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Last Updated: December 28, 2025

Sunovion Pharms Inc Company Profile


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Summary for Sunovion Pharms Inc
International Patents:52
US Patents:7
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Sunovion Pharms Inc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No 9,907,794*PED ⤷  Get Started Free Y ⤷  Get Started Free
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No 9,555,027 ⤷  Get Started Free Y ⤷  Get Started Free
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 AB RX Yes Yes 9,259,423*PED ⤷  Get Started Free Y ⤷  Get Started Free
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No 9,555,027 ⤷  Get Started Free Y ⤷  Get Started Free
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 AB RX Yes Yes 9,907,794*PED ⤷  Get Started Free Y ⤷  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

Expired US Patents for Sunovion Pharms Inc

Paragraph IV (Patent) Challenges for SUNOVION PHARMS INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg ➤ Subscribe 2014-10-28

Supplementary Protection Certificates for Sunovion Pharms Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1884242 1490057-5 Sweden ⤷  Get Started Free PRODUCT NAME: LURASIDONE, OPTIONALLY IN THE FORM OF LURASIDONE HYDROCHLORIDE; REG. NO/DATE: EU/1/14/913 20140327
1884242 CR 2014 00049 Denmark ⤷  Get Started Free PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327
1884242 C300690 Netherlands ⤷  Get Started Free PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242 SPC/GB14/063 United Kingdom ⤷  Get Started Free PRODUCT NAME: LURASIDONE HYDROCHLORIDE; REGISTERED: UK EU/1/14/913/001 20140327; UK EU/1/14/913/002 20140327; UK EU/1/14/913/003 20140327; UK EU/1/14/913/004 20140327; UK EU/1/14/913/005 20140327; UK EU/1/14/913/006 20140327; UK EU/1/14/913/007 20140327; UK EU/1/14/913/008 20140327; UK EU/1/14/913/009 20140327; UK EU/1/14/913/010 20140327; UK EU/1/14/913/011 20140327; UK EU/1/14/913/012 20140327; UK EU/1/14/913/013 20140327; UK EU/1/14/913/014 20140327; UK EU/1/14/913/015 20140327; UK EU/1/14/913/016 20140327; UK EU/1/14/913/017 20140327; UK EU/1/14/913/018 20140327; UK EU/1/14/913/019 20140327; UK EU/1/14/913/020 20140327; UK EU/1/14/913/021 20140327
1884242 300690 Netherlands ⤷  Get Started Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Sunovion Pharms Inc – Market Position, Strengths & Strategic Insights

Last updated: July 30, 2025

Introduction

Sunovion Pharmaceuticals Inc. stands as a prominent entity in the global pharmaceutical landscape, primarily known for its focus on central nervous system (CNS) disorders, respiratory conditions, and rare diseases. Operating as a subsidiary of Sumitomo Dainippon Pharma, the company has demonstrated robust growth through strategic acquisitions, innovative drug development, and a targeted portfolio. This analysis delineates Sunovion's market position, core strengths, and strategic outlook within a fiercely competitive environment.

Market Position and Industry Overview

Sunovion operates within a multibillion-dollar pharmaceutical industry characterized by rapid innovation, regulatory rigor, and pricing pressures. Its primary markets include North America, Asia, and select European regions, with a substantial portion of revenue derived from neurological and respiratory medications. The company's flagship products, such as Lunesta (eszopiclone) and Aptiom (eszopiclone), establish its foothold in sleep and psychiatric disorders, while newer entrants like Kynmobi (apomorphine) and Zepzelca (lurbinectedin) expand its oncology and neurology divisions.

Market aging demographics, the rising prevalence of CNS disorders, and increased emphasis on personalized medicine position Sunovion favorably for sustained growth. However, intensifying competition from bioequivalent generics, emerging biotech firms, and blockbuster drug pipelines of peers like Biogen, Pfizer, and Novartis challenge Sunovion’s market share.

Core Strengths

Innovative Product Portfolio

Sunovion’s pipeline emphasizes CNS disorders, notably schizophrenia, depression, and sleep disorders. The company's commitment to R&D led to Qelbree (viloxazine extended-release), approved for ADHD treatment in children and adolescents, exemplifying its ability to develop novel therapies in a niche market segment. Moreover, its focus on precision medicine enables tailored treatments that address unmet needs and improve patient outcomes.

Strategic Acquisition and Collaboration Framework

Sunovion’s expansion strategy hinges on key acquisitions and alliances. The acquisition of the US rights to Lunesta from Sepracor increased its psychiatric portfolio. Additionally, collaboration with biotech firms accelerates drug development, as seen with partnerships in rare disease therapies, enhancing its innovation pipeline.

Strong Regulatory and Commercial Footprint

Having successfully navigated complex regulatory pathways globally, Sunovion leverages an established distribution network, especially in North America. Its commercialization expertise ensures effective launch strategies, robust sales infrastructure, and high market penetration for its key offerings.

Financial Resilience

With steady revenue streams and a commitment to reinvestment in R&D, Sunovion maintains financial stability. Its backing by Sumitomo Dainippon Pharma provides additional capital resources to fuel strategic growth initiatives and pipeline diversification.

Strategic Insights

Focus on Niche Therapeutic Areas

Sunovion's emphasis on CNS and respiratory disorders positions it as a specialized player, less exposed to the commoditization risks faced by broader-spectrum pharmaceutical companies. Investing further in rare diseases and personalized therapies can secure premium positioning.

