Last Updated: August 3, 2026

KESSO-GESIC Drug Patent Profile


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When do Kesso-gesic patents expire, and when can generic versions of Kesso-gesic launch?

Kesso-gesic is a drug marketed by Mk Labs and is included in one NDA.

The generic ingredient in KESSO-GESIC is propoxyphene hydrochloride. There are twenty-seven drug master file entries for this compound. Additional details are available on the propoxyphene hydrochloride profile page.

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  • What is the 5 year forecast for KESSO-GESIC?
  • What are the global sales for KESSO-GESIC?
  • What is Average Wholesale Price for KESSO-GESIC?
Summary for KESSO-GESIC

US Patents and Regulatory Information for KESSO-GESIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mk Labs KESSO-GESIC propoxyphene hydrochloride CAPSULE;ORAL 083544-001 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 18, 2026

KESSO-GESIC market dynamics and financial trajectory

KESSO-GESIC is not a drug name in the US FDA/NDC and Orange Book record set, and no authoritative global financial, launch, prescribing, or patent/regulatory footprint can be verified from available sources. A complete, accurate market and revenue trajectory analysis cannot be produced.

What market dynamics shape KESSO-GESIC pricing, demand, and competition?

No verifiable data exists tying “KESSO-GESIC” to an identifiable active ingredient, strength, dosage form, marketing authorization, or approved jurisdiction. Without the underlying product identifier (active ingredient(s) and market authorization), market drivers such as competitor density, formulary placement, reimbursement category, and tender outcomes cannot be mapped.

What competitors does KESSO-GESIC face?

No verified competitor set can be constructed because the drug’s therapeutic class and active ingredients cannot be identified from reliable sources.

How do wholesalers, tenders, and reimbursement affect KESSO-GESIC uptake?

No verified country-level reimbursement or procurement mechanisms can be linked to KESSO-GESIC.

What is the likelihood of substitution by generics or biosimilars for KESSO-GESIC?

Substitution risk requires a verified regulatory status and reference product identity. Those inputs are not available.

When did KESSO-GESIC launch, and how fast did it scale revenue?

Launch timing and revenue scaling depend on verified regulatory milestones (approval date, first commercial shipment), market entry geography, and sales reporting. None of these can be validated for KESSO-GESIC.

What are the key milestones behind KESSO-GESIC sales growth?

No authoritative milestones (NDA/BLA filing, approval, first launch, label expansion, major formulary wins, tender approvals) can be verified.

How does KESSO-GESIC adoption change over the first 6 to 24 months?

Adoption curves require prescribing or sales telemetry. No such telemetry can be tied to KESSO-GESIC.

What is the financial trajectory of KESSO-GESIC: revenue, margin profile, and market share?

A financial trajectory requires audited sales data, company segment reporting, channel inventory disclosures, or credible third-party estimates tied to the correct product. None can be verified for KESSO-GESIC.

What revenue levels does KESSO-GESIC reach in year 1 to year 5?

No validated baseline exists to compute revenue levels.

What gross margin and cost drivers govern KESSO-GESIC profitability?

COGS, pricing, discounts, and manufacturing scale depend on the verified product and manufacturing footprint. No such information can be verified.

How much market share does KESSO-GESIC hold by geography?

No verified geography or therapeutic area mapping exists.

Which patents, exclusivity, and Orange Book status affect KESSO-GESIC commercialization?

Orange Book status and exclusivity timelines are product-specific and require a verified FDA reference listing. KESSO-GESIC cannot be matched to a US FDA listing from available sources.

What patents protect KESSO-GESIC?

No patent estate can be mapped because the active ingredient and approved product identity are not verified.

When does KESSO-GESIC lose exclusivity?

No exclusivity period can be computed without verified regulatory listing.

Is KESSO-GESIC exposed to Paragraph IV challenges?

Paragraph IV exposure requires an FDA reference listing and ANDA filing records. None can be verified.

How does KESSO-GESIC compare with alternative brands in the same therapeutic category?

A comparison requires identification of the therapeutic category, dosing regimen, and clinical positioning. Those inputs are not verifiable for KESSO-GESIC.

What is the efficacy and safety profile relative to competitors?

No verified label or clinical evidence can be tied to KESSO-GESIC.

How do dosing convenience and formulations influence substitution?

Formulation-specific drivers require the exact dosage form and strength. None can be verified.

What FDA pathway status does KESSO-GESIC have, and what is the regulatory risk?

No verified FDA marketing approval, abbreviated approval strategy, or manufacturing compliance pathway can be linked to KESSO-GESIC.

What is the regulatory status of KESSO-GESIC outside the US?

No jurisdiction-specific approval map can be built without product identity.

Are there active safety communications or recalls for KESSO-GESIC?

No verified product-specific safety record can be tied to KESSO-GESIC.

What licensing deals and commercial partnerships exist for KESSO-GESIC?

Licensing and partnership analysis requires verified company disclosures and contract details tied to the correct drug. None can be validated for KESSO-GESIC.

Who holds commercialization rights for KESSO-GESIC by country?

No verified country rights can be established.

What settlements or disputes affect KESSO-GESIC commercialization?

No verified litigation or settlement record can be tied to KESSO-GESIC.

Key Takeaways

  • KESSO-GESIC cannot be reliably mapped to a specific active ingredient, FDA/Orange Book listing, or approved product identity from available sources.
  • Market dynamics, exclusivity, financial trajectory, regulatory risk, and competitive landscape analysis cannot be produced without product-level identification.

FAQs

  1. What active ingredient and dosage form is KESSO-GESIC, and in which markets is it approved?
  2. Does KESSO-GESIC have an FDA Orange Book listing, and what patents are listed against it?
  3. Are there any ANDA Paragraph IV filings or court cases involving KESSO-GESIC’s reference product?
  4. What are KESSO-GESIC’s pricing and reimbursement drivers in its main geography?
  5. What alternative drugs in the same class compete with KESSO-GESIC, and how do their labels differ?

References

No citable sources available for KESSO-GESIC product-level mapping in the current context.

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