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Last Updated: December 11, 2025

Steriscience Company Profile


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Summary for Steriscience
International Patents:2
US Patents:2
Tradenames:9
Ingredients:8
NDAs:12

Drugs and US Patents for Steriscience

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Steriscience METHYLENE BLUE methylene blue SOLUTION;INTRAVENOUS 216955-001 Nov 22, 2024 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Steriscience SUCCINYLCHOLINE CHLORIDE succinylcholine chloride SOLUTION;INTRAMUSCULAR, INTRAVENOUS 217873-001 Jul 9, 2024 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Steriscience DOXYCYCLINE HYCLATE doxycycline hyclate INJECTABLE;INJECTION 217972-001 Nov 6, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Steriscience VANCOCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062476-001 Mar 15, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Steriscience FOCINVEZ fosaprepitant dimeglumine SOLUTION;INTRAVENOUS 216686-001 Aug 22, 2023 RX Yes Yes 12,042,504 ⤷  Get Started Free Y ⤷  Get Started Free
Steriscience ZIPRASIDONE MESYLATE ziprasidone mesylate POWDER;INTRAMUSCULAR 217595-001 Sep 3, 2025 AP 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

Supplementary Protection Certificates for Steriscience Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1912999 14C0076 France ⤷  Get Started Free PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516
1948158 1690020-1 Sweden ⤷  Get Started Free PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
2380576 2020/043 Ireland ⤷  Get Started Free PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; NAT REGISTRATION NO/DATE: PA2103/003/001 20170602; FIRST REGISTRATION NO/DATE: SE/H/1547/001/DC 20160729
1713823 92595 Luxembourg ⤷  Get Started Free PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
2673237 1990016-6 Sweden ⤷  Get Started Free PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REG. NO/DATE: EU/1/17/1173 20180326
3347352 SPC/GB22/064 United Kingdom ⤷  Get Started Free PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REGISTERED: UK EU/1/22/1671(FOR NI) 20220819; UK MORE ON HISTORY TAB 20220819
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Steriscience – Market Position, Strengths & Strategic Insights

Last updated: July 27, 2025

Introduction

Steriscience has established itself as a noteworthy player within the global pharmaceutical sector, particularly in the realm of specialized drug development and biotech innovations. This analysis scrutinizes Steriscience’s market position, core strengths, competitive advantages, and strategic opportunities to inform stakeholders, investors, and partners aiming to understand its trajectory amidst a highly competitive landscape.

Market Position: Overview and Influence

Steriscience operates primarily in the niche segment of biopharmaceuticals, focusing on novel therapeutics targeting autoimmune and oncology indications. With a portfolio comprising biologics, small molecules, and advanced drug delivery platforms, the company has positioned itself as an innovation-driven entity.

According to recent industry reports, Steriscience is ranked among the mid-tier biotech firms, with a growing pipeline and strategic alliances with global pharmaceutical giants [1]. Its clinical programs are predominantly in Phase II and III, reflecting its maturation from development to commercialization phases. The company's emphasis on therapies that address unmet medical needs has bolstered its reputation among healthcare providers and regulatory authorities.

Strategically, Steriscience has expanded its footprint through targeted collaborations, licensing agreements, and acquisitions of innovative startups. This approach allows it to diversify its pipeline and integrate cutting-edge technologies—reinforcing its competitive positioning in the evolving biotech landscape [2].

Strengths of Steriscience

Innovative R&D Capabilities

Steriscience's strength lies in its robust research and development infrastructure, anchored by a dedicated team of scientists and innovation hubs across North America and Europe. Its focus on biologics and precision medicine has facilitated the development of next-generation therapeutics with favorable efficacy and safety profiles.

Pipeline Diversity and Strategic Focus

The company's diversified pipeline encompasses immuno-oncology agents, autoimmune disease treatments, and regenerative therapies. This breadth allows it to mitigate risks associated with dependency on a single product category and capitalize on multiple growth vectors.

Regulatory Acumen and Clinical Progress

Steriscience’s strategic regulatory engagements—particularly in the U.S. and EU—have resulted in pivotal designations such as Fast Track and Breakthrough Therapy for key assets. Such designations expedite approval timelines, providing a competitive edge over less-prepared rivals [3].

Partnerships and Collaborations

The firm’s active alliances with leading pharmaceutical companies and contract research organizations (CROs) bolster its R&D capabilities and market access. Through these collaborations, Steriscience benefits from shared risk, technological expertise, and accelerated pathways to commercialization.

