You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

Chiesi Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Chiesi
International Patents:329
US Patents:53
Tradenames:15
Ingredients:9
NDAs:14
Patent Litigation for Chiesi: See patent lawsuits for Chiesi

Drugs and US Patents for Chiesi

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 DISCN Yes No 10,555,938 ⤷  Get Started Free ⤷  Get Started Free
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 DISCN Yes No 9,861,622 ⤷  Get Started Free ⤷  Get Started Free
Chiesi KENGREAL cangrelor POWDER;INTRAVENOUS 204958-001 Jun 22, 2015 AP RX Yes Yes 9,439,921 ⤷  Get Started Free Y ⤷  Get Started Free
Chiesi KENGREAL cangrelor POWDER;INTRAVENOUS 204958-001 Jun 22, 2015 AP RX Yes Yes 9,427,448 ⤷  Get Started Free ⤷  Get Started Free
Chiesi MYCAPSSA octreotide acetate CAPSULE, DELAYED RELEASE;ORAL 208232-001 Jun 26, 2020 RX Yes Yes 11,969,471 ⤷  Get Started Free Y ⤷  Get Started Free
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 DISCN Yes No 9,265,758 ⤷  Get Started Free ⤷  Get Started Free
Chiesi MYCAPSSA octreotide acetate CAPSULE, DELAYED RELEASE;ORAL 208232-001 Jun 26, 2020 RX Yes Yes 9,265,812 ⤷  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 Chiesi

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 9,265,758 ⤷  Get Started Free
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 8,618,135 ⤷  Get Started Free
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015 9,433,617 ⤷  Get Started Free
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012 5,712,279 ⤷  Get Started Free
Chiesi CLEVIPREX clevidipine EMULSION;INTRAVENOUS 022156-003 Nov 8, 2013 5,739,152 ⤷  Get Started Free
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 9,265,758 ⤷  Get Started Free
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012 9,861,622 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for CHIESI drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 0.1 mg/mL, 200 mL and0.2mg/mL, 200 mL ➤ Subscribe 2013-06-20
➤ Subscribe Tablets 500 mg ➤ Subscribe 2016-01-29
➤ Subscribe Injection 2.5 mg/mL, 10 mL Ampoules ➤ Subscribe 2006-12-27
➤ Subscribe Inhalation Solution 300 mg/4 mL ➤ Subscribe 2017-08-31

Supplementary Protection Certificates for Chiesi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0726894 SPC/GB12/011 United Kingdom ⤷  Get Started Free PRODUCT NAME: CLEVIDIPINE; REGISTERED: UK PL16881/0003 20111123
1725234 92349 Luxembourg ⤷  Get Started Free PRODUCT NAME: LOMITAPIDE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130805
1725234 122014000003 Germany ⤷  Get Started Free PRODUCT NAME: LOMITAPID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER DAS PIPERIDIN-N-OXID DAVON; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
0726894 12C0053 France ⤷  Get Started Free PRODUCT NAME: CLEVIDIPINE; NAT. REGISTRATION NO/DATE: NL 37621 20120725; FIRST REGISTRATION: GB - PL 16881/0003 20111123
1758555 C20160023 00332 Estonia ⤷  Get Started Free PRODUCT NAME: BETULIIN;REG NO/DATE: EU/1/15/1069 18.01.2016
1725234 2013/063 Ireland ⤷  Get Started Free PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
1758555 2016/031 Ireland ⤷  Get Started Free PRODUCT NAME: BETULIN (BIRCH BARK EXTRACT); REGISTRATION NO/DATE: EU/1/15/1069 20160114
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Chiesi – Market Position, Strengths & Strategic Insights

Last updated: July 27, 2025

Introduction

Chiesi Farmaceutici S.p.A., founded in 1935 and headquartered in Parma, Italy, exemplifies a dynamically evolving player within the global pharmaceutical industry. Known for its focus on respiratory, rare diseases, and specialty medicines, Chiesi leverages a patient-centered approach and innovation-driven strategies to carve a competitive niche. As the pharmaceutical landscape becomes increasingly crowded with both generic entrants and innovative biotechs, understanding Chiesi’s market stance, core strengths, and strategic maneuvers is essential for stakeholders seeking opportunities or assessing competitive risks.

Market Position

Global Footprint and Revenue Trajectory

Chiesi operates across approximately 80 countries, with a notable presence in Europe, North America, and emerging markets. The company reported €2.6 billion in revenues in 2022, reflecting steady growth driven primarily by its respiratory segment [1]. Its revenue distribution underscores a reliance on chronic disease management, especially respiratory disorders such as asthma and COPD.

Segment Focus and Portfolio Strength

Chiesi's portfolio is predominantly centered on respiratory therapies, with key products like Foster (formoterol/budesonide) and Relvar (vilanterol/umeclidinium), which position the company favorably within the inhalation therapy domain. Additionally, its expansion into rare diseases—particularly lysosomal storage disorders (LSDs) and pulmonary hypertension—diversifies its revenue streams and mitigates sector-specific risks.

Competitive Position Within the Industry

While Chiesi is a mid-sized entity globally, its competitive positioning hinges on innovation-driven niche markets and a strong emphasis on pediatric and rare disease treatments. It remains behind multinational giants like GlaxoSmithKline, AstraZeneca, and Novartis but distinguishes itself through agility, specialized focus, and strategic partnerships.

Core Strengths

1. Focused R&D and Innovation

Chiesi invests approximately 20% of its revenues into R&D, underscoring its commitment to innovation. Its pipeline boasts promising candidates in respiratory, rare diseases, and gene therapy vectors, positioning it for future growth [2]. Notably, Chiesi’s internal innovation is complemented by strategic acquisitions and licensing agreements, accelerating access to novel therapeutics.

