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Last Updated: March 14, 2025

RUBEX Drug Patent Profile


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

Rubex is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in RUBEX is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

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Summary for RUBEX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 105
Patent Applications: 3,513
DailyMed Link:RUBEX at DailyMed
Drug patent expirations by year for RUBEX

US Patents and Regulatory Information for RUBEX

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bristol Myers Squibb RUBEX doxorubicin hydrochloride INJECTABLE;INJECTION 062926-001 Apr 13, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol Myers Squibb RUBEX doxorubicin hydrochloride INJECTABLE;INJECTION 062926-002 Apr 13, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol Myers Squibb RUBEX doxorubicin hydrochloride INJECTABLE;INJECTION 062926-003 Apr 13, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

EU/EMA Drug Approvals for RUBEX

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
YES Pharmaceutical Development Services GmbH Celdoxome pegylated liposomal doxorubicin hydrochloride EMEA/H/C/005330
Celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).
Authorised no no no 2022-09-15
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Doxorubicin (Rubex)

Introduction to Doxorubicin

Doxorubicin, marketed under names such as Adriamycin and Rubex, is a potent anthracycline antibiotic used in the treatment of various types of cancer. Its efficacy in targeting a wide range of cancers, including breast cancer, leukemia, and lymphoma, has made it a cornerstone in oncology treatment.

Market Size and Growth Projections

The global doxorubicin market is poised for significant growth, driven by several key factors:

  • Increasing Incidence of Cancer: The rising global incidence of cancer is a primary driver of the doxorubicin market. With an estimated 20 million new cancer cases and 9.7 million deaths in 2022, the demand for effective cancer treatments like doxorubicin is on the rise[3][4].
  • Market Size: The doxorubicin market was valued at USD 0.98 billion in 2023 and is projected to grow to USD 1.90 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 6.6% during the forecast period from 2024 to 2032[4].

Regional Market Dynamics

The market is geographically segmented, with different regions contributing to its growth:

  • Americas: This region is expected to dominate the doxorubicin market due to the high prevalence of cancer, the presence of major manufacturers, and the adoption of advanced healthcare facilities. The strong healthcare expenditure and increasing awareness about cancer treatment in the general population also contribute to this dominance[4].
  • Europe: The European market is anticipated to be the second-largest, driven by the growing prevalence of cancer and rising healthcare expenditure. European nations have invested significantly in healthcare, with 16.2% of total expenditure dedicated to this sector in 2016[4].

Key Market Drivers

Several factors are driving the growth of the doxorubicin market:

  • Geriatric Population: The increasing elderly population is a significant driver, as older individuals are more prone to cancer. This demographic shift is expected to continue driving the market[4].
  • Awareness and Healthcare Infrastructure: Increased awareness about cancer treatment and the strong presence of advanced healthcare facilities in regions like North America and Europe are crucial drivers[1][4].
  • Strategic Alliances and New Product Developments: Mergers, acquisitions, and partnerships among pharmaceutical companies are enhancing the market. New product launches, such as generic Doxorubicin Hydrochloride Liposome injections, are also stimulating growth[1][4].

Market Challenges and Side Effects

Despite its efficacy, doxorubicin faces several challenges and side effects that impact its market dynamics:

  • Cardiotoxicity: One of the most significant side effects is cardiotoxicity, which can lead to heart failure and cardiomyopathy. This risk is higher at higher doses and in patients who receive other cardio-toxic medications or radiation to the chest area[5].
  • Other Side Effects: Doxorubicin can cause myelosuppression, alopecia, and other systemic side effects, which can affect patient compliance and overall market growth[2][5].

Competitive Landscape

The doxorubicin market is characterized by the presence of several major pharmaceutical players:

  • Key Vendors: Companies such as Pfizer Inc., Sun Pharmaceutical Industries Ltd., Janssen Pharmaceuticals, Accord Healthcare, Novartis AG, Sandoz, Dr. Reddy’s Laboratories Ltd., and Teva Pharmaceuticals are actively involved in product development and regulatory approvals[4].
  • Innovation and Competition: The market is expected to witness increased competition and innovation, with new product launches and strategic alliances aimed at advancing clinical trials and developing innovative doxorubicin formulations[1].

Financial Trajectory

The financial trajectory of the doxorubicin market is promising, with several indicators pointing to sustained growth:

  • Revenue Projections: The market is expected to grow from USD 1.06 billion in 2024 to USD 1.90 billion by 2032, driven by the increasing demand for cancer treatments and the expanding geriatric population[4].
  • Investment Trends: The broader pharmaceutical market, including oncology, is seeing significant investment. The global pharmaceutical market revenue is projected to exceed $1.4 trillion by 2028, with oncology representing a substantial portion of this growth[3].

Investment and R&D

The development and marketing of doxorubicin involve significant investment and R&D efforts:

  • Cost of Drug Development: The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years. However, the potential rewards for successful drugs are substantial, as seen with blockbuster drugs like Humira[3].
  • Regulatory Hurdles: Despite the challenges, pharmaceutical companies are strategically aligning their R&D investments to address unmet medical needs, including the development of new cancer treatments like doxorubicin[3].

Balancing Profit and Public Health

The development of doxorubicin and other cancer treatments must balance profit with public health needs:

  • Public Health Initiatives: Governments and health organizations are ramping up efforts to combat cancer through awareness and new treatment initiatives, which is expected to increase the demand for doxorubicin[1].
  • Economic Models: New economic models are being explored to incentivize investment in areas like antimicrobial resistance and neglected tropical diseases, which can also impact the broader pharmaceutical market[3].

Key Takeaways

  • The doxorubicin market is expected to grow significantly due to the increasing incidence of cancer and the expanding geriatric population.
  • The Americas and Europe are the leading regions in the doxorubicin market.
  • Major pharmaceutical players are driving innovation and competition through strategic alliances and new product developments.
  • Despite challenges like cardiotoxicity, the market is poised for growth driven by increasing awareness and healthcare infrastructure.
  • The financial trajectory indicates sustained growth, with the market projected to reach USD 1.90 billion by 2032.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the doxorubicin market? A: The doxorubicin market was valued at USD 0.98 billion in 2023 and is projected to grow to USD 1.90 billion by 2032[4].

Q: What are the primary drivers of the doxorubicin market? A: The primary drivers include the increasing incidence of cancer, the growing geriatric population, and the adoption of advanced healthcare facilities[1][4].

Q: Which regions are expected to dominate the doxorubicin market? A: The Americas are expected to dominate the market, followed by Europe[4].

Q: What are the significant side effects associated with doxorubicin? A: Cardiotoxicity, myelosuppression, and alopecia are among the significant side effects associated with doxorubicin[2][5].

Q: Who are the key players in the doxorubicin market? A: Key players include Pfizer Inc., Sun Pharmaceutical Industries Ltd., Janssen Pharmaceuticals, Accord Healthcare, Novartis AG, and others[4].

Sources

  1. Mordor Intelligence: Global Doxorubicin Market Size (2024 - Mordor Intelligence)
  2. BC Cancer: DRUG NAME: Doxorubicin - BC Cancer
  3. DrugBank Blog: Investment Trends in Pharmaceutical Research
  4. Market Research Future: Doxorubicin Market Size, Share | Industry Growth 2032
  5. OncoLink: Doxorubicin (Adriamycin®, Rubex®) | OncoLink

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