You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 17, 2025

Novartis Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Drugs and US Patents for Novartis

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis FAMVIR famciclovir TABLET;ORAL 020363-003 Dec 11, 1995 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Novartis AREDIA pamidronate disodium INJECTABLE;INJECTION 020036-001 Oct 31, 1991 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-003 Jul 7, 2015 AB RX Yes Yes 8,877,938*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 Novartis

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 7,160,870*PED ⤷  Get Started Free
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 7,741,338 ⤷  Get Started Free
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 7,795,293*PED ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for NOVARTIS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 m ➤ Subscribe 2009-09-14
➤ Subscribe Nasal Spray 0.665 mg/ Spray ➤ Subscribe 2009-06-29
➤ Subscribe Tablets 125 mg, 250 mg and 500 mg ➤ Subscribe 2004-12-28
➤ Subscribe Oral Suspension 300 mg/5 mL ➤ Subscribe 2006-12-26
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe 2014-02-04
➤ Subscribe Delayed-release Tablets 180 mg ➤ Subscribe 2009-06-04
➤ Subscribe Tablets 250 mg ➤ Subscribe 2011-03-14
➤ Subscribe Capsules 1.5 mg, 3 mg, 4.5 mg and 6 mg ➤ Subscribe 2004-04-21
➤ Subscribe Tablets 125 mg, 250 mg, and 500 mg ➤ Subscribe 2011-10-28
➤ Subscribe Tablets for Oral Suspension 2 mg, 3 mg and 5 mg ➤ Subscribe 2016-12-30
➤ Subscribe Transdermal System Extended-release 13.3 mg/24 hr ➤ Subscribe 2013-01-22
➤ Subscribe Tablets 2.5 mg, 5 mg, and 7.5 mg ➤ Subscribe 2014-12-10
➤ Subscribe Tablets 90 mg and 360 mg ➤ Subscribe 2015-10-19
➤ Subscribe Tablets 100 mg and 400 mg ➤ Subscribe 2007-03-12
➤ Subscribe Tablets 320 mg/12.5 mg and 320 mg/25 mg ➤ Subscribe 2007-02-07
➤ Subscribe Capsules 20 mg and 40 mg ➤ Subscribe 2008-06-04
➤ Subscribe Tablets 180 mg ➤ Subscribe 2016-04-28
➤ Subscribe Tablets 5 mg/320 mg ➤ Subscribe 2007-11-26
➤ Subscribe Injection 0.8 mg (base) /mL ➤ Subscribe 2008-06-11
➤ Subscribe Tablets 10 mg/320 mg ➤ Subscribe 2007-11-09
➤ Subscribe Ophthalmic Solution 0.003% ➤ Subscribe 2015-12-30
➤ Subscribe Tablets 10 mg/12.5 mg/160 mg ➤ Subscribe 2009-10-22
➤ Subscribe Tablets 150 mg, 300 mg and 600 mg ➤ Subscribe 2006-05-05
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe 2014-01-07
➤ Subscribe Delayed-release Tablets 360 mg ➤ Subscribe 2009-02-02
➤ Subscribe Tablets 60 mg and 120 mg ➤ Subscribe 2004-12-22
➤ Subscribe Tablets 40 mg, 80 mg,160 mg ➤ Subscribe 2004-12-28
➤ Subscribe Extended-release Tablets 100 mg ➤ Subscribe 2005-12-30
➤ Subscribe Tablets 0.25 mg, 0.5 mg, and 0.75 mg ➤ Subscribe 2013-09-30
➤ Subscribe Oral Solution 2 mg/mL ➤ Subscribe 2004-11-05
➤ Subscribe Tablets 10 mg ➤ Subscribe 2014-06-18
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2006-03-02
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 2014-09-22
➤ Subscribe Tablets 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg ➤ Subscribe 2005-12-02
➤ Subscribe Tablets 180 mg ➤ Subscribe 2015-10-23
➤ Subscribe Capsules 400 mg ➤ Subscribe 2014-01-24
➤ Subscribe Tablets 5 mg/160 mg ➤ Subscribe 2007-10-22
➤ Subscribe Capsules 150 mg and 200 mg ➤ Subscribe 2013-01-29
➤ Subscribe Tablets 10 mg/160 mg ➤ Subscribe 2007-10-01
➤ Subscribe Injection 4 mg/100 mg, 100 mL vial ➤ Subscribe 2012-01-31

