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Last Updated: December 22, 2024

DRAX EXAMETAZIME Drug Patent Profile


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

Drax Exametazime is a drug marketed by Jubilant and is included in one NDA.

The generic ingredient in DRAX EXAMETAZIME is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.

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Summary for DRAX EXAMETAZIME
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in DRAX EXAMETAZIME?DRAX EXAMETAZIME excipients list
DailyMed Link:DRAX EXAMETAZIME at DailyMed
Drug patent expirations by year for DRAX EXAMETAZIME
Pharmacology for DRAX EXAMETAZIME

US Patents and Regulatory Information for DRAX EXAMETAZIME

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant DRAX EXAMETAZIME technetium tc-99m exametazime kit POWDER;INTRAVENOUS 208870-001 Aug 17, 2017 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DRAX EXAMETAZIME Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DRAX Exametazime

Introduction to DRAX Exametazime

DRAX Exametazime, also known by its trade name Ceretec, is a radiopharmaceutical diagnostic agent that utilizes Technetium Tc-99m. It is primarily used for the detection of altered regional cerebral perfusion in stroke and other cerebrovascular diseases, as well as for leukocyte labeling to localize intra-abdominal infections and inflammatory bowel disease[3][4].

Market Size and Growth

The radiopharmaceutical theranostics market, within which DRAX Exametazime operates, is experiencing significant growth. The global radiopharmaceutical theranostics market is projected to grow from USD 1,814.58 million in 2022 to USD 3,441.97 million by 2028, at a Compound Annual Growth Rate (CAGR) of 11.3% during the forecast period[1].

Segmentation and Application

DRAX Exametazime falls under the category of Technetium-99m based radiopharmaceuticals, which is a key segment in the market. The product is used in various applications, including:

  • Detection of Altered Regional Cerebral Perfusion: It serves as an adjunct in the detection of stroke and other cerebrovascular diseases.
  • Leukocyte Labeled Scintigraphy: It helps in localizing intra-abdominal infections and inflammatory bowel disease[3][4].

Regulatory Approvals and Milestones

Recent regulatory approvals have been a significant driver for the growth of DRAX Exametazime. For instance, Jubilant Radiopharma, a business unit of Jubilant Pharma Limited, received approval from Health Canada for DRAX Exametazime (Kit for the Preparation of Tc99m Exametazime) for leukocyte labeling. Additionally, the US FDA approved Technetium (Tc 99m) Sulfur Colloid Injection, another product in the radiopharmaceutical portfolio of Jubilant, in FY24[2].

Impact of COVID-19 Pandemic

The COVID-19 pandemic had a mixed impact on the radiopharmaceutical theranostics market. While it caused disruptions in supply chains and transport restrictions, affecting the availability of radioisotopes, it also highlighted the need for advanced diagnostic and therapeutic tools. Post-pandemic, there is an expected increase in cases of advanced cancers due to delayed diagnoses, which will drive the demand for radiopharmaceuticals like DRAX Exametazime[1].

Financial Performance

Jubilant Pharma Limited, the parent company of Jubilant Radiopharma, has shown improved financial performance in recent years. In FY24, the total income grew by 7% to INR 6,772 Cr, driven by growth in radiopharmaceuticals, among other segments. The EBITDA increased by 20% to INR 994 Cr, and the normalized PAT increased by 63% to INR 195 Cr. The radiopharmacy business, which includes DRAX Exametazime, has pivoted to profitability in FY24, contributing significantly to these financial gains[2].

Capacity Expansion and Future Outlook

Jubilant Radiopharma is investing in capacity expansion, with plans to start commercial production in new lines by FY26 and FY28. This expansion is expected to enhance the production capacity and meet the growing demand for radiopharmaceuticals. The company is also diversifying its customer base and adding development capabilities to its research and manufacturing operations, which will further support the growth of products like DRAX Exametazime[2].

Competitive Landscape

The radiopharmaceutical market is competitive, with several players offering a range of products. However, Jubilant Radiopharma has established itself through long-term supply contracts and strategic expansions. The company's ability to secure regulatory approvals and its focus on backward integration to mitigate pricing pressures are key factors in its competitive advantage[5].

Key Indicators and Statistics

  • Market Growth Rate: The global radiopharmaceutical theranostics market is expected to grow at a CAGR of 11.3% from 2022 to 2028[1].
  • Revenue Growth: Jubilant Pharma Limited's total income grew by 7% in FY24, with significant contributions from the radiopharmacy segment[2].
  • EBITDA Margins: The EBITDA margins for Jubilant Pharma Limited expanded by 160 basis points to 14.7% in FY24[2].
  • Regulatory Approvals: Recent approvals from Health Canada and the US FDA for various radiopharmaceutical products, including DRAX Exametazime, have been crucial for market growth[2].

Challenges and Opportunities

Despite the positive growth trajectory, the market faces challenges such as supply chain disruptions and pricing pressures. However, the increasing demand for advanced diagnostic and therapeutic tools, especially in the post-pandemic era, presents significant opportunities for growth. The expansion of new radionuclides for cancer nuclear imaging and internal radiotherapy will also support the long-term growth of radiopharmaceuticals like DRAX Exametazime[1].

Conclusion

The market dynamics and financial trajectory for DRAX Exametazime are highly favorable, driven by regulatory approvals, capacity expansions, and growing demand in the radiopharmaceutical theranostics market. As the global market continues to grow, Jubilant Radiopharma is well-positioned to capitalize on these opportunities and contribute significantly to the company's financial performance.

Key Takeaways

  • Market Growth: The global radiopharmaceutical theranostics market is projected to grow at a CAGR of 11.3% from 2022 to 2028.
  • Regulatory Approvals: Recent approvals from Health Canada and the US FDA are driving growth.
  • Financial Performance: Jubilant Pharma Limited's radiopharmacy segment has pivoted to profitability in FY24.
  • Capacity Expansion: Plans for new production lines will enhance capacity and meet growing demand.
  • Competitive Advantage: Long-term supply contracts and backward integration strategies are key to the company's success.

Frequently Asked Questions (FAQs)

What is DRAX Exametazime used for?

DRAX Exametazime is used for the detection of altered regional cerebral perfusion in stroke and other cerebrovascular diseases, as well as for leukocyte labeling to localize intra-abdominal infections and inflammatory bowel disease[3][4].

How is the radiopharmaceutical theranostics market growing?

The global radiopharmaceutical theranostics market is expected to grow from USD 1,814.58 million in 2022 to USD 3,441.97 million by 2028, at a CAGR of 11.3%[1].

What are the recent regulatory approvals for DRAX Exametazime?

Recent approvals include the approval from Health Canada for DRAX Exametazime for leukocyte labeling and the US FDA approval for Technetium (Tc 99m) Sulfur Colloid Injection[2].

How has the COVID-19 pandemic impacted the market?

The pandemic caused supply chain disruptions but also highlighted the need for advanced diagnostic and therapeutic tools, leading to increased demand post-pandemic[1].

What are the financial highlights for Jubilant Pharma Limited in FY24?

In FY24, Jubilant Pharma Limited's total income grew by 7%, EBITDA increased by 20%, and normalized PAT increased by 63%. The radiopharmacy business pivoted to profitability[2].

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