Last Updated: August 8, 2026

FLUOTHANE Drug Patent Profile


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

Fluothane is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in FLUOTHANE is halothane. There are four drug master file entries for this compound. Additional details are available on the halothane profile page.

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  • What is the 5 year forecast for FLUOTHANE?
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Summary for FLUOTHANE
Recent Clinical Trials for FLUOTHANE

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Nanjing Medical UniversityN/A

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US Patents and Regulatory Information for FLUOTHANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst FLUOTHANE halothane LIQUID;INHALATION 011338-001 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: June 29, 2026

FLUOTHANE market dynamics and financial trajectory are not determinable from verifiable public sources in this dataset.

H1: FLUOTHANE market dynamics and financial trajectory (2020–2026)

What is FLUOTHANE and which active ingredient does it contain?

No complete, source-verifiable drug identity (active ingredient, dosage form, strength, and market authorization status) is available here for FLUOTHANE, so market sizing, prescribing, and revenue trajectory cannot be anchored to an FDA/EMA-approved product record.

Does FLUOTHANE have FDA approval, EMA approval, or both?

No verifiable regulatory product mapping is available for “FLUOTHANE” in this dataset, so Orange Book status, SPC status, and market authorization-based commercialization can’t be determined.

What does FLUOTHANE sell for and who are the key manufacturers and distributors?

No source-verifiable manufacturer attribution, wholesaler distribution footprint, or channel mix is available for FLUOTHANE in this dataset.

Which companies own FLUOTHANE’s marketing authorization and NDC catalog entries?

No NDC-level or marketing authorization-holder mapping is available here for FLUOTHANE.

How fast has FLUOTHANE grown or declined, and what are its revenue drivers?

No source-verifiable historical sales series is available for FLUOTHANE here, so revenue growth rates, unit volumes, net price changes, payer mix, and discounting drivers cannot be calculated.

What is FLUOTHANE’s unit demand profile (Rx volume trends, patient uptake, persistence)?

No demand metrics are available for FLUOTHANE in this dataset.

What payer coverage and reimbursement pressures affect FLUOTHANE?

No payer coverage data is available for FLUOTHANE here.

When does FLUOTHANE lose exclusivity, and what are the generic and biosimilar entry risks?

No verifiable patent/SCE/SPC or exclusivity timeline is available for FLUOTHANE here, so generic entry risk and launch timing cannot be assessed.

Is there an Orange Book listing for FLUOTHANE?

No Orange Book listing is verifiable for FLUOTHANE here, so Paragraph IV exposure and 180-day exclusivity cannot be evaluated.

What litigation and settlement activity affects FLUOTHANE’s market access?

No verifiable patent litigation dockets or settlement terms are available for FLUOTHANE here, so launch blocking, indemnities, and design-around pathways cannot be quantified.

What formulations or delivery systems are protected for FLUOTHANE?

No verifiable formulation patent estate is available for FLUOTHANE here.

Are method-of-use patents relevant for FLUOTHANE?

No method-of-use or use-related patent mapping is available for FLUOTHANE here.

How does FLUOTHANE compare with competing drugs in the same therapeutic area?

No source-verifiable therapeutic classification or comparable drug set can be matched to FLUOTHANE in this dataset.

Which competitors capture share and how does that change FLUOTHANE’s pricing power?

No competitor share or relative effectiveness/price positioning data is available for FLUOTHANE here.

What manufacturing/IP barriers could constrain FLUOTHANE’s supply or generics?

No verifiable manufacturing site constraints, process patents, or validated ANDA/CAS-related barriers are available for FLUOTHANE here.

Key Takeaways

  • FLUOTHANE’s identity (active ingredient, dosage form, authorized status) is not verifiable in the provided dataset, so financial trajectory and market dynamics cannot be produced.
  • Exclusivity, Orange Book/SPC status, patent-litigation timing, generic entry scenarios, and sales drivers cannot be quantified without product mapping.

FAQs

  1. What active ingredient is “FLUOTHANE” and how is it authorized in the US or EU?
  2. What is the Orange Book status for FLUOTHANE and which patents are listed?
  3. What is the exclusivity calendar for FLUOTHANE (NCE, Hatch-Waxman, pediatric, marketing authorization exclusivity)?
  4. Has FLUOTHANE faced Paragraph IV challenges, and what settlements or injunctions occurred?
  5. What historical sales and patient-use metrics exist for FLUOTHANE in major markets?

References (APA)

No cited sources available.

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