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Last Updated: December 22, 2024

TEMSIROLIMUS - Generic Drug Details


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What are the generic sources for temsirolimus and what is the scope of freedom to operate?

Temsirolimus is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Gland Pharma Ltd, and Pf Prism Cv, and is included in three NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Temsirolimus has seventy-six patent family members in thirty-three countries.

There are five drug master file entries for temsirolimus. Five suppliers are listed for this compound.

Summary for TEMSIROLIMUS
International Patents:76
US Patents:5
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 5
Raw Ingredient (Bulk) Api Vendors: 36
Clinical Trials: 222
Patent Applications: 6,775
What excipients (inactive ingredients) are in TEMSIROLIMUS?TEMSIROLIMUS excipients list
DailyMed Link:TEMSIROLIMUS at DailyMed
Recent Clinical Trials for TEMSIROLIMUS

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

SponsorPhase
Barrow Neurological InstituteEarly Phase 1
Nader SanaiEarly Phase 1
Ivy Brain Tumor CenterEarly Phase 1

See all TEMSIROLIMUS clinical trials

Paragraph IV (Patent) Challenges for TEMSIROLIMUS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TORISEL Injection temsirolimus 25 mg/mL, 1.8 mL vial 022088 1 2011-05-25

US Patents and Regulatory Information for TEMSIROLIMUS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 203153-001 Jul 30, 2018 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TEMSIROLIMUS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Subscribe ⤷  Subscribe
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088-001 May 30, 2007 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TEMSIROLIMUS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG Torisel temsirolimus EMEA/H/C/000799
Renal-cell carcinomaTorisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors.Mantle-cell lymphomaTorisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).
Authorised no no no 2007-11-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TEMSIROLIMUS

Country Patent Number Title Estimated Expiration
Denmark 2462934 ⤷  Subscribe
Australia 2008236621 Anti-tumor activity of temsirolimus in papillary renal cell cancer ⤷  Subscribe
Germany 60319118 ⤷  Subscribe
European Patent Office 3106164 ACTIVITÉ ANTI-TUMORALE DU TEMSIROLIMUS CONTRE LE CANCER À CELLULES RÉNALES PAPILLAIRES (ANTI-TUMOR ACTIVITY OF TEMSIROLIMUS IN PAPILLARY RENAL CELL CANCER) ⤷  Subscribe
Australia 2003254168 PARENTERAL FORMULATIONS CONTAINING A RAPAMYCIN HYDROXYESTER ⤷  Subscribe
Hong Kong 1076390 Parenteral formulations containing a rapamycin hydroxyester ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEMSIROLIMUS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0763039 SPC/GB08/025 United Kingdom ⤷  Subscribe PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
0763039 C300348 Netherlands ⤷  Subscribe PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 PA2008009 Lithuania ⤷  Subscribe PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
0763039 18/2008 Austria ⤷  Subscribe PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 08C0018 France ⤷  Subscribe PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 122008000023 Germany ⤷  Subscribe PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

TEMSIROLIMUS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Temsirolimus

Introduction

Temsirolimus, a targeted therapeutic agent, is primarily used in the treatment of renal cell carcinoma and other cancer indications. The market for temsirolimus is driven by several key factors, including advancements in oncology research, the increasing incidence of cancer, and the need for effective treatment alternatives.

Market Size and Growth Projections

The global market for temsirolimus is experiencing significant growth. As of 2023, the market was valued at USD 5.03 billion and is projected to reach USD 7.49 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.1% from 2024 to 2031[4].

Regional Market Analysis

The temsirolimus market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region presents unique market dynamics and growth opportunities. For instance, the European market for temsirolimus is expected to grow from its 2023 valuation to reach USD 226.7 million by 2030, with a CAGR of 6.2% during the forecast period of 2024-2030[1].

Application and Product Segments

The market is categorized based on application and product types. The applications include tablets, injectable solutions, and oral solutions, while the product segments encompass oncology, renal cell carcinoma, organ transplantation, and tumor treatment. These segments are crucial for understanding the diverse uses and market potential of temsirolimus[4].

Key Players and Competitive Landscape

The temsirolimus market is dominated by several major pharmaceutical companies, including Pfizer, Gland Pharma, Accord Healthcare, Novartis, Teva Pharmaceuticals, Eli Lilly, Amgen, Roche, Merck & Co., Bristol-Myers Squibb, Genentech, and Sanofi. These companies play a significant role in driving market growth through product innovation, clinical trials, and strategic collaborations[1][4].

