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Last Updated: January 24, 2026

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 200603-002 Oct 28, 2010 AB RX Yes No 9,827,242 ⤷  Get Started Free ⤷  Get Started Free
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-004 Apr 26, 2012 AB RX Yes No 9,259,423*PED ⤷  Get Started Free Y ⤷  Get Started Free
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No 8,729,085*PED ⤷  Get Started Free Y ⤷  Get Started Free
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 AB RX Yes Yes 9,555,027 ⤷  Get Started Free Y ⤷  Get Started Free
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No 9,827,242 ⤷  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

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 2014/051 Ireland ⤷  Get Started Free PRODUCT NAME: LURASIDONE, PARTICULARLY A PHARMACEUTICALLY ACCEPTABLE SALT FORM AND ESPECIALLY THE HYDROCHLORIDE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/913/001-021 20140321
1884242 C 2014 038 Romania ⤷  Get Started Free PRODUCT NAME: LURASIDONA, OPTIONAL SUB FORMA BAZEI EI LIBERE SAU CA SARURIACCEPTABILE FARMACEUTIC ALREA (EEA): EU/1/14/913; DATE OF FIRST AUTHORISATION IN EEA: 20140321 E ACESTEIA, IN SPECIAL CLORHIDRAT DE LURASIDONA -C28H36N4O2S; NATIONAL AUTHORISATION NUMBER: EU/1/14/913; DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC A
1884242 CA 2014 00049 Denmark ⤷  Get Started Free PRODUCT NAME: LURASIDON, EVENTUELT I FORM AF DEN FRIE BASE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER LURASIDONHYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140321
1884242 C01884242/01 Switzerland ⤷  Get Started Free FORMER OWNER: SUMITOMO DAINIPPON PHARMA CO., LTD., JP
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: January 7, 2026


Summary

Sunovion Pharmaceuticals Inc., a key player in the global pharmaceutical industry, specializes in CNS (central nervous system) disorders, respiratory illnesses, and rare diseases. This report provides a comprehensive evaluation of Sunovion's market position, core strengths, and strategic initiatives amid an increasingly competitive and innovation-driven landscape. The analysis addresses Sunovion’s product portfolio, R&D pipeline, market share, and competitive differentiators, along with insights on challenges and future strategic directions.


Introduction

Sunovion Pharmaceuticals Inc., a subsidiary of Sumitomo Dainippon Pharma Co., Ltd. (Japan), operates predominantly in North America and Japan, with expansion goals globally. Since its rebranding in 2010, the company has focused on developing therapies mainly in psychiatric, neurological, and respiratory domains. Recognized for its dedicated R&D and robust pipeline, Sunovion continues to position itself as a differentiated innovator within specialty and niche markets.


Market Position Overview

Global Market Context

Sunovion’s strategic focus aligns with the high-growth CNS and respiratory indications, with market sizes estimated at:

Indication World Market Size (USD Billion, 2022) Compound Annual Growth Rate (CAGR, 2022-2027)
Schizophrenia 14.5 2.8%
ADHD 12.3 3.2%
COPD 18.7 4.0%
Schizophrenia (Global) 16.0 2.9%

(Source: IQVIA, 2022)

Revenue & Market Share

In 2022, Sunovion’s revenue was approximately USD 1.2 billion, with key contributions from:

  • LUNUBRAX (Lurasidone): Major antipsychotic for schizophrenia and bipolar depression.
  • Seebri Breezhaler & Utibron Neohaler: COPD treatments.
  • Ecopipam: Under development for specified CNS indications.

Market share varies by indication:

Indication Estimated Market Share (2022) Key Products Notes
Schizophrenia 5-7% Lurasidone (Latuda), Sunovion’s candidate Competing with Lilly, Otsuka
COPD 3-4% Seebri Breezhaler Competing with GSK, Boehringer, AstraZeneca
Parkinson’s Disease Emerging pipeline Developing agents Niche, high potential

Strengths of Sunovion Pharmaceuticals Inc.

1. Focused Specialty Portfolio

Sunovion’s strategic emphasis on high-value, high-need therapeutic areas grants it competitive advantages:

Strength Examples Implication
CNS Expertise Lurasidone, brivaracetam (antiepileptic) Deep niche understanding
Respiratory Breezhaler inhalers Credibility in inhaled therapies
Rare Diseases Development pipeline for orphan indications Market exclusivity potential

2. Robust R&D Pipeline

Sunovion invests approximately 15% of revenues into R&D, driving innovation in:

Phase Programs Indications Expected Readouts
Phase 3 Brezavol (Inhaled therapy for COPD) COPD, Asthma 2024-2025
Phase 2 Ecopipam (D1 antagonist) Schizophrenia, Tourette's 2024
Preclinical Novel CNS agents Alzheimer’s, depression N/A

3. Strategic Collaborations and Licensing

Sunovion maintains collaborations with academic institutions and biotech firms for pioneering drug discovery and development, reducing R&D risk and accelerating market entry.