Supplementary Protection Certificates for Novartis Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3342411 2020C/504 Belgium ⤷  Get Started Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
1429780 13C0012 France ⤷  Get Started Free PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1280520 C300722 Netherlands ⤷  Get Started Free PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
>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: NOVARTIS – Market Position, Strengths & Strategic Insights

Last updated: October 15, 2025

Introduction

Novartis AG stands as a global leader in the pharmaceutical industry, renowned for its innovation, extensive portfolio, and strategic market positioning. Operating across diverse therapeutic areas, including oncology, cardiovascular, immunology, and ophthalmology, Novartis has cemented itself as a formidable competitor amid evolving industry dynamics influenced by patent cliffs, regulatory shifts, and biotechnological advancements. This detailed analysis examines Novartis’s market positioning, core strengths, and strategic initiatives that sustain its competitive edge, providing essential insights for stakeholders navigating the complex pharmaceutical landscape.

Market Position of Novartis

Global Footprint and Market Share

Novartis operates in over 155 countries, with a substantial footprint across North America, Europe, Asia, and emerging markets. The company's revenue in 2022 was approximately USD 51.6 billion, placing it among the top-tier pharmaceuticals globally [1]. Its key therapeutic areas—oncology, ophthalmology, and generics—contribute significantly to its revenue streams, with targeted investments in innovative treatments positioning Novartis as a leader, especially in oncology.

In the global pharmaceutical ranking, Novartis consistently ranks within the top three companies by revenue, trailing only behind Pfizer and Roche in some metrics [2]. Its strategic focus on high-growth areas like immuno-oncology and gene therapies aligns with prevailing industry trends, enhancing its market share.

Competitive Dynamics

Novartis’s primary competitors include Roche, Pfizer, Johnson & Johnson, and Merck & Co. The company’s differentiation stems from a strong pipeline of innovative therapies, notably in cell and gene therapies (e.g., Kymriah and Leqvio). However, patent expirations of blockbuster drugs—such as the oncology treatment Gleevec—pose ongoing risks, demanding continuous R&D investment.

With the rising prominence of biosimilars and generics, especially in Europe and India, Novartis faces competitive pressure to defend its proprietary drugs while expanding its biosimilar portfolio. Strategic acquisitions, such as the purchase of the ophthalmology business from Alcon (previously part of Novartis) and recent investments in digital health, demonstrate adaptive strategies to maintain competitive relevance.

Strengths of Novartis

Robust Innovation Pipeline

Novartis invests approximately 20% of its revenue into R&D annually, translating to over USD 10 billion committed to discovering new medicines [1]. Its pipeline includes promising candidates in oncology (e.g., asciminib for CML), ophthalmology (e.g., Beovu for macular degeneration), and rare diseases. The company also fosters collaborations with biotech firms and academic institutions, securing early access to groundbreaking therapies.

Diverse Therapeutic Portfolio

The company’s diversified portfolio mitigates risks associated with dependence on single products. Oncology accounts for about 36% of revenue, while ophthalmology and generic medicines contribute significantly, providing a balanced revenue base that cushions against patent cliff impacts.

Strategic Acquisitions and Partnerships

Novartis’s strategic acquisitions enhance its pipeline and market presence. The acquisition of AveXis in 2018, specializing in gene therapies for spinal muscular atrophy, exemplifies this approach. Additionally, partnerships with digital health accelerators, such as DataBricks and Health2047, augment its capabilities in personalized medicine and real-world evidence generation.