Cost-Effectiveness and Economic Impact

The cost-effectiveness of temsirolimus is a critical factor in its market dynamics. Studies have shown that while temsirolimus offers significant clinical benefits compared to traditional treatments like interferon-alpha, its cost per Quality-Adjusted Life Year (QALY) is high, ranging from £74,369 to £154,752. This makes it a less cost-effective option in some healthcare settings, despite its clinical efficacy[2].

Clinical Trials and New Indications

Ongoing clinical trials investigating novel indications and combination therapies with existing oncology medications are driving the demand for temsirolimus. The approval of temsirolimus for more cancer indications and its inclusion in treatment recommendations further support market growth[4].

Market Drivers

Several factors are driving the growth of the temsirolimus market:

  • Increasing Incidence of Cancer: The rising global incidence of cancer, particularly renal cell carcinoma, necessitates effective treatment alternatives.
  • Advancements in Targeted Therapeutics: Developments in targeted cancer therapies and personalized medicine are boosting the market.
  • Oncology Research: Continuous advancements in oncology research are leading to new applications and improved treatment outcomes for temsirolimus[4].

Market Challenges

Despite the growth potential, the temsirolimus market faces several challenges:

  • High Cost: The high cost per QALY and the overall treatment cost can limit its adoption in some healthcare settings.
  • Competition: The market is competitive, with several other therapeutic agents available for similar indications.
  • Regulatory Approvals: The need for regulatory approvals for new indications and combination therapies can be a barrier to market expansion[2][4].

Geographical Market Dynamics

The market dynamics vary significantly across different geographical regions:

  • North America: This region is a significant market due to advanced healthcare infrastructure and high adoption rates of new therapies.
  • Europe: The European market is growing steadily, driven by the increasing incidence of cancer and the need for effective treatments.
  • Asia-Pacific: This region presents a high growth potential due to a large patient population and increasing healthcare expenditure[4].

Financial Performance of Key Players

The financial performance of key players in the temsirolimus market is a crucial indicator of market health. Companies like Pfizer and Novartis have significant financial resources to invest in research and development, marketing, and strategic acquisitions, which helps in sustaining market growth[4].

Future Outlook

The future outlook for the temsirolimus market is promising, driven by ongoing clinical trials, new indications, and the increasing demand for targeted cancer therapies. As the global incidence of cancer continues to rise, the need for effective and innovative treatments like temsirolimus will only grow.

Key Takeaways

  • The global temsirolimus market is projected to grow from USD 5.03 billion in 2023 to USD 7.49 billion by 2031.
  • The market is driven by the increasing incidence of cancer, advancements in oncology research, and the need for effective treatment alternatives.
  • Key players include Pfizer, Gland Pharma, Accord Healthcare, and other major pharmaceutical companies.
  • The high cost per QALY is a significant challenge, but ongoing clinical trials and new indications are expected to drive market growth.
  • Geographical regions like North America, Europe, and Asia-Pacific are key markets due to their healthcare infrastructure and patient population.

FAQs

Q: What is the projected market size of temsirolimus by 2031? A: The global temsirolimus market is expected to reach USD 7.49 billion by 2031[4].

Q: Who are the main players in the temsirolimus market? A: The main players include Pfizer, Gland Pharma, Accord Healthcare, Novartis, Teva Pharmaceuticals, and others[1][4].

Q: What are the primary applications of temsirolimus? A: Temsirolimus is primarily used in the treatment of renal cell carcinoma, organ transplantation, and other oncology indications[4].

Q: What is the cost-effectiveness of temsirolimus compared to other treatments? A: Temsirolimus has a high cost per QALY, ranging from £74,369 to £154,752, making it less cost-effective in some healthcare settings[2].

Q: What factors are driving the growth of the temsirolimus market? A: The growth is driven by the increasing incidence of cancer, advancements in targeted therapeutics, and ongoing clinical trials investigating new indications and combination therapies[4].

Sources

  1. Temsirolimus - Market, Report Size, Worth, Revenue, Growth ... - Valuates Reports
  2. Cost-effectiveness of temsirolimus for first line treatment of ... - PubMed
  3. Global PI3K/AKT/mTor Pathway Inhibitors for Breast Cancer Market Size - Market Research Intellect
  4. Temsirolimus Market Size and Projections - Market Research Intellect
  5. Cost trends of metastatic renal cell carcinoma therapy - Oxford Academic

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