Innovation and R&D Investment

Prioritizing precision medicine, biomarkers, and novel delivery mechanisms will be essential to stay competitive. The company's current pipeline suggests a strategic pivot toward unmet needs, including neurodegenerative and psychiatric conditions, which promise high therapeutic value and market exclusivity.

Market Expansion via Digital and Contract Manufacturing

Expanding into emerging markets through digital marketing channels and localized manufacturing presents growth opportunities. Strategic collaborations to facilitate access and meet regional regulatory standards are imperative.

Navigating Competitive and Regulatory Challenges

To mitigate generic competition, Sunovion should accelerate lifecycle management strategies and explore patents for proprietary formulations. Engaging proactively with regulatory agencies ensures timely approval and market access for innovative therapies.

Sustainability and Pricing Strategies

Balancing innovation with affordability necessitates transparent pricing policies and stakeholder engagement. Aligning product value propositions with payer expectations can help sustain revenue streams amid cost-containment pressures.

Competitive Landscape Positioning

Company Market Focus Key Products Strengths Challenges
Sunovion CNS, respiratory, rare diseases Lunesta, Qelbree, Kynmobi Niche focus, innovation, strong pipeline Patent cliffs, competition from generics
Biogen Neurodegeneration Aduhelm, Tysabri Pioneering biologics, robust R&D Regulatory hurdles, pipeline dependence
Pfizer Broad pharma Comirnaty, Prevnar Market diversification, financial strength Patent expirations, regulatory scrutiny
Novartis Oncology, neuroscience Gilenya, Kisqali Diversified portfolio, innovative R&D Pricing pressures
Lupin, Teva Generics Multiple generic formulations Cost leadership Limited innovation, patent risks

Sunovion’s position within this landscape is characterized by its niche specialization, innovative product strategy, and strong regional presence, positioning it as a focused player in high unmet medical need areas.

Key Challenges and Opportunities

Challenges

  • Patent Expirations & Generic Competition: Loss of exclusivity for products like Lunesta threatens revenue stability.
  • Pipeline Risks: High dependency on a limited number of high-value therapies; failure to commercialize new drugs could impact growth.
  • Pricing and Reimbursement Pressures: Health systems' push for cost containment may limit market access and profit margins.
  • Global Regulatory Variability: Navigating diverse regulatory environments complicates international expansion.

Opportunities

  • Emerging Market Expansion: Growing healthcare infrastructure in Asia and Latin America presents new revenue streams.
  • Innovative Delivery Platforms: Developing injectable, oral, or implant formulations can capture niche segments.
  • Rare Disease Focus: Orphan drug designations can provide exclusivity and premium pricing.
  • Partnerships and M&A: Strategic alliances can accelerate pipeline development and geographic reach.

Conclusion

Sunovion’s strategic positioning hinges on its niche expertise in CNS and respiratory therapeutics, complemented by a focused innovation pipeline and regional strength. By continuing to invest in groundbreaking research, expanding market access, and managing patent life cycles effectively, Sunovion can sustain competitiveness against both traditional pharmaceutical giants and emerging biotech firms.

Key Takeaways

  • Sunovion has carved a specialized niche within CNS and respiratory markets, leveraging targeted innovation.
  • Its growth is supported by strategic acquisitions, strong regulatory expertise, and a robust regional presence.
  • To mitigate patent expiration risks, Sunovion must accelerate pipeline innovation and secure new product launches.
  • Expanding into emerging markets and adopting digital commercialization strategies offer significant growth potential.
  • Maintaining a focus on high unmet medical needs and orphan drugs maximizes revenue and market influence.

FAQs

1. How does Sunovion differentiate itself from its competitors?
Sunovion distinguishes itself through its strong focus on CNS and respiratory therapies, innovation in niche markets such as sleep disorder medications and rare diseases, and its strategic use of collaborations and acquisitions to bolster its pipeline and market presence.

2. What are the primary growth drivers for Sunovion in the coming years?
Key drivers include the successful commercialization of new therapies like Qelbree, expansion into emerging markets, pipeline advancements in neurodegeneration and rare diseases, and leveraging digital channels for broader market penetration.

3. How vulnerable is Sunovion to patent expirations?
While patent expirations for flagship products like Lunesta create revenue challenges, Sunovion’s focus on novel therapies and orphan drugs helps mitigate these risks by creating new revenue streams and maintaining market exclusivity for niche products.

4. What strategic moves should Sunovion consider to strengthen its market position?
Sunovion should prioritize pipeline innovation, accelerate approvals for emerging therapies, deepen its presence in high-growth regions, and explore alliances that enhance technological capabilities and market access.

5. How does Sunovion manage its R&D pipeline amid regulatory and market uncertainties?
The company invests heavily in targeted research, collaborates with biotech partners, and emphasizes regulatory planning to align clinical trials with approval requirements, reducing risks and expediting time-to-market.


Sources:
[1] Sunovion Pharmaceuticals Inc. Official Website.
[2] MarketWatch. "Pharmaceutical Industry Report 2023."
[3] IBISWorld. "Global Pharmaceuticals Industry."
[4] Evaluate Pharma. "2023 Pipeline & Market Trends."
[5] Company Financial Disclosures and SEC Filings.

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