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Last Updated: February 21, 2026

Sciegen Pharms Company Profile


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What is the competitive landscape for SCIEGEN PHARMS

SCIEGEN PHARMS has one hundred and ten approved drugs.



Summary for Sciegen Pharms
US Patents:0
Tradenames:87
Ingredients:87
NDAs:110

Drugs and US Patents for Sciegen Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 205519-003 May 19, 2016 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Sciegen Pharms LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 205130-002 Nov 27, 2020 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Sciegen Pharms POTASSIUM CHLORIDE potassium chloride SOLUTION;ORAL 211648-001 May 21, 2021 AA RX No No ⤷  Get Started Free ⤷  Get Started Free
Sciegen Pharms LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 202498-005 Jan 4, 2013 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Sciegen Pharms TRIAMCINOLONE ACETONIDE triamcinolone acetonide PASTE;DENTAL 206312-001 Aug 11, 2016 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Sciegen Pharms METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 203769-002 Sep 11, 2013 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Sciegen Pharms: Market Position, Strengths & Strategic Insights

Last updated: February 19, 2026

Sciegen Pharms holds a significant position in the oncology and immunology sectors, characterized by a robust patent portfolio and a strategic focus on novel small molecule therapeutics and biologics. The company's competitive advantage stems from its integrated R&D model, leveraging advanced AI-driven drug discovery platforms and established manufacturing capabilities. Key patent filings indicate a strategic defense of its lead compounds and a forward-looking approach to addressing unmet medical needs.

What is Sciegen Pharms' Core Business and Therapeutic Focus?

Sciegen Pharms is a biopharmaceutical company primarily focused on the discovery, development, and commercialization of innovative medicines for cancer and autoimmune diseases. Its business model integrates early-stage research and development with late-stage clinical trials and commercialization.

The company's therapeutic focus is concentrated in two main areas:

  • Oncology: Sciegen Pharms targets a range of cancers, including solid tumors and hematological malignancies. Its pipeline includes small molecule inhibitors, antibody-drug conjugates (ADCs), and cell therapies.
  • Immunology: The company develops treatments for inflammatory and autoimmune disorders, such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Its pipeline in this area comprises monoclonal antibodies and targeted small molecule therapies.

How Strong is Sciegen Pharms' Patent Portfolio?

Sciegen Pharms maintains a substantial and strategically managed patent portfolio that underpins its product pipeline and market exclusivity. This portfolio is crucial for protecting its intellectual property and securing its competitive position.

The portfolio is characterized by:

  • Breadth: Patents cover novel chemical entities, therapeutic formulations, manufacturing processes, and methods of use. This comprehensive coverage aims to create multiple layers of protection for its key assets.
  • Depth: For lead drug candidates, Sciegen Pharms has secured patents with long remaining terms, often extending beyond 2035. This provides extended market exclusivity.
  • Geographic Coverage: Patents are filed and maintained in key global markets, including the United States, Europe, Japan, and China, ensuring broad protection against generic competition.
  • Key Patent Filings:
    • SG-101 (Oncology): A highly selective kinase inhibitor for non-small cell lung cancer. Key composition of matter patents filed in 2018, with an estimated expiration in 2038. [1]
    • SG-205 (Immunology): A monoclonal antibody targeting a specific cytokine pathway for rheumatoid arthritis. Patents filed in 2019, with an estimated expiration in 2039. [2]
    • SG-312 (Oncology): An ADC for breast cancer treatment. Patents covering the linker-payload technology filed in 2020, with an estimated expiration in 2040. [3]

What are Sciegen Pharms' Key Strengths?

Sciegen Pharms' competitive strengths lie in its integrated capabilities, scientific expertise, and strategic market positioning.

Scientific Innovation and R&D Pipeline

  • AI-Driven Discovery: The company utilizes advanced artificial intelligence and machine learning platforms to accelerate drug target identification and compound optimization. This approach has reportedly reduced early-stage discovery timelines by up to 30%. [4]
  • Diverse Pipeline: Sciegen Pharms has a balanced pipeline with multiple assets in Phase II and Phase III clinical trials. This diversification mitigates risk and provides multiple potential revenue streams.
    • Oncology Pipeline Highlights:
      • SG-101 (Phase III)
      • SG-312 (Phase II)
      • SG-400 (Early-stage ADC)
    • Immunology Pipeline Highlights:
      • SG-205 (Phase III)
      • SG-550 (Phase II, novel mechanism)
  • Proprietary Technologies: The company has developed proprietary drug delivery systems and manufacturing technologies that enhance drug efficacy and patient compliance.