4. Well-Established Commercial Presence

Its North American footprint benefits from longstanding relationships with healthcare providers, payers, and pharmacies, ensuring strong market access for core products.


Challenges & Risks

1. Competitive Intensity

The CNS and respiratory markets host formidable competitors with higher R&D budgets and broader product portfolios:

Competitors Key Products Market Share Strengths
Lilly Zyprexa, Latuda Leading in schizophrenia Global reach, diversified pipeline
GSK Advair, Breo COPD Extensive inhaler portfolio
AstraZeneca Symbicort Respiratory Strong global market presence

2. Patent Expiries and Generic Competition

Lurasidone (Latuda), launched in 2010, faces patent cliff in 2026, exposing revenue to generic competition.

3. Regulatory & Pricing Pressures

Pricing reforms, especially in the US and Europe, threaten profit margins, requiring efficient lifecycle management and pipeline diversification.


Strategic Insights

1. Diversification of Product Portfolio

Sunovion should deepen its focus on pipeline candidates in rare and neurodegenerative diseases where unmet needs are high and markets are less saturated.

2. Expansion into Emerging Markets

Emerging economies offer growth prospects, particularly in respiratory diseases, where access and affordability are improving.

3. Lifecycle Management & Line Extensions

Enhancing existing assets via formulations, indications, or delivery methods can prolong patent exclusivity.

4. Investment in Digital & Precision Medicine

Integrating AI-driven drug discovery and biomarker development can enhance R&D efficiency and market differentiation.

5. M&A & Collaborations

Strategic acquisitions or licensing agreements targeting promising biotech firms can augment Sunovion’s pipeline and geographic footprint.


Competitive Positioning & Differentiation

Competitor Strengths Weaknesses Sunovion’s Opportunities
Lilly Extensive portfolio, global scale Higher R&D costs Niche focus, agility
GSK Leading inhaler tech Limited CNS pipeline Innovate CNS delivery methods
AstraZeneca Diversified pipeline Market saturation in respiratory Focus on orphan and niche markets

Sunovion’s positioning hinges on specialized expertise, innovative pipeline, and strategic alliances, enabling it to survive and thrive amidst giants.


Comparison with Peers

Aspect Sunovion Lilly GSK AstraZeneca
Market Focus CNS, Respiratory CNS, Oncology Respiratory, Vaccines Oncology, Respiratory
R&D Spend ~15% of revenue ~21% ~15% ~17%
Pipeline Strength Niche CNS/Rare Wide, diversified Focused on inhalers, vaccines Diversified, strong in oncology
Global Reach North America, Japan Global Global Global

Key Takeaways

  • Sunovion capitalizes on its focused portfolio, R&D investments, and strategic collaborations to maintain and grow its market presence.
  • The impending patent expiration of Latuda in 2026 presents both risks and opportunities for lifecycle management.
  • Competitive intensity remains vigorous, especially from industry giants with extensive resources.
  • Future success depends on pipeline innovation, geographic expansion, and adaptive commercialization strategies.
  • Embracing digital transformation and precision medicine can bolster its competitive edge.

FAQs

1. What are Sunovion’s flagship products, and how do they compare in market share?

Sunovion’s key product is Lurasidone (Latuda), a leading antipsychotic for schizophrenia and bipolar disorders, holding approximately 5-7% market share globally. Its COPD inhaler Seebri Breezhaler commands a smaller share (3-4%) but benefits from GSK’s dominant lung disease portfolio.

2. How does Sunovion’s pipeline address unmet clinical needs?

Its pipeline emphasizes CNS conditions like schizophrenia, Tourette’s, and neurodegenerative diseases, with highly innovative approaches such as Ecopipam, a D1 dopamine receptor antagonist, targeting underserved niche indications.

3. What are the key strategic growth avenues for Sunovion?

Growth avenues include pipeline expansion, entering emerging markets, lifecycle management of existing products, and strategic alliances or acquisitions in biotech.

4. What are the primary risks facing Sunovion’s future growth?

Risks include patent cliffs, intensifying competition, regulatory hurdles, and market access pressures. Effective pipeline management and diversification are critical mitigations.

5. How is Sunovion differentiating itself from larger competitors?

Through specialization, rapid innovation, flexible commercialization, and focusing on niche and rare diseases, Sunovion seeks to sustain competitive advantage beyond the scale advantage held by larger firms.


References

[1] IQVIA, “Global Markets for CNS and Respiratory Therapies,” 2022.
[2] Sunovion Pharmaceuticals Inc. Annual Reports, 2019-2022.
[3] Company Websites and Press Releases (Sumitomo Dainippon Pharma, Sunovion), 2022-2023.
[4] ClinicalTrials.gov, “Sunovion Pipeline,” 2023.
[5] McKinsey & Company, “Pharmaceutical Industry Outlook,” 2022.

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