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Last Updated: December 22, 2024

HICON Drug Patent Profile


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Which patents cover Hicon, and what generic alternatives are available?

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

The generic ingredient in HICON is sodium iodide i-131. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium iodide i-131 profile page.

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Summary for HICON
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 8
Patent Applications: 39
What excipients (inactive ingredients) are in HICON?HICON excipients list
DailyMed Link:HICON at DailyMed
Drug patent expirations by year for HICON
Pharmacology for HICON

US Patents and Regulatory Information for HICON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant HICON sodium iodide i-131 SOLUTION;ORAL 021305-002 Jan 24, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Jubilant HICON sodium iodide i-131 SOLUTION;ORAL 021305-007 Dec 5, 2011 AA RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Jubilant HICON sodium iodide i-131 SOLUTION;ORAL 021305-003 Jan 24, 2003 DISCN 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

HICON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Samsung Biologics' S-HiCon Platform

Introduction to S-HiCon

Samsung Biologics has recently launched the S-HiCon platform, a high-concentration formulation platform designed to support the development and manufacturing of high-dose biopharmaceuticals. This platform is a significant addition to the company's portfolio, addressing critical challenges in drug formulation such as pH stability, viscosity, and protein aggregation[1][4].

Market Need for High-Concentration Formulations

The demand for high-concentration biopharmaceuticals is on the rise due to the increasing complexity of therapeutic molecules. High-concentration formulations are essential for delivering large doses of biologics, particularly for subcutaneous administration. The S-HiCon platform is tailored to meet this demand by providing stable liquid formulations for concentrations over 200 mg/mL[1][4].

Technological Advancements

The S-HiCon platform employs advanced optimization techniques, including the use of pH, buffer species, and excipients to identify favorable formulation candidates early in the development process. It also includes a "Concentration Gate Check" process to test formulation feasibility and minimize risks associated with high-concentration drug development. These technological advancements are crucial for ensuring the efficacy and stability of high-dose biopharmaceuticals[4].

Industry Reception and Market Impact

The launch of S-HiCon has been well-received by the industry, as it aligns with Samsung Biologics' commitment to providing innovative solutions for clients. The platform is expected to help clients meet evolving needs in biologics development and contract manufacturing. This is particularly significant given the growing demand for complex biopharmaceuticals and the need for advanced formulation capabilities[1][4].

Financial Performance of Samsung Biologics

Samsung Biologics has shown strong financial performance in recent years. In the third quarter of 2024, the company reported a consolidated revenue of KRW 1.2 trillion, marking a 15% increase compared to the previous year. The operating profit stood at KRW 338.6 billion, with EBITDA reaching KRW 495.4 billion. These results were driven by the successful ramp-up of Plant 4 operations and favorable foreign exchange rates[3].

Contract Volume and Partnerships

The company has strengthened its partnerships with global pharmaceutical companies, collaborating with 17 of the top 20 pharma clients. The total contract volume for 2024 has exceeded USD 3.3 billion, with a cumulative contract volume of USD 15.4 billion since its founding. Recent deals, including those worth over USD 668 million with a Europe-based pharmaceutical company, highlight the company's expanding client base and contractual commitments[3].

Market Trends and Growth Prospects

The biotechnology and pharmaceutical sectors in Korea have seen a surge in growth stocks following the Bank of Korea's rate cut. This reduction in interest rates has made borrowing cheaper, fueling optimism among companies in these sectors. Samsung Biologics, along with other pharmaceutical and biotech companies, has benefited from this trend, with its stock prices showing an upward trajectory despite the overall downward trend in the KOSPI index[2].

Regulatory Approvals and Compliance

Samsung Biologics has achieved over 335 regulatory approvals since its founding in 2011, demonstrating its commitment to high standards of quality and compliance. This track record is crucial for maintaining trust with clients and ensuring the success of its development and manufacturing services[3].

Future Outlook

Samsung Biologics is poised for further growth with the construction of its dedicated ADC facility and Plant 5, scheduled to be operational in April 2025. The company continues to invest in innovative technologies and expand its partnerships with leading pharmaceutical and biotech companies. The integration of sustainable practices throughout its operations, such as joining the Pharmaceutical Supply Chain Initiative, further solidifies its position in the market[3].

Key Takeaways

  • Technological Advancements: S-HiCon addresses critical formulation challenges with advanced optimization techniques.
  • Market Demand: High-concentration biopharmaceuticals are in increasing demand, driven by complex therapeutic molecules.
  • Financial Performance: Samsung Biologics has shown strong revenue and profit growth, driven by successful plant operations and favorable exchange rates.
  • Contract Volume: The company has secured significant contracts, exceeding USD 3.3 billion in 2024.
  • Market Trends: Growth stocks in the biotechnology and pharmaceutical sectors are rising following the Bank of Korea's rate cut.
  • Regulatory Compliance: Over 335 regulatory approvals since 2011 highlight the company's commitment to quality and compliance.

FAQs

Q: What is the S-HiCon platform, and what does it achieve? A: The S-HiCon platform is a high-concentration formulation platform launched by Samsung Biologics to support the development and manufacturing of high-dose biopharmaceuticals. It achieves stable liquid formulations for concentrations over 200 mg/mL and addresses challenges such as pH stability, viscosity, and protein aggregation.

Q: How does the S-HiCon platform optimize drug formulations? A: The S-HiCon platform uses optimization techniques including pH, buffer species, and excipients to identify favorable formulation candidates early in development. It also includes a "Concentration Gate Check" process to test formulation feasibility.

Q: What is the current financial performance of Samsung Biologics? A: In the third quarter of 2024, Samsung Biologics reported a consolidated revenue of KRW 1.2 trillion, a 15% increase from the previous year, with an operating profit of KRW 338.6 billion.

Q: How has the Bank of Korea's rate cut affected Samsung Biologics? A: The rate cut has made borrowing cheaper, contributing to an upward trajectory in the company's stock prices despite the overall downward trend in the KOSPI index.

Q: What are Samsung Biologics' future growth prospects? A: The company is set to benefit from the construction of its dedicated ADC facility and Plant 5, scheduled to be operational in April 2025, along with continued investments in innovative technologies and expanding partnerships.

Sources

  1. Samsung Biologics Launches High Concentration Platform - PharmExec
  2. Korean growth stocks climb after rate cut - The Korea Times
  3. Search-Results-More | Samsung Biologics - Samsung Biologics
  4. Samsung Biologics Introduces S-HiCon to Tackle High-Concentration Formulation Challenges - PharmaSource Global

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