation in diagnostics or new clinical applications.

4. What are the key risks for investors?
Generic price erosion, regulatory restrictions, and the lack of pipeline expansion pose risks.

5. Could TENSILON be replaced by newer compounds?
Current alternatives like neostigmine are used, but TENSILON remains a preferred diagnostic agent due to its specificity and rapid action.


Citations

[1] MarketsandMarkets. “Neurodiagnostics Market,” 2022.
[2] FDA. “Approved Drugs and Patents,” 2023.
[3] GlobalData. “Pharmaceuticals Forecast,” 2023.

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