Last Updated: June 8, 2026

IDAMYCIN Drug Patent Profile


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When do Idamycin patents expire, and when can generic versions of Idamycin launch?

Idamycin is a drug marketed by Pfizer and is included in two NDAs.

The generic ingredient in IDAMYCIN is idarubicin hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.

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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The First Affiliated Hospital of Guangzhou Medical UniversityPhase 2/Phase 3
Maternal and Child Health Hospital of FoshanPhase 2/Phase 3
First Affiliated Hospital of Shantou University Medical CollegePhase 2/Phase 3

See all IDAMYCIN clinical trials

US Patents and Regulatory Information for IDAMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer IDAMYCIN idarubicin hydrochloride POWDER;INTRAVENOUS 050661-002 Sep 27, 1990 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer IDAMYCIN PFS idarubicin hydrochloride SOLUTION;INTRAVENOUS 050734-001 Feb 17, 1997 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer IDAMYCIN idarubicin hydrochloride POWDER;INTRAVENOUS 050661-001 Sep 27, 1990 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer IDAMYCIN idarubicin hydrochloride POWDER;INTRAVENOUS 050661-003 Apr 25, 1995 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

Market Dynamics and Financial Trajectory for Idamycin (Idarubicin)

Last updated: April 2, 2026

What is Idamycin?

Idamycin is the brand name for idarubicin, an anthracycline antibiotic used primarily in chemotherapy treatments. It is effective against acute myeloid leukemia (AML) and other hematologic malignancies. Approved in multiple countries, Idamycin functions by intercalating DNA strands, inhibiting topoisomerase II, thereby preventing DNA replication in cancer cells.

Current Market Landscape

Regulatory Status and Approvals

  • FDA: Approved for AML in adult patients.
  • EMA (European Medicines Agency): Approved for AML.
  • Other markets: Approved or authorized in countries across Asia, Latin America, and the Middle East.

Market Size and Segments

  • Global chemotherapy agent market estimated at USD 18.5 billion in 2022.
  • Anthracyclines account for approximately USD 3 billion of this segment.
  • Idarubicin specifically contributes to an estimated USD 0.3 billion market, dominated by large oncology drug portfolios.

Competitive Positioning

  • Sold primarily through hospital and infusion center channels.
  • Major competitors include daunorubicin, doxorubicin, and newer agents such as mitoxantrone.
  • Limited patent protection beyond original formulations; recent biosimilar entrants pose competitive pressure.

Market Drivers

  • Rising incidence of AML, particularly among aging populations.
  • Expanding indications in oncology, including off-label uses.
  • Advances in supportive care improving treatment outcomes and enabling combination regimens.
  • Growing adoption of personalized medicine enhancing effectiveness.

Market Restraints

  • Toxicity profile—cardiotoxicity and myelosuppression—limits broader use.
  • Emergence of targeted therapies and immunotherapies reducing reliance on traditional agents like idarubicin.
  • Patent expirations leading to increased generic competition, reducing prices.

Financial Trajectory

Revenue Trends

Year Estimated Revenue (USD millions) Notes
2020 250 Stable, driven by AML treatment efficacy
2021 240 Slight decline amid emerging competition
2022 230 Price erosion and market saturation

Pricing Dynamics

  • Average price per treatment cycle: USD 1,500–2,000.
  • Biosimilar entry in select markets since 2019 has reduced prices by approximately 20–30%.

R&D and Pipeline

  • Limited pipeline; a few investigational combinations with targeted agents.
  • No recent FDA approval filings since 2018, indicating stable but mature market status.

Regional Market Variability

  • North America: Largest revenue contributor due to high AML prevalence and established healthcare infrastructure.
  • Asia-Pacific: Accelerating growth, driven by increased cancer incidence and expanding healthcare access.
  • Europe: Mature market with moderate growth; constrained by pricing controls.

Future Outlook

  • CAGR estimated at approximately 2% for the next five years, driven by existing indications and incremental adoption.
  • Sustainability challenged by patent expiration and emerging therapies.
  • Potential growth from combination regimens, especially with immunotherapies, though clinical data remains limited.

Strategic Considerations

  • Companies should monitor biosimilar developments, particularly in Europe and Asia.
  • Focus on differentiating safety profiles and combination strategies could sustain market share.
  • Collaborations with biotech firms exploring targeted therapies may open novel positioning opportunities.

Key Takeaways

  • Idamycin’s market is mature with steady revenue streams but faces pricing pressures from biosimilars and alternative therapies.
  • Growth hinges on clinical adoption, supportive care improvements, and pipeline innovation.
  • Regional differences impact revenue, with North America leading and Asia-Pacific presenting growth opportunities.
  • Market dynamics are shifting towards targeted and immunotherapy combinations reducing reliance on traditional chemotherapy agents.
  • Patent expirations create both challenges and opportunities for price competition and market expansion.

FAQs

Q1: What are the primary indications for Idamycin?
A1: The main indication is treatment of acute myeloid leukemia (AML) in adults.

Q2: How is Idamycin positioned against competitors like doxorubicin?
A2: Idamycin has a similar mechanism but is often preferred for AML due to its efficacy. However, doxorubicin has broader use, especially in solid tumors, giving it a more diversified market position.

Q3: What impact do biosimilars have on the Idamycin market?
A3: Biosimilars have reduced prices by 20–30% and increased market competition, especially in Europe and Asia.

Q4: What are the main challenges facing Idamycin’s market growth?
A4: Toxicity concerns, competition from targeted therapies, patent expirations, and limited pipeline development.

Q5: What regions offer the highest growth potential?
A5: Asia-Pacific shows fast growth due to increased cancer prevalence and expanding healthcare infrastructure.


References

  1. MarketResearch.com. (2023). Oncology Drug Market Size and Trends.
  2. FDA. (2022). Approved Oncology Drugs List.
  3. European Medicines Agency. (2022). Summary of Product Characteristics for Idarubicin.
  4. Global Data. (2022). Oncology Market Analysis.
  5. ClinicalTrials.gov. (2023). Registered Trials involving Idarubicin.

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