2. Niche Specialization and Patient-Centric Approach

The company's dedication to underserved markets, specifically pediatric and rare diseases, provides a competitive advantage. Its early investment in these segments positions it as a leader in niche therapeutic areas, where market penetration and exclusivity can be optimized.

3. Strategic Collaborations and Licensing Agreements

Chiesi has cultivated fruitful partnerships with biotech and academic entities, enabling it to expand its pipeline and access cutting-edge technologies. For instance, collaborations with developers of gene therapies and inhalation devices foster product differentiation and technological advantage [3].

4. Operational Agility and Regional Strengths

With a manufacturing footprint in Europe and strategic manufacturing and distribution centers globally, Chiesi benefits from operational flexibility. Its deep understanding of local markets enhances its ability to tailor product offerings and navigate regulatory environments efficiently.

5. Commitment to Sustainability and Corporate Responsibility

Chiesi’s focus on environmental sustainability and social responsibility—integrating eco-friendly manufacturing practices and patient access initiatives—strengthens corporate reputation and stakeholder loyalty in an increasingly conscientious market.

Strategic Insights

Market Expansion and Pipeline Development

Chiesi’s growth strategy emphasizes geographic expansion into North America and Asia, markets that present high growth potential, especially in respiratory and pediatric segments. Its pipeline includes emerging therapies for pulmonary hypertension and rare genetic disorders, aligning with global unmet needs.

Digital Transformation and Patient Engagement

Embracing digital health, Chiesi leverages telemedicine, remote monitoring, and digital therapeutics to enhance patient adherence and outcomes. This move aligns well with industry trends and may foster a competitive advantage in implementing personalized medicine approaches.

Focus on Rare Diseases and Orphan Drugs

The orphan drug market offers high margins and market exclusivity. Chiesi's strategic focus on rare diseases—such as lysosomal storage disorders and pulmonary arterial hypertension—aims to capitalize on regulatory incentives and patient unmet needs.

Mergers, Acquisitions, and Alliances

To bolster its pipeline and market reach, Chiesi pursues targeted acquisitions and licensing deals. Its recent partnership with Amryt Pharma to develop rare disease therapeutics illustrates this strategy. Such alliances enable rapid market entry and technological infusion [4].

Sustainability and Market Differentiation

Chiesi’s sustainability initiatives resonate with global health and environmental standards, providing differentiation in a crowded industry. Commitment to eco-friendly manufacturing and equitable access programs enhances brand reputation and consumer trust.

Challenges and Risks

Intense Competition in Core Segments

Chiesi faces formidable competition from larger multinational corporations with entrenched market positions and extensive R&D budgets. The respiratory segment, particularly, is saturated with generic and branded products.

Regulatory Barriers and Pricing Pressures

Navigating complex regulatory environments across jurisdictions presents ongoing challenges. Additionally, cost containment policies, especially in Europe and North America, threaten profit margins.

Pipeline Uncertainties

Despite active R&D, the inherent risk of clinical trial failures could impact future growth. High costs and lengthy approval timelines further compound this risk.

Market Access and Reimbursement

Securing favorable reimbursement in diverse healthcare systems remains critical. Discrepancies in pricing and access policies may hinder product adoption, particularly for high-cost orphan drugs.

Conclusion

Chiesi stands out as a focused, innovation-driven pharmaceutical firm with a robust regional presence and strategic emphasis on niche markets such as rare diseases and pediatric therapies. Its strengths in R&D, strategic alliances, and sustainability commitments position it well for future growth, especially through geographic expansion and pipeline development. However, its success depends on navigating intense competition, regulatory complexities, and market access challenges. For stakeholders, Chiesi’s trajectory offers promising opportunities, particularly in the expanding orphan and specialty drug markets.


Key Takeaways

  • Chiesi’s core competencies in respiratory and rare disease therapeutics position it distinctively in specialized pharmaceutical niches.
  • Aggressive pipeline development, strategic collaborations, and expanding geographic footprint are central to its growth strategy.
  • Its focus on sustainability and patient-centric approaches enhances brand equity and stakeholder loyalty.
  • Navigating competitive, regulatory, and reimbursement challenges remains critical for sustained success.
  • Continuous innovation and market diversification are vital to maintain competitive advantage and capitalize on emerging healthcare trends.

FAQs

1. How does Chiesi differentiate itself from larger pharmaceutical competitors?
Chiesi’s narrow focus on niche markets such as pediatric respiratory and rare diseases, combined with agility and innovation, allows it to develop specialized therapies and foster strong patient and healthcare provider relationships, setting it apart from broader industry players.

2. What are Chiesi’s most promising pipeline assets?
Chiesi’s pipeline includes candidates for pulmonary hypertension, gene therapies for rare genetic disorders, and innovative inhalation devices. Specifically, its experimental therapies in lysosomal storage disorders and targeted biologics are gaining attention.

3. How significant are partnerships for Chiesi’s growth?
Partnerships are vital, enabling access to new technologies, enhancing pipeline breadth, and accelerating market entry, particularly in complex areas like gene therapy and orphan drugs.

4. What regional markets offer the most growth opportunities for Chiesi?
North America and Asia represent key growth frontiers due to increasing demand for respiratory and specialty medicines, alongside expanding healthcare infrastructure.

5. What risks could hinder Chiesi’s future expansion?
Regulatory hurdles, pricing and reimbursement pressures, pipeline risks, and intense competition are primary challenges that could impede growth.


References

[1] Chiesi Annual Report 2022.
[2] Company R&D Overview. Chiesi Corporate Website.
[3] Strategic Alliances Report, 2022.
[4] Recent Partnership Announcements, 2023.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.