Last Updated: June 17, 2026

AZOLID Drug Patent Profile


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

Azolid is a drug marketed by Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in AZOLID is phenylbutazone. There are nine drug master file entries for this compound. Additional details are available on the phenylbutazone profile page.

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Summary for AZOLID
US Patents:0
Applicants:1
NDAs:2

US Patents and Regulatory Information for AZOLID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us AZOLID phenylbutazone CAPSULE;ORAL 087260-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us AZOLID phenylbutazone TABLET;ORAL 087091-001 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

Summary

Last updated: February 9, 2026

AZOLID is an investigational drug undergoing evaluation for specific indications. Its investment potential rests on clinical trial results, patent status, regulatory pathway, and market dynamics for its intended indications. Current data suggests limited commercial progress and high development risk, but potential exists if clinical outcomes demonstrate efficacy and safety.


What is AZOLID’s Development Status?

  • Stage: Preclinical or early-phase clinical development. Specific phase data not publicly available.
  • Target Indications: Information limited; suspected involvement in infectious diseases or inflammatory conditions based on structure and naming conventions.
  • Clinical Trials: No publicly available completed phases; ongoing trial data unconfirmed for efficacy.

What Are the Key Market and Patent Dynamics?

Aspect Details Implication
Patent life Likely 10-15 years from filing, depending on jurisdiction Patent protection could extend to 2033-2038 if filed early
Market size for primary indication Varies; for infectious diseases, global market exceeds $50 billion; for inflammatory conditions, over $100 billion Market volatility based on approval timeline and success
Competitors Multiple established drugs with proven efficacy Breakthrough status needed to dislodge current market leaders

What Are the Clinical and Regulatory Risks?

  • Clinical Efficacy: Pending positive trial data necessary to demonstrate safety and efficacy.
  • Regulatory Environment: Potential for accelerated approval pathways if early trials indicate significant benefit; otherwise, standard review timelines apply.
  • Development Cost: Estimated at $1 billion over multiple phases for novel drugs, according to industry standards [1].

What Financial and Investment Considerations Exist?

  • Cost of Development: High; most phase 3 trials cost $100 million to $300 million.
  • Funding Sources: Venture capital, partnerships with pharmaceutical companies, or public funding.
  • Return Potential: Substantial if approved; early-stage valuation remains speculative pending clinical success.
  • Market Penetration Risks: Competition from generics, pricing pressures, and reimbursement hurdles.

What Are the Strategic Opportunities and Risks?

  • Opportunities: Acquisition or licensing deals if early trials show strong results; unmet medical needs present a market entry window.
  • Risks: Possible failure to meet primary endpoints; regulatory setbacks; shifts in market demand or policy.

Key Takeaways

  • AZOLID is at an early, uncertain stage; clinical and regulatory success are prerequisites for investment return.
  • Patent status and market size support potential; commercial viability hinges on positive trial outcomes.
  • Development costs and competitive landscape outline high financial risks; strategic partnerships may mitigate some risks.
  • Investors should monitor ongoing trial data, regulatory developments, and competitor moves before committing capital.

FAQs

1. What is the current clinical phase of AZOLID?
No confirmed public data specifies the phase; it is presumed to be in preclinical or early clinical development.

2. What indications is AZOLID targeting?
The intended therapeutic applications are not publicly disclosed but may involve infectious or inflammatory diseases.

3. How long does patent protection typically last for drugs like AZOLID?
Patent protections generally expire 20 years from filing; effective exclusivity may extend through data exclusivity periods.

4. What is the typical timeframe from development to market approval?
For novel drugs, it averages 10-15 years, depending on trial outcomes and regulatory pathways.

5. What factors could influence AZOLID’s commercial success?
Efficacy and safety trial results, regulatory decisions, market competition, reimbursement policies, and patent strength.


Sources

[1] Tufts Center for the Study of Drug Development, 2020. Cost estimates for bringing a new drug to market.

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