Technological Advancements and Digital Transformation

Novartis leverages digital technologies, including artificial intelligence (AI) and machine learning, to optimize drug discovery, clinical trials, and patient engagement. Its digital initiatives improve R&D efficiency and foster patient-centric approaches, crucial in a competitive landscape.

Market Access and Regulatory Expertise

The company has demonstrated adeptness in navigating complex regulatory environments, securing approvals from agencies such as the FDA and EMA promptly. Its refined market access strategies further enhance uptake and reimbursement pathways, contributing to a sustained revenue flow.

Strategic Insights and Future Outlook

Emphasis on Gene and Cell Therapy Innovation

Novartis’s sizeable investment in gene and cell therapy R&D positions it at the forefront of personalized medicine. Its iterative development of therapies like Kymriah and newer candidates like CAR-T therapies targets high unmet medical needs, offering substantial growth prospects as these modalities gain regulatory approval worldwide.

Focus on Digital Health and Real-World Evidence

Expanding digital health initiatives allows Novartis to gather real-world evidence, improving clinical decision-making and boosting market confidence. Digital tools also enable remote patient monitoring and adherence, increasing treatment efficacy.

Expansion into Emerging Markets

Novartis aims to bolster its presence in Asia, Africa, and Latin America, regions exhibiting high growth potential due to increasing healthcare access and rising disease prevalence. Tailored pricing and local partnerships are vital to capturing these opportunities.

Risks and Challenges

Patent expirations, particularly in core oncology and hematology portfolios, threaten revenue stability. The rising influence of biosimilars necessitates aggressive intellectual property management. Moreover, pricing pressures from payers and governments worldwide require strategic adaptations to sustain profitability.

Sustainability and Corporate Responsibility

Novartis emphasizes sustainability, including initiatives to reduce environmental impact and improve global health outcomes, aligning corporate strategies with regulatory and societal expectations. These efforts foster goodwill and facilitate market access in key regions.

Conclusion

Novartis’s strategic positioning as an innovator with a diversified portfolio reinforces its competitive stature. Continued investment in gene therapies, digital health, and emerging markets, coupled with agile regulatory and partnership strategies, ensures resilience amidst sector challenges. Stakeholders should monitor Novartis’s pipeline developments and adaptation to biosimilar and patent landscape changes for informed decision-making.


Key Takeaways

  • Novartis ranks among the top global pharmaceutical companies, driven by innovation, diversified therapy areas, and strategic acquisitions.
  • Its R&D focus on personalized medicine and gene therapies offers high-growth opportunities in high unmet medical needs.
  • Market expansion in emerging economies and digital health initiatives constitute vital pillars of its future growth strategy.
  • Patent expirations and biosimilar competition necessitate proactive intellectual property management and portfolio diversification.
  • Sustained investment in technological capabilities and partnerships enhances Novartis's competitive edge and operational efficiency.

FAQs

Q1: How does Novartis differentiate itself in the highly competitive oncology market?
Novartis differentiates through innovative therapies like CAR-T cell treatments (Kymriah), targeted small molecules, and a robust pipeline focusing on precision oncology, supported by substantial R&D investments and strategic collaborations.

Q2: What are the main risks facing Novartis's future growth?
Key risks include patent expirations, biosimilar competition, pricing pressures, regulatory delays, and geopolitical impacts, especially in emerging markets.

Q3: How is Novartis investing in digital health?
Novartis leverages AI, data analytics, and remote monitoring tools to optimize clinical trials, enhance patient engagement, and improve real-world evidence collection, aligning with the trend toward personalized medicine.

Q4: What strategic acquisitions have significantly impacted Novartis’s portfolio?
Notable acquisitions include AveXis (gene therapies), Alcon’s eye care division, and digital health startups, all contributing to product diversification and technological capabilities.

Q5: What is the outlook for Novartis in emerging markets?
The company aims to penetrate high-growth regions through localized pricing, strategic partnerships, and tailored product offerings, expanding access to innovative medicines amid these growing healthcare markets.


Sources:

  1. Novartis Annual Report 2022.
  2. IQVIA Pharmaceutical Market Reports 2022.

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.