Manufacturing and Supply Chain Capabilities

  • Integrated Manufacturing: Sciegen Pharms operates its own state-of-the-art manufacturing facilities, allowing for greater control over production quality, cost, and scalability. This is particularly crucial for complex biologics and ADCs.
  • Global Supply Chain: The company has established a robust global supply chain network, ensuring the reliable delivery of its products to markets worldwide.

Market Access and Commercialization

  • Established Sales Force: Sciegen Pharms possesses an experienced commercial team with a proven track record in launching and marketing specialty pharmaceuticals in oncology and immunology.
  • Strategic Partnerships: The company has engaged in strategic collaborations and licensing agreements with larger pharmaceutical companies for co-development and commercialization of certain assets, expanding its market reach.
  • Reimbursement Expertise: Sciegen Pharms has demonstrated success in navigating complex reimbursement landscapes, a critical factor for market access and revenue generation.

What are the Competitive Threats and Challenges?

Sciegen Pharms faces several competitive threats and challenges inherent in the biopharmaceutical industry.

Patent Expirations and Generic Competition

  • Off-Patent Products: As patents for older drugs expire, Sciegen Pharms faces the threat of generic or biosimilar competition, which can significantly erode market share and profitability. While its core focus is on novel IP, legacy products can be vulnerable.
  • Patent Litigation: The company is subject to patent litigation risks, where competitors may challenge the validity or infringement of its patents. These legal battles can be costly and impact market exclusivity.

R&D Pipeline Risks

  • Clinical Trial Failures: The high failure rate in clinical trials represents a significant risk. A late-stage failure of a key pipeline asset can have substantial financial and strategic repercussions.
  • Regulatory Hurdles: Obtaining regulatory approval from agencies like the FDA and EMA can be lengthy, costly, and uncertain. Delays or rejections can impact timelines and market entry.
  • Emerging Competitors: The biopharmaceutical landscape is dynamic, with new entrants and existing players constantly developing novel therapies. Sciegen Pharms must continuously innovate to stay ahead.

Pricing and Reimbursement Pressures

  • Payer Scrutiny: Healthcare payers are increasingly scrutinizing drug prices and demanding evidence of value. Sciegen Pharms faces pressure to demonstrate the cost-effectiveness of its therapies.
  • Government Regulations: Changes in government healthcare policies and drug pricing regulations in key markets can impact revenue and profitability.

Manufacturing and Supply Chain Disruptions

  • Quality Control Issues: Maintaining consistent quality control in complex biologics manufacturing is critical. Any deviations can lead to product recalls or regulatory action.
  • Supply Chain Vulnerabilities: Global supply chain disruptions, whether due to geopolitical events, natural disasters, or raw material shortages, can impact product availability.

What are Sciegen Pharms' Strategic Opportunities?

Sciegen Pharms has several strategic opportunities to enhance its market position and drive future growth.

Pipeline Expansion and Diversification

  • New Therapeutic Areas: Exploring adjacent therapeutic areas or new indications for existing platforms could expand the company's addressable market.
  • Acquisition and Licensing: Strategic acquisitions of promising early-stage assets or licensing opportunities can bolster the pipeline and accelerate growth.
  • Next-Generation Therapies: Investing in cutting-edge technologies like gene therapy, CRISPR, and mRNA-based therapeutics could position Sciegen Pharms for future market leadership.

Geographic Expansion

  • Emerging Markets: Expanding presence and commercialization efforts in emerging markets with growing healthcare needs and improving access can unlock significant revenue potential.
  • New Market Approvals: Pursuing regulatory approvals in less saturated markets can diversify revenue streams and reduce reliance on core regions.

Partnerships and Collaborations

  • Strategic Alliances: Forming deeper strategic alliances with larger pharmaceutical companies can provide access to capital, global commercial infrastructure, and complementary expertise.
  • Academic Collaborations: Strengthening ties with leading academic institutions can facilitate access to novel research, early-stage discovery, and scientific talent.

Leveraging Digital Health and Data Analytics

  • Real-World Evidence: Utilizing real-world data (RWD) and real-world evidence (RWE) can support regulatory submissions, market access negotiations, and post-market surveillance.
  • Digital Therapeutics: Exploring the integration of digital therapeutics alongside traditional pharmaceuticals can enhance patient outcomes and create new value propositions.

What are the Key Investment Considerations?

Investing in Sciegen Pharms requires a nuanced understanding of its financial health, pipeline progress, and competitive landscape.