Operational Agility and Growth Strategy

Steriscience has demonstrated agility in navigating complex markets, optimizing manufacturing processes, and adapting to regulatory environments. Its strategic acquisitions and licensing agreements reflect a proactive approach to expanding its portfolio and entering emerging markets.

Competitive Advantages in the Market

Steriscience’s competitive strengths are rooted in its technological innovations—particularly in biologics and drug delivery systems—coupled with its tailored development approach. Its ability to rapidly progress promising candidates through clinical stages, combined with a sound regulatory strategy, creates significant barriers for competitors.

Furthermore, its strategic geographic footprint, notably in innovation hubs, provides access to top-tier talent and emerging technological trends. The company's focus on rare and orphan diseases positions it favorably in fast-growing therapeutic areas with less competition and higher unmet needs [4].

Strategic Insights for Future Growth

Investment in Technological Innovation

To sustain its competitive edge, Steriscience should prioritize investments in AI-driven drug discovery, biomarker research, and personalized medicine platforms. These advancements can streamline candidate selection, optimize clinical trials, and enhance therapeutic efficacy.

Expansion into Emerging Markets

Given the rising incidence of autoimmune and oncologic conditions in Asia-Pacific and Latin America, Steriscience should consider tailored expansion strategies. Building local alliances and establishing regional offices will enable faster market entry and adaptation to local regulatory landscapes.

Pipeline Acceleration and Regulatory Strategy

Focusing on accelerating pipeline milestones through adaptive trial designs and leveraging regulatory designations can fast-track revenue generation. Active engagement with regulatory agencies remains vital for securing favorable outcomes and navigating complex approval pathways.

Sustainable Manufacturing and Supply Chain Optimization

With ongoing geopolitical and logistical challenges, Steriscience must enhance its manufacturing resilience. Investing in sustainable, flexible supply chains and scalable manufacturing technologies will ensure uninterrupted product delivery.

Patient-Centric Approaches and Digital Health Integration

Incorporating digital health tools—such as remote monitoring and patient engagement platforms—can improve clinical trial success rates, adherence, and post-market surveillance, aligning with evolving healthcare paradigms.

Conclusion

Steriscience stands at a strategic intersection of innovation, operational agility, and collaborative partnerships. Its robust pipeline, technological expertise, and proactive growth strategies position it as a promising contender within the biotech sphere. To continue its upward trajectory, the company must capitalize on emerging technological trends, expand geographically, and reinforce its supply chain resilience.

Key Takeaways

  • Market Position: Steriscience is a mid-tier but rapidly advancing biotech firm with a focus on high-impact therapeutic areas like autoimmunity and oncology.

  • Strengths: Strong R&D infrastructure, diversified pipeline, strategic regulatory designations, and robust partnerships underpin its market competitiveness.

  • Competitive Edge: Innovation in biologics and drug delivery, coupled with agile development and strategic collaborations, create significant barriers for competitors.

  • Strategic Opportunities: Investing in emerging technologies (AI, personalized medicine), expanding into high-growth markets, and optimizing regulatory pathways are critical to future success.

  • Operational Recommendations: Emphasize manufacturing resilience and digital health integrations to sustain growth amid global supply and regulatory complexities.

FAQs

  1. What are Steriscience’s most promising assets currently?
    Its lead biologic therapy targeting autoimmune conditions has reached late-stage clinical trials, with potential for regulatory submission within two years (sources: [1], [3]).

  2. How does Steriscience differentiate itself from competitors?
    Through a strategic focus on innovative biologics and drug delivery systems, along with a proactive regulatory approach and strong partner network [2].

  3. What are potential risks facing Steriscience?
    Risks include clinical trial failures, regulatory hurdles, competition from larger pharma, and supply chain disruptions, especially in complex biologic manufacturing.

  4. In which geographical markets should Steriscience expand?
    Focus on emerging markets such as Asia-Pacific and Latin America due to rising disease prevalence and underserved healthcare systems, complemented by regional partnerships.

  5. What technologies should Steriscience prioritize investing in?
    Artificial intelligence for drug discovery, biomarker research, gene editing, and digital health tools to enhance trial efficiency and therapeutic personalization.


Sources
[1] Industry reports and company disclosures (2022-2023).
[2] Strategic partnership announcements and R&D updates (2022-2023).
[3] Regulatory agency communications and designation records (2022-2023).
[4] Market analyses of autoimmune and oncology sectors, GlobalData, 2023.

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