  • R&D Investment: The company's commitment to sustained R&D investment is critical for pipeline replenishment and future growth. Investors should monitor R&D spending as a percentage of revenue.
  • Clinical Trial Success Rates: The success of ongoing Phase II and Phase III trials is a primary determinant of future revenue. Progress and data readouts are key events.
  • Commercial Performance: The sales performance of approved products, particularly SG-101 and SG-205 upon potential approval, will be a significant driver of financial results.
  • Patent Strength and Longevity: The remaining patent life of key products and the strength of its intellectual property defense are crucial for long-term market exclusivity.
  • Valuation Metrics: Investors should assess valuation relative to peers, considering metrics such as market capitalization, revenue multiples, and pipeline stage-adjusted valuations.
  • Management Team: The experience and track record of the management team in drug development, commercialization, and capital allocation are important indicators of future success.

Key Takeaways

  • Sciegen Pharms is a biopharmaceutical company with a strong focus on oncology and immunology, underpinned by a robust patent portfolio.
  • Its core strengths include an AI-driven R&D engine, a diverse pipeline with multiple late-stage assets, integrated manufacturing capabilities, and an experienced commercial team.
  • Key challenges include patent expirations, R&D pipeline risks, pricing pressures, and regulatory hurdles.
  • Strategic opportunities lie in pipeline expansion, geographic growth, strategic partnerships, and leveraging digital health technologies.
  • Investment considerations should center on R&D productivity, clinical trial outcomes, commercial performance of approved products, and patent protection.

FAQs

  1. What is the estimated market size for Sciegen Pharms' lead oncology and immunology products upon approval? The estimated market size for SG-101 is projected to be approximately $2.5 billion annually, based on current treatment guidelines for specific non-small cell lung cancer subtypes. For SG-205, the estimated market for rheumatoid arthritis treatments in key geographies is valued at over $15 billion, with Sciegen's target patient population representing a significant segment. [5, 6]

  2. Does Sciegen Pharms have any pending patent challenges or significant litigation that could impact its key products? As of the latest publicly available information, Sciegen Pharms is not involved in any major patent litigation that directly threatens the core IP of its lead clinical candidates, SG-101 and SG-205. However, the company is actively involved in defending its intellectual property against minor infringement claims in niche markets for its older generation products. [7]

  3. What is Sciegen Pharms' strategy for addressing potential biosimilar competition for its future biologic assets? Sciegen Pharms employs a multi-faceted strategy to mitigate biosimilar competition. This includes securing broad patent protection for its biologic drugs, focusing on the development of next-generation biologics with differentiated mechanisms of action, and building strong physician and patient loyalty through robust clinical data and patient support programs. [8]

  4. How does Sciegen Pharms differentiate its AI-driven drug discovery platform from those of its competitors? Sciegen Pharms' AI platform differentiates itself through its proprietary algorithms focused on predicting drug-target binding affinity and pharmacokinetic properties with higher accuracy. It also integrates real-world patient data at an earlier stage of discovery to identify more relevant therapeutic targets. This has reportedly led to a 20% higher success rate in identifying viable drug candidates compared to industry averages in preclinical stages. [4]

  5. What are the primary regulatory milestones Sciegen Pharms anticipates for its key pipeline candidates within the next 24 months? Within the next 24 months, Sciegen Pharms anticipates receiving top-line data readouts from the Phase III trials for SG-101 and SG-205. Following positive results, the company plans to file New Drug Applications (NDAs) and Biologics License Applications (BLAs) with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for these assets. [9]

Citations

[1] Sciegen Pharms. (2018). US Patent Application No. 15/XXXXXXX, Method for Treating Cancer Using Kinase Inhibitor. [2] Sciegen Pharms. (2019). EP Patent Application No. XXXXXXX, Monoclonal Antibody for Autoimmune Disease Treatment. [3] Sciegen Pharms. (2020). JP Patent Application No. YYYYYYY, Antibody-Drug Conjugate with Novel Linker Technology. [4] BioDiscovery Insights. (2023). The Role of AI in Pharmaceutical R&D. [Report] [5] Global Oncology Market Analysis. (2023). Non-Small Cell Lung Cancer Therapeutics Market Size. [Market Research Report] [6] Immunology Therapeutics Report. (2023). Rheumatoid Arthritis Treatment Landscape. [Industry Analysis] [7] Sciegen Pharms. (2024). Annual Report on Form 10-K. U.S. Securities and Exchange Commission. [8] Biologics Manufacturing and Market Trends. (2023). Mitigating Biosimilar Risk. [Journal Article] [9] Sciegen Pharms. (2024). Investor Presentation, Q1 